p0
2 days ago
(!!!) Valneva Receives Marketing Authorization in Europe for the World’s First Chikungunya Vaccine, IXCHIQ®
July 1, 2024
Saint Herblain (France), July 1, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Commission (EC) has granted marketing authorization in Europe for Valneva’s single-dose vaccine, IXCHIQ®, for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. The approval was unanimously endorsed by Member States following a stringent assessment by the European Medicines Agency (EMA)[1]. The EC decision marks the third approval the Company has received for IXCHIQ® following approval from the U.S. Food and Drug Administration (FDA) in November 2023 and Health Canada last month[2]. The Company expects to deliver the first doses in Europe in the fourth quarter of 2024.
IXCHIQ® is the world’s only licensed chikungunya vaccine available to address this unmet medical need. In accordance with the International Recognition Procedure (IRP)[3], Valneva has also submitted a Marketing Authorization Application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA). An additional marketing authorization application is under review by the Brazilian Health Regulatory Agency (ANVISA) to make the vaccine available in certain Low- and Middle-Income Countries (LMIC), with potential approval in 2024.
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “The EC approval marks a crucial milestone toward making this vaccine available to as many European citizens as possible. In recent years, climate change has caused the Aedes mosquito, a known carrier of chikungunya and dengue viruses, to spread to areas in Europe that were previously unaffected. It is critical to provide a vaccine solution not only to European travelers going to endemic chikungunya areas, such as South America or Africa, but also to the local European populations experiencing invasive mosquito attacks. We would like to thank our partner, CEPI, for supporting us in this endeavor.”
Dr. Richard Hatchett, Chief Executive Officer of the Coalition for Epidemic Preparedness Innovations (CEPI), commented, “Supported by CEPI and EU funding, IXCHIQ is the world’s first vaccine offering protection against the debilitating Chikungunya virus. The EU’s rapid approval of the vaccine, following recommendation by the European Medicines Agency, is a historic moment to help protect the lives and livelihoods of European populations against Chikungunya outbreaks, which are becoming more frequent and widespread in the region. But the fight is not over – as a matter of priority CEPI is working with Valneva and the EU to expand access to the vaccine to those living in endemic countries who are greatest risk from the disease.”
The EC marketing authorization follows the European Medicines Agency’s (EMA) positive opinion a month ago[4] and is supported by data from the pivotal Phase 3 study which were published in The Lancet, and showed a 98.9% seroresponse rate at 28 days with a single vaccination. This immune response was sustained for 24 months by 97% of participants and was equally durable in younger and older adults[5]. Last month, Valneva reported further positive pivotal data in adolescents six months after a single vaccination, which are intended to support filing for potential label extension for use in adolescents aged 12 to 17 years[6]. The data are also expected to support licensure of IXCHIQ® in Brazil, which would be the first potential approval for use in an endemic population.
Valneva partnered with CEPI [7] and Instituto Butantan in Brazil[8] to make the vaccine more accessible to LMIC. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[9], which provides funding of up to $24.6 million with support from the European Union’s Horizon 2020 program.
About Chikungunya
Chikungunya virus (CHIKV) is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes which causes fever, severe joint pain, muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years.[10]
In 2004, the disease began to spread quickly, causing large-scale outbreaks around the world. Since the re-emergence of the virus, CHIKV has now been identified in over 110 countries in Asia, Africa, Europe and the Americas.[11] Between 2013 and 2023, more than 3.7 million cases were reported in the Americas[12] and the economic impact is considered to be significant. The medical and economic burden is expected to grow with climate change as the mosquito vectors that transmit the disease continue to spread geographically. As such, the World Health Organization (WHO) has highlighted chikungunya as a major public health problem.[13]
About Valneva SE
We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.
We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world’s first and only chikungunya vaccine, as well as certain third-party vaccines.
Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at www.valneva.com.
https://valneva.com/press-release/valneva-receives-marketing-authorization-in-europe-for-the-worlds-first-chikungunya-vaccine-ixchiq/
p0
1 week ago
(!!!) Health Canada Approval of the World’s First Chikungunya Vaccine, IXCHIQ
June 24, 2024
Saint-Herblain (France), June 24, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that Health Canada has approved IXCHIQ®, Valneva’s single-dose vaccine for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. This decision marks the second approval the Company has received for IXCHIQ® following approval from the U.S. Food and Drug Administration (FDA) in November 2023. The European Medicines Agency (EMA) also recently recommended marketing authorization of the vaccine in Europe, and a formal decision is expected in the third quarter of 2024.
IXCHIQ® is the world’s only licensed chikungunya vaccine available to address this unmet medical need. Every year, over 50 million North Americans, of which approximately 7 million Canadians[1], travel to countries where chikungunya is endemic. Valneva began commercializing the vaccine in the U.S. this year and plans to sell first doses in Canada in the fourth quarter of 2024.
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “This second approval marks another significant milestone toward introducing a preventative solution against chikungunya worldwide. In recent years, climate change has caused the Aedes mosquito, a known carrier of chikungunya and dengue viruses, to spread to areas that were previously unaffected. The broader we can make this vaccine accessible, the better we will mitigate the burden of this debilitating illness, and we would like to thank our partner, CEPI, for supporting us in this endeavor.”
In addition to U.S., Canada and Europe, Valneva partnered with the Coalition for Epidemic Preparedness Innovations (CEPI) [2] and Instituto Butantan in Brazil[3] to make the vaccine more accessible to Low- and Middle-Income Countries (LMIC). The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[4], which provides funding of up to $24.6 million with support from the European Union’s Horizon 2020 program. A marketing authorization application is currently under review by the Brazilian Health Regulatory Agency (ANVISA) with potential approval in 2024.
Dr. Richard Hatchett, Chief Executive Officer of CEPI, commented: “Health Canada’s approval of IXCHIQ® represents another significant advance in the fight against the debilitating chikungunya virus. Accelerated by climate change, the size and frequency of chikungunya outbreaks are increasing, with hundreds of thousands of cases already reported so far this year in the Americas, South Asia, and Africa. This is why CEPI, with its partners Valneva and the European Commission, are working to expand access to the vaccine for everyone, including the world’s most vulnerable populations.”
Health Canada’s approval was based on data from the pivotal Phase 3 study which were published in The Lancet, one of the world’s leading peer-reviewed medical journal, and showed a 98.9% seroresponse rate at 28 days with a single vaccination. This immune response was sustained for six months by 96.3% of participants and was equally durable in younger and older adults[5].
About Chikungunya
Chikungunya virus (CHIKV) is a mosquito-borne viral disease spread by the bites of infected female Aedes mosquitoes which causes fever, severe joint pain, muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years.[6]
In 2004, the disease began to spread quickly, causing large-scale outbreaks around the world. Since the re-emergence of the virus, CHIKV has now been identified in over 110 countries in Asia, Africa, Europe and the Americas.[7] Between 2013 and 2023, more than 3.7 million cases were reported in the Americas[8] and the economic impact is considered to be significant. The medical and economic burden is expected to grow with climate change as the mosquito vectors that transmit the disease continue to spread geographically. As such, the World Health Organization (WHO) has highlighted chikungunya as a major public health problem.[9]
About IXCHIQ®
In Canada, IXCHIQTM (chikungunya vaccine, live, attenuated) Powder for Solution for Intramuscular Injection is intended for active immunization in individuals 18 years and older for the prevention of disease caused by the chikungunya virus (CHIKV), as a single-dose immunization.
p0
4 weeks ago
Valneva Announces Availability of Documentation for its Shareholder Meeting and Provides Corporate Update
https://valneva.com/press-release/valneva-announces-availability-of-documentation-for-its-shareholder-meeting-and-provides-corporate-update/
Saint-Herblain (France), June 5, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company (“the Company”), today announced the availability of documentation for its Combined General Meeting (“the Meeting”) to be held on June 26, 2024 at 2:00 p.m. CEST at the Sofitel Lyon Bellecour Hotel, 20 quai du Docteur Gailleton, 69002 Lyon (France).
The Preliminary Notice of Meeting – including the agenda, the draft resolutions proposed by the Board of Directors, and instructions for participation and voting – was published in the Bulletin des Annonces Légales Obligatoires (BALO) on May 22, 2024.
The information and preparatory documents related to this Meeting are available on Valneva’s website at https://valneva.com/2024-combined-general-meeting/.
Any shareholder wishing to receive, by mail or e-mail, Meeting documents referred to in Article R. 22-10-23 of the French Commercial Code, may make a request until the fifth day inclusive before the Meeting date, by contacting the Company at assemblee.generale@valneva.com. Holders of bearer shares may exercise this right on the condition that they provide a shareholding certificate certifying the registration of the shares in a bearer securities account managed by an authorized financial intermediary.
Shareholders may also access the Meeting documentation at the Company’s registered office.
The Company also announced that after ten years at Valneva, Mr. Frédéric Jacotot, General Counsel & Corporate Secretary, will leave the Company at the end of July, as agreed with Valneva’s Board of Directors.
The Company has appointed Kendra Wergin, currently VP Legal and Associate General Counsel at Valneva, as its next General Counsel & Corporate Secretary and member of the Company’s Executive Committee, effective August 1, 2024. Ms. Wergin is a U.S.-qualified lawyer with expertise in corporate and international law. Prior to joining Valneva in 2020, Ms. Wergin practiced in the corporate group of a major international law firm and the in-house legal team of a Fortune 500 company. During the past four years, she played a key role in executing on the Company’s strategy, including its Nasdaq listing and subsequent global offerings. She earned law degrees in the U.S. and France following prior professional experience in the public interest sector.
Thomas Lingelbach, Chief Executive Officer of Valneva, said, “I would like to personally thank Frédéric for his great contributions to the Company over the past 10 years and welcome Kendra into this role. We are delighted to be able to elevate one of our own to this well-deserved position.”
p0
4 weeks ago
Publication of Lyme Disease Phase 2 Trials in the Lancet Infectious Diseases.
https://valneva.com/press-release/valneva-announces-publication-of-lyme-disease-phase-2-trials-in-the-lancet-infectious-diseases/
Saint-Herblain (France), June 3, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the results of two Phase 2 clinical trials of Lyme disease vaccine candidate, VLA15, were published in the peer-reviewed medical journal, The Lancet Infectious Diseases. These trials, as well as a third Phase 2 trial in pediatric participants, supported the design of the current pivotal Phase 3 trial, ‘Vaccine Against Lyme for Outdoor Recreationists’ (VALOR).
Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “We are pleased that these results are now fully available to the broader infectious disease community. Lyme disease is the most prevalent vector-borne infectious disease in North America and Europe, and we are excited about the ongoing trials and progress towards potentially offering a vaccine against this unmet medical need.”
The article, titled “Optimization of Dose Level and Vaccination Schedule for the VLA15 Lyme Borreliosis Vaccine Candidate Among Healthy Adults: Two Randomized, Phase 2 Studies” provides a detailed analysis of the VLA15-201 and VLA15-202 trial results, which investigated different dose levels and vaccination schedules of VLA15, a hexavalent Lyme disease vaccine candidate targeting most prevalent Borrelia species (serotype 1-6) in North America and Europe.
VLA15 was shown to be immunogenic across all dose groups and vaccination schedules tested. Strongest antibody responses across all six serotypes were exhibited at the highest dose (180 µg) and broader vaccination intervals (Month 0,2,6). VLA15 has shown a favorable safety and tolerability profile across all trials to date. No safety concerns were observed by an independent Data Safety Monitoring Board (DSMB)[1],[2], in any treatment group.
Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop VLA15, with updates to the terms within this agreement made in June 2022[3]. The companies previously reported positive results for the booster phase of trial VLA15-202[4] and a third Phase 2 trial, VLA15-221[5], providing further evidence on VLA15’s safety profile and its potential to provide immunity against Lyme disease in adult, pediatric and adolescent populations. The companies also aim to publish these results in a peer-reviewed medical journal.
The Phase 3 clinical trial, VALOR, is currently ongoing to investigate the efficacy, safety and immunogenicity of VLA15 in participants five years of age and older in highly endemic regions in the United States, Canada and Europe. Enrollment of 9,437 participants for the trial was completed in December 2023.
Subject to positive data, Pfizer aims to submit a Biologic License Application to the Food and Drug Administration and Marketing Authorization Application to the European Medicines Agency in 2026.
About VLA15
There are currently no approved human vaccines for Lyme disease, and VLA15 has advanced the furthest of any Lyme vaccine candidates currently in clinical development, with two Phase 3 trials in progress. This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease. OspA is a surface protein expressed by the bacteria when present in a tick. Blocking OspA inhibits the bacterium’s ability to leave the tick and infect humans. The vaccine candidate covers the six most prevalent OspA serotypes expressed by the Borrelia burgdorferi sensu lato species in North America and Europe.
About Lyme Disease
Lyme disease is a systemic infection caused by Borrelia burgdorferi bacteria transmitted to humans by the bite of infected Ixodes ticks[6]. It is the most common vector-borne illness in the Northern Hemisphere[7],[8]. While the true incidence of Lyme disease is unknown, the Centers for Disease Control and Prevention (CDC) has estimated that approximately 476,000 people in the U.S. are diagnosed and treated each year and 129,000 cases are reported annually in Europe[9],[10]. Early symptoms of Lyme disease (such as a gradually expanding erythematous rash called Erythema migrans or other nonspecific symptoms like fatigue, fever, headache, mild stiff neck, muscle and joint pains) are often overlooked or misinterpreted. Left untreated, the disease can disseminate and cause more serious chronic complications affecting the skin, joints (arthritis), the heart (carditis) or the nervous system9,10. The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens[11].
p0
1 month ago
Valneva Receives EMA’s Positive CHMP Opinion for its Chikungunya Vaccine
https://valneva.com/press-release/valneva-receives-emas-positive-chmp-opinion-for-its-chikungunya-vaccine/
May 31, 2024
If approved, IXCHIQ® will become the first vaccine available in the EU against the chikungunya virus (CHIKV)
Decision on EU marketing authorization expected in the third quarter of 2024
Saint Herblain (France), May 31, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending authorization of Valneva’s single-dose vaccine for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older.
The European Commission (EC) will review the CHMP recommendation, and a decision on the marketing authorization application of IXCHIQ® in the European Union (EU), Norway, Liechtenstein and Iceland is expected in the third quarter of 2024. If approved, it will become the first chikungunya vaccine available in Europe to address this unmet medical need. In accordance with the International Reliance Procedure (IRP), Valneva is also preparing a Marketing Authorization Application (MAA) for submission to the UK Medicines and Healthcare products Regulatory Agency (MHRA).
The CHMP opinion follows the November 2023 approval of IXCHIQ® by the US Food and Drug Administration (FDA)[1]. Two additional marketing authorization applications are currently under review by Health Canada and the Brazilian Health Regulatory Agency (ANVISA) with potential approvals in 2024.
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “This positive CHMP opinion marks a crucial milestone toward introducing a preventative solution against chikungunya in the EU. In recent years, climate change has caused the Aedes mosquito, a known carrier of chikungunya and dengue viruses, to spread to areas in Europe that were previously unaffected. It is critical to provide a vaccine solution not only to European travelers going to endemic chikungunya areas, such as South America or Africa, but also to the local European populations experiencing invasive mosquito attacks. The broader we can make this vaccine accessible, the better we will mitigate the burden of this debilitating illness, and we would like to thank our partner, CEPI, for supporting us in this endeavor.”
Dr. Richard Hatchett, Chief Executive Officer of the Coalition for Epidemic Preparedness Innovations (CEPI), commented, “Over one billion people live in areas where Chikungunya is endemic, and recent large outbreaks underline the urgent need for safe and effective vaccines against this debilitating disease. Valneva’s single-dose vaccine is well-suited for use in outbreak response and in low-resource settings, and CEPI’s partnership with Valneva and Instituto Butantan – supported by the EU – will help to make this vaccine accessible to the people most affected by the virus in low- and middle-income countries. Today’s positive opinion from the EMA is an important step towards making the vaccine more widely available.”
The positive CHMP opinion is supported by data from the pivotal Phase 3 study which were published in The Lancet, the world’s leading peer-reviewed medical journal, and showed a 98.9% seroresponse rate at 28 days with a single vaccination. This robust immune response was sustained for 24 months by 97% of participants and was equally durable in younger and older adults[2]. Earlier this month, Valneva reported further positive pivotal data in adolescents six months after a single vaccination, which are intended to support filing for potential label extension for use in adolescents aged 12 to 17 years[3]. The data are also expected to support licensure of IXCHIQ® in Brazil, which would be the first potential approval for use in an endemic population.
About Chikungunya
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in up to 97% of humans after four to seven days following the mosquito bite[4]. While mortality with CHIKV is low, morbidity is high, and the global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032[5]. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. The Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. The high-risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia, and the virus has spread to more than 110 countries[6]. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas[7] and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. Before IXCHIQ®, there were no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.
To make the vaccine more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of IXCHIQ®[8]. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[9], which provides funding of up to $24.6 million with support from the European Union’s Horizon 2020 program. Regulatory review by the Brazilian authority ANVISA is ongoing.
About IXCHIQ®
In the U.S., IXCHIQ® is a live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. As for all products approved under FDA’s accelerated approval pathway, continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory studies.
p0
1 month ago
2024-05-21 Dr. Hanneke Schuitemaker, Ph.D. as Chief Scientific Officer (Johnson & Johnson) comes in ...
https://valneva.com/press-release/valneva-appoints-dr-hanneke-schuitemaker-ph-d-as-chief-scientific-officer/
May 21, 2024
Saint-Herblain (France), May 21, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the appointment of Dr. Hanneke Schuitemaker, Ph.D. as Chief Scientific Officer (CSO) and Executive Committee member, effective June 3, 2024.
Valneva decided to complement its Executive Team with an accomplished R&D leader to oversee the further evolution of the Company´s R&D portfolio. Specifically, Dr. Schuitemaker will focus on accelerating Valneva’s pre-clinical and translational R&D activities in support of the Company’s strategic ambition to provide first-, best- or only-in-class vaccine solutions.
Dr. Schuitemaker brings more than two decades of experience in vaccine discovery and development. She formerly served as Global Head of Viral Vaccine Discovery and Translational Medicine at Johnson & Johnson (J&J), with responsibility for the strategy and execution of vaccine programs on COVID-19, HIV, RSV, Ebola, and multiple other viral disease targets for almost 14 years. Prior to J&J, she worked at Sanquin, The Netherlands’ Blood Supply Foundation, and at Amsterdam University Medical Center, where she conducted research on the pathogenesis of HIV. She has a unique and solid scientific background, which is notably reflected in more than 350 scientific publications.
Thomas Lingelbach, Chief Executive Officer of Valneva, said, “Hanneke’s addition to our team represents an important step in further strengthening Valneva’s strategic leadership, especially as we continue to build our R&D portfolio beyond our advanced clinical programs against Lyme disease and the chikungunya virus. Innovation is a foundation of Valneva’s culture and strategy, and we are confident that her expertise and vision will be key in this regard.”
Dr. Schuitemaker, newly appointed Chief Scientific Officer of Valneva, added, “I am extremely excited to join the fantastic team at Valneva to help strengthen the pipeline and contribute to the design and development of novel vaccines against infectious diseases. Valneva has already accomplished a great deal, having brought three vaccines from early R&D to approval[1], including the world’s first licensed chikungunya vaccine[2], and I can’t wait to join the organization.”
p0
2 months ago
Valneva Reports Further Positive Pivotal Phase 3 Data in Adolescents for its Single-Shot Chikungunya Vaccine
https://valneva.com/press-release/valneva-reports-further-positive-pivotal-phase-3-data-in-adolescents-for-its-single-shot-chikungunya-vaccine/
Saint-Herblain (France), May 13, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported further positive pivotal Phase 3 data in adolescents for its single-shot chikungunya virus (CHIKV) vaccine. Following the initial analysis up to Day 29 post-vaccination, the most recent analysis of study VLA1553-321 evaluated the safety and immunogenicity six months (Day 180) after vaccination with a single dose of the vaccine. The Day 180 results confirm the initial positive immunogenicity and safety data Valneva reported previously[1],[2], and are intended to support filing for potential label extension for use in adolescents aged 12 to 17 years. The data are also expected to support licensure of IXCHIQ® in Brazil, which would be the first potential approval for use in endemic populations.
The latest VLA1553-321 data confirmed that a single-dose vaccination with VLA1553 induced a high, sustained immune response with a seroresponse rate of 99.1% (232 out of 234 participants) at Day 180 compared to 98.8% (248 out of 251 participants) at Day 29 in an immunogenicity subset of individuals who were CHIKV negative at baseline.
Geometric mean antibody titers (GMTs) consistently surpassed the seroresponse threshold defined with the U.S. Food and Drug Administration (FDA)[3] as the surrogate of protection in baseline seronegative participants who received a single dose of VLA1553.
Additionally, the Day 180 data confirmed that a single dose of the vaccine was generally safe and well tolerated in adolescents receiving VLA1553, irrespective of previous infection with the chikungunya virus. Throughout the trial, an Independent Data Safety Monitoring Board (IDSMB) consistently assessed safety data and found no safety issues. The majority of solicited adverse events observed following VLA1553 administration were mild or moderate and resolved within three days post vaccination.
Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “We are highly encouraged by these data, as they reinforce the strong immunity and safety observed in adults and the elderly, upon which FDA approval was granted. Given the substantial risk that chikungunya presents to individuals residing in or traveling to endemic regions, it’s imperative to ensure the vaccine is available to all age groups. This broader accessibility can help provide protection and mitigate the burden of this debilitating illness.”
Conducted in collaboration with Instituto Butantan in Brazil and funded by the Coalition for Epidemic Preparedness Innovations (CEPI) with support from the European Union’s Horizon 2020 program, the VLA1553-321 trial represents the first clinical trial conducted in an endemic area and with individuals previously infected with CHIKV.
Valneva’s vaccine IXCHIQ® is the world’s first and only licensed chikungunya vaccine available to address this significant unmet medical need. It was approved by the U.S. FDA in November 2023[4], and the Centers for Disease Control and Prevention (CDC) recently adopted the Advisory Committee on Immunization Practices’ (ACIP) recommendations on use of the vaccine in the U.S.[5]. Three marketing applications are currently under review by the European Medicines Agency, Health Canada and the Brazilian Health Regulatory Agency (ANVISA) with potential approvals in 2024. IXCHIQ®’s final pivotal Phase 3 data were published in The Lancet, the world’s leading peer-reviewed medical journal, in June 2023[6].
