Gritstone bio Announces Presentations from Phase 1 Studies Evaluating Next-Generation Vaccine Candidate for COVID-19 at IDWeek 2023
04 Oktober 2023 - 10:05PM
Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology
company working to develop the world’s most potent vaccines, today
announced results from all three (3) Phase 1 studies evaluating its
self-amplifying mRNA (samRNA) vaccine candidates against COVID-19
(part of the company’s CORAL program) are to be presented at IDWeek
2023, occurring October 11-15, 2023, in Boston, MA. Last week,
Gritstone bio announced a contract with the Biomedical Advanced
Research and Development Authority (BARDA) to advance the program
into a 10,000 patient, randomized Phase 2b comparative study
against COVID-19. The agreement 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.
Gritstone last presented data from the CORAL-BOOST and
CORAL-CEPI studies in April 2023 (press release). At IDWeek,
Gritstone will present further follow up from both of those
studies. Additionally, representatives from the Infectious Diseases
Clinical Research Consortium (IDCRC), a clinical trials network
established by the National Institute of Allergy and Infectious
Disease (NIAID), will present the first results from the CORAL-NIH
study, a Phase 1 study conducted by IDCRC and supported by NIAID
(and the third and final Phase 1 study from the CORAL program).
CORAL-CEPI and CORAL-BOOST presentations (presented by
Gritstone):
- Abstract 1538194 (Poster Presentation): Preliminary
evidence of durable immune responses induced by self-amplifying
mRNA (samRNA) vaccine candidates against SARS-CoV-2 in
vaccine-naive South African population (CORAL-CEPI
study)Date/Time: Saturday, Oct 14, 2023, 12:15 - 1:30
PMPoster #: 2372Presenter: Atul Nagare, MDLocation: BCEC
Poster Hall
- Abstract 1530224 (Poster Presentation): Preliminary
results of durable immune response induced by a self-amplifying
mRNA (samRNA) SARS-CoV-2 vaccine candidate, GRT-R910, in adults
previously vaccinated with mRNA or AZD1222 primary series
(CORAL-BOOST study)Date/Time: Saturday, Oct 14, 2023, 12:15 -
1:30 PMPoster #: 2346Presenter: Meghan G. HartLocation: BCEC Poster
Hall
CORAL-NIH presentation (presented by
IDCRC):
- Abstract 1530224 (Poster Presentation): An Interim
Report of the Safety, Reactogenicity, and Immunogenicity of a
Self-amplifying mRNA (samRNA) COVID-19 Vaccine GRT-R910 as a
Booster in Healthy AdultsDate/Time: Saturday, Oct 14,
2023, 12:15 - 1:30 PMPoster #: 2395Presenter: Jennifer
WhitakerLocation: BCEC Poster Hall
Copies of the presentations will be posted on the Events page of
the Gritstone bio website after their conclusion.
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
Gritstone bio (NASDAQ:GRTS)
Historical Stock Chart
Von Apr 2024 bis Mai 2024
Gritstone bio (NASDAQ:GRTS)
Historical Stock Chart
Von Mai 2023 bis Mai 2024