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3 months ago
Chikungunya Outbreak in La Réunion: Valneva Responds to French Government’s Call for Vaccine Supply
https://valneva.com/press-release/valneva-responds-to-french-governments-call-for-vaccine-supply-of-ixchiq-against-chikungunya-outbreak-in-la-reunion/
March 24, 2025
Saint Herblain (France), March 24, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it is responding to the chikungunya outbreak that is rapidly intensifying in France’s Island of La Réunion with its vaccine IXCHIQ®. In agreement and with support from the local public health agency, the Agence Régionale de Santé La Réunion, Valneva will provide 40,000 doses starting early April, with an option to provide more, through distribution agreements with the Island’s wholesalers. This supply of doses, paid for by the French authorities, is in line with the recommendation of France’s national public health agency, the Haute Autorité de Santé (HAS), to prioritize for vaccination adults aged 65 and over, with co-morbidities. IXCHIQ® remains available for purchase in France (mainland and overseas).
Chikungunya cases have spiked substantially in La Réunion since early 2025, with 8,600 cases recorded and almost 3,000 new cases during the week of March 3 to 9, 2025[1]. Similar to the 2005-2006 chikungunya outbreak, there is a risk of transmission to mainland France and other French overseas territories. Local authorities of La Réunion have published a Level 4 emergency crisis management plan to contain the outbreak, while the Centers for Disease Control and Prevention (CDC) agency of the United States (U.S.) also issued a travel alert as millions of international travelers visit France’s southern resorts and La Réunion Island annually.
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, “Chikungunya outbreaks spread rapidly, so it is crucial to vaccinate as many people as possible to help contain the virus. We have the capacity to supply more doses and will continue working closely with Agence Régionale de Santé La Réunion to manage this outbreak locally and prevent its spread to other regions through international travel.”
IXCHIQ® is the world’s first licensed chikungunya vaccine available to address this significant unmet medical need. It is approved in the United States[2], Europe[3], Canada[4] and the United Kingdom[5] for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. The European Medicines Agency (EMA) recently adopted a positive opinion recommending authorization of a label extension for IXCHIQ® to individuals 12 years of age and older[6].
On March 5, 2025, the Haute Autorité de Santé recommended to prioritize for vaccination adults aged 65 and over, especially those with comorbidities, followed by adults aged 18 and over with comorbidities, and vector control workers[7].
Valneva is focused on expanding the vaccine’s label and access. In the third quarter of 2024, the Company expanded its partnership with the Coalition for Epidemic Preparedness (CEPI)[8], with support from the EU Horizon Europe program, through a $41.3 million grant to advance broader access to the vaccine in Low- and Middle-Income Countries (LMICs), post-marketing studies and research to support potential label extensions in children, adolescents and pregnant women.
Within the framework of this partnership, Valneva recently announced the signing of an exclusive license agreement with the Serum Institute of India (SII)[9], the world’s largest manufacturer of vaccines by number of doses, enabling the supply of the vaccine in Asia, with a commitment to priority supply of the chikungunya vaccine at an affordable price to public health markets in LMICs.
This new agreement complements the license agreement Valneva signed in 2021 with Instituto Butantan in Brazil for the development, manufacturing and marketing of a local chikungunya vaccine at an affordable price for distribution in Latin American countries and selected LMICs affected by the disease.
p0
5 months ago
World’s First Chikungunya Vaccine, IXCHIQ
Valneva Receives Marketing Authorization in the UK for the World’s First Chikungunya Vaccine, IXCHIQ®
Valneva Receives Marketing Authorization in the UK for the World’s First Chikungunya Vaccine, IXCHIQ®
February 5, 2025
Saint Herblain (France), February 5, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in the United Kingdom (UK) for the world’s first and only chikungunya vaccine, IXCHIQ®. The single-dose vaccine is indicated for active immunization for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older. The vaccine is manufactured at Valneva’s leading vaccine production site in Livingston, Scotland.
The approval is based on IXCHIQ®’s final pivotal Phase 3 data, published in The Lancet, which included more than 4,000 participants and demonstrated that a single dose of the live-attenuated IXCHIQ® vaccine induces a rapid and strong immune response. Data has since shown this response can be maintained for at least three years in both younger and older adults[1].
The UK approval marks the fourth regulatory approval Valneva has received for its single-shot chikungunya vaccine. The vaccine is currently approved in the United States (U.S.)[2], Europe[3] and Canada[4] in adults 18 years of age and older. Valneva expects to receive marketing approval in Brazil in the first quarter of 2025, which would represent the first approval in an endemic country. Valneva submitted label extension applications to the U.S. Food and Drug Administration (FDA)[5], the European Medicines Agency (EMA) and Health Canada[6] to potentially extend the use of IXCHIQ® to adolescents aged 12 to 17 years. The Company now also plans to submit a label extension application to MHRA.
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “This latest approval is a further recognition of IXCHIQ®’s strong product profile and the medical need for a chikungunya vaccine. Travelers from the UK consistently rank among India’s largest tourist groups given cultural ties and shared history. With the current outbreak in India, it is critical to ensure UK travelers have access to this vaccine, not only for their protection when travelling to India or other chikungunya endemic countries but also to prevent potential chikungunya transmission when returning to the UK. Considering the significant risk chikungunya poses to individuals living in or traveling to endemic areas, it’s crucial to ensure that the vaccine is accessible to people of all ages and capable of potentially offering long-term protection from a single shot.”
In 2023, 920,000 UK travellers visited India[7], which recorded the second highest number of chikungunya cases worldwide over five years, with 370,000 cases reported between January 2019 and July 2024[8]. The number of cases in India is rapidly increasing due to the current outbreak in the Indian states of Maharashtra and Telangana, for which the U.S. Centers for Disease Control and Prevention (CDC) issued a travel notice after identifying higher-than-expected numbers of chikungunya cases in returning travelers[9].
Dr. Richard Hatchett, Chief Executive Officer of the Coalition for Epidemic Preparedness Innovations (CEPI), supporting late-stage development and broader access to the vaccine, commented, “In a warming world, mosquito-borne diseases like chikungunya are causing more frequent and severe outbreaks around the world, so it is vital that we keep people safe from this debilitating illness. Today’s MHRA approval of Valneva’s IXCHIQ® vaccine is an important step forward in protecting UK citizens travelling to affected countries – but the fight is not over. Our work now focusses on expanding access to vaccine doses, at an affordable price, in those endemic regions. As a major investor in CEPI, the UK Government is providing vital support to advance this goal, helping to make the vaccine accessible to those in Low- and Middle- Income Countries (LMICs) who are most at risk from the disease, while also protecting their own population.”
Valneva entered a partnership with CEPI in 2019[10], with support from the European Union (EU) Horizon program, to support late-stage development of IXCHIQ® and expand access to the vaccine for at-risk populations in affected countries. Valneva and CEPI expanded their partnership in the third quarter of 2024[11], with support from the EU, through a $41.3 million grant to advance broader access to the vaccine in LMICs, including outbreak-affected countries, post-marketing studies and research to support potential label extensions in children, adolescents and pregnant women.
Within the framework of this partnership, Valneva recently announced the signing of an exclusive license agreement with the Serum Institute of India (SII), the world’s largest manufacturer of vaccines by number of doses[12], enabling the supply of the vaccine in Asia, with a commitment to priority supply of the chikungunya vaccine at an affordable price to public health markets in LMICs. This new agreement complements the license agreement Valneva signed in 2021 with Instituto Butantan in Brazil for the development, manufacturing and marketing of a local chikungunya vaccine at an affordable price for distribution in Latin American countries and selected LMICs affected by the disease.