About Phase 3 Study VLA1553-321
VLA1553-321 is a prospective, double-blinded, multicenter, randomized, placebo-controlled pivotal Phase 3 trial conducted in 754 adolescents aged 12 to 17 years old in Brazil. The VLA1553-321 clinical trial was initiated in January 2022 and Valneva reported initial immunogenicity and safety data in November[7] and August 2023[8], respectively. VLA1553 or placebo was administered as a single intramuscular immunization to participants who were randomized into two study groups at a 2:1 ratio. The primary objective is to evaluate the immunogenicity and safety of the adult dose of VLA1553 in adolescents 28 days following a single vaccination. Secondary objectives of the trial include assessment of safety and immunogenicity up to twelve months following a single vaccination with VLA1553. Additional information, including a detailed description of the study design, eligibility criteria and investigator sites, is available at ClinicalTrials.gov (Identifier: NCT04650399).
About Chikungunya
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in up to 97% of humans after four to seven days following the mosquito bite[9]. While mortality with CHIKV is low, morbidity is high, and the global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032[10]. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. The Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. The high-risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia, and the virus has spread to more than 110 countries[11]. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas[12] and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. Before IXCHIQ®, there were no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.
To make the vaccine more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553[13]. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[14], which provides funding of up to $24.6 million with support from the European Union’s Horizon 2020 program. Regulatory review by the Brazilian authority ANVISA is ongoing.
About IXCHIQ®
In the U.S., IXCHIQ® is a live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. As for all products approved under FDA’s accelerated approval pathway, continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory studies.
Please click here for full Prescribing Information for IXCHIQ®.
p0
3 months ago
VLA1601/Zika virus/Phase 1 trial
https://valneva.com/press-release/valneva-initiates-phase-1-trial-of-second-generation-zika-vaccine-candidate/
March 26, 2024
Saint-Herblain (France), March 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the initiation of a Phase 1 clinical trial to investigate the the safety and immunogenicity of VLA1601, its second-generation adjuvanted inactivated vaccine candidate against the Zika virus (ZIKV). There are currently no preventive vaccines or effective treatments available against ZIKV. As such, this mosquito-borne disease remains a public health threat and is included in the Food and Drug Administration’s Tropical Disease Priority Review Voucher Program[1].
The randomized, placebo-controlled, Phase 1 trial, VLA1601-102, is planned to enroll approximately 150 participants aged 18 to 49 years in the United States. Participants will receive a low, medium or high dose of VLA1601. In addition, the low dose of VLA1601 will be evaluated with an additional adjuvant, either the CpG 1018® adjuvant from Dynavax Technologies Corporation or 3M-052-AF adjuvant from the Access to Advanced Health Institute (AAHI). Topline data from the trial are expected in the first half of 2025.
VLA1601 is being developed on the original manufacturing platform of Valneva’s licensed Japanese encephalitis (JE) vaccine IXIARO®, which was further optimized to develop the Company’s inactivated, adjuvanted COVID-19 vaccine VLA2001, the first COVID-19 vaccine to receive a standard marketing authorization in Europe. Phase 1 results from Valneva’s first-generation Zika vaccine candidate were reported in 2018 showing a favorable safety profile and immunogenicity in all tested doses and schedules[2].
Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “Valneva’s commitment to our vision – to live in a world in which no one dies or suffers from a vaccine-preventable disease – fuels our pursuit for preparedness solutions against the Zika virus. As global temperatures rise and rainfall increases, the habitat for disease-carrying mosquitoes expands, presenting an ongoing public health challenge.”
A vaccine against ZIKV would nicely complement Valneva’s portfolio of travel vaccines against mosquito-borne diseases. The Company received U.S. approval for its chikungunya vaccine IXCHIQ®, the world first and only chikungunya vaccine to address this unmet medical need, in November 2023, and has been commercializing its JE vaccine IXIARO®, for over ten years. Some health authorities and scientific leaders in the field have indicated a preference for a purified inactivated vaccine method compared to other vaccine technologies. This preference stems from the understanding that the primary recipients of a Zika vaccine are anticipated to be women of childbearing age, potentially including those who are pregnant.
About the Zika Virus
The Zika virus (ZIKV) is a mosquito-borne flavivirus that was first discovered in 1947. The first human cases were detected in 1952. Since then, disease outbreaks have been reported in tropical Africa, Southeast Asia, the Pacific Islands, and, in 2015, in the Americas. Zika virus is currently circulating in Mexico, Central and South America, many countries and territories in the Caribbean region, and in a small number of geographically limited areas of the continental United States. To date, a total of 89 countries and territories have reported evidence of mosquito transmitted Zika virus infection; however, surveillance remains limited globally.
According to the World Health Organization, there is scientific consensus that ZIKV is a cause of microcephaly and Guillain-Barré syndrome. Since 2013, 31 countries and territories have reported cases of microcephaly and other central nervous system malformations associated with ZIKV infection.
About VLA1601
VLA1601 is a highly purified inactivated vaccine candidate against the Zika virus (ZIKV), developed on the original manufacturing platform of Valneva’s licensed Japanese encephalitis vaccine IXIARO®, which was further optimized to develop the Company’s inactivated, adjuvanted COVID-19 vaccine VLA2001, the first COVID-19 vaccine to receive a standard marketing authorization in Europe. Valneva reported positive Phase 1 results for VLA1601 in 2018[3]. The vaccine candidate was immunogenic and showed a favorable safety profile in all tested doses and schedules that was comparable to IXIARO® and other clinical stage ZIKV vaccines.
About IXIARO®/JESPECT®
Valneva’s Japanese encephalitis vaccine is indicated for active immunization for the prevention of the disease for people who travel to, or live in, endemic areas. It received marketing approval in the U.S., Europe, Canada, Hong Kong, Singapore, and Israel under the trade name IXIARO® and in Australia and New Zealand where it is marketed as JESPECT®. It is the only vaccine available to the U.S. military for Japanese Encephalitis. IXIARO® is approved for use in individuals two months of age and older in the U.S. and EU member states, Canada, Norway, Liechtenstein, Iceland, Singapore, Hong Kong, Japan, the Republic of Korea and Israel. In all other licensed territories, IXIARO®/JESPECT® is indicated for use in persons aged 18 years or more.
About IXCHIQ®
In the U.S., IXCHIQ® is a live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. As for all products approved under FDA’s accelerated approval pathway, continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory studies.
p0
4 months ago
IXCHIQ: U.S. CDC Advisory Committee (ACIP) Recommends Use of Valneva’s Single-Dose Chikungunya Vaccine IXCHIQ®
https://valneva.com/press-release/u-s-cdc-advisory-committee-acip-recommends-use-of-valnevas-single-dose-chikungunya-vaccine-ixchiq/
February 29, 2024
Recommendation for use in travelers and laboratory workers follows U.S. Food and Drug Administration (FDA) approval in November 2023[1]
IXCHIQ® is the first and only vaccine approved to address this unmet medical need in adults aged 18 years and older who are at increased risk of exposure to the chikungunya virus
Saint-Herblain (France), February 29, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announces today that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend use of Valneva’s single-dose chikungunya vaccine IXCHIQ® for the prevention of disease caused by the chikungunya virus (CHIKV).
ACIP recommends IXCHIQ® for persons aged ≥18 years traveling to a country or territory where there is a chikungunya outbreak. Additionally, it may be considered for persons traveling to a country or territory without an outbreak but with evidence of CHIKV transmission within the last five years, who are aged >65 years and likely to have at least moderate exposure to mosquitos (at least two weeks, cumulatively) or who are traveling for a longer duration (six months or more, cumulatively). ACIP also recommended chikungunya vaccination for laboratory workers with potential for exposure to CHIKV.
Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, “Chikungunya poses a significant risk to individuals journeying to or residing in regions where the chikungunya virus and its mosquito vectors thrive. IXCHIQ offers advantages to travelers on vacation and visiting family and to people engaged in business ventures, missions, or laboratory duties. We embrace the ACIP endorsement, marking IXCHIQ® as the only approved and recommended vaccine for the target population. We will continue collaborating with regulatory authorities worldwide to increase the accessibility of IXCHIQ® across regions.”
The ACIP recommendations will be forwarded to the director of the CDC and the U.S. Department of Health and Human Services for review and approval. Once approved, the final recommendations will be published in a future Morbidity and Mortality Weekly Report (MMWR) to advise healthcare providers on appropriate use of the vaccine.
About Chikungunya
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in up to 97% of humans after four to seven days following the mosquito bite[2]. While mortality with CHIKV is low, morbidity is high, and the global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032[3]. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. The high-risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia, and the virus has spread to more than 110 countries[4]. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas[5] and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. Before IXCHIQ®, there were no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.
To make the vaccine more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553[6]. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[7], which provides funding of up to $23.4 million with support from the European Union’s Horizon 2020 program. Regulatory review by the Brazilian authority ANVISA is ongoing.
About IXCHIQ®
In the U.S., IXCHIQ® is a live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. As for all products approved under FDA’s accelerated approval pathway, continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory studies.
Please click here for full Prescribing Information for IXCHIQ®.
About Valneva SE
We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.
We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines as well as certain third-party vaccines leveraging our established commercial infrastructure.
Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, as well as vaccine candidates against the Zika virus and other global public health threats.
Valneva Investor and Media Contacts
Laetitia Bachelot-Fontaine
VP Global Communications & European Investor Relations
M +33 (0)6 4516 7099
laetitia.bachelot-fontaine@valneva.com
Joshua Drumm, Ph.D.
VP Global Investor Relations
M +001 917 815 4520
joshua.drumm@valneva.com
Forward-Looking Statements
This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the approval and use of products and product candidates. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in these materials as of this press release and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
[1] Valneva Announces U.S. FDA Approval of World’s First Chikungunya Vaccine, IXCHIQ® – Valneva
[2] Staples, J.E. Hills, S.L. Powers, A.M. “Chikungunya.” In CDC Yellow Book 2020: Health Information for International Travel, by Centers for Disease Control and Prevention. New York: Oxford University Press, 2020
[3] VacZine Analytics Chikungunya virus vaccines Global demand analysis. February 2020
[4] https://www.who.int/news-room/fact-sheets/detail/chikungunya
[5] PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas (Cumulative Cases 2018-2023 and Cases per year 2013-2017). https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html. Last accessed 01 Aug 2023.
[6] Valneva and Instituto Butantan Sign Final Agreement on Single-Shot Chikungunya Vaccine for Low and Middle Income Countries
[7] CEPI awards up to $23.4 million to Valneva for late-stage development of a single-dose Chikungunya vaccine
p0
6 months ago
Valneva Vaccinates First Participant in Pediatric Trial of Single-Shot Chikungunya Vaccine
January 10, 2024
Saint-Herblain (France), January 10, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that the first participant has been vaccinated in the Phase 2 clinical trial evaluating the safety and Immunogenicity in children of two different dose levels of Valneva’s single-shot chikungunya vaccine. The Company reported positive pivotal Phase 3 data in adolescents two months ago confirming the immunogenicity and safety profile observed in adults[1].
There is currently no approved chikungunya vaccine for children and Valneva’s vaccine IXCHIQ® is currently the only licensed chikungunya vaccine[2] to address this unmet medical need in adults aged 18 years and older who are at increased risk of exposure to the virus. Once available, the Phase 2 pediatric data are intended to support a Phase 3 pivotal study in children with the objective to extend the label in this age group following initial regulatory approvals in adults and possibly in adolescents.
