PUNE, India and EMERYVILLE, Calif., Dec. 23, 2020 /PRNewswire/ -- Further
strengthening its fight against COVID-19, Serum Institute of
India (SIIPL), the world's
largest vaccine manufacturer by volume, has partnered with Dynavax
Technologies Corporation (Nasdaq: DVAX) a biopharmaceutical
company focused on developing and commercializing novel vaccines,
and today jointly announced that the first participants have been
dosed in the Phase 1 part of the Phase 1/2 clinical trial
evaluating SIIPL's vaccine candidate adjuvanted with CpG
1018 to prevent COVID-19.
The Phase 1/2 clinical trial will evaluate the safety and
immunogenicity of SIIPL's vaccine candidate consisting of the
SARS-COV-2 virus receptor binding domain (RBD) delivered as a
virus-like particle (VPL), along with Dynavax's advanced adjuvant
CpG 1018 plus alum. The Phase 1 portion of the clinical trial will
enroll 39 healthy volunteers and post the completion of the study a
decision will be taken regarding the dosing of up to 216 subjects
in Phase 2.
Sharing his thoughts, Adar Poonawalla, Chief
Executive Officer, Serum Institute of India, said, "The
collaboration with Dynavax is our effort in developing and
exploring avenues to bolster our fight against the pandemic. We are
hopeful that delivering the CpG 1018 adjuvant in the vaccine will
enhance the immune response of the candidate. Through this we seek
to provide our expertise and capability to produce large quantities
of affordable vaccine to supply global needs."
Ryan Spencer, Chief Executive
Officer, Dynavax commented, "We are pleased to be
partnering with Serum Institute of India to advance their approach to leverage a
VLP utilizing the receptor binding domain of the SARS-COV-2 spike
protein. We believe continued development of multiple programs is
critical to ensure the availability of safe and effective vaccines
that can protect the global population from this devastating
disease in the near term and for years to come."
About Serum Institute of India Pvt. Ltd.
(SIIPL):
Driven by the philanthropic philosophy of
affordable vaccines, Serum Institute of India Pvt, Ltd.
(SIIPL) is the world's largest vaccine manufacturer by number
of doses produced and sold globally (more than 1.5 billion doses),
supplying the world's cheapest and WHO accredited vaccines to as
many as 170 countries. It was founded in 1966 with the aim of
manufacturing lifesaving immunobiological drugs including vaccines
worldwide. With a strong commitment towards global health, the
institute's objective has been proliferated by bringing down the
prices of newer vaccines such as such as Diphtheria, Tetanus,
Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps and Rubella
vaccines. SII is credited with bringing world-class technology to
India, through its
state-of-the-art equipped multifunctional production facility in
Manjri, Pune; association with
Zipline and government agencies to transform emergency medicine and
critical care along with spearheading the race of vaccine
development against the COVID-19 pandemic.
About CpG 1018
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's first commercial product, HEPLISAV-B®
[Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the
U.S. 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.
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 combined with the
Serum's antigen vaccine candidate will prove to be beneficial in
clinical trials, whether use of CpG 1018 in the vaccine will
enhance the immune response and help accelerate the development and
large scale manufacturing of a COVID-19 vaccine, 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.
For more details please contact:
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
SIIPL
Mayank Sen
mayank@moes-art.com
+919867974055
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SOURCE Dynavax Technologies