News2020-07-24
Medigen Collaborates with Dynavax to Develop Novel Adjuvanted COVID-19 Vaccine Candidate

Dynavax and Medigen Announce Collaboration to
Develop a Novel Adjuvanted COVID-19
Vaccine Candidate

Jul 23, 2020

  • Collaboration focused on developing an adjuvanted COVID-19 vaccine using
    Medigen’s subunit vaccine candidate with Dynavax’s CpG 1018

  • In preclinical testing, the combination generated strong virus neutralizing
    antibody responses

  • Medigen anticipates initiating a Phase 1 clinical trial evaluating the
    combination in September 2020
 

EMERYVILLE, Calif. and TAPEI, Taiwan, July 23, 2020 (GLOBE NEWSWIRE) -- 
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 Adjuvants
An 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 Adjuvant
CpG 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 Dynavax
Dynavax 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 Medigen
MVC 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 Statements
This 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 Relations
narndt@dynavax.com
510-665-7264

Derek Cole, President
Investor Relations Advisory Solutions
derek.cole@IRadvisory.com

Medigen Contact:
Paul Torkehagen, Director, Overseas Business Development
paul@medigenvac.com 

For more information, please visit Dynavax’ website : https://investors.dynavax.com