About Chikungunya
Chikungunya virus (CHIKV) is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes which causes fever, severe joint and muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years[13].
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[14]. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas[15] 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.[16]
https://valneva.com/press-release/valneva-receives-marketing-authorization-in-the-uk-for-the-worlds-first-chikungunya-vaccine-ixchiq/
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5 months ago
Valneva Reports Positive Phase 2 Results in Children for its Chikungunya Vaccine and Announces Phase 3 Dose Decision
https://valneva.com/press-release/valneva-reports-positive-phase-2-results-in-children-for-its-chikungunya-vaccine-and-announces-phase-3-dose-decision/
Saint-Herblain (France), January 22, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced positive results for its Phase 2 clinical trial evaluating the safety and immunogenicity of two different dose levels of its single-shot chikungunya vaccine, IXCHIQ®, in 304 children. Partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI), with support from the European Union, the trial is intended to support a pivotal Phase 3 study in children, which the Company expects to initiate in the fourth quarter of 2025, with the objective to extend the product label to this age group.
Trial VLA1553-221 met its primary endpoint, demonstrating that the vaccine was well tolerated by children aged one to eleven years regardless of the dose (half dose or full dose) or previous chikungunya infection (CHIKV), and, to a similar extent, to an active control MenACYW vaccine (Nimenrix®). Overall, the safety profile was consistent with the profile observed in Valneva’s pivotal Phase 3 trials in adults and adolescents [1],[2],[3],[4],[5]. An independent Data Safety Monitoring Board (DSMB) rigorously monitored safety data throughout the trial and confirmed the absence of any safety concerns.
Valneva’s vaccine was highly immunogenic in both dose groups. A full dose of the vaccine exhibited a more robust immune response compared to a half dose by providing protective antibody titers already at Day 15 and Day 29 post-vaccination, confirming the excellent immunogenicity previously observed in?adults and adolescents[6],[7],[8],[9],[10].
The comparability of the full and half dose in post-vaccination safety and tolerability, along with the more pronounced immune response of the full dose observed for all age groups tested in children, confirm the suitability of the full dose for this population and led to the selection of this dose (licensed IXCHIQ® formulation and presentation) for the pivotal Phase 3 evaluation in participants aged one to eleven years.
Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “These first data in children are aligned with the robust antibody response and good safety profile we reported in both adolescents and adults after a single vaccination. Considering the significant risk chikungunya poses to individuals living in or traveling to endemic areas, it’s crucial to ensure that the vaccine is accessible to people of all ages and capable of potentially offering long-term protection from a single shot. This is especially important in Low- and Middle-Income countries (LMICs) where access to vaccines is often limited.”
IXCHIQ® is the world’s first and only licensed chikungunya vaccine available to address this significant unmet medical need. It is currently approved in the U.S.[11], Europe[12], and Canada[13] in adults 18 years of age and older. Brazil has reported the highest number of chikungunya cases, with over one million cases between January 2019 and July 2024[14], followed by India with 370,000 cases during the same period. This number is rapidly increasing due to the current outbreak in the Indian states of Maharashtra and Telangana, for which the U.S. Centers for Disease Control and Prevention (CDC) issued a travel notice after identifying higher-than-expected numbers of chikungunya cases in returning travelers[15]. An active outbreak was recently declared on the French island La Reunion[16].
Valneva expects to receive marketing approval in Brazil and the United Kingdom (UK) in the first quarter of the year and submitted label extension applications to the U.S. Food and Drug Administration (FDA)[17], the European Medicines Agency (EMA) and Health Canada[18] in 2024 to potentially broaden the use of IXCHIQ® to adolescents aged 12 to 17 years. Earlier this week, the Company reported positive Phase 3 data in adolescents one year after a single vaccination, confirming the robust and long-lasting antibody response observed in adults[19].
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5 months ago
⚠ VLA-1553: Valneva Reports High Sustained Immune Response in Adolescents One Year After Single Vaccination with its Chikungunya Vaccine ⚠
nice! they'd really deserved that the corona vaccine is also a done deal.
https://valneva.com/press-release/valneva-reports-high-sustained-immune-response-in-adolescents-one-year-after-single-vaccination-with-its-chikungunya-vaccine/
January 20, 2025
Saint-Herblain (France), January 20, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported further positive Phase 3 data in adolescents for its single-shot chikungunya virus (CHIKV) vaccine, IXCHIQ®, which showed a sustained 98.3% sero-response rate one-year after single vaccination. These results support and strengthen the pivotal data previously reported for adolescents (12 to 17 years old) which supported filing for potential label extension to this age group in the U.S.[1], Europe, and Canada[2]. Data from this trial are also expected to support licensure of IXCHIQ® in Brazil, which would be the first potential approval for use in endemic populations.
The one-year VLA1553-321 data showed that a single-dose vaccination induced a high, sustained immune response in an immunogenicity subset of participants who were CHIKV negative at baseline, with a seroresponse rate of 98.3% (232 out of 236 participants) one year after vaccination (Day 360) compared to 99.1% (232 out of 234 participants) after six month[3] (Day 180) and 98.8% (248 out of 251 participants) 28 days[4],[5] after vaccination. The results complement the long-term persistence data previously reported for adults[6], confirming a strong and long-lasting antibody response to the vaccine.
Geometric mean antibody titers (GMTs) consistently surpassed the seroresponse threshold defined with the U.S. Food and Drug Administration (FDA)[7] as the surrogate of protection in baseline seronegative participants who received a single dose of the vaccine.
Additionally, the one-year data confirmed that a single dose of the vaccine was generally well tolerated in adolescents. Throughout the trial, an Independent Data Safety Monitoring Board (IDSMB) consistently assessed safety data and found no safety issues.
Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “These additional adolescent data confirm IXCHIQ®’s ability to induce a robust, long-lasting antibody response in both younger people and adults with a single vaccination. 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 and has the potential to offer long-term protection, particularly in low- and middle-income countries (LMICs) where vaccine access is often limited. We are now looking forward to the first data in children which we expect to report imminently.”
Conducted in collaboration with Instituto Butantan in Brazil and funded by the Coalition for Epidemic Preparedness Innovations (CEPI) with support from the European Union (EU)’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. This trial supported the submission of label extension applications to the U.S. Food and Drug Administration (FDA)[8], the European Medicines Agency (EMA) and Health Canada[9] to potentially extend the use of IXCHIQ® to adolescents aged 12 to 17 years. Data from this trial may support regulatory approval of the vaccine in Brazil and other countries in Latin America.
Valneva expanded its partnership with CEPI, with support from the EU’s Horizon Europe programme, in the third quarter of 2024[10] through a $41.3 million grant to advance broader access to the vaccine in LMICs, including outbreak-affected countries, post-marketing studies and potential label extensions in children, adolescents and pregnant women. Within the framework of this agreement, Valneva recently announced the signing of an exclusive license agreement with the Serum Institute of India (SII), the world’s largest manufacturer of vaccines by number of doses[11], enabling the supply of the vaccine in Asia, with a commitment to priority supply of the chikungunya vaccine at an affordable price to public health markets in LMICs.
IXCHIQ® is the world’s first and only licensed chikungunya vaccine available to address this significant unmet medical need. The vaccine is currently approved in the U.S.[12], Europe[13], and Canada[14] for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. In addition to Brazil, Valneva also expects to receive marketing approval in the United Kingdom in the first quarter of the year.