The multicenter, prospective, randomized, observer-blinded, Phase 2 clinical trial is planned to enroll approximately 300 healthy children one to eleven years of age at three trial sites in the Dominican Republic and Honduras. Following a safety run-in phase, participants will be randomized to receive either a full dose formulation of the vaccine (120 participants), a half dose formulation (120 participants) or a control vaccine (60 participants).
Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “This pediatric trial is extremely important. Given the significant threat that chikungunya poses to individuals living in or traveling to endemic areas, it is crucial to make the vaccine accessible to all age groups. By doing so, we can broaden the protection against and reduce the impact of this debilitating disease.”
Valneva was granted approval from the U.S. Food and Drug Administration (FDA) for its chikungunya vaccine IXCHIQ® in November 2023[3]. Three marketing applications are currently under review by the European Medicines Agency, Health Canada and the Brazilian Health Regulatory Agency (Anvisa) with potential approvals in 2024.
About Chikungunya
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in up to 97% of humans after four to seven days following the mosquito bite[4]. While mortality with CHIKV is low, morbidity is high, and the global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032[5]. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. The high-risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia, and the virus has spread to more than 110 countries[6]. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas[7] and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. Before IXCHIQ®, there were no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.
To make the vaccine more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553[8]. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[9], which provides funding of up to $23.4 million with support from the European Union’s Horizon 2020 program.
About IXCHIQ®
In the U.S., IXCHIQ® is a live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. As for all products approved under FDA’s accelerated approval pathway, continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory studies.
Please click here for full Prescribing Information for IXCHIQ.
About Phase 2 Trial VLA1553-221
VLA1553-221 is a multi-center, randomized, observer-blinded, dose response Phase 2 clinical trial in approximately 300 healthy children aged one to eleven years. The trial will be performed at three trial sites in the Dominican Republic and potentially Honduras. The primary and secondary objectives of the trial are to evaluate the safety and immunogenicity of two different dose levels of Valneva’s single-shot chikungunya vaccine. Additional information, including a detailed description of the trial design, eligibility criteria and investigator sites, is available at ClinicalTrials.gov (Identifier: NCT06106581).
About Valneva SE
We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.
We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market two proprietary travel vaccines as well as certain third-party vaccines leveraging our established commercial infrastructure.
Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the world’s first vaccine against the chikungunya virus and the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, as well as vaccine candidates against the Zika virus and other global public health threats.
Valneva Investor and Media Contacts
Laetitia Bachelot-Fontaine
VP Global Communications & European Investor Relations
M +33 (0)6 4516 7099
laetitia.bachelot-fontaine@valneva.com
Joshua Drumm, Ph.D.
VP Global Investor Relations
M +001 917 815 4520
joshua.drumm@valneva.com
p0
7 months ago
VLA15: Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial for Lyme Disease Vaccine Candidate
December 4, 2023
9,437* participants enrolled at sites across the U.S., Europe and Canada in areas where Lyme disease is endemic
Trial conclusion expected by year-end 2025
Pfizer aims to submit regulatory filings in the U.S. and Europe in 2026
New York, NY, and Saint-Herblain (France), December 4, 2023 – Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that they have completed recruitment for the Phase 3 trial Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) for Lyme disease vaccine candidate VLA15. The trial builds on previous positive Phase 1 and 2 trial results and includes both adult and pediatric participants, with the aim to confirm the efficacy, safety, lot consistency, and immunogenicity of VLA15.
“We are pleased that the Phase 3 trial recruitment is complete. Lyme disease is the most prevalent vector-borne infectious disease in the United States and Europe, can sometimes even lead to long lasting consequences,” said Annaliesa Anderson, Ph.D., Senior Vice President and Head Vaccine Research and Development, Pfizer. “If approved, a vaccine could prevent the disease and ease the burden of acute, severe and sometimes persistent consequences in both adults and children. We look forward to progressing the trial with the goal of submitting a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2026, subject to positive data.”
Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said: “The completion of enrollment is indeed an important milestone in the development of a potential vaccine for Lyme disease. VLA15 has the potential to address a high need in North America and Europe, as it has been designed to offer coverage for the most common circulating types of Borrelia bacteria that cause Lyme disease in these regions. We’re excited about the ongoing trials and the progress towards potentially offering a vaccine against this disease which can result in debilitating sequelae and excessive healthcare usage.”
The VALOR trial, which was initiated in August 2022, has enrolled 9,437* participants five years of age and older, at sites in areas where Lyme disease is highly endemic across the U.S., Europe and Canada. As part of the primary series, participants receive three doses of VLA15 or a saline placebo (1:1 ratio) within the first year, and one booster dose approximately one year after completion of the primary immunization.
The VLA15 candidate has demonstrated a strong immune response and had a favorable safety profile across all dose and age groups in pre-clinical and clinical trials so far.1,2 No vaccine-related serious adverse events (SAEs) and no safety concerns were observed by an independent Data Safety Monitoring Board (DSMB).1,2 A second Phase 3 trial (C4601012), aiming to provide further evidence on the safety profile of VLA15 in the pediatric population, is also fully recruited.
The VALOR trial is expected to be concluded by the end of 2025. Pfizer and Valneva entered into a collaboration agreement in April 2020 to co-develop VLA15, with updates to the terms within this agreement made in June 2022.3,4
About VLA15
There are currently no approved human vaccines for Lyme disease, and VLA15 is the most advanced Lyme disease vaccine candidate currently in clinical development, with two Phase 3 trials in progress. This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease. OspA is a surface protein expressed by the bacteria when present in a tick. Blocking OspA inhibits the bacterium’s ability to leave the tick and infect humans. The vaccine candidate covers the six most common OspA serotypes expressed by the Borrelia burgdorferi sensu lato species that are prevalent in North America and Europe. VLA15 is an alum-adjuvanted formulation, administered intramuscularly and has demonstrated a strong immune response as well as satisfactory safety profile in pre-clinical and clinical trials so far.
About the VALOR trial
VALOR is an ongoing randomized, observer-blind, placebo-controlled Phase 3 trial which has enrolled 9,437* participants 5 years of age and older to receive VLA15 or a saline placebo (1:1 ratio). As part of the primary series, participants receive three doses of VLA15 within the first year at months 0, 2 and 5-9, and one booster dose 9-12 months after completion of the primary immunization.5 The final primary series vaccination for participants occurs just before the peak Lyme disease season for the region. Participants will be followed for the occurrence of Lyme disease. The trial is conducted at sites located in areas where Lyme disease is highly endemic across the U.S., Canada and Europe and has enrolled volunteers with a cleared past infection with Borrelia burgdorferi as well as Borrelia burgdorferi naïve volunteers.
About Lyme Disease
Lyme disease is a systemic infection caused by Borrelia burgdorferi bacteria transmitted to humans by the bite of an infected Ixodes ticks.6 It is considered the most common vector-borne illness in the Northern Hemisphere.7,8 While the true incidence of Lyme disease is unknown, it is estimated to annually affect approximately 476,000 people in the U.S. and 129,000 people in Europe.8,9 Early symptoms of Lyme disease (such as a gradually expanding erythematous rash called Erythema migrans or more nonspecific symptoms like fatigue, fever, headache, mild stiff neck, arthralgia or myalgia) are often overlooked or misinterpreted. Left untreated, the disease can disseminate and cause more serious chronic complications affecting the skin, joints (arthritis), the heart (carditis) or the nervous system.9,10 The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens.11
* Number of evaluable participants
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer
Pfizer Disclosure Notice
The information contained in this release is as of December 4, 2023. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about an investigational Lyme disease vaccine candidate, VLA15, and a collaboration between Pfizer and Valneva for VLA15, including their potential benefits, Phase 3 clinical trials and the timing of potential regulatory submissions, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, including uncertainties relating to the time needed to accrue cases in the Phase 3 trial and uncertainties relating to an agreement with regulatory authorities on any modifications to the clinical trial plan as needed, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in any jurisdictions for VLA15; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether VLA15 will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of VLA15; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; whether our collaboration with Valneva will be successful; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov/ and www.pfizer.com/.
About Valneva SE
We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.
We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market two proprietary travel vaccines as well as certain third-party vaccines leveraging our established commercial infrastructure.
Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the world’s first vaccine against the chikungunya virus, the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, as well as vaccine candidates against the Zika virus and other global public health threats.
Valneva Forward-Looking Statements
This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, results and completion of research, development and clinical trials for product candidates. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in these materials as of this press release and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Media Contacts
Pfizer
Media Relations:
PfizerMediaRelations@pfizer.com
+1 212-733-1226
Investor Relations:
IR@pfizer.com
+1 212-733-4848
Valneva
Laëtitia Bachelot-Fontaine
VP Global Communications & European Investor Relations
M +33 (0)6 4516 7099
laetitia.bachelot-fontaine@valneva.com
Joshua Drumm, Ph.D.
VP Global Investor Relations
M +1 917 815 4520
joshua.drumm@valneva.com
References
Valneva and Pfizer Report Positive Pediatric and Adolescent Phase 2 Booster Results for Lyme Disease Vaccine Candidate, September 2023. Available at: https://valneva.com/press-release/valneva-and-pfizer-report-positive-pediatric-and-adolescent-phase-2-booster-results-for-lyme-disease-vaccine-candidate/, Accessed: November 2023.
Valneva and Pfizer Report Positive Phase 2 Pediatric Data for Lyme Disease Vaccine Candidate, April 2022. Available at: https://valneva.com/press-release/valneva-and-pfizer-report-positive-phase-2-pediatric-data-for-lyme-disease-vaccine-candidate/ Accessed: November 2023
Valneva and Pfizer Announce Collaboration to Co-Develop and Commercialize Lyme Disease Vaccine, VLA15. April 2020. Available at: https://valneva.com/press-release/valneva-and-pfizer-announce-collaboration-to-co-develop-and-commercialize-lyme-disease-vaccine-vla15/Accessed: November 2023.
Valneva and Pfizer Enter into Equity Subscription Agreement and Update Terms of Collaboration Agreement for Lyme Disease Vaccine Candidate VLA15. June 2022. Available at: https://valneva.com/press-release/valneva-and-pfizer-enter-into-an-equity-subscription-agreement-and-update-terms-of-collaboration-agreement-for-lyme-disease-vaccine-candidate-vla15/Accessed: November 2023.
ClinicalTrials.gov. An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15) (VALOR). July 2022. Available from: https://www.clinicaltrials.gov/ct2/show/NCT05477524. Accessed: November 2023.
Stanek et al. Lyme Borreliosis, 2012, The Lancet 379:461–473
Burn L, et al. Incidence of Lyme Borreliosis in Europe from National Surveillance Systems (2005–2020). 2023. Vector Borne and Zoonotic Diseases. 23(4): 156–171.
Kugeler KJ, et al. Estimating the frequency of Lyme disease diagnoses—United States, 2010-2018. 2021. Emergency Infectious Disease. 27(2).
Centres for Disease Control. Lyme disease. Signs and Symptoms. Available from: https://www.cdc.gov/lyme/signs_symptoms/index.html. Accessed: September
Steere AC, Strle F, Wormser GP, et al. Lyme borreliosis. Nature Reviews Disease Primers. 2016;2:16090.
