Gritstone bio Announces Publication of Interim Results from Phase 1 Study of Self-amplifying mRNA (samRNA) Vaccine Against COVID-19 in Nature Communications
08 Junho 2023 - 8:00AM
Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology
company that aims to develop the world’s most potent vaccines,
today announced that interim results from an ongoing Phase 1 study
evaluating the company’s self-amplifying mRNA (samRNA) vaccine as a
boost against COVID-19 (CORAL-BOOST) were published in Nature
Communications. The results, which demonstrate
that Gritstone’s samRNA vaccine candidate boosted immunity for
at least 6 months in previously vaccinated older adults, are
generally consistent with initial results from a separate Phase 1
study in previously unvaccinated subjects (CORAL-CEPI). Gritstone
is currently evaluating multiple samRNA candidates across three
ongoing Phase 1 studies. All candidates deliver full-length Spike
and selected conserved non-Spike T cell epitopes with the aim of
driving a potent, broad, and durable immune response against the
virus.
“Publication of these results in Nature Communications supports
the scientific rigor of our work and potential clinical utility of
our next-generation vaccine platform for the prevention of
infectious diseases, including coronaviruses, such as COVID-19,”
said Andrew Allen, M.D., Ph.D., Co-founder, President and Chief
Executive Officer of Gritstone. “The published results are part of
a rapidly growing body of evidence demonstrating the potential
advantages of samRNA over first-generation COVID-19 vaccines,
including extended antigen expression and dose sparing potential.
It’s clear that new technologies are needed to help prevent and
manage future pandemics, and we believe the results we are seeing
from our CORAL program represent a promising step forward in this
endeavor.”
The publication details interim analyses from a Phase 1
dose-escalation trial evaluating Gritstone's samRNA candidate
(GRT-R910) in previously vaccinated healthy older adults
(CORAL-BOOST/NCT05148962). Results demonstrate a favorable safety
and tolerability profile in this vulnerable population. Most
adverse events (AEs) following dosing were mild to moderate and
transient with no treatment-related serious AEs observed. With
respect to immunogenicity, neutralizing antibody titers against
ancestral Spike and variants of concern were boosted by the samRNA
candidate, and contrasting to authorized vaccines, persisted
through at least 6 months following the booster dose. Furthermore,
Gritstone's samRNA increased and potentially broadened functional
Spike-specific T cell responses and primed T cell responses to
conserved non-Spike epitopes.
“The ability of a next-generation vaccine candidate to drive
more potent, durable, and broad neutralizing antibodies and T cell
responses against variants of concern not included in the vaccine
is key to delivering long-term variant-proof protection,” said
Karin Jooss, Ph.D., Executive Vice President and Head of R&D at
Gritstone. “These data support the potential of a samRNA-based
SARS-CoV-2 vaccine candidate to safely induce broad protection by
boosting T cell responses in addition to durable,
cross-neutralizing antibodies that are maintained for at least 6
months. We are excited by the differentiating characteristics we
are seeing with our novel vaccine candidates, and the results
published in Nature Communications further support our hypothesis
that samRNA has the potential to be a next-generation vaccine
platform technology with dose sparing potential against SARS-CoV-2
and beyond.”
About Self-amplifying mRNA
(samRNA) Gritstone’s samRNA vector is based on a
synthetic RNA molecule derived from a wild-type Venezuelan Equine
Encephalitis Virus (VEEV) replicon with the goal of extending the
duration and magnitude of immunogen expression to drive potent and
durable immune responses. The samRNA is delivered in a lipid
nanoparticle (LNP) formulation. Like traditional mRNA vaccines,
samRNA vaccines use the host cell’s transcription system to produce
target antigens to stimulate adaptive immunity. Unlike traditional
mRNA, samRNA has an inherent ability to replicate by creating
copies of the original strand of RNA once it is in the cell.
Potential benefits of samRNA may include extended duration and
magnitude of antigen expression, strong and durable induction of
neutralizing antibody and T cell immunity (CD4+ and CD8+), dose
sparing, and a refrigerator stable product.
About the CORAL Program Gritstone’s CORAL
program is applying Gritstone’s infectious disease approach, which
aims to drive both B cell and T cell immunity using self-amplifying
mRNA (samRNA), against SARS-CoV-2. CORAL currently includes three
ongoing Phase 1 trials: CORAL-BOOST, which is evaluating one
construct in a boost setting (following primary series of
currently-approved COVID-19 vaccines); CORAL-CEPI, which is
evaluating multiple constructs in virus-naïve, convalescent, and
HIV+ subjects in South Africa; and CORAL-NIH, which is being run by
the National Institute of Allergy and Infectious Disease (NIAID)
and is evaluating multiple constructs in previously vaccinated
healthy volunteers. The program serves as proof-of-concept for the
application of Gritstone’s platform against coronaviruses and other
infectious diseases and is supported by the Bill & Melinda
Gates Foundation, NIAID, and the Coalition for Epidemic
Preparedness Innovations (CEPI).
About Gritstone bio Gritstone 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 bio ContactsInvestors:George E.
MacDougallDirector, Investor Relations & Corp CommsGritstone
bio, Inc.ir@gritstone.com
Media:Dan Budwick1AB(973) 271-6085dan@1abmedia.com
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