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 immunogenicity and safety data 28 days and six months after a single vaccination in 2023[15],[16] and 2024[17], respectively. Valneva’s chikungunya vaccine 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 was to evaluate the immunogenicity and safety of the adult dose of the vaccine in adolescents 28 days following a single vaccination. Secondary objectives of the trial included assessment of safety and immunogenicity up to twelve months following a single vaccination with the vaccine. 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 virus (CHIKV) is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes which causes fever, severe joint and muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years[18].
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[19]. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas[20] 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.[21]
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6 months ago
Valneva Successfully Expands Access to Asia for its Chikungunya Vaccine with Serum Institute of India
https://valneva.com/press-release/valneva-successfully-expands-access-to-asia-for-its-chikungunya-vaccine-with-serum-institute-of-india/
Saint-Herblain (France), Pune, (India), December 19, 2024 – Valneva SE (“Valneva” or “the Company”), a specialty vaccine company, and Serum Institute of India (SII), the world’s largest manufacturer of vaccines by number of doses, today announced an exclusive license agreement for Valneva’s single-shot chikungunya vaccine that enables supply of the vaccine in Asia. The collaboration to support broader access to the vaccine in low-and-middle-income countries (LMICs) in the region falls within the framework of the $41.3 million funding agreement Valneva signed with the Coalition for Epidemic Preparedness Innovations (CEPI) in July 2024 with co-funding from the European Union(1).
The companies will work urgently to bring the vaccine to the Indian market, and certain other Asian countries, subject to local regulatory approvals, as India is currently enduring one of its worst chikungunya outbreaks. Nearly 370,000 cases were confirmed in India between January 2019 and July 2024, a number rapidly increasing due to the current outbreak(2) .
Under the agreement, the Companies will conduct a technology transfer of the current drug product manufacturing process. Valneva will supply its chikungunya vaccine drug substance to?SII, which will complete manufacturing and be responsible for seeking and maintaining regulatory approval of the vaccine in India and other countries in Asia. Future commercialization will be based on a profit-sharing model along with single-digit million milestone payments towards technology transfer and regulatory approvals to Valneva.
Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “The current outbreak in India underscores the fact that containing chikungunya is an international public health priority. SII has extensive manufacturing and commercialization infrastructure and broad market reach in the Asian territory. We are very pleased to enter into this collaboration to help address this urgent medical need by accelerating further access to our highly differentiated vaccine.”
Adar Poonawalla, CEO of Serum Institute of India, said, “We are pleased to collaborate with Valneva to bring this chikungunya vaccine to India and other parts of Asia. This collaboration reflects our focus on providing effective and accessible vaccines to address pressing public health needs.”
SII, Valneva and CEPI are committed to enabling equitable access to chikungunya vaccine doses manufactured and licensed by SII for the region.
Under the terms of the agreement, SII has committed to priority supply of the chikungunya vaccine at an affordable price to public health markets in LMICs.
SII will also make available a stockpile of 100,000 doses of the drug product to CEPI as an ‘investigational ready reserve’ that could be used in clinical trials in the region. Such research could provide additional data on the performance of the vaccine among local populations.
A safety stock of up to 100,000 doses of the chikungunya vaccine will also be made available and directly accessible to CEPI, at costs incurred by CEPI, for potential use when responding to a future chikungunya outbreak in the region.
Dr Richard Hatchett, CEO of CEPI, said: “Chikungunya continues to pose a troubling and debilitating danger to the world, including in Asia, with climate change threatening to worsen its spread. Today’s new collaboration is a historic achievement which provides a crucial launchpad for the manufacture of a chikungunya vaccine in Asia, for Asia, while also enhancing regional health security and guaranteeing the priority supply of affordable doses to local populations most in need.”
Valneva’s chikungunya vaccine is the world’s first and only licensed chikungunya vaccine, currently approved in the U.S.(3), Europe(4), and Canada(5) for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. Regulatory reviews to expand the age range to individuals 12 years of age and older are currently ongoing (6,7).
Supported by CEPI and the European Union (EU)’s Horizon program, Valneva remains focused on expanding the vaccine’s access in LMICs. Under an earlier funding agreement with CEPI(8), Valneva partnered with Brazil’s Instituto Butantan (IB) to expand access to the vaccine in the Americas. Review of the marketing authorization application by the Brazilian Health Regulatory Agency (ANVISA) is ongoing.
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7 months ago
IXCHIQ: Valneva Submits Label Extension Application for its Chikungunya Vaccine, IXCHIQ®, to the U.S. FDA
https://valneva.com/press-release/valneva-submits-label-extension-application-for-its-chikungunya-vaccine-ixchiq-to-the-u-s-fda/
Saint Herblain (France), November 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has submitted a label extension application to the U.S. Food and Drug Administration (FDA) to potentially extend the use of its chikungunya vaccine IXCHIQ®, which is currently approved in adults, to adolescents aged 12 to 17 years. The application also includes adding the two-year antibody persistence data to the product label, which is a key differentiator for IXCHIQ®. This FDA application follows the submission of label extension applications to the European Medicines Agency (EMA) and Health Canada two months ago [1].
These label extension applications are based on positive adolescent Phase 3 data, which the Company reported in May 2024 [2]. These data showed that a single-dose vaccination with IXCHIQ® induces a high and sustained immune response in 99.1% of adolescents, and that the vaccine was generally well tolerated. The Lancet Infectious Diseases, a world leading infectious diseases journal, also recently published an article showing that the vaccine was well tolerated in adolescents aged 12 to 17 years 28 days after a single injection, regardless of previous CHIKV infection.
In addition to the adolescent data, the U.S. and Canadian label extension applications included IXCHIQ®’s long-term antibody persistence data, which showed that the vaccine’s immune response was sustained by 97% of participants after 24 months and was equally durable in younger and older adults [3]. These persistence data were already included in the initial EMA filing. The Company expects to publish 36-month persistence data in the coming weeks.
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “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 would certainly help provide protection and mitigate the burden of this debilitating illness which is currently spreading in areas that were previously unaffected. The long-term durability of the immune response from a single shot is also extremely important, especially for endemic countries where access to immunization can be difficult.”
IXCHIQ® is the world’s first and only licensed chikungunya vaccine available to address this significant unmet medical need. The vaccine is currently approved in the U.S.[4], Europe [5], and Canada[6] for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. It was launched in the U.S. at the beginning of March 2024, following adoption of the U.S. Advisory Committee on Immunization Practices (ACIP)’s recommendations by the U.S. Centers for Disease Control and Prevention (CDC), and launches in France and Canada are underway.
In addition to ramping up sales, Valneva is focused on expanding the vaccine’s label and access. The Company expects a marketing authorization in Brazil before the end of the year and expanded its partnership with The Coalition for Epidemic Preparedness Innovations (CEPI) earlier this year[7] to support broader access to the vaccine in Low and Middle-Income Countries (LMICs), post-marketing trials and potential label extensions in children, adolescents and pregnant women. CEPI will provide Valneva up to $41.3 million of additional funding over the next five years, with support from the European Union’s (EU) Horizon Europe 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 and muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years.[8]
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.[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 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.[11]
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, the world’s most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at www.valneva.com.
