HYDERABAD, India
and HOUSTON and EMERYVILLE,
Calif., Nov. 16, 2020
/PRNewswire/ -- Biological E. Limited (BE), a
Hyderabad-based vaccines and
pharmaceutical company, Dynavax Technologies Corporation
(NASDAQ: DVAX), a US-based vaccine focused biopharmaceutical
company, and Baylor College of
Medicine, a health sciences university in Houston, TX, today announced that BE has
initiated a Phase I/II clinical trial of its COVID-19 subunit
vaccine candidate in India
following approval from the Drugs Controller General of
India (DGCI).
The vaccine candidate includes an antigen in-licensed from BCM
Ventures, Baylor College of Medicine's
integrated commercialization team, along with Dynavax's advanced
adjuvant CpG 1018.
BE's Phase I/II clinical trial will evaluate the safety and
immunogenicity of the vaccine candidate consisting of the Receptor
Binding Domain of the Spike Protein of SARS-CoV-2 at
three dose levels adjuvanted with CpG 1018 plus alum, in about
360 healthy subjects in the age range of 18 to 65 years. The
vaccination schedule consists of two doses for each study
participant, administered via intramuscular injection 28 days
apart.
The results of this clinical trial are expected to be available
by February 2021.
"The transition of our vaccine candidate into human trials is an
important milestone, and exemplifies a successful transfer of
technology with BE, that could lead to a safe, effective and
affordable vaccine," said Dr. Maria Elena
Bottazzi, associate dean of the National School of Tropical
Medicine at Baylor College of Medicine
and co-director of Texas Children's Hospital Center for Vaccine
Development.
"This vaccine represents an urgent biotechnology innovation for
ensuring health equity and combating the COVID-19 pandemic," said
Dr. Peter Hotez, professor and dean
of the National School of Tropical Medicine at Baylor and
co-director of Texas Children's Hospital Center for Vaccine
Development.
"We are very happy indeed to transition our potential vaccine
candidate to clinical trials and offer one more potential option
for the prophylaxis of COVID-19," said Ms. Mahima Datla, Managing Director, Biological E.
Limited.
"We are proud to contribute CpG 1018 to support development of
an adjuvanted vaccine to prevent COVID-19. CpG 1018's
potential to boost the immune response to produce more antibodies
and longer lasting immunity may also minimize the dose of antigen
needed, enabling vaccination of a greater number of people,"
commented Ryan Spencer, Chief
Executive Officer of Dynavax.
About Biological E. Limited
Biological E. Limited
(BE), a Hyderabad-based
Pharmaceuticals & Biologics Company founded in 1953, is the
first private sector biological products company in India and the first pharmaceutical company in
Southern India. BE develops,
manufactures and supplies vaccines and therapeutics. BE supplies
its vaccines to over 100 countries and its therapeutic products are
sold in India and the USA. BE currently has 8 WHO-prequalified
vaccines in its portfolio.
In recent years, BE has embarked on new initiatives for
organisational expansion such as developing generic injectable
products for the regulated markets, exploring synthetic biology and
metabolic engineering as a means to manufacture APIs sustainably
and developing novel vaccines for the global market.
For further details, please visit www.biologicale.com and follow
us on Facebook, LinkedIn and Twitter.
About Baylor College of
Medicine
Baylor College of
Medicine (www.bcm.edu) in Houston is recognized as a health sciences
university and is known for excellence in education, research and
patient care. It is the only private medical school in the greater
southwest and is ranked 22nd among medical schools for
research and 4th for primary care by U.S. News &
World Report. Baylor is listed 21th among all U.S.
medical schools for National Institutes of Health funding and No. 1
in Texas. The Baylor pediatrics
program ranked 6th among all pediatric programs,
reflecting the strong affiliation with Texas Children's Hospital
where our faculty care for pediatric patients and our students and
residents train. Located in the Texas Medical Center, Baylor has
affiliations with seven teaching hospitals and jointly owns and
operates Baylor St. Luke's Medical Center, part of CHI St. Luke's
Health. Currently, Baylor has more than 3,000 trainees in medical,
graduate, nurse anesthesia, physician assistant, orthotics and
genetic counseling as well as residents and postdoctoral fellows.
Follow Baylor College of Medicine on
Facebook and Twitter.
About BCM Ventures
Baylor College
of Medicine Ventures is the commercial engine of
the health sciences university, created to support the translation
of academic knowledge and intellectual assets for the benefit of
society. We do this by engaging university innovators,
entrepreneurs and industry to fully develop ideas along their best
commercial path. We foster a culture of commercialization and
engage with industry to identify market opportunities for
collaborative ventures. To learn more about partnering with BCM
Ventures and accessing our available technologies, contact
bcmventures@bcm.edu.
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.
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'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 global
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
antigen in BE's subunit vaccine candidate will prove to be
beneficial in clinical trials, whether use of CpG 1018 will reduce
the amount of antigen required per dose, 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.
Media Contacts:
Baylor College of
Medicine
|
Dynavax
|
Biological E.
Limited
|
Molly Chiu
|
Nicole
Arndt
|
Vijay Amruth
Raj
|
Molly.chiu2@bcm.edu
|
narndt@dynavax.com
|
Vijay.kammari@biologicale.com
|
713-798-4710
|
Derek Cole
|
+91 83740
77433
|
www.bcm.edu/news
|
derek.cole@IRadvisory.com
|
www.biologicale.com/news
|
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SOURCE Dynavax Technologies