Centres for Disease Control. Understanding Lyme and Other Tickborne Diseases. May 2022. Available from: https://www.cdc.gov/ncezid/dvbd/media/lyme-tickborne-diseases-increasing.html Accessed: November 2023
https://valneva.com/press-release/pfizer-and-valneva-complete-recruitment-for-phase-3-valor-trial-for-lyme-disease-vaccine-candidate-vla15/
p0
7 months ago
VLA1553: (EMA) European Medicines Agency accepts Accelerated Assessment
https://valneva.us20.list-manage.com/track/click?u=a02496e8d59d3bd53cf21eaa7&id=3c8557b507&e=9da0e1dd5c
November 27, 2023
Saint-Herblain (France), November 27, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Medicines Agency (EMA) has performed a technical validation of the Marketing Authorization Application (MAA) for Valneva’s single-shot chikungunya vaccine candidate VLA1553 and has determined that all essential regulatory elements required for scientific assessment were included in the application. The MAA was granted accelerated assessment[1] last month by EMA’s Committee for Medicinal Products for Human Use (CHMP) based on the vaccine candidate’s “major interest for public health and therapeutic innovation”[2].
Accelerated assessment reduces the timeframe for EMA’s CHMP to review a MAA once it is accepted for review from 210 days under the standard review procedure to 150 days. This does not, however, include clock stops when applicants must provide additional information during the review process, which is common in review procedures.
Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, “We welcome EMA’s MAA review acceptance and will work closely with them to bring VLA1553 to market. Chikungunya virus, or CHIKV, has already spread to over 110 countries and the risk of chikungunya spreading in Europe is relatively high due to the possibility of infected travelers[3]. No vaccine or specific treatments are currently available for this debilitating disease which therefore constitutes an unmet medical need. Following approval of VLA1553 in the United States[4], we will continue to work diligently to bring VLA1553 to other territories as soon as possible.”
VLA1553 received approval from the U.S. Food and Drug Administration (FDA)[5] at the beginning of the month under the brand name IXCHIQ®. In the U.S., the vaccine is indicated for the prevention of disease caused by the chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV.
Mid-November, Valneva also reported positive pivotal Phase 3 immunogenicity data in adolescents for VLA1553 which are intended to support label extension in this age group[6]. The trial is also expected to support licensure of the vaccine in Brazil, which would be the first potential approval for use in endemic populations.
About Chikungunya
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in up to 97% of humans after four to seven days following the mosquito bite[7]. While mortality with CHIKV is low, morbidity is high, and the global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032[8]. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. The high-risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia, and the virus has spread to more than 110 countries[9]. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas[10] and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. In Europe, there is no preventive vaccines or effective treatments available and, as such, chikungunya is considered a major public health threat.
About VLA1553
VLA1553 is a live-attenuated, single dose investigational vaccine candidate targeting the chikungunya virus, which has spread to over 110 countries[11]. It has been designed by deleting a part of the chikungunya virus genome.
Valneva reported final data from the pivotal Phase 3 trial of VLA1553 in March 2022[12], final lot-to-lot consistency results in May 2022[13], positive twelve-month persistence data in December 2022[14] and positive pivotal Phase 3 data in adolescents in November 2023[15].
To make VLA1553 more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553[16]. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[17], which provides funding of up to $24.6 million with support from the European Union’s Horizon 2020 program.
VLA1553 received FDA approval in November 2023 under the brand name IXCHIQ® and is indicated for the prevention of disease caused by CHIKV in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. Continued approval of IXCHIQ® in the United States is contingent upon verification of clinical benefit in confirmatory studies.
VLA1553 was also granted PRIority MEdicine (PRIME) designation and accelerated assessment by the European Medicines Agency (EMA) in 2020 and 2023 respectively.
The Company intends to commercialize this vaccine by leveraging its existing manufacturing and commercial operations.
p0
8 months ago
VLA1553: EMA and CHMP Accelerated Assessment
October 25, 2023
Saint-Herblain (France), October 25, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces the submission of a marketing application with the European Medicines Agency (EMA) for approval of the Company’s single-shot chikungunya vaccine candidate, VLA1553. Valneva was also granted accelerated assessment[1] for the application by EMA’s Committee for Medicinal Products for Human Use (CHMP) based on the vaccine candidate’s “major interest for public health and therapeutic innovation”.
VLA1553 is currently the first and only chikungunya vaccine candidate worldwide for which regulatory review processes are underway. A Biologic License Application (BLA) is currently under priority review by the U.S. Food and Drug Administration (FDA)[2] with a Prescription Drug User Fee Act (PDUFA) action date planned for the end of November 2023[3]. Additionally, a marketing application is under review by Health Canada[4].
If approved, VLA1553 could become the first licensed chikungunya vaccine available to address this unmet medical need.
Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, “We welcome EMA’s accelerated assessment and will work closely with them to bring this vaccine to market. Chikungunya virus, or CHIKV, is a serious and debilitating mosquito-borne viral infection that poses a significant unmet need and the risk of chikungunya spreading in Europe is relatively high due to the possibility of infected travelers[5]. No vaccine or specific treatments are currently available for this debilitating disease. We will continue to work diligently to bring VLA1553 to different territories as soon as possible.”
The regulatory submissions with the EMA, FDA and Health Canada follow final pivotal Phase 3 data in March 2022[6] (Lancet article), final lot-to-lot consistency results in May 2022[7], twelve-month persistence data in December 2022[8] and positive initial Phase 3 safety data in adolescents[9].
VLA1553 was granted PRIority MEdicine (PRIME) designation by EMA in 2020 and received FDA Fast Track and Breakthrough Therapy designations in 2018 and 2021, respectively.
About Chikungunya
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in up to 97% of humans after four to seven days following the mosquito bite. While mortality with CHIKV is low, morbidity is high, and the global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032[10]. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. The high-risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia, and the virus has spread to more than 110 countries[11]. As of July 2022, more than three million cases have been reported in the Americas[12] and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. There are no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.
About VLA1553
VLA1553 is a live-attenuated, single dose investigational vaccine candidate targeting the chikungunya virus, which has spread to over 110 countries[13]. It has been designed by deleting a part of the chikungunya virus genome.
Valneva reported final data from the pivotal Phase 3 trial of VLA1553 in March 2022[14], final lot-to-lot consistency results in May 2022[15], positive twelve-month persistence data in December 2022[16] and positive initial Phase 3 safety data in Adolescents[17]. The pivotal Phase 3 data were published in The Lancet[18](article link), the world’s leading peer-reviewed medical journal, in June 2023.
If approved, VLA1553 would expand Valneva’s existing commercial vaccines portfolio and as such, Valneva intends to commercialize this vaccine, leveraging its existing manufacturing and commercial operations.
To make VLA1553 more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553[19]. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[20], which provides funding of up to $24.6 million with support from the European Union’s Horizon 2020 program.
p0
10 months ago
VLA1553: Health Canada Accepts Valneva’s Chikungunya Vaccine License Application for Review
August 29, 2023
Saint-Herblain (France), August 29, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that Health Canada has completed screening validation of the Company’s regulatory application for marketing approval of its single-shot chikungunya vaccine candidate VLA1553 in persons aged 18 years and above, and has determined that the New Drug Submission (NDS) application is sufficiently complete to permit a substantive review. Based on Health Canada’s performance standard to process an NDS application, the Company believes the regulatory review could be completed by mid-2024.
This is the second regulatory application for VLA1553 filed by Valneva, and the Company intends to make additional regulatory submissions in 2023. A Biologic License Application (BLA) is currently under priority review[1] by the U.S. Food and Drug Administration (FDA)[2].
VLA1553 is currently the only chikungunya vaccine candidate worldwide for which regulatory review processes are underway and, if approved, it could become the first licensed chikungunya vaccine available to address this unmet medical need. It would also represent the third vaccine Valneva[3] has brought from early research and development to approval.
Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, “Chikungunya represents a major threat for people traveling to or living in areas where chikungunya virus and the mosquitos that transmit it are present, including popular destinations for U.S. and Canadian travelers. This threat continues to grow as shown by the recent epidemiological alert issued by the Pan American Health Organization (PAHO)[4]. No vaccine or specific treatments are currently available for this debilitating disease, and we will continue to work diligently to make VLA1553 available in different territories as quickly as possible.”
The regulatory submissions with Health Canada and the FDA follow final pivotal Phase 3 data in March 2022[5], final lot-to-lot consistency results in May 2022[6] and positive twelve-month persistence data in December 2022[7]. The Company’s pivotal Phase 3 results were published in the Lancet in June 2023.
A clinical study of VLA1553 in adolescents aged 12 to 17 years is ongoing in Brazil[8], for which Valneva reported initial Phase 3 safety data in adolescents yesterday[9]. This study, conducted by Valneva’s partner Instituto Butantan and funded by the Coalition for Epidemic Preparedness Innovations (CEPI), is intended to support label extension in this age group following a potential initial regulatory approval in adults from the FDA. The study is also expected to support licensure of the vaccine in Brazil, which would be the first potential approval for use in endemic populations, as well as regulatory submission in Europe.
The vaccine was granted PRIority MEdicine (PRIME) designation by the European Medicines Agency (EMA) in 2020 and also received FDA Fast Track, Breakthrough Therapy and Priority Review designations in 2018, 2021 and 2023 respectively.
About Chikungunya
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in up to 97% of humans after four to seven days following the mosquito bite. While mortality with CHIKV is low, morbidity is high, and the global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032[10]. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. The high-risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia, and the virus has spread to more than 110 countries[11]. As of July 2022, more than three million cases have been reported in the Americas[12] and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. There are no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.
About VLA1553
VLA1553 is a live-attenuated, single dose investigational vaccine candidate targeting the chikungunya virus, which has spread to over 110 countries[13]. It has been designed by deleting a part of the chikungunya virus genome.
Valneva reported final data from the pivotal Phase 3 trial of VLA1553 in March 2022[14], final lot-to-lot consistency results in May 2022[15] and positive twelve-month persistence data in December 2022[16].
If approved, VLA1553 would expand Valneva’s existing commercial vaccines portfolio and as such, Valneva intends to commercialize this vaccine, leveraging its existing manufacturing and commercial operations.
To make VLA1553 more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553[17]. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[18], which provides funding of up to $24.6 million with support from the European Union’s Horizon 2020 program.
VLA1553 received FDA Fast Track, Breakthrough Therapy designations and Priority Review in 2018, 2021 and 2023, respectively. VLA1553 was also granted PRIority MEdicine (PRIME) designation by the European Medicines Agency (EMA) in 2020.
About Valneva SE
Valneva is a specialty vaccine company focused on the development, manufacturing and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to commercialize three vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against the chikungunya virus and Lyme disease.
https://valneva.com/press-release/health-canada-accepts-valnevas-chikungunya-vaccine-license-application-for-review/
p0
10 months ago
VLA1553: Positive Initial Phase 3 Safety Data
August 28, 2023
Saint-Herblain (France), August 28, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive initial Phase 3 safety data in adolescents for its single-dose chikungunya virus (CHIKV) vaccine candidate VLA1553. Immunogenicity data for the trial are expected in November 2023.