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
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7 months ago
Valneva and LimmaTech Announce First Vaccination in Phase 2b Human Challenge Study of Tetravalent Shigella Vaccine Candidate S4V2
https://valneva.com/press-release/valneva-and-limmatech-announce-first-vaccination-in-phase-2b-human-challenge-study-of-tetravalent-shigella-vaccine-candidate-s4v2/
November 13, 2024
Saint Herblain (France) and Schlieren (Zurich), November 13, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced today that the first participant has been vaccinated in a Phase 2b controlled human infection model (CHIM) study of Shigella4V2 (S4V2), the world’s most clinically advanced tetravalent bioconjugate shigellosis vaccine candidate, for which Valneva obtained an exclusive worldwide license from LimmaTech[1].
In the CHIM study S4V03 (Identifier: NCT06615375), S4V2 will be tested for safety and preliminary efficacy in approximately 120 healthy Shigella-naïve participants aged 18 to 50 years at three sites in the United States. The study, sponsored and conducted by LimmaTech, is a parallel-group, randomized, double-blind, multicenter, placebo-controlled study and will include two steps. In a first step, the vaccine dose will be confirmed and, in a second step, participants will be challenged with the Shigella sonnei strain 53G one month after injection of S4V2 or placebo, in order to assess the ability of S4V2 to protect against the Shigella infection. The infection rate of shigellosis caused by the Shigella sonnei strain 53G in the group vaccinated with S4V2 will then be compared to the group of participants who received placebo injections.
Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “Human challenge studies are unique in their ability to investigate and understand the onset and development of disease in a safe and highly controlled environment. This CHIM study forms part of our staggered and risk-mitigating development strategy for S4V2, as it should provide the first results on efficacy before potentially advancing to further CHIM and Phase 3 studies.”
Dr. Patricia Martin, Chief Operating Officer of LimmaTech, stated, “The start of this trial is a significant milestone for the S4V2 program and our combined efforts with Valneva to bring an effective vaccine against shigellosis to market. Today, we are an important step closer to LimmaTech’s vision of developing vaccines to fight against serious diseases and antimicrobial resistant pathogens.”
In addition to the CHIM study, LimmaTech will conduct a Phase 2 pediatric study in Low- and Middle-Income Countries expected to begin before the end of 2024. Valneva will assume all further development, including CMC (chemistry, manufacturing and controls) and regulatory activities, and be responsible for its commercialization worldwide, if approved.
Last month, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to S4V2, recognizing its potential to address a serious condition and fill an unmet medical need[2].
Shigellosis is the second leading cause of fatal diarrheal disease worldwide. However, there is currently no approved Shigella vaccine and the development of Shigella vaccines has been identified as a priority by the World Health Organization (WHO)[3].
About Shigellosis
Shigellosis is a global health threat caused by the Gram-negative Shigella bacteria. It is estimated that up to 165 million infections[4] are due to Shigella of which 62.3 million occur in children younger than five years. Diarrheal infection is one of the major causes of morbidity and mortality in numerous countries as well as in travelers and deployed military personnel in endemic regions. There are an estimated 600,000 deaths attributed to Shigella each year and it is the second leading cause for diarrheal deaths[5]. The standard treatment for shigellosis is oral rehydration and antibiotic therapy, however, the bacteria have acquired resistance to many antibiotics with numerous reports of outbreaks of multidrug-resistant strains, making treatment extremely difficult. Currently, no licensed Shigella vaccine is available.
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, the world’s most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at www.valneva.com.
About LimmaTech Biologics AG
LimmaTech Biologics is at the forefront of combating the global antimicrobial resistance epidemic based on its unparalleled track record in vaccine technology and clinical candidate development. The company is leveraging its proprietary self-adjuvanting and multi-antigen vaccine platform alongside additional disease-specific vaccine approaches to prevent increasingly untreatable microbial infections. With decades of expertise and an expanding, robust pipeline, the LimmaTech team is dedicated to generating protective solutions to deliver transformative value worldwide. LimmaTech Biologics is backed by specialist healthcare investors, including Adjuvant Capital, AXA IM Alts, Novo Holdings REPAIR Impact Fund, and Tenmile.
For more information, please visit www.lmtbio.com.
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8 months ago
Shigella4V (S4V): (time to "xplode" pls ,-) - ehm Saint Herblain (France) and Schlieren (Zurich), October 16, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Shigella4V (S4V), the world’s most clinically advanced tetravalent bioconjugate shigellosis vaccine candidate, for which Valneva obtained an exclusive worldwide license from LimmaTech.
Fast Track designation is granted by the FDA to products under development that have the potential to treat serious conditions and fill an unmet medical need. It is designed to facilitate the clinical development and expedite the review of important new products with the intention to get them to the people who need them earlier[1].
Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “Shigellosis is the second leading cause of fatal diarrheal disease worldwide. However, there is currently no approved Shigella vaccine and the development of Shigella vaccines has been identified as a priority by the World Health Organization (WHO). Fast Track designation allows us to work closely with the FDA to accelerate our efforts to deliver a preventative solution against this deadly disease.”
Dr. Franz-Werner Haas, Chief Executive Officer of LimmaTech, stated, “We are highly encouraged by the FDA’s Fast Track designation, which reinforces our efforts and underscores the significant potential of the S4V Shigella vaccine candidate to address a serious global health threat.”
It is estimated that up to 165 million cases of disease and an estimated 600,000 deaths are attributed to Shigella each year, particularly among children in Low- and Middle-Income Countries (LMICs). Shigellosis also affects international travelers from high-income countries and deployed military personnel in endemic regions.
In August 2024, Valneva entered into a strategic partnership and exclusive licensing agreement with LimmaTech [2] for the development, manufacturing and commercialization of S4V. Following positive Phase 1/2 results[3] earlier this year, LimmaTech will conduct a Phase 2 Controlled Human Infection Model study (CHIM) in the U.S. and a Phase 2 pediatric study in LMICs, both expected to begin before the end of 2024. Valneva will assume all further development, including CMC (chemistry, manufacturing and controls) and regulatory activities, and be responsible for its commercialization worldwide, if approved.
The anticipated regulatory pathway for S4V will leverage a combination of CHIM studies to support potential initial approval in adults followed by field efficacy studies to potentially expand the indication to children.
About Shigellosis
Shigellosis is a global health threat caused by the Gram-negative Shigella bacteria. It is estimated that up to 165 million infections[4] are due to Shigella of which 62.3 million occur in children younger than five years. Diarrheal infection is one of the major causes of morbidity and mortality in numerous countries as well as in travelers and deployed military personnel in endemic regions. There are an estimated 600,000 deaths attributed to Shigella each year and it is the second leading cause for diarrheal deaths[5]. The standard treatment for shigellosis is oral rehydration and antibiotic therapy, however, the bacteria have acquired resistance to many antibiotics with numerous reports of outbreaks of multidrug-resistant strains, making treatment extremely difficult. Currently, no licensed Shigella vaccine is available.
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, the world’s most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at www.valneva.com.
About LimmaTech Biologics AG
LimmaTech Biologics is at the forefront of combating the global antimicrobial resistance epidemic based on its unparalleled track record in vaccine technology and clinical candidate development. The company is leveraging its proprietary self-adjuvanting and multi-antigen vaccine platform alongside additional disease-specific vaccine approaches to prevent increasingly untreatable microbial infections. With decades of expertise and an expanding, robust pipeline, the LimmaTech team is dedicated to generating protective solutions to deliver transformative value worldwide. LimmaTech Biologics is backed by specialist healthcare investors, including Adjuvant Capital, AXA IM Alts, Novo Holdings REPAIR Impact Fund, and Tenmile.
