Gritstone Announces Results from Preclinical Study of its Self-amplifying mRNA (samRNA) Vaccine Against SARS-CoV-2 Published in Nature Communications
June 10 2022 - 8:00AM
Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology
company that aims to develop the world’s most potent vaccines,
today announced results from a preclinical study evaluating a
self-amplifying mRNA (samRNA) vaccine candidate against SARS-CoV-2
were published in Nature Communications, in an article titled
“Low-dose self-amplifying mRNA COVID-19 vaccine drives strong
protective immunity in non-human primates against SARS-CoV-2
infection”. The results of the study, which were previously
pre-printed in bioRxiv (in November 2021), show that the samRNA
vaccine candidate induced broad and potent neutralizing antibodies
and T cell immune responses following administration to non-human
primates (NHP) at low doses, and that these immune responses were
protective against SARS-CoV-2 challenge. Since the pre-publication
of these data in November 2021, Gritstone disclosed initial results
from a Phase 1 study of a samRNA vaccine candidate demonstrating
similar outcomes against SARS-CoV-2 (Press release announcing
initial results from CORAL-BOOST study issued on January 4, 2022).
The company is currently evaluating samRNA vaccines for
coronaviruses and other infectious diseases.
“The publication of this study in Nature
Communications, a top-tier journal, validates the quality of
Gritstone’s science and endorses the significance of our novel
approach to infectious diseases,” said Andrew Allen, M.D., Ph.D.,
Co-founder, President, and Chief Executive Officer of Gritstone.
“Strong neutralizing antibody titers can offer protection in
short-term viral challenge experiments, but when combined with
potent CD8+ T cell responses against conserved regions of the viral
genome, that protection may be more durable and less subject to
immune escape, which is a key challenge facing first-generation
mRNA vaccines today. The attractive properties of dose-sparing and
expansive, more durable immunity underpin our plans to explore the
broad protective and therapeutic utility of samRNA vaccines against
COVID-19 and other viral pathogens.”
Karin Jooss, Ph.D., Executive Vice President,
and Head of R&D added, “Self-amplifying mRNA is an attractive
platform for potentially superior next-generation mRNA vaccines.
Since we began working on this delivery platform in 2016, we have
optimized multiple components of samRNA to increase potency and
reduce reactogenicity. These exciting NHP data, together with the
emerging clinical data from our SARS-CoV-2 program, further
demonstrate the success of these vaccine improvements as well as
samRNA’s potential applicability across a variety of other
pathogens.” Gritstone is currently evaluating four distinct
SARS-CoV-2 product candidates across three different Phase 1
clinical trials containing various Spike variants plus additional
highly conserved non-Spike T cell epitope sequences (and also
full-length nucleocapsid) within its CORAL program. These studies
include homologous and heterologous prime-boost regimens. All three
of these studies are ongoing, and data from all are expected during
the second half of 2022.
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 ProgramGritstone’s CORAL
program is a second-generation SARS-CoV-2 vaccine platform
delivering spike and additional SARS-CoV-2 T cell epitopes,
offering the potential for more durable protection and broader
immunity against SARS-CoV-2 variants. Delivery vectors can comprise
a chimpanzee adenovirus, self-amplifying mRNA (samRNA) or both. The
program is supported by several key relationships: Bill &
Melinda Gates Foundation, National Institute of Allergy and
Infectious Disease (NIAID), and the Coalition for Epidemic
Preparedness Innovations (CEPI).
About Gritstone Gritstone bio, Inc. (Nasdaq:
GRTS) is a clinical-stage biotechnology company that aims to create
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 the potential of Gritstone’s therapeutic
programs; the advancements in the company’s ongoing clinical
trials; the timing of data announcements related to ongoing
clinical trials and the initiation of future clinical trials. 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’ early 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 Quarterly Report on Form 10-Q filed on May
5, 2022 and any current and periodic reports filed with the
Securities and Exchange Commission.
Gritstone ContactsInvestors:George E.
MacDougallDirector, Investor Relations & Corporate
CommunicationsGritstone bioIr@gritstone.com
Media:Dan Budwick1AB(973) 271-6085dan@1abmedia.com
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