Gritstone bio Awarded BARDA Contract to Conduct Comparative Phase 2b Study Evaluating Next-Generation Vaccine Candidate for COVID-19 Valued at up to $433 Million
27 Settembre 2023 - 10:01PM
Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology
company working to develop the world’s most potent vaccines,
announced today that it was awarded a contract by the Biomedical
Advanced Research and Development Authority (BARDA) to conduct a
Phase 2b comparative study evaluating Gritstone’s self-amplifying
mRNA (samRNA) vaccine candidate containing Spike plus other viral
targets to protect against COVID-19. The agreement, which is valued
at up to $433 million, was awarded as part of ‘Project NextGen,’ an
initiative by the U.S. Department of Health and Human Services
(HHS) to advance a pipeline of new, innovative vaccines and
therapeutics providing broader and more durable protection for
COVID-19.
Under the contract, Gritstone bio will conduct a 10,000
participant, randomized Phase 2b double-blinded study to compare
the efficacy, safety, and immunogenicity of the Gritstone
next-generation COVID-19 vaccine candidate with an approved
COVID-19 vaccine. Preparations for the study are underway, and
execution of the study will be fully funded by
BARDA. Gritstone will run the study in the United States in
collaboration with the COVID-19 Prevention Network (CoVPN), a
NIAID-supported network of clinical trial sites based at Fred
Hutchinson Cancer Center with experience conducting large COVID-19
vaccine trials.
“We are honored to receive this award from BARDA to advance our
next-generation samRNA vaccine against COVID-19 (the CORAL
program), which provides strong validation of our innovative
vaccine platform in infectious diseases. Not only does this
contract supply the necessary resources to advance the development
of CORAL, but it also signifies the trust and confidence the U.S.
government has placed in our novel vaccine approach,” said Andrew
Allen, M.D., Ph.D., Co-founder, President, and Chief Executive
Officer of Gritstone bio. “First-generation COVID-19 vaccines
provided great utility during the height of the pandemic but are
limited in breadth and durability of clinical protection. CORAL was
designed to address these limitations by inducing durable
neutralizing antibody and T cell-based immunity against current and
future SARS-CoV-2 variants. Across multiple Phase 1 studies, our
samRNA vaccine, which incorporates both Spike and other viral
targets (Spike plus), has demonstrated induction of potent immune
responses with potential to drive broad and durable clinical
protection – this potential will now be tested in a randomized
setting. We are excited about this opportunity to work alongside
BARDA and look forward to initiating the Phase 2b study
(CORAL-BARDA) in the first quarter of 2024. With CORAL moving into
a randomized Phase 2 study alongside our personalized cancer
vaccine program (GRANITE), Gritstone now sits at the precipice of
unlocking the full potential of our novel vaccine platforms in both
oncology and infectious diseases.”
This project has been funded with Federal funds from the
Department of Health and Human Services; Office of the Assistant
Secretary for Preparedness and Response; Biomedical Advanced
Research and Development Authority, under Contract No.
75A50123C00062.
About the CORAL ProgramGritstone’s CORAL
program is applying Gritstone’s infectious disease approach for the
prevention of COVID-19. The program aims to drive both B cell and T
cell immunity using self-amplifying mRNA (samRNA) and novel
immunogens containing Spike plus additional viral targets. To date,
the CORAL program has comprised three Phase 1 trials evaluating
multiple samRNA vaccine candidates across various patient
populations and settings: CORAL-BOOST (healthy volunteers following
primary series of currently approved COVID-19 vaccines); CORAL-CEPI
(vaccine-naïve healthy and HIV+ subjects in South Africa); and
CORAL-NIH (run by the National Institute of Allergy and Infectious
Disease [NIAID] in previously vaccinated healthy volunteers).
Results to date have demonstrated induction and persistence of high
neutralizing antibody levels through at least 6 months as well as
broad T cell responses. The CORAL program is supported by
Biomedical Advanced Research and Development Authority (BARDA),
NIAID, the Coalition for Epidemic Preparedness Innovations (CEPI)
and the Bill & Melinda Gates Foundation.
About Self-amplifying mRNA (samRNA)
Self-amplifying mRNA (samRNA) is rapidly emerging as a
well-tolerated, scalable and widely-applicable platform technology
which can be used to develop multiple vaccines simply by changing
the sequence of the antigen (the target of the immune system) that
is encoded in the vector RNA and delivered in a lipid nanoparticle.
Like traditional mRNA vaccines, samRNA vaccines use the host cell’s
translation system to convert mRNA to protein target antigens in
order to stimulate immunity. Unlike traditional mRNA, samRNA
creates multiple copies of the antigen RNA once in the cell,
potentially leading to extended duration and magnitude of antigen
expression. Gritstone designs novel immunogens, the vaccine regions
encoding virus antigens, and includes both Spike antigen (similar
to first-generation COVID-19 vaccines) and evolutionarily
conserved, non-Spike antigens likely to drive T cell responses in
its next-generation COVID-19 vaccines. Potential benefits of this
samRNA “Spike plus” approach include (1) strong and durable
induction of neutralizing antibodies to Spike, (2) broad and
durable T cell immunity (CD4+ and CD8+) to multiple viral proteins,
(3) potency at lower doses (dose sparing), and (4) refrigerator
stability.
About Gritstone bioGritstone bio, Inc. (Nasdaq:
GRTS) is a clinical-stage biotechnology company that aims to
develop the world’s most potent vaccines. We leverage our
innovative vectors and payloads to train multiple arms of the
immune system to attack critical disease targets. Independently and
with our collaborators, we are advancing a portfolio of product
candidates to treat and prevent viral diseases and solid tumors in
pursuit of improving patient outcomes and eliminating disease.
www.gritstonebio.com.
Gritstone Forward-Looking StatementsThis
press release contains forward-looking statements, including, but
not limited to, statements related to our clinical and regulatory
development plans for our product candidates; our expectations
regarding the data to be derived in our ongoing and planned
clinical trials; the timing of commencement of our future
nonclinical studies, clinical trials and research and development
programs; our ability to discover, develop and advance product
candidates into, and successfully complete, clinical trials; and
our plans and strategy regarding maintaining existing and entering
into new collaborations and/or partnerships. Such forward-looking
statements involve substantial risks and uncertainties that could
cause Gritstone’s research and clinical development programs,
future results, performance or achievements to differ significantly
from those expressed or implied by the forward-looking statements.
Such risks and uncertainties include, among others, the
uncertainties inherent in the drug development process, including
Gritstone’s programs’ clinical stage of development, the process of
designing and conducting preclinical and clinical trials, the
regulatory approval processes, the timing of regulatory filings,
the challenges associated with manufacturing drug products,
Gritstone’s ability to successfully establish, protect and defend
its intellectual property and other matters that could affect the
sufficiency of existing cash to fund operations. Gritstone
undertakes no obligation to update or revise any forward-looking
statements. For a further description of the risks and
uncertainties that could cause actual results to differ from those
expressed in these forward-looking statements, as well as risks
relating to the business of the company in general, see Gritstone’s
most recent Annual Report on Form 10-K filed on March 9,
2023 and any subsequent current and periodic reports filed
with the Securities and Exchange Commission.
Gritstone ContactsInvestors:George E.
MacDougallGritstone bio, Inc.ir@gritstone.com
Media:Dan Budwick1AB(973) 271-6085dan@1abmedia.com
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