Gritstone and CEPI Announce Agreement to Advance Second-Generation COVID-19 Vaccine Program (CORAL) Against SARS-CoV-2 Variants of Concern
August 17 2021 - 07:00AM
Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology
company developing next generation cancer and infectious disease
immunotherapies, today announced that the company entered into a
funding agreement of up to $20.6 million with the Coalition for
Epidemic Preparedness Innovations (CEPI) to advance the development
of Gritstone’s CORAL COVID-19 vaccine program with an initial focus
in South Africa.
“COVID-19 variants are already rendering some of our vaccines
less effective, so it is critical that we don’t let our guard down:
we must continue to invest in critical vaccine R&D if we are to
stay one step ahead of this deadly virus,” said Richard Hatchett,
M.D., CEO of CEPI. “CEPI is planning for the longer-term management
of COVID-19 by investing in vaccines to address the threat of
variants, and I’m pleased to work with Gritstone to advance the
development of this innovative vaccine candidate which can be made
globally accessible through COVAX if it is proven to be safe and
effective.”
“Our unique approach combines our self-amplifying mRNA platform
with a broad set of viral antigens beyond spike intended to drive
robust and durable immune responses comprising both neutralizing
antibodies and CD8+ T cells. With this unique antigenic breadth,
our CORAL vaccine may offer protection against emerging spike
variants of SARS-CoV-2 that appear challenging for first generation
vaccines,” said Andrew Allen, M.D., Ph.D., co-founder, president
and chief executive officer of Gritstone. “We are honored to be
supporting CEPI in their mission to help find new vaccine solutions
to battle this deadly virus on a global scale and help prevent
current and perhaps future COVID outbreaks.”
Professor Shabir Madhi, dean of the Faculty of Health Sciences
and professor of vaccinology at the University of the
Witwatersrand, Johannesburg, South Africa and a member of the WHO
Strategic Advisory Group of Experts on Immunization (SAGE)
commented, “The ongoing mutations in SARS-CoV-2 leading to
increased transmissibility and relative immune evasion from most
first generation COVID-19 vaccines that primarily target the spike
protein, call for alternate approaches aimed at driving CD8+
immunity against spike and more conserved epitopes. This could
assist in reducing both infectiousness of breakthrough cases and
overall virus transmission.” Professor Mahdi will lead the
Gritstone clinical trial in South Africa.
Under the terms of the agreement, CEPI will fund
a multi-arm Phase 1 study evaluating the CORAL program’s SAM
vaccine in naïve, convalescent, and HIV+ patients. The funding will
also support pre-clinical studies, scale-up and formulation
development to enable more stable drug product. The study will
evaluate two different SAM vaccine constructs that each target both
the spike protein and other SARS-CoV-2 targets and are designed to
drive both robust B and T cell immune responses. The trial is
expected to initiate before the end of 2021.
CEPI is committed to global equitable access to COVID-19
vaccines so, through this agreement, CEPI and Gritstone bio have
agreed that this vaccine candidate will be made available to the
COVAX Facility for procurement and allocation, if proven to be safe
and effective. The COVAX Facility aims to deliver equitable access
to COVID-19 vaccines for all countries, at all levels of
development, that wish to participate.
About the CORAL Program
Gritstone’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 deep, broad,
and durable protection against SARS-CoV-2 variants. Delivery
vectors can comprise a chimpanzee adenovirus, self-amplifying mRNA
or both. The program is supported by several key relationships: La
Jolla Institute for Immunology, Bill & Melinda Gates
Foundation, National Institute of Allergy and Infectious Disease
(NIAID), and the Coalition for Epidemic Preparedness Innovations
(CEPI). A Phase 1 clinical trial is currently being sponsored by
NIAID examining the reactogenicity and immunogenicity of CORAL in
healthy volunteers and as a booster for previously vaccinated
volunteers. Gritstone is sponsoring and conducting its own Phase 1
studies in select populations, which are anticipated to begin
before the end of 2021. Together with the CEPI supported study,
this set of clinical trials will test four different vaccine
candidates and establish optimal dosing and antigenic content for
the CORAL program in young individuals, the elderly, the previously
vaccinated, and the immunocompromised.
About Gritstone Gritstone bio, Inc. (Nasdaq:
GRTS), a clinical-stage biotechnology company, is developing the
next generation of immunotherapies against multiple cancer types
and infectious diseases. Gritstone develops its products by
leveraging two key pillars—first, a proprietary AI -based platform,
Gritstone EDGETM, which is designed to predict antigens that are
presented on the surface of cells, such as tumor or
virally-infected cells, that can be seen by the immune system; and,
second, the ability to develop, manufacture, and deliver selected
antigens to the patient’s immune system to drive the destruction of
tumors or virally-infected cells. . The company’s lead oncology
programs include an individualized neoantigen-based immunotherapy,
GRANITE, and an “off-the-shelf” shared neoantigen-based
immunotherapy, SLATE, which are being evaluated in clinical
studies. Within its infectious disease pipeline, Gritstone is
advancing CORAL, a COVID-19 program to develop a second-generation
vaccine, with support from departments within the National
Institutes of Health (NIH), the Bill & Melinda Gates
Foundation, the Coalition for Epidemic Preparedness Innovations
(CEPI) and through a license agreement with La Jolla Institute for
Immunology. Additionally, the company has a global collaboration
for the development of a therapeutic HIV vaccine with Gilead
Sciences. For more information, please visit gritstone.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
August 5, 2021 and any current and periodic reports filed with the
Securities and Exchange Commission.
Gritstone ContactsMedia:Dan Budwick1AB(973)
271-6085dan@1abmedia.com
Investors:Celia EconomidesChief Financial
Officercelia@gritstone.com
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