For more information, please visit www.lmtbio.com.
https://valneva.com/press-release/valneva-and-limmatech-awarded-fda-fast-track-designation-for-tetravalent-shigella-vaccine-candidate-s4v/
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9 months ago
Valneva to Host Investor Day in New York on Thursday, October 10, 2024 at 10:00 AM ET
October 3, 2024
Saint Herblain (France), October 3, 2024 –Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it will host an investor day at the Lotte New York Palace Hotel in New York, NY on Thursday, October 10, 2024 at 10:00 AM ET (4:00 pm CET).
The meeting will be conducted in a hybrid way – in person and webcast. To register, click here.
The event will focus on Valneva’s robust R&D pipeline of potentially first-, only-, or best-in-class vaccine candidates addressing major unmet medical needs in infectious disease: Lyme disease (Phase 3, led by Pfizer), Shigella (Phase 2), and Zika (Phase 1). It will also highlight Valneva’s growing portfolio of revenue-generating vaccines, including the launch of the world’s first and only approved vaccine against chikungunya virus.
Speakers from Company management will include Thomas Lingelbach, Chief Executive Officer and member of the Board of Directors, as well as other members of the Management Team.
A live question and answer session will follow the formal presentation.
https://valneva.com/press-release/valneva-to-host-investor-day-in-new-york-on-thursday-october-10-2024-at-1000-am-et/
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9 months ago
Valneva Submits Label Extension Applications for its Chikungunya Vaccine, IXCHIQ®, to EMA and Health Canada
https://valneva.com/press-release/valneva-submits-label-extension-applications-for-its-chikungunya-vaccine-ixchiq-to-ema-and-health-canada/
Saint Herblain (France), September 18, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has submitted label extension applications to the European Medicines Agency (EMA) and Health Canada to potentially expand the use of its chikungunya vaccine, IXCHIQ®, to adolescents aged 12 to 17 years in Europe and Canada. The Canadian label extension application also includes two-year antibody persistence data, which is a key differentiator for IXCHIQ® that was already included in the initial EMA filing. Valneva expects to submit data to the U.S. Food and Drug Administration (FDA) this year to also support potential label extensions in the U.S.
IXCHIQ® is the world’s first and only licensed chikungunya vaccine available to address this significant unmet medical need. The vaccine is currently approved in the U.S.[1], Europe[2], and Canada[3] for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. The U.S. launch is underway while first sales in Canada and Europe are anticipated in the fourth quarter of 2024.
In addition to ramping up sales, Valneva is focused on expanding the vaccine’s label and access. The Company expects a marketing authorization in Brazil in the second half of 2024 and recently expanded its partnership with The Coalition for Epidemic Preparedness Innovations (CEPI)[4] to support broader access to the vaccine in Low Middle-Income Countries (LMICs), post-marketing trials and potential label extensions in children, adolescents and pregnant women. CEPI will provide Valneva up to $41.3 million of additional funding over the next five years, with support from the European Union’s (EU) Horizon Europe program.
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “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 would certainly help provide protection and mitigate the burden of this debilitating illness which is currently spreading in areas that were previously unaffected. The durability of the immune response is also extremely important, especially for endemic countries where access to immunization can be difficult.”
EMA and Health Canada’s label extension applications are based on positive six-month adolescent Phase 3 data which the Company reported in May 2024[5]. These data showed that a single-dose vaccination with IXCHIQ® induces a high and sustained immune response in 99.1% of adolescents, and that the vaccine was generally well tolerated. The Lancet Infectious Diseases, a world leading infectious diseases journal, also recently published an article showing that the vaccine was well tolerated in adolescents aged 12 to 17 years 28 days after a single injection, regardless of previous CHIKV infection.
In addition to the adolescent data, Health Canada’s label extension application included IXCHIQ®‘s antibody persistence data which showed that the vaccine’s immune response was sustained for 24 months by 97% of participants and was equally durable in younger and older adults[6]. The Company expects to publish 36 months persistence data later this year.
About Chikungunya
Chikungunya virus (CHIKV) is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes which causes fever, severe joint and muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years.[7]
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.[8] Between 2013 and 2023, more than 3.7 million cases were reported in the Americas[9] 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.[10]
p0
9 months ago
€60 Million. Valneva Announces the Success of its Private Placement Raising approximately €60 Million
Saint-Herblain (France), September 13, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (“Valneva” or the “Company”), a specialty vaccine company, today announces the successful pricing of its Private Placement (as defined below) for a final amount of €61,180,000.
Peter Bühler, Valneva’s Chief Financial Officer, commented, “We would like to thank our existing shareholders for their continued support, as well as the new healthcare specialist investors joining us through this raise. In addition to supporting our current commercial and R&D activities, this additional capital will give us greater flexibility to invest in our future growth, including in the Shigella vaccine program for which we recently acquired an exclusive worldwide license”.
Context of the Offering
The Issuer intends to use the net proceeds of the Private Placement primarily to fund the continuing development of the Company’s clinical programs which include notably the Phase 3 pediatric and Phase 4 programs for the chikungunya vaccine as well as the anticipated Phase 2 programs for the Shigella and Zika vaccine candidates. A portion of the net proceeds will also be used for the further commercialization of the Company’s existing chikungunya vaccine, IXCHIQ®, to fund the acceleration of the Company’s pre-clinical research and development activities and for general corporate purposes. Valneva believes this new funding will provide greater flexibility to invest in its future growth, including in its Shigella vaccine program for which it recently obtained an exclusive worldwide license.
The Company believes it will have sufficient resources to finance its operational business, excluding debt repayment, until potential milestone and commercial revenues from its program against the Lyme disease enable the Company to operate in a sustained profitable way.
Conclusion of the Lyme disease VALOR Phase trial 3 is still expected by the end of 2025, with the aim for Pfizer to submit a Biologic License Application (BLA) to the Food and Drug Administration and a Marketing Authorization Application (MAA) to the European Medicine Agency in 2026, subject to positive data.
At the end of June 2024, the Company’s debt amounted to $200 million. Reimbursements of the first $100 million tranche will start in January 2026 and mature in the first quarter of 2027. Reimbursements of the second $100 million tranche will start in the first quarter of 2027 and mature in the fourth quarter of 2028.
Terms of the Private Placement
A total of 23,000,000 new ordinary shares (the “Offer Shares”), each with a nominal value of €0.15, have been issued at a price of €2.66 each, without shareholders’ preferential subscription rights, (i) to a limited number of institutional investors within the United States, or that are U.S. persons (as defined in Regulation S (“Regulation S”) of the Securities Act of 1933, as amended (the “Securities Act”)) who have represented that they are qualified institutional buyers (as defined in Rule 144A under the Securities Act) in an offering exempt from registration under Section 4(a)(2) of the Securities Act, and (ii) outside of the United States to non-U.S. persons in an offering exempt from registration under Regulation S, in the European Union (including France) to qualified investors within the meaning of Article 2(e) of Regulation 2017/1129 of the European Parliament and of the Council of 14 June 2017, as amended (the “Prospectus Regulation”) and outside of the European Union (with the exception of the United States, Australia and Japan), in each case for the benefit of categories of investors defined by the 33rd resolution of the Company’s combined ordinary and extraordinary general shareholders’ meeting of 26 June 2024 (“General Meeting”) (the “Private Placement”).
