Dynavax and Medigen Announce Collaboration to Develop a Novel Adjuvanted COVID-19 Vaccine Candidate
July 23 2020 - 8:00AM
Dynavax Technologies Corporation (Nasdaq: DVAX), a
biopharmaceutical company focused on developing and commercializing
novel vaccines, and Medigen Vaccine Biologics Corporation (MVC)
(TPEx: 6547.TWO), a biopharmaceutical company focusing on the
development and production of vaccines and biologics, today
announced their collaboration to develop an adjuvanted vaccine
candidate to protect against COVID-19. The collaboration is
evaluating the combination of MVC’s stable prefusion form of the
SARS-CoV2 recombinant spike protein with Dynavax’s advanced
adjuvant CpG 1018™, the adjuvant contained in Dynavax’s U.S.
FDA-approved adult hepatitis B vaccine.
“The COVID-19 pandemic is straining healthcare
systems across the globe, making a safe, effective and affordable
vaccine an important tool in combatting the disease and protecting
patients, especially for low and middle-income countries (LMICs),”
said Charles Chen, Chief Executive Officer of Medigen. “In
preclinical testing, the combination of Dynavax’s proven adjuvant
with our recombinant spike protein vaccine candidate generated
strong virus neutralizing antibody responses and cellular immunity.
These results support advancing evaluation of the combination into
Phase 1 human testing, which we expect to begin in September of
this year.”
“Combining our technology with Medigen’s
reinforces the collaborative approach needed to address this
pandemic,” commented Ryan Spencer, Chief Executive Officer of
Dynavax. “CpG 1018 is expected to enhance the immune response and
may play an important role in developing an effective vaccine,
especially for populations traditionally less responsive to
vaccination such as older adults who are at greatest risk for
severe disease from COVID-19.”
MVC’s subunit vaccine is based on the stable prefusion form of
the SARS-CoV2 recombinant spike protein with global technology
license from the U.S Vaccine Research Center at National Institutes
of Health (NIH). Preclinical studies demonstrated that the vaccine
candidate adjuvanted with CpG 1018 generated strong immune
responses in experimental animals.
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 minimizing 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 advancing
CpG 1018 as a premier vaccine adjuvant through research
collaborations and partnerships. Current collaborations are focused
on adjuvanted vaccines for COVID-19, pertussis and universal
influenza. For more information, visit www.dynavax.com and follow
the company on LinkedIn.
About MedigenMVC is a
cell-based biopharmaceutical company focusing on the development
and production of vaccines and biologics. MVC’s business partners
include US NIH, US CDC, UCAB, Taiwan CDC, and Taiwan National
Health Research Institute. MVC’s pipeline includes enterovirus EV71
vaccine, dengue vaccine, influenza quadrivalent vaccine which all
entered late clinical stage. For more information, visit
www.medigenvac.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 14.7 million people and has
caused over 612,000 reported deaths (as of July 22, 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, whether CpG 1018 combined with MVC’s subunit vaccine
will prove to be beneficial in clinical trials, whether and when
the vaccine will be approved for use, and whether sufficient
quantities of CpG 1018 and of vaccine 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.
Dynavax Contacts:Nicole Arndt, Senior Manager,
Investor Relationsnarndt@dynavax.com510-665-7264
Derek Cole, President Investor Relations Advisory Solutions
derek.cole@IRadvisory.com
Medigen Contact:Paul Torkehagen, Director,
Overseas Business Developmentpaul@medigenvac.com
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