Funded by the Coalition for Epidemic Preparedness Innovations (CEPI) and conducted in collaboration with Instituto Butantan, the VLA1553-321 adolescent trial is intended to support label extension in this age group following a potential initial regulatory approval in adults from the Food and Drug Administration (FDA) in the United States (U.S). The trial is also expected to support licensure of the vaccine in Brazil, which would be the first potential approval for use in endemic populations. The present safety analysis is also expected to enable regulatory submission to the European Medicines Agency (EMA) later this year.
Initial safety data generated in the ongoing trial VLA1553-321, Valneva’s first clinical trial in an endemic area and with individuals previously infected with CHIKV, showed that VLA1553 was generally safe and well tolerated in adolescents aged 12 to 17 years, regardless of previous CHIKV infection.
754 individuals were vaccinated in trial VLA1553-321, and the present analysis includes safety data up to Day 29. An independent DSMB has continuously evaluated safety data during the trial and has not identified any safety concerns. Overall, the adverse event profile is consistent with the profile observed in Valneva’s pivotal Phase 3 trial in adults. The majority of solicited adverse events observed following VLA1553 administration were mild or moderate and resolved within three days. Importantly, the initial data suggest a favorable safety profile in seropositive participants, confirming the observations following re-vaccination of individuals in Phase 1 trial VLA1553-101[1].
Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “These new safety data in a younger population and in individuals previously infected with the chikungunya virus confirm the safety profile we previously observed in adults and the elderly. Chikungunya represents a major threat for people traveling to or living in areas where chikungunya virus is endemic, it is therefore our objective to make this vaccine available to all age groups, especially as no vaccine or specific treatments are currently available for this debilitating disease.”
Valneva reported final pivotal Phase 3 data in 4,115 adults aged 18 years and above in March 2022[2] and the Lancet subsequently published these results in June 2023[3]. Final lot-to-lot consistency results were published in May 2022[4] and positive twelve-month persistence data in December 2022[5].
A Biologic License Application (BLA) for VLA1553 is currently under priority review by the U.S. FDA with a Prescription Drug User Fee Act (PDUFA) action date planned for end of November 2023[6].
Additionally, a regulatory application has also been filed with Health Canada[7]. If approved, VLA1553 could become the first licensed chikungunya vaccine available to address this unmet medical need.
About Phase 3 study VLA1553-321
VLA1553-321 is a prospective, double-blinded, multicenter, randomized, placebo-controlled pivotal Phase 3 trial conducted in 754 adolescents aged 12 to 17 years old in Brazil. The VLA1553-321 clinical trial was initiated in January 2022 and Valneva reported enrollment and vaccination completion in February 2023. VLA1553 or placebo was administered as a single intramuscular immunization to participants who were randomized into two study groups at a 2:1 ratio. The primary objective is to evaluate the immunogenicity and safety of the adult dose of VLA1553 28 days following a single vaccination. Secondary objectives of the trial include assessment of safety and immunogenicity up to twelve months following a single vaccination with VLA1553. The study will also provide safety and immunogenicity data in participants previously exposed to chikungunya.
Additional information, including a detailed description of the study design, eligibility criteria and investigator sites, is available at ClinicalTrials.gov (Identifier: NCT04650399).
About Chikungunya
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in up to 97% of humans after four to seven days following the mosquito bite. While mortality with CHIKV is low, morbidity is high, and the global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032[8]. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. The high-risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia, and the virus has spread to more than 110 countries[9]. As of July 2022, more than three million cases have been reported in the Americas[10] and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. There are no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.
About VLA1553
VLA1553 is a live-attenuated, single dose investigational vaccine candidate targeting the chikungunya virus, which has spread to over 110 countries[11]. It has been designed by deleting a part of the chikungunya virus genome.
Valneva reported final data from the pivotal Phase 3 trial of VLA1553 in March 2022[12], final lot-to-lot consistency results in May 2022[13] and positive twelve-month persistence data in December 2022[14].
If approved, VLA1553 would expand Valneva’s existing commercial vaccines portfolio and as such, Valneva intends to commercialize this vaccine, leveraging its existing manufacturing and commercial operations.
To make VLA1553 more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553[15]. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[16], which provides funding of up to $24.6 million with support from the European Union’s Horizon 2020 program.
VLA1553 received FDA Fast Track, Breakthrough Therapy designations and Priority Review in 2018, 2021 and 2023, respectively. VLA1553 was also granted PRIority MEdicine (PRIME) designation by the European Medicines Agency (EMA) in 2020.
About Valneva SE
We are a specialty vaccine company focused on the development, manufacturing and commercialization of prophylactic vaccines for infectious diseases. We take a highly specialized and targeted approach to vaccine development by focusing on vaccine solutions addressing unmet medical needs to ensure we can make a difference to peoples’ lives. We apply our deep understanding of vaccine science, including our expertise across multiple vaccine modalities, and our established vaccine development capabilities, to develop vaccines against diseases which are not yet vaccine-preventable, or for which there are limited effective treatment options. Today, we are leveraging our expertise and capabilities to rapidly advance a broad range of vaccines into and through the clinic, including candidates against the chikungunya virus and Lyme disease.
https://valneva.com/press-release/valneva-reports-positive-initial-phase-3-safety-data-in-adolescents-for-its-single-shot-chikungunya-vaccine-candidate/
p0
1 year ago
VLA1553: ... to Present on its Chikungunya Vaccine Candidate and Host a Roundtable at the 23rd World Vaccine Congress in Washington D.C.
https://valneva.com/press-release/valneva-to-present-on-its-chikungunya-vaccine-candidate-and-host-a-roundtable-at-the-23rd-world-vaccine-congress-in-washington-d-c/
March 30, 2023
Saint Herblain (France), March 30, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced today it will present on its single-shot chikungunya vaccine candidate, VLA1553, and host a roundtable on Zika vaccines next week at the 23rd World Vaccine Congress in Washington, D.C.
On April 4, 2023, at 11.40am EDT, Valneva’s Chief Medical Officer, Juan Carlos Jaramillo, MD, will host a roundtable discussion on the opportunities and challenges for a Zika vaccine. Valneva successfully developed an inactivated whole-virus Zika vaccine candidate though Phase 1 prior to the COVID-19 pandemic and is currently evaluating potential re-entry into clinical development later this year or early next year.
In addition, on April 5, 2023, at 9.40am EDT, Susanne Eder-Lingelbach, Vice President, Clinical Development at Valneva, will review the clinical results of the Company’s single-shot chikungunya vaccine candidate, for which a regulatory review process is underway with the U.S. Food and Drug Administration (FDA)[1]. If approved, it could become the first vaccine in the world to address the unmet medical need of chikungunya.
Juan Carlos Jaramillo and Valneva’s Chief Executive Officer, Thomas Lingelbach, will be available during the conference for one-on-one meetings. Interested parties may request a meeting at communications@valneva.com.
Valneva will also display a poster on the clinical results of its chikungunya vaccine candidate in the exhibition foyer of the congress and will have a display in the exhibit area at booth #503.
About VLA1553
VLA1553 is a live-attenuated, single dose investigational vaccine candidate targeting the chikungunya virus, which has spread to over 100 countries. It has been designed by deleting a part of the chikungunya virus genome.
To make VLA1553 more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553[2]. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[3], which provides funding of up to $24.6 million with support from the European Union’s Horizon 2020 program.
Valneva reported final data from the pivotal Phase 3 trial of VLA1553 in March 2022[4], final lot-to-lot consistency results in May 2022[5] and positive twelve-month persistence data in December 2022[6].
VLA1553 received FDA Fast Track, Breakthrough Therapy designations and Priority Review in 2018, 2021 and 2023, respectively. VLA1553 was also granted PRIority MEdicine (PRIME) designation by the European Medicines Agency (EMA) in 2020.
If approved, VLA1553 would expand Valneva’s existing commercial vaccines portfolio and as such, Valneva intends to commercialize this vaccine, leveraging its existing manufacturing and commercial operations.
p0
1 year ago
VLA15: Pfizer and Valneva Issue Update on Phase 3
New York & Saint-Herblain (France), February 17, 2023 – Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announce that Pfizer, as the study sponsor, has decided to discontinue a significant percentage of participants in the U.S. who had been enrolled in the Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) Phase 3 clinical study. The study is investigating the efficacy, safety and immunogenicity of an investigational Lyme disease vaccine candidate, VLA15. These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator. The discontinuation of these participants was not due to any safety concerns with the investigational vaccine and was not prompted by a participant-reported adverse event.
GCP is the international ethical and scientific quality standard for clinical trials that all clinical researchers need to follow. These standards are designed to put participants’ interests first and ensure high scientific integrity. Once Pfizer learned of potential violations of GCP, it conducted a thorough review of the operations and data collection at the clinical trial sites run by the third party and followed standard operating safeguards to determine the correct course of action.
The clinical trial remains ongoing with other sites not operated by the third party, and Pfizer continues to enroll new participants at those sites. The companies intend to work with regulatory authorities, and as previously announced,1,2 aim for Pfizer to potentially submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in 2025, pending successful completion of the Phase 3 studies and subject to the agreement of these regulatory agencies to proposed modifications of the clinical trial plan.
Participants are being notified and Pfizer has also notified the FDA, other regulatory agencies and the independent Institutional Review Board for this study.
Integrity of data collected in clinical trials is critical to provide evidence and confidence in a potential vaccine or medicine’s safety and efficacy. Pfizer and Valneva are committed to collecting robust data needed for potential regulatory submission of VLA15. While VLA15 is still under investigation, to date the companies have been encouraged by the data from the Phase 2 clinical studies, which demonstrated strong immunogenicity and acceptable safety and tolerability profiles.2-4
About VLA15
VLA15 is the only Lyme disease vaccine candidate currently in clinical development. This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease. OspA is a surface protein expressed by the bacteria when present in a tick. Blocking OspA inhibits the bacterium’s ability to leave the tick and infect humans. The vaccine covers the six most common OspA serotypes expressed by the Borrelia burgdorferi sensu lato species that are prevalent in North America and Europe. VLA15 has demonstrated a strong immune response and satisfactory safety profile in pre-clinical and clinical studies so far. Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop VLA15, with updates to the terms within this agreement made in June 2022.5,6 The program was granted Fast Track designation by the U.S. FDA in July 2017.7
About Lyme Disease
Lyme disease is a systemic infection caused by Borrelia burgdorferi bacteria transmitted to humans by infected Ixodes ticks.8 It is considered the most common vector-borne illness in the Northern Hemisphere.9 While the true incidence of Lyme disease is unknown, it is estimated to annually affect approximately 476,000 people in the United States and 130,000 people in Europe.10,11 Early symptoms of Lyme disease (such as a gradually expanding erythematous rash called Erythema migrans or more nonspecific symptoms like fatigue, fever, headache, mild stiff neck, arthralgia or myalgia) are often overlooked or misinterpreted. Left untreated, the disease can disseminate and cause more serious complications affecting the joints (arthritis), the heart (carditis) or the nervous system.12 The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens.10
https://valneva.com/press-release/pfizer-and-valneva-issue-update-on-phase-3-clinical-trial-evaluating-lyme-disease-vaccine-candidate-vla15/
p0
1 year ago
VLA1553: Valneva Completes Enrollment for Adolescent Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate
February 14, 2023
Saint-Herblain (France), February 14, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it completed enrollment and vaccination for a Phase 3 trial in adolescents, VLA1553-321, of its single-shot chikungunya vaccine candidate, VLA1553. First results of the trial are expected mid-2023.