Dilution
The Offer Shares represent 16.5% of the Company’s share capital on a non-diluted basis prior to the completion of the Private Placement and 14.2% of the Company’s share capital on a non-diluted basis following the Private Placement. By way of illustration a shareholder holding 1% of the share capital of the Company prior to the launch of the Private Placement will now hold an interest of 0.86%.
Breakdown of the share capital before the Private Placement
Shareholder Shares % Capital Voting Rights % of Voting Rights
Groupe CDC 13,539,703 9.72% 22,159,181 14.21%
Pfizer Inc. 9,554,395 6.86% 9,549,761 6.13%
Groupe Grimaud La Corbière 6,744,702 4.84% 12,949,533 8.31%
Polar Capital 5,423,702 3.89% 5,423,702 3.48%
Free Float 104,014,399 74.68% 105,812,191 67.87%
Total 139,276,901 100.00% 155,894,368 100.00%
Breakdown of the share capital after the Private Placement
Shareholder Shares % Capital Voting Rights % of Voting Rights
Groupe CDC 14,089,703 8.68% 22,709,181 12.69%
Pfizer Inc. 9,554,395 5.89% 9,549,761 5.34%
Polar Capital 8,123,702 5.01% 8,123,702 4.54%
Groupe Grimaud La Corbière 6,744,702 4.16% 12,949,533 7.24%
Braidwell LP 5,400,000 3.33% 5,400,000 3.02%
Free Float 118,364,399 72.94% 120,162,191 67.17%
Total 162,276,901 100.00% 178,894,368 100.00%
Admission to trading of the Offer Shares
The settlement and delivery of the Offer Shares to be issued in the Private Placement and their admission to trading on the regulated market of Euronext Paris (“Euronext Paris”) are expected on September 17, 2024. Other than being “restricted securities” in the United States, the Offer Shares will be of the same category and fungible with the existing ordinary shares, will be entitled to all rights associated with the existing ordinary shares and will be admitted to trading on Euronext Paris under the same ISIN as the existing ordinary shares: ISIN FR0004056851.
Lock-Up Commitments
In connection with the Private Placement, the Company, members of the management and of the Board of Directors have signed a lock-up commitment pursuant to which they have each agreed to a lock-up period of 90 days following the settlement and delivery of the Private Placement, subject to certain customary exceptions.
Financial Intermediaries
Jefferies GmbH and Bryan, Garnier & Co are acting as Joint Global Coordinators and Joint Bookrunners in connection with the Private Placement.
Risk Factors
Attention is drawn to the risk factors associated with the Company and its activity presented in section 1.5 of the universal registration document registered with the French Financial Market Authority (Autorité des Marchés Financiers) (the “AMF”) on March 22, 2024 under number D.24-0157 as updated in chapter I.5 of the Company’s interim financial report for the first half of 2024 published and filed with the AMF on August 13, 2024, which are available free of charge on the Company’s website (https://valneva.com/investors). The occurrence of all or part of these risks could have a negative impact on the Company’s activity, financial situation, results, development or outlook.
Additionally, investors are invited to consider the following risks specific to this Private Placement: (i) the market price of the Company’s shares may fluctuate and fall below the subscription price of the Offer Shares, (ii) the volatility and liquidity of the Company’s shares may fluctuate significantly, (iii) sales of the Company’s shares may take place on the market and have a negative impact on the market price of its shares,(iv) the Company’s shareholders could suffer potentially significant dilution resulting from any future capital increases required to provide the Company with additional financing and (v) the Company has broad discretion in the use of the net proceeds from the Private Placement.
Prospectus
The Private Placement is not subject to a prospectus requiring an approval from the AMF.
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10 months ago
VLA15-221 Phase 2: Positive Phase 2 Booster Results for Lyme Disease Vaccine Candidate - Valneva and Pfizer Report ...
https://valneva.com/press-release/valneva-and-pfizer-report-further-positive-phase-2-booster-results-for-lyme-disease-vaccine-candidate/
September 3, 2024
VLA15-221 Phase 2 study: strong immune response shown one month after a second booster dose (month 31) in pediatric and adult populations
Significant anamnestic antibody response observed across all six serotypes, consistent with previous results
Favorable safety profile of VLA15 observed in all age groups and for all vaccinations
Saint-Herblain (France) and New York, NY, September 3, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) and Pfizer Inc. (NYSE: PFE) announced today positive immunogenicity and safety data from their VLA15-221 Phase 2 study following a second booster vaccination of their Lyme disease vaccine candidate, VLA15, given one year after receiving the first booster dose. The immune response and safety profile of VLA15 one month after receiving the second booster dose were similar to those reported after receiving the first booster dose, showing compatibility with the anticipated benefit of a booster vaccination prior to each Lyme season. There are currently no approved human vaccines for Lyme disease, and VLA15 is the Lyme disease vaccine candidate which has advanced the furthest along the clinical development timeline, with two Phase 3 trials in progress. The Centers for Disease Control and Prevention (CDC) has estimated that approximately 476,000 people in the U.S. are diagnosed and treated for Lyme disease each year and 129,000 cases are reported annually in Europe.1,2
These latest results from the VLA15-221 Phase 2 study again demonstrated a significant anamnestic antibody response across all six serotypes covered by the vaccine candidate in pediatric (5 to 11 years of age) and adolescent (12 to 17 years of age) participants, as well as in adults (18 to 65 years of age), measured one month after administration of this second booster dose (month 31). A high proportion of participants seroconverted after the second booster dose, yielding seroconversion rates* (SCRs) above 90% for all outer surface protein A (OspA) serotypes in all age groups, in-line with SCRs after the first booster. Geometric Mean Titers at one month post first and second booster (i.e. month 19 vs. month 31) were comparably high.
The participants of this Phase 2 study received VLA15 or placebo during the primary vaccination phase in two immunization schedules (month 0-2-6 or month 0-6), followed by a first booster dose at month 18 and a second booster dose at month 30.
Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “We are encouraged by these data, which support the potential benefit of booster doses across all examined age groups. As Lyme disease continues to spread, it represents a significant unmet medical need, affecting numerous individuals throughout the Northern Hemisphere. Each new set of positive data brings us one step closer to potentially bringing this vaccine to both adults and children living in areas where Lyme disease is endemic.”
The safety and tolerability profile of VLA15 after a second booster dose was comparable to the profile observed after the first booster. To date, no safety concerns were observed by an independent Data Monitoring Committee (DMC) in any treatment or age group.
“Personal preventive behaviors are currently the only recommended strategies to help protect yourself from Lyme disease. These data from the VLA15-221 study are an important step towards a potential vaccine that could help prevent the disease and ease the burden of acute, severe and sometimes persistent consequences,” said Annaliesa Anderson, Ph.D., Senior Vice President and Head Vaccine Research and Development at Pfizer. “Together with our partner Valneva, we look forward to progressing our vaccine candidate in the ongoing Phase 3 clinical trials.”
In August 2022, Pfizer and Valneva initiated the currently ongoing Phase 3 clinical study, Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524), 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 (U.S.) and Europe.3 The primary vaccination series for all participants was completed in July 2024.4 A second Phase 3 study (VLA15-1012), aiming to provide further evidence on the safety profile of VLA15 in the pediatric population, is also ongoing.
Pfizer aims to submit 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 Phase 3 data.
