TAPEI, Taiwan and EMERYVILLE, Calif., Oct. 13, 2020 /PRNewswire/ -- Medigen
Vaccine Biologics Corporation (MVC) (TPEx: 6547.TWO), a
biopharmaceutical company focusing on the development and
production of vaccines and biologics, and Dynavax Technologies
Corporation (Nasdaq: DVAX), a biopharmaceutical company
focused on developing and commercializing novel vaccines, today
announced that MVC has obtained a Taiwan government subsidy for successfully
initiating a Phase 1 clinical trial in Taiwan. The first
participant in MVC's Phase 1 clinical trial was dosed with MVC's
COVID-19 vaccine combined with Dynavax's CpG 1018 adjuvant at
National Taiwan University Hospital in early October. The subsidy
will be released at agreed upon milestones in the total amount of
up to NT$ 472 million (US$ 16.4 million). The grant received by MVC was
earmarked by the Taiwan government
for purposes of research and development of a locally produced
COVID-19 vaccine.
MVC's Phase 1 study is an open-label, single-center,
staggered dose-escalation study intended to assess the safety and
immunogenicity of the stable prefusion form of SARS-CoV-2
recombinant spike protein S-2P at three dose levels (low, medium
and high) adjuvanted with CpG 1018 plus alum, in approximately 45
healthy subjects 20 to 50 years of age. The vaccination schedule
consists of two doses for each study participant, administered via
intramuscular (IM) injection 28 days apart, on Day 1 and Day
29.
"The pre-clinical study results demonstrated that the
combination of our S-2P vaccine candidate and CpG 1018 plus alum
provided safety and immunogenicity sufficient to advance to Phase 1
development," said Charles Chen,
Chief Executive Officer of MVC. "We are pleased with the
pre-clinical data and the potential to demonstrate clinical benefit
and have a positive impact fighting this global pandemic motivates
our team to undertake the clinical development ahead."
"Dynavax is proud to be working with MVC as they begin the Phase
1 trial for an adjuvanted vaccine candidate to help prevent
COVID-19," commented Ryan Spencer,
Chief Executive Officer of Dynavax. "Based on the preclinical
studies the combination of S-2P and CpG 1018 plus alum has the
potential to provide critical enhancements to the immune response
to drive increased protection for adults, especially those who are
traditionally less responsive to vaccination and 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).
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. 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.
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 further developing CpG 1018 as an advanced 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 MVC
MVC is a biopharmaceutical company using
cell-based technologies for the development of vaccines and
biosimilars. With a goal of national self-sufficiency, MVC also
aims to provide vaccines and biopharmaceuticals to meet regional
needs and with a desire to help globally against the threats of
infectious diseases. MVC's pipeline includes enterovirus EV71
vaccine, dengue vaccine, influenza quadrivalent vaccine which all
have entered late clinical stage. MVC's large-scale production
facility is state of the art and adherent to
international PIC/s and GMP requirements. 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 19.9 million people and has
caused over 732,000 reported deaths (as of August 11, 2020). It has been declared a pandemic
by the World Health Organization (WHO). Currently there
is no vaccine available for COVID-19.
Dynavax Forward-Looking
Statements
This press release
contains "forward-looking" statements, including statements
regarding the potential to develop a COVID-19 vaccine containing
CpG 1018. 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 plus aluminum 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 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.
Medigen Contact:
Paul Torkehagen
Director, Overseas Business Development
paul@medigenvac.com
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
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SOURCE Dynavax Technologies