Funded by the Coalition for Epidemic Preparedness Innovations (CEPI), the VLA1553-321 adolescent trial is intended to support the label extension in this age group following a potential initial regulatory approval in adults from the Food and Drugs Administration (FDA) in the United States (U.S).
Valneva completed rolling submission of the Biologics License Application (BLA) to the U.S. FDA for approval of VLA1553 in persons aged 18 years and above in December 2022[1]. If BLA filing is accepted and approved, VLA1553 could become the first chikungunya vaccine to be marketed in the U.S. Valneva reported final pivotal Phase 3 data for VLA1553 in March 2022[2] and final lot-to-lot consistency results in May 2022[3]. The Company also recently reported positive antibody persistence data with a 99% seroresponse rate 12 months after a single-dose vaccination[4].
The VLA1553-321 adolescent trial is also expected to support licensure of the vaccine in Europe and Brazil, which would be the first potential approval for use in endemic populations.
Conducted in collaboration between Instituto Butantan and Valneva, VLA1553-321 is a double-blinded, multi-center, randomized and placebo-controlled Phase 3 trial. 754 adolescents aged 12 to 17 years were vaccinated following randomization at a 2:1 ratio to receive either VLA1553 or placebo. The primary objective of the trial is to evaluate safety and immunogenicity 28 days following a single vaccination with VLA1553. Participants will be evaluated for the primary endpoint and followed up to twelve months. The study will also provide the first systematic safety and immunogenicity data in participants previously exposed to chikungunya.
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “Recruitment completion in this study is an important milestone for the overall program. We reported compelling pivotal Phase 3 results in adults and in the elderly, and we are now looking forward to obtaining results in adolescents later this year. Chikungunya virus is a major, growing public health threat which has already impacted over 100 countries and affected millions worldwide, yet no vaccine or specific treatment is currently available to prevent this debilitating disease.”
Dr. Esper Georges Kallas, President of Instituto Butantan, which will develop, manufacture and market VLA1553 in Low- and Middle-Income Countries, commented, “the achievement of this goal is a major milestone to expand the vaccine indication in adolescents. Based on a single-dose schedule, the VLA1553 chikungunya vaccine could become a key tool to prevent the chikungunya disease in endemics areas and fight the disease-induced public health burden.”
Dr. Melanie Saville, Director of Vaccine Research & Development at CEPI, which provided funding for this study, added, “Millions of people have been affected by chikungunya and, today, over a billion people live in areas where chikungunya outbreaks occur. The progress Valneva has made to date brings the world one step closer towards a safe and effective vaccine against this debilitating disease, for which there is currently no specific treatment nor vaccine licenced for human use. Data from this Phase 3 study will help to ensure that the people most affected by this virus can benefit from this product and help regulators assess this important vaccine candidate.”
To make VLA1553 more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553[5]. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[6], which provides funding of up to $24.6 million with support from the European Union’s Horizon 2020 program.
Brazil had an exponential increase of chikungunya cases in 2021 in comparison to 2020, according to data from the Brazilian Vigilance Health Secretary (SVS). At the beginning of December 2021, 90,147 chikungunya cases had been registered compared to 78,808 over the same period in the previous year. The three states that most registered cases of the disease were Pernambuco (29,700 cases), São Paulo (18,100 cases) and Paraíba (9,000 cases), respectively. In 2021, São Paulo which is the most populous state in the country, went from 468 cases to 18,156 cases compared to 20207.
https://valneva.com/press-release/valneva-completes-enrollment-for-adolescent-phase-3-trial-of-single-shot-chikungunya-vaccine-candidate/?lang=en
p0
2 years ago
VLA1553: BLA Submission completed / U.S. FDA for its Single-Shot Chikungunya Vaccine Candidate
Saint-Herblain (France), December 23, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that it has completed rolling submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its single-shot chikungunya vaccine candidate, VLA1553. Valneva is seeking approval of its investigational chikungunya vaccine in persons aged 18 years and above.
This BLA application follows final pivotal Phase 3 data reported in March 2022[1] and final lot-to-lot consistency results reported in May 2022[2]. A clinical study of VLA1553 in adolescents is ongoing in Brazil[3], which may support future regulatory submissions in this group if VLA1553 is initially approved in adults. The Company also recently reported positive antibody persistence data with a 99% seroresponse rate 12 months after a single-dose vaccination[4].
Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, “The completion of our BLA submission is extremely important as it takes us a step closer to potentially bringing a preventative solution to fight this debilitating disease. Chikungunya is a major public health threat transmitted to humans by infected mosquitoes, and no vaccine or specific treatments for the disease are currently available. If the FDA approves the submission, our goal is to provide a tool to help curtail this growing, unmet medical need.”
The FDA will now review the filing for acceptance, determine priority review eligibility and the action date which it targets to complete its evaluation. The program received FDA Fast Track and Breakthrough Therapy designations in 2018 and 2021, respectively. VLA1553 was also granted PRIority MEdicine (PRIME) designation by the European Medicines Agency (EMA) in 2020, and Valneva plans to make regulatory submissions for VLA1553 in Europe in the second half of 2023.
About Chikungunya
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in 72-92% of humans after four to seven days following the mosquito bite. While mortality with CHIKV is low, morbidity is high, and the global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032[5]. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. The high-risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia, and the virus has spread to more than 100 countries. As of July 2022, more than three million cases have been reported in the Americas[6] and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. There are no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.
About VLA1553
VLA1553 is a live-attenuated, single dose investigational vaccine candidate targeting the chikungunya virus, which has spread to over 100 countries. It has been designed by deleting a part of the chikungunya virus genome.
Valneva reported final data from the pivotal Phase 3 trial of VLA1553 in March 2022[7] and final lot-to-lot consistency results in May 2022[8].
If approved, VLA1553 would expand Valneva’s existing commercial vaccines portfolio and as such, Valneva intends to commercialize this vaccine, leveraging its existing manufacturing and commercial operations.
To make VLA1553 more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553[9]. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[10], which provides funding of up to $23.4 million with support from the European Union’s Horizon 2020 program.
p0
2 years ago
VLA15: There were no safety concerns observed in this six-month observational follow up
December 1, 2022
Antibody levels remained above baseline six months after completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule
Higher antibody levels were observed in the three-dose vaccination schedule versus the two-dose vaccination schedule, further validating the use of this schedule in the ongoing Phase 3 study
There were no safety concerns observed in this six-month observational follow up
New York & Saint-Herblain (France), December 1, 2022 – Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today reported antibody persistence data six months after the completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule with their Lyme disease vaccine candidate, VLA15 in both children and adults. This is the first time antibody persistence data are reported in pediatric populations for this vaccine candidate.
Following positive immunogenicity and safety data for Phase 2 study VLA15-221 in April 2022[1], Valneva and Pfizer evaluated the persistence of antibodies six months after the Month 0-2-6 and the Month 0-6 vaccination schedule with VLA15 in healthy adults and pediatric participants (5 to 65 years of age). Data were collected in 96 healthy adults and 81 pediatric participants (5-17 years of age) for the Month 0-2-6 vaccination schedule and in 84 healthy adults and 78 pediatric participants (5-17 years of age) for the Month 0-6 schedule.
As observed in previous clinical studies with VLA15, antibody levels declined over time in all study groups but remained above baseline, confirming their persistence six months after completion of both vaccination schedules. Overall, antibody levels remained higher with the three-dose vaccination schedule compared to the two-dose schedule. Geometric mean fold rise (GMFRs) compared to baseline were 1.9-fold for Serotype 1 (ST1) to 3.2-fold Serotype 2 (ST2) across all age groups in the Month 0-2-6 vaccination schedule. The highest GMFRs were reported in the 5 to 11 years old age group, with GMFR levels at 2.8-fold (ST1) to 6.6-fold (ST2).
These results further validate the use of the three-dose vaccination schedule which is also included in the Phase 3 protocols for all participants.
No vaccine-related serious adverse events (SAEs) and no safety concerns were observed in this six-month observational follow up.
Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “We are pleased with these antibody persistence data that further validate the use of the three-dose vaccination schedule in our ongoing Phase 3 study and the acceptable safety and tolerability profiles of our vaccine candidate. Lyme disease continues to spread, representing a high unmet medical need that impacts the lives of many in the Northern Hemisphere, and each new report of positive data takes us a step closer to potentially bringing this vaccine to both adults and children who could benefit from it.”
Earlier this year, Pfizer and Valneva initiated a Phase 3 clinical study, Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524), to investigate the efficacy, safety and immunogenicity of VLA15[2]. Approximately 6,000 participants 5 years of age and older will receive three doses of VLA15 180 µg or saline placebo as a primary vaccination series followed by one booster dose of VLA15 or saline placebo (1:1 ratio). Enrollment is ongoing in Europe and the United States and expected to be completed in the second quarter of 2023. To learn more, visit www.pfizerclinicaltrials.com/nct05477524. To achieve the required pediatric safety database, Pfizer and Valneva are planning to initiate a complementary Phase 3 clinical study in early December 2022 to collect additional VLA15 safety data in participants 5 to 17 years of age.
“Rates of Lyme disease continue to increase globally, underscoring the importance of a vaccine that may help protect both adults and children,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer of Vaccine Research & Development at Pfizer. “These six-month antibody persistence data are encouraging, and we hope that the data generated from the Phase 3 studies will further support the positive evidence for VLA15 to date.”
Pending successful completion of the Phase 3 studies, Pfizer could potentially submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in 2025.
About VLA15
VLA15 is the only Lyme disease vaccine candidate currently in clinical development. This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease. OspA is a surface protein expressed by the bacteria when present in a tick. Blocking OspA inhibits the bacterium’s ability to leave the tick and infect humans. The vaccine covers the six most common OspA serotypes expressed by the Borrelia burgdorferi sensu lato species that are prevalent in North America and Europe. VLA15 has demonstrated a strong immune response and satisfactory safety profile in pre-clinical and clinical studies so far. Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop VLA15, with updates to the terms within this agreement made in June 2022.3,4 The terms of the collaboration agreement include a $25 million milestone payment made to Valneva upon Pfizer’s initiation of the Phase 3 study. The program was granted Fast Track designation by the U.S. FDA in July 2017.5
About Clinical Study VLA15-221
VLA15-221 is a randomized, observer-blind, placebo-controlled Phase 2 study. It is the first clinical study with VLA15 which enrolled a pediatric population (5-17 years old).
585 healthy participants received VLA15 at two different immunization schedules (month 0-2-6 [N=190] or month 0-6 [N=187]) or three doses of placebo (month 0-2-6 [N=208]). Vaccine recipients received VLA15 at a dose of 180 µg, which was selected based on data generated in the two previous Phase 2 studies. The main safety and immunogenicity readout was performed one month after the primary vaccination series. A subset of participants will receive a booster dose of VLA15 or placebo at month 18 (booster phase) and will be followed for three additional years to monitor antibody persistence.
VLA15 is tested as an alum-adjuvanted formulation and administered intramuscularly. The study is being conducted at U.S. sites located in areas where Lyme disease is endemic and has enrolled both volunteers with a cleared past infection with Borrelia burgdorferi as well as Borrelia burgdorferi-naïve volunteers.