About VLA15
VLA15 is an investigational multivalent protein subunit vaccine that 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 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). 560 healthy participants received either VLA15 in two immunization schedules (month 0-2-6 [N=190] or month 0-6 [N=181]) or placebo (month 0-2-6 [N=189]). Vaccine recipients received VLA15 at a dose of 180 µg, which was selected based on data generated in two previous Phase 2 studies. The main safety and immunogenicity readout (primary endpoint) was performed one month after completion of the primary series vaccination schedule. All eligible subjects received booster doses of VLA15 or placebo at month 18 and 30 (booster phase) and will be followed for an additional year to monitor antibody persistence. In addition, all eligible subjects will be asked to receive another booster dose of VLA15 or placebo at month 42, in order to assess the effect of periodic booster doses.
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 prior 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 infected Ixodes ticks.5 It is considered the most common vector-borne illness in the Northern Hemisphere.6,7 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), heart (carditis) or nervous system.8,9 The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens.10
p0
11 months ago
Valneva and LimmaTech Enter into a Strategic Partnership to Accelerate the Development of the World’s Most Clinically Advanced Tetravalent Shigella Vaccine Candidate
August 1, 2024
Valneva obtains exclusive worldwide license for LimmaTech’s S4V Shigella vaccine candidate and adds an attractive Phase 2 clinical asset to Valneva’s R&D pipeline
LimmaTech to receive upfront payment, is eligible for future milestone and royalty payments, and will collaborate on S4V clinical development through Phase 2
Valneva will host a live webcast on this announcement at 3 p.m. CEST/9 a.m. EDT today. Please refer to this link: https://edge.media-server.com/mmc/p/ck932u2n
Saint-Herblain (France) and Schlieren (Zurich), August 1, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company and LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, today announced that the companies have entered into a strategic partnership and exclusive licensing agreement for the development, manufacturing and commercialization of Shigella4V (S4V), a tetravalent bioconjugate vaccine candidate against shigellosis.
Shigellosis, caused by Shigella bacteria, is the second leading cause of fatal diarrheal disease worldwide. It is estimated that up to 165 million cases of disease and an estimated 600,000 deaths are attributed to Shigella each year[1], particularly among children in Low- and Middle-Income Countries (LMICs). No approved Shigella vaccine is currently available and the development of Shigella vaccines has been identified as a priority by the World Health Organization (WHO)[2]. Shigellosis also affects international travelers from high-income countries and deployed military personnel in endemic regions. The global market for a vaccine against Shigella is estimated to exceed $500 million annually[3].
Under the terms of the agreement with Valneva, LimmaTech will receive an upfront payment of €10 million and be eligible to receive additional regulatory, development and sales-based milestone payments as well as low double-digit royalties on sales. LimmaTech will be responsible for conducting a Phase 2 Controlled Human Infection Model (CHIM) and a Phase 2 pediatric study in LMICs. Both clinical trials are expected to begin in the second half of 2024. Valneva will assume all further development, including CMC (chemistry, manufacturing and controls) and regulatory activities, and be responsible for its commercialization worldwide if approved.
Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “We are very pleased to partner with LimmaTech to advance a promising program in an area of high unmet medical need. The Shigella vaccine candidate enables a potential first-in-class vaccine solution for both LMICs and travelers and, as such, represents a potentially highly synergistic product for Valneva. The anticipated development path follows a staggered and risk-mitigated strategy, and hence allows an efficient capital allocation in line with our communicated plan of having a new R&D program in Phase 3 by 2027.”
Dr. Franz-Werner Haas, Chief Executive Officer of LimmaTech, said, “Having developed the S4V Shigella vaccine candidate from its early discovery phase to the promising clinical data we achieved to date, we are excited to accelerate the program with our partnership with Valneva. Their proven expertise in late-stage development and commercialization of vaccines will expedite potential market approval and bring a Shigella vaccine to people in need. This agreement underscores our capabilities to leverage LimmaTech’s proficiency in vaccine development with the best path to develop programs rapidly. We continue to expand our pipeline of vaccine candidates to combat microbial-based infectious diseases, providing protection against antimicrobial resistance, a dramatically increasing global health threat.”
LimmaTech initiated the tetravalent Shigella vaccine candidate and continued to lead its development as part of its ongoing collaboration with GSK, and later in-licensed the vaccine candidate from GSK. In February 2024, LimmaTech reported positive interim Phase 1/2 data for the S4V vaccine candidate, including a favorable safety and tolerability profile as well as robust data on immunogenicity against the four most common pathogenic Shigella serotypes, S. flexneri 2a, 3a, 6, and S. sonnei[4]. The results of the completed Phase 1/2 study confirmed the interim data.
About Shigellosis
Shigellosis is a global health threat caused by the Gram-negative Shigella bacteria. It is estimated that up to 165 million infections[5] are due to Shigella of which 62.3 million occur in children younger than five years. Diarrheal infection is one of the major causes of morbidity and mortality in numerous countries as well as in travelers and deployed military personnel in endemic regions. There are an estimated 600,000 deaths attributed to Shigella each year and it is the second leading cause for diarrheal deaths[6]. The standard treatment for shigellosis is oral rehydration and antibiotic therapy, however, the bacteria have acquired resistance to many antibiotics with numerous reports of outbreaks of multidrug-resistant strains, making treatment extremely difficult. Currently, no licensed Shigella vaccine is available.
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.
About LimmaTech Biologics AG
LimmaTech Biologics is at the forefront of combating the global antimicrobial resistance epidemic based on its unparalleled track record in vaccine technology and clinical candidate development. The company is leveraging its proprietary self-adjuvanting and multi-antigen vaccine platform alongside additional disease-specific vaccine approaches to prevent increasingly untreatable microbial infections. With decades of expertise and an expanding, robust pipeline, the LimmaTech team is dedicated to generating protective solutions to deliver transformative value worldwide. LimmaTech Biologics is backed by specialist healthcare investors, including Adjuvant Capital, AXA IM Alts, Novo Holdings REPAIR Impact Fund, and Tenmile.
For more information, please visit www.lmtbio.com.
Contacts
For Valneva
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
For LimmaTech
LimmaTech Biologics AG
Franz-Werner Haas, CEO
E-mail: media@lmtbio.com
For media enquiries
Trophic Communications
Sara Ortiz or Jacob Verghese
Phone: +49 151 7441 6179
E-mail: limmatech@trophic.eu
https://valneva.com/press-release/valneva-and-limmatech-enter-into-a-strategic-partnership-to-accelerate-the-development-of-the-worlds-most-clinically-advanced-tetravalent-shigella-vaccine-candidate/
p0
11 months ago
(!) CEPI Expands Partnership with Valneva with a $41.3 Million Grant
https://valneva.com/press-release/cepi-expands-partnership-with-valneva-with-a-41-3-million-grant-to-support-broader-access-to-the-worlds-first-chikungunya-vaccine/
July 22, 2024
Valneva to receive up to $41.3 million from CEPI and the European Union to expand access to chikungunya vaccine, IXCHIQ®
Funding will support clinical trials in vulnerable groups, such as children and pregnant women
Partnership will also support technology transfer to an additional manufacturer to supply IXCHIQ® to Asian LMICs
IXCHIQ® is already approved for use in adults 18 years of age and older in the U.S., Canada and Europe
Oslo, Norway, and Saint-Herblain, France, July 22, 2024—The Coalition for Epidemic Preparedness Innovations (CEPI) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, have expanded their partnership to support broader access to the world’s first chikungunya vaccine, IXCHIQ®, in Low- and Middle-Income countries (LMICs), as well as post-marketing trials and potential label extensions in children, adolescents and pregnant women.
