Gritstone bio Announces Update to Comparative Phase 2b COVID-19 Clinical Trial
February 12 2024 - 7:00AM
Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology
company working to develop the world’s most potent vaccines, today
announced that it is now preparing to launch the Phase 2b
head-to-head trial of its next-generation COVID-19 vaccine in the
Fall of 2024 rather than 1Q24. This is to allow use of fully
GMP-grade raw materials in the vaccine, which is expected to
increase the regulatory utility of the trial.
“After recent communication with the FDA and input from our
colleagues at BARDA, we are now making the necessary preparations
to begin the Phase 2b study later this year using fully GMP-grade
materials in the manufacture of our self-amplifying mRNA (samRNA)
vaccine,” said Andrew Allen, MD, PhD, Co-founder President &
CEO of Gritstone bio. “The change likely increases the regulatory
value of this large study, is expected to improve study
interpretability, and may enable us to contemporaneously address
the latest seasonal variant. We would like to thank the FDA for
their collaboration and BARDA for their teamwork in support of this
study, which aims to help deliver to the world a broader and more
durable vaccine against COVID-19.”
This project has been supported in whole or in part with federal
funds from the U.S. Department of Health and Human Services;
Administration for Strategic Preparedness and Response; Biomedical
Advanced Research and Development Authority (BARDA), under contract
number 75A50123C00062.
About the CORAL-BARDA studyThe CORAL-BARDA
study is an intended 10,000 participant, randomized Phase 2b
double-blinded study to compare the efficacy, safety, and
immunogenicity of Gritstone bio’s next-generation COVID-19 vaccine
candidate with an approved COVID-19 vaccine. The goal of this study
is to determine whether Gritstone bio’s next-generation vaccine
candidate, a self-amplifying mRNA (samRNA) vaccine, can provide
better and longer protection against COVID-19 than the currently
FDA-approved vaccines.
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
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 next-generation COVID-19 vaccine, the timing of
commencement of our CORAL-BARDA study and our belief regarding the
use of GMP-grade raw materials in the vaccine manufacturing process
and its impact on the regulatory utility of our CORAL-BARDA trial;
our expectations regarding the data to be derived in our ongoing
and planned clinical trials; our ability to discover, develop,
manufacture and advance product candidates into, and successfully
complete, clinical trials, including, in particular, our
next-generation COVID-19 vaccine. 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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