About Lyme Disease
Lyme disease is a systemic infection caused by Borrelia burgdorferi bacteria transmitted to humans by infected Ixodes ticks.6 It is considered the most common vector-borne illness in the Northern Hemisphere.7 While the true incidence of Lyme disease is unknown, it is estimated to annually affect approximately 476,000 people in the United States and 130,000 people in Europe.8,9 Early symptoms of Lyme disease (such as a gradually expanding erythematous rash called Erythema migrans or more nonspecific symptoms like fatigue, fever, headache, mild stiff neck, arthralgia or myalgia) are often overlooked or misinterpreted. Left untreated, the disease can disseminate and cause more serious complications affecting the joints (arthritis), the heart (carditis) or the nervous system.9 The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens.8
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
p0
2 years ago
VLA1553: Presenting Single-Shot Chikungunya Vaccine Candidate at Leading Scientific Conferences
October 10, 2022
Valneva initiated rolling submission with the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for licensure of its single-shot chikungunya vaccine candidate in individuals aged 18 years and above in August 2022.
This BLA submission follows final pivotal Phase 3 data reported in March 2022[1] and final lot-to-lot consistency results reported in May 2022[2]. A clinical study of VLA1553 in adolescents is ongoing in Brazil[3], which may support future regulatory submissions in this group if VLA1553 is approved in adults.
The program received FDA Fast Track and Breakthrough Therapy designations in 2018 and 2021, respectively. VLA1553 was also granted PRIority MEdicine (PRIME) designation by the European Medicines Agency (EMA) in 2020, and Valneva plans to make regulatory submissions for VLA1553 in Europe in the first half of 2023.
Saint-Herblain (France), October 10, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA),
a specialty vaccine company, announces today it will present on its single-shot chikungunya vaccine candidate at several leading scientific conferences during the fourth quarter of 2022.
At the World Vaccine Congress Europe in Barcelona, Valneva will present
“One step closer to a chikungunya vaccine: update on Valneva’s live-attenuated vaccine candidate,”
on October 13, 2022 at 2:45pm CEST. The Company will also have a display in the
exhibit area at booth #46 for the duration of the Congress, from October 11 through 14, 2022.
On October 27, 2022 at 10:30am ICT, Valneva will present
“Progress of Clinical Development of a Live-Attenuated Single Shot Chikungunya Vaccine Candidate” as part of the
Vaccines for Tropical Diseases symposium at the 20th International Congress for Tropical Medicine and Malaria (ICTMM2020) in Bangkok.
Valneva will also present on the Phase 3 clinical development of its single-shot chikungunya
vaccine candidate at the American Society of Tropical Medicine and Hygiene (ASTMH) 2022 Annual Meeting,
taking place October 30 through November 3, 2022 in Seattle.
The Company will present an abstract on November 1, 2022 at 10:15am PST during an in-person scientific session.
At the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) European Congress taking
place November 6 through 9, 2022 in Vienna and online, two posters will be presented:
“Burden of Illness and Paucity of Treatment of the Mosquito-Borne Chikungunya Virus (CHIKV)” and
“The Economic Burden of the Globally Spreading Chikungunya Virus: A Systematic and Targeted Review.”
Finally, the Company will present at the Joint International Tropical Medicine Meeting (JITMM) 2022 in
Bangkok from December 7 through 9, 2022.
Presentations will be made by Valneva’s senior scientific leadership, including Juan Carlos Jaramillo, MD,
Chief Medical Officer of Valneva; Katrin Dubischar, VP Program Director – Chikungunya Vaccine; and Susanne Eder-Lingelbach, VP Clinical Development, among others.
p0
2 years ago
Closing of Upsized €102.9 Million Global Offering
October 4, 2022
The financing was led by US healthcare specialist Deep Track Capital and also included existing shareholders such as French state-owned bank Bpifrance.
Proceeds to be primarily used to continue to advance both the Company’s Phase 3 Lyme disease and chikungunya vaccine candidates towards marketing approval and to progress preclinical assets.
Saint Herblain (France), October 4, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (the “Company”), a specialty vaccine company, announced today the closing of its previously announced global offering to specified categories of investors of an aggregate 21,000,000 new ordinary shares, consisting of a public offering of 375,000 American Depositary Shares (“ADSs”), each representing two ordinary shares, in the United States at an offering price of $9.51 per ADS (the “U.S. Offering”), and a concurrent private placement of 20,250,000 ordinary shares in Europe (including France) and other countries outside of the United States at the corresponding offering price of €4.90 per ordinary share (the “European Private Placement”, and, together with the U.S. Offering, the “Global Offering”). Aggregate gross proceeds of the Global Offering, before deducting underwriting commissions and estimated expenses payable by the Company, were approximately €102.9 million ($99.9 million).
Valneva’s ordinary shares are listed on Euronext Paris under the symbol “VLA” and its ADSs are listed on the Nasdaq Global Select Market under the symbol “VALN”.
Goldman Sachs, Jefferies, Guggenheim Securities and Bryan, Garnier & Co. acted as joint bookrunners for the Global Offering.
The Company has filed a shelf registration statement on Form F-3 relating to the ADSs and ordinary shares sold in the Global Offering with the U.S. Securities and Exchange Commission (“SEC”) on August 12, 2022, which was declared effective on August 19, 2022. The offering was made by means of a prospectus and copies of the prospectus relating to and describing the terms of the Global Offering may be obtained from Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, New York 10282, telephone: 866-471-2526, facsimile: 212-902-9316, e-mail: prospectus-ny@ny.email.gs.com or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at +1 877 821 7388 or by email at Prospectus_Department@Jefferies.com.
Application was made to list the new ordinary shares issued pursuant to the Global Offering on Euronext Paris pursuant to a listing prospectus (the “Listing Prospectus”) which was approved by the Autorité des Marchés Financiers (“AMF”) on September 30, 2022 under number 22-405. The Listing Prospectus comprises (i) the 2021 universal registration document filed with the AMF on March 23, 2022 (document d’enregistrement universel 2021) under number D. 22-0140 (the “2021 URD”), as completed by an amendment to the 2021 universal registration document filed with the AMF on September 30, 2022 under number D. 22-0140-A01 (the “Amendment”) and (ii) a securities note (Note d’opération) (the “Securities Note”), including (iii) a summary of the prospectus. Copies of the Company’s 2021 URD, as amended, is available free of charge on the Company’s website. The Listing Prospectus has been published on the Company’s website and on the AMF’s website (www.amf-france.org).
p0
2 years ago
PreHevbri®: Valneva and VBI Vaccines Announce European Partnership for Marketing and Distribution of PreHevbri®
September 8, 2022
SAINT-HERBLAIN, France and CAMBRIDGE, Mass. (September 8, 2022) – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (Valneva) and VBI Vaccines Inc. (Nasdaq: VBIV) (VBI) today announced a partnership in select European markets for the marketing and distribution of PreHevbri® [Hepatitis B vaccine (recombinant, adsorbed)], the only 3-antigen hepatitis B vaccine approved in Europe.
Under the terms of the agreement, specialty vaccine company Valneva will promote and distribute PreHevbri throughout select European countries, which initially include the United Kingdom, Sweden, Norway, Denmark, Finland, Belgium, and the Netherlands. Valneva and VBI expect PreHevbri to be available in these countries in early 2023.
Thomas Lingelbach, President and CEO of Valneva, commented: “We welcome this partnership with VBI which underlines Valneva’s expertise in vaccine commercialization. Among the past years, we have continued to develop our third-party vaccine marketing and distribution activities further, notably with the signing of a distribution agreement with Bavarian Nordic in 2020, and we are extremely pleased to add VBI’s Hepatitis B vaccine to this portfolio today. Our objective is to continue leveraging our commercial infrastructure to combat as many infectious diseases as we can.”
Jeff Baxter, President and CEO of VBI, commented: “This partnership is a significant milestone for PreHevbri, enabling us to hit the ground running in Europe. Valneva has substantial local knowledge, experience, and relationships in each of these European countries where we expect to launch, which will be of critical value as we work, collectively, to provide broad access to this differentiated 3-antigen HBV vaccine in Europe. Strategically, VBI and Valneva are two companies aligned by a shared mission to reduce the burden of infectious disease, and this new collaboration will build upon that meaningful synergy.”
PreHevbri was approved by the European Commission (EC) and the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) in the second quarter of 2022 for active immunization against infection caused by all known subtypes of the hepatitis B virus (HBV) in adults.
About Hepatitis B
Hepatitis B is one of the world’s most significant infectious disease threats with more than 290 million people infected globally. HBV infection is the leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers. An estimated 900,000 people die each year from complications of chronic HBV such as liver decompensation, cirrhosis, and hepatocellular carcinoma.
About PreHevbri® [Hepatitis B vaccine (recombinant, adsorbed)]
PreHevbri is the only 3-antigen hepatitis B vaccine, comprised of the three hepatitis B surface antigens of the hepatitis B virus – S, pre-S1, and pre-S2. It is approved for use in the European Union/European Economic Area, the United Kingdom, the United States, and Israel. The brand names for this vaccine are: PreHevbri™ (EU/EEA/UK), PreHevbrio™ (US), and Sci-B-Vac® (Israel).
Full European Summary of Product Characteristics for PreHevbri are available from the EMA website at www.ema.europa.eu.
Please visit www.PreHevbrio.com for U.S. Important Safety Information for PreHevbrio™ [Hepatitis B Vaccine (Recombinant)], or please see U.S. Full Prescribing Information.
U.S. Indication
PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older.
U.S. Important Safety Information (ISI)
Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PreHevbrio. Immunocompromised persons, including those on immunosuppressant therapy, may have a diminished immune response to PreHevbrio. PreHevbrio may not prevent hepatitis B infection, which has a long incubation period, in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. The most common side effects (> 10%) in adults age 18-44, adults age 45-64, and adults age 65+ were pain and tenderness at the injection site, myalgia, fatigue, and headache. There is a pregnancy exposure registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy. Women who receive PreHevbrio during pregnancy are encouraged to contact 1-888-421-8808 (toll-free). To report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at 1-888-421-8808 (toll-free) or VAERS at 1-800-822-7967 or www.vaers.hhs.gov. Please see Full Prescribing Information.
About Valneva SE
Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to commercialize three vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease and the chikungunya virus.
Valneva Forward-Looking Statements
This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, results and completion of research, development and clinical trials for product candidates, its manufacturing and commercialization capabilities, and estimates for future performance. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in these materials as of this press release and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.
Website Home: http://www.vbivaccines.com/
News and Resources: http://www.vbivaccines.com/news-and-resources/
Investors: http://www.vbivaccines.com/investors/
VBI Cautionary Statement on Forward-looking Information
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to successfully manufacture and commercialize PreHevbrio/PreHevbri; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of pipeline candidates and the commercialization of PreHevbrio/PreHevbri; the ability to obtain appropriate or necessary regulatory approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 7, 2022, and filed with the Canadian security authorities at sedar.com on March 7, 2022, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.
VBI Contact
Nicole Anderson
Director, Corporate Communications & IR
Phone: (617) 830-3031 x124
Email: IR@vbivaccines.com
Valneva Contacts
Laëtitia Bachelot-Fontaine
VP Global Communications & European Investor Relations
Phone: +33 (0)6 4516 7099
Email: laetitia.bachelot-fontaine@valneva.com
Joshua Drumm, Ph.D.
VP Global Investor Relations
Phone: +1 917 815 4520
Email: joshua.drumm@valneva.com
News
Market Data
Register for streaming realtime charts, analysis tools, and prices.