CEPI will provide Valneva up to U.S. $41.3 million of additional funding over the next five years, with support from the European Union’s (EU) Horizon Europe programme. The project will help generate additional data to potentially support extended IXCHIQ® labels in chikungunya- endemic countries and vulnerable populations at risk of being infected with this debilitating mosquito-borne disease.
Several thousand participants are set to take part in the planned trials, due to start in 2025. The research will include assessment of the vaccine in children aged 1-11 and pregnant women in countries that may be affected by a chikungunya outbreak. Some trials are planned to be conducted in Brazil, which is currently facing a significant chikungunya outbreak with over 340,000 cases reported so far this year.
The expanded partnership strengthens an earlier agreement[1] which awarded Valneva U.S. $24.6 million in CEPI-EU funding to develop, manufacture, and market its single-shot vaccine in certain LMICs affected by chikungunya. Under this initial agreement, Valneva partnered with Brazil’s Instituto Butantan (IB) in 2021 and conducted an adolescent clinical trial in Brazil to support licensure of the vaccine in this country, which would be the first potential approval for use in endemic populations, as well as label extension in this age group in the U.S. and other territories. Review of the marketing authorization application for IXCHIQ® by the Brazilian Health Regulatory Agency (ANVISA) is ongoing with potential approval in 2024. IB is committed to providing the chikungunya vaccine it will develop and produce in Brazil at an affordable price for distribution in Latin American countries and selected LMICs.
CEPI-EU funding will also support technology transfer of the vaccine drug product to an additional vaccine manufacturer to accelerate and expand access to IXCHIQ® in Asian LMICs that are vulnerable to chikungunya outbreaks.
Dr Richard Hatchett, Chief Executive Officer of CEPI, said, “Millions of people have been affected by chikungunya and, today, over a billion people live in areas where chikungunya outbreaks occur. Access to an affordable chikungunya vaccine in areas where the burden of disease is the greatest is a joint priority for CEPI, Valneva and our European Union partners. These clinical studies and tech transfer to an additional endemic-region manufacturer will accelerate endemic country access, inform future vaccine rollout strategies and alleviate the burden of future chikungunya outbreaks.”
Thomas Lingelbach, Chief Executive Officer of Valneva, said, “We are extremely pleased to strengthen our partnership with CEPI. Chikungunya infection is a major unmet medical need, and we believe that our single-dose vaccine is uniquely positioned to help protect people living in areas where chikungunya occurs and for travelers to these regions. With climate change, more areas across the world are becoming habitable for the mosquito vectors that transmit the virus, thereby increasing the size of the human population at risk of infection.”
Esper Kallás, Director of Instituto Butantan, said, “Arboviruses have become an increasing concern worldwide, due to climate change, which favors the adaptation of mosquitoes in other environments. This is highly relevant, and Butantan’s effort to codevelop the chikungunya vaccine aligns with our mission to address public health problems not only in Brazil but worldwide.”
The European Commission’s Laurent Muschel, Head of HERA, and Irene Norstedt, Director at DG Research and Innovation, said“Access to medical countermeasures for the most vulnerable, such as the vaccine against Chikungunya, is a key priority for the EU when it comes to health emergency preparedness and response. €38 million have been mobilised under Horizon Europe, the Union’s funding programme for research, in partnership with CEPI, to support clinical studies on the effectiveness of Valneva’s new vaccine in low- and middle-income countries. Such vaccine, authorised in the EU since last month, also strongly contributes to improving preparedness against vector-borne diseases, that due to climate change, may expand to non-endemic regions such as the EU. Support for research is essential and the EU remains committed to strengthening global health.”
IXCHIQ® was granted approval in the U.S. in November 2023[2] and in Canada and Europe in June 2024[3],[4]. Regulatory reviews for IXCHIQ® are ongoing in Brazil and the United Kingdom.
—ENDS—
About the trials
Pending approvals, the new chikungunya vaccine trials will evaluate:
Effectiveness of IXCHIQ® in Brazil – Part-funded by CEPI and the European Union’s (EU) Horizon Europe programme, as part of a larger development program with over 120,000 participants assessing chikungunya in vaccinated and unvaccinated populations, as a measure of vaccine effectiveness
Efficacy of IXCHIQ® in an outbreak setting in a LMIC – Part- funded by CEPI and the European Union’s (EU) Horizon Europe programme as part of a trial in 20,000 participants to determine vaccine efficacy in a randomised-controlled trial outside of Brazil
Safety and immunogenicity of IXCHIQ® in pregnant women in Brazil
Optimal IXCHIQ® doses in children aged 1-11 in a low- and middle-income country in Latin America
Safety and immunogenicity of IXCHIQ® in children aged 1-11 in a LMIC, potentially located in Asia
Trial partners, including clinical research organisations and trial sponsors, are expected to be selected over the coming months.
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.[5]
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.[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 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 risk.[8]
About CEPI
CEPI was launched in 2017 as an innovative partnership between public, private, philanthropic and civil organizations. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need. CEPI has supported the development of more than 50 vaccine candidates or platform technologies against multiple known high-risk pathogens or a future Disease X. Central to CEPI’s pandemic-beating five-year plan for 2022-2026 is the ‘100 Days Mission’ to compress the time taken to develop safe, effective, globally accessible vaccines against new threats to just 100 days.
Learn more at CEPI.net. Follow us on Twitter (@CEPIvaccines), LinkedIn and Facebook.
p0
12 months 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
12 months ago
Valneva Announces Successful Outcome of its Combined General Meeting and Appointment of a New Director to its Board
https://valneva.com/press-release/valneva-announces-successful-outcome-of-its-combined-general-meeting-and-appointment-of-a-new-director-to-its-board/
Saint-Herblain (France), June 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that all the resolutions recommended by the Board of Directors were approved by the shareholders at its Combined General Meeting (CGM) held today in Lyon, France.
Among the adopted resolutions were approval of the 2023 financial statements, delegations for the management board to increase Valneva’s share capital and/or issue financial instruments, and the appointment of a new director to its Board.
Ms. Danièle Guyot-Caparros was appointed to Valneva’s Board of Directors for a three-year term. Ms. Guyot-Caparros has a proven track record in finance and business operations. She started her career in Audit and Corporate Finance with PWC specializing in the Chemical/Pharma Industry. In 1992, she joined Rhône-Poulenc-Rorer (later Aventis and Sanofi) where she held several senior finance positions (CFO Global R&D, CFO Europe, Group Planning). She also held responsibilities in business development, pricing, and portfolio management. In 2008, she became Senior Advisor for Deloitte France to support the development of the Life Sciences and Health Care Industry practice. Ms. Guyot-Caparros is also an experienced non-executive director with a focus on Biotech/Medtech. She sat on Diaxonhit’s (now Eurobio Scientific) and ONXEO’s Board of Directors and chaired Supersonic Imagine’s and ONXEO’s audit committees. In October 2022, she joined the board of DBV Technologies, listed on Euronext Paris and Nasdaq, and is member of the audit committee as well as of the compensation committee. She is a graduate from ICN (Institut Commercial de Nancy), with a major in finance and accounting. She holds a chartered accountant degree and a certificate of corporate governance/non-executive director from IFA-Science-Po.
The AGM’s voting results will be made available in the “Investors & Media” section of Valneva’s corporate website in the coming days.
p0
1 year 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
1 year 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.”
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