Dynavax Announces First Participants Dosed in Phase 1 Clinical Trial Evaluating Medicago’s COVID-19 Vaccine Candidate with ...
July 14 2020 - 8:00AM
Dynavax Technologies Corporation (Nasdaq: DVAX), a
biopharmaceutical company focused on developing and commercializing
novel vaccines, announced today that the first participants have
been dosed in the Phase 1 clinical trial evaluating Medicago’s
plant-derived vaccine candidate adjuvanted with CpG 1018 to prevent
COVID-19.
The previously announced collaboration is
evaluating the combination of Medicago’s Coronavirus Virus-Like
Particle (CoVLP) with Dynavax’s CpG 1018, the adjuvant contained in
Dynavax’s U.S. FDA-approved adult hepatitis B vaccine. Adding
CpG 1018 is intended to enhance the immune response of Medicago’s
COVID-19 vaccine which may reduce the amount of antigen required
per dose, providing more doses to help protect a greater number of
people.
“We are committed to supporting the development
of an adjuvanted vaccine to prevent COVID-19,” commented Ryan
Spencer, Chief Executive Officer of Dynavax. “CpG 1018’s ability to
enhance the immune response, as successfully demonstrated in
HEPLISAV-B, is expected to reduce the dose of antigen needed,
helping ensure broader availability to patients. Additionally, the
unique mechanism of action of CpG 1018 may provide important
enhancements including increased protection in populations
traditionally less responsive to vaccination such as older adults
who are at greatest risk for severe disease from COVID-19.”
The study is a Phase 1 randomized,
partially-blinded, prime-boost, staggered dose-escalation study
intended to assess the safety, tolerability, and immunogenicity of
the Coronavirus-Like Particle COVID-19 Vaccine at three dose levels
(3.75 µg, 7.5 µg, and 15 µg VLP) unadjuvanted or adjuvanted with
either CpG 1018, or another company’s adjuvant, in approximately
180 healthy subjects 18 to 55 years of age, who have been tested
for the absence of SARS-CoV-2 antibodies. Preliminary safety
and immunogenicity results are expected in October 2020.
Medicago is also planning a Phase 2/3 trial to be initiated this
October.
Medicago’s innovative plant-based production
platform will be used to manufacture the COVID-19 vaccine antigen.
This platform uses plants as mini-factories which create proteins
that self-assemble into the virus-like particles that are used in
the CoVLP vaccine candidate. Combining Medicago’s technology with
Dynavax’s CpG 1018 adjuvant, the companies expect to be able to
deliver up to 100 million doses by the end of 2021. By the end of
2023, Medicago expects to complete the construction of a
large-scale manufacturing facility in Quebec City, Canada that
Medicago anticipates will have the capacity to produce up to 1
billion vaccine doses annually. About Vaccine
AdjuvantsAn adjuvant is a pharmacological or immunological
agent that modifies the effect of other agents. Adjuvants are added
to a vaccine to boost the immune response to produce more
antibodies and longer-lasting immunity, thus reducing the dose of
antigen needed. Adjuvants may also be used to enhance the efficacy
of a vaccine by helping to modify the immune response by particular
types of immune system cells.
About CpG 1018 AdjuvantCpG 1018
is the adjuvant used in HEPLISAV-B® [Hepatitis B Vaccine
(Recombinant), Adjuvanted], an adult hepatitis B vaccine approved
by the U.S. Food and Drug Administration (FDA). Dynavax developed
CpG 1018 to provide an increased vaccine immune response, which has
been demonstrated in HEPLISAV-B. In pre-clinical and clinical
studies, results demonstrated that the addition of CpG 1018
increases antibody concentrations, stimulates helper (CD4+) and
cytotoxic (CD8+) T cell populations and generates robust T and B
cell memory responses. Additionally, CpG 1018 strongly favors
development of the Th1 subset of helper T cells, the type of helper
T cell that is essential for protection from infections with
viruses and intracellular bacteria. CpG 1018 targets a single, well
defined receptor (TLR9) expressed on only a few key cell types and
the mechanisms of action as an adjuvant are quite well
understood. CpG 1018 provides a well- developed technology
and a significant safety database, potentially accelerating the
development and large-scale manufacturing of a COVID-19
vaccine. Upon completion of on-going scale up activities, the
existing equipment capacity for CpG 1018 will be 600 million to 1.2
billion adjuvant doses annually, depending on final dose
selected.
About DynavaxDynavax is a
commercial stage biopharmaceutical company developing and
commercializing novel vaccines. The Company launched its first
commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant),
Adjuvanted], in February 2018, following U.S. FDA approval for
prevention of infection caused by all known subtypes of hepatitis B
virus in adults age 18 years and older. Dynavax is also
further developing CpG 1018 as an advanced vaccine adjuvant through
research collaborations and partnerships. Current
collaborations are focused on adjuvanted vaccines for COVID-19 and
pertussis. For more information, visit www.dynavax.com and follow
the company on LinkedIn.
About MedicagoMedicago is a
biopharmaceutical company headquartered in Quebec City with
production sites in Quebec, Canada and Durham, North Carolina, USA.
Medicago’s mission is to improve global health outcomes by
leveraging innovative plant-based technologies for rapid responses
to emerging global health challenges. Medicago is committed to
advancing therapeutics against life-threatening diseases worldwide.
For more information please visit www.medicago.com.
About the Novel Coronavirus SARS-CoV-2
(and COVID-19 Disease)SARS-CoV-2 is a new coronavirus
identified in late 2019 which belongs to a family of enveloped RNA
viruses that include MERS and SARS, both of which caused serious
human infections of the respiratory system. The virus causes
a disease named COVID-19. Since this outbreak was first reported in
late 2019, the virus has infected over 12.7 million people and has
caused over 566,000 reported deaths (as of July 13, 2020). It has
been declared a pandemic by the World Health Organization
(WHO). Currently there is no vaccine available for
COVID-19.
Forward-Looking StatementsThis
press release contains "forward-looking" statements, including
statements regarding the potential to develop a COVID-19 vaccine
containing CpG 1018, and to do so on an accelerated basis.
Actual results may differ materially from those set forth in this
press release due to the risks and uncertainties inherent in
vaccine research and development, including the timing of
completing development, the timing and results of clinical trials,
whether CpG 1018 is proven to be beneficial when combined with
Medicago’s CoVLP, whether and when the vaccine will be
approved for use, and whether sufficient quantities of CpG 1018 and
of vaccine timely will be able to be manufactured, as well as other
risks detailed in the "Risk Factors" section of our Annual Report
on Form 10-K for the fiscal year ended December 31, 2019, as well
as discussions of potential risks, uncertainties and other
important factors in our other filings with the U.S. Securities and
Exchange Commission. We undertake no obligation to revise or update
information herein to reflect events or circumstances in the
future, even if new information becomes available. Information on
Dynavax's website at www.dynavax.com is not incorporated by
reference in our current periodic reports with the SEC.
Contacts - DynavaxNicole Arndt, Senior Manager,
Investor Relationsnarndt@dynavax.com510-665-7264
Derek Cole, President Investor Relations Advisory Solutions
derek.cole@IRadvisory.com
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