Dynavax Announces First Participants Dosed in Phase 1 Clinical Trial Evaluating Clover Biopharmaceuticals’ COVID-19 S-Trime...
June 19 2020 - 6:00AM
Dynavax Technologies Corporation (Nasdaq: DVAX), a
biopharmaceutical company focused on developing and commercializing
novel vaccines, announced today that the first participants have
been dosed in the Phase 1 clinical trial to evaluate Clover
Biopharmaceuticals’ vaccine candidate to prevent COVID-19 that
contains the Company’s CpG 1018 adjuvant.
In this previously announced collaboration,
Clover is advancing its COVID-19 S-Trimer vaccine (SCB-2019), which
is based on Clover’s proprietary Trimer-Tag© vaccine technology
platform, while Dynavax is providing the Company’s proprietary
toll-like receptor 9 (TLR9) agonist adjuvant, CpG 1018.
“We are proud to contribute CpG 1018 to this
global effort to rapidly develop an adjuvanted vaccine to prevent
COVID-19,” commented Ryan Spencer, Chief Executive Officer of
Dynavax. “CpG 1018’s ability to enhance the immune response, as
successfully demonstrated in HEPLISAV-B, is expected to reduce the
dose of antigen needed, helping ensure broader availability to
patients. Additionally, an adjuvanted vaccine may be especially
important for older adults and people with chronic conditions who
are traditionally less responsive to vaccination and have the
greatest risk of severe disease and death from COVID-19.”
The study is a Phase 1 randomized, double blind,
placebo controlled, first-in-human (FIH) study to assess safety,
reactogenicity, and immunogenicity of SCB-2019 at multiple dose
levels, administered as 2 intramuscular (IM) injections in
approximately 90 adult healthy subjects 18 to 54 years of age and
approximately 60 elderly healthy subjects 55 to 75 years of age.
The trial and Clover’s COVID-19 vaccine program are being
supported by funding and collaboration with the Coalition for
Epidemic Preparedness Innovations (CEPI).
The Phase 1 study will evaluate SCB-2019 alone,
SCB-2019 in combination with Dynavax’s CpG 1018 adjuvant combined
with alum, and SCB-2019 in combination with a different adjuvant.
Based on preclinical results demonstrating the ability of CpG
1018-adjuvanted SCB-2019 to elicit neutralizing antibodies in
multiple animal species, the collaboration has been expanded to
include clinical supply of CpG 1018 to Clover. Preliminary safety
and immunogenicity results of the study are expected in August
2020.
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 8.2 million people and has
caused over 445,000 reported deaths (as of June 18, 2020). It has
been declared a pandemic by the World Health Organization
(WHO). Currently there is no vaccine available for
COVID-19.
About COVID-19 S-Trimer
VaccineUtilizing Trimer-Tag© technology, S-Trimer is a
trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate.
Similar to other enveloped RNA viruses such as HIV, RSV and
Influenza, SARS-CoV-2 is also an RNA virus that has a trimeric
spike (S) protein on its viral envelope. The trimeric S protein of
SARS-CoV-2 is responsible for binding to host cell surface receptor
ACE2 and subsequent viral entry, making it the primary target
antigen for vaccine development. S-Trimer resembles the native
trimeric viral spike protein and is produced via a rapid mammalian
cell-culture based expression system.
About Clover
BiopharmaceuticalsChina based Clover Biopharmaceuticals is
a global, clinical-stage, research-based biotechnology company
focused on discovering, developing and commercializing
transformative biologic therapies, with a focus on oncology and
autoimmune diseases, as well as viral vaccines. Having raised more
than US$ 200 million in total capital since 2016, Clover is
utilizing its proprietary Trimer-Tag© technology platform to
develop novel biologics targeting trimerization-dependent pathways.
Additionally, Clover is leveraging its in-house cGMP
biomanufacturing capabilities to develop select biosimilars. For
more information, please visit: www.cloverbiopharma.com.
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. 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
further developing CpG 1018 as an advanced vaccine adjuvant through
research collaborations and partnerships. Current
collaborations are focused on adjuvanted vaccines for COVID-19 and
pertussis. For more information, visit www.dynavax.com and follow
the company on LinkedIn.
Forward-Looking StatementsThis
press release contains "forward-looking" statements, including
statements regarding the potential to develop a COVID-19 vaccine
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, when
clinical trial results will be obtained and what they will
demonstrate, whether and when the vaccine will be approved for use,
and whether the Company will be able to manufacture sufficient
quantities of CpG 1018 to meet demand, 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 (SEC). 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.
Contacts - DynavaxNicole Arndt, Senior Manager,
Investor Relationsnarndt@dynavax.com510-665-7264
Derek Cole, President Investor Relations Advisory Solutions
derek.cole@IRadvisory.com
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