Gritstone Announces First Person Dosed with its Second-Generation COVID-19 Vaccine in Phase 1 Study Conducted and Supported b...
March 29 2021 - 7:00AM
Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage
biotechnology company developing the next generation of cancer and
infectious disease immunotherapies, today announced that the first
person has been dosed under Gritstone’s “CORAL” program with its
candidate COVID-19 vaccine in a Phase 1 study. The study is
evaluating the immunogenicity and safety of using its
self-amplifying mRNA (SAM) and/or adenoviral vectors to deliver
SARS-CoV-2 viral antigens, including both Spike and other viral
antigens outside of Spike that are not included in currently
authorized vaccines. The Phase 1 study (clinicaltrials.gov
identifier: NCT04776317) is supported by the National Institute of
Allergy and Infectious Diseases (NIAID) and is being conducted
through their Infectious Diseases Clinical Research Consortium
(IDCRC).
“This study has been met with great enthusiasm as
Gritstone’s vaccine is differentiated in its potential to broaden
the immune response to SARS-CoV-2, potentially preserving clinical
protection even if Spike variants arise,” said Daniel Hoft, M.D.,
Ph.D., director of Saint Louis University’s Center for Vaccine
Development and Division of Infectious Diseases, Allergy and
Immunology; National Vaccine Advisory Committee member; and
protocol chair and lead principal investigator of Gritstone’s
COVID-19 vaccine study. “Based on pre-clinical work and data from
Gritstone’s cancer patients, we hope and expect to see strong
neutralizing antibodies to Spike, as well as CD8+ T cell responses
to both Spike and additional viral antigens, which may provide
clinical protection against emerging Spike variants. We are also
exploring the potential to use a lower dose of the self-amplifying
mRNA vaccine, which could enable more patients to be treated with a
given amount of manufactured vaccine.”
The Phase 1 clinical trial is a multicenter,
open-label, dose- and age-escalation study to examine the
immunogenicity and safety of Gritstone’s CORAL COVID-19 vaccine in
healthy adult volunteers. Both heterologous and homologous
prime-boost vaccinations of the adenoviral vector and/or SAM vector
expressing either SARS-CoV-2 Spike alone or Spike plus additional
SARS-CoV-2 T cell epitopes are being studied in a parallel
design.
“We are excited to be advancing CORAL, our
second-generation COVID-19 vaccine candidate, under our clinical
collaboration with NIAID,” said Andrew Allen, M.D., Ph.D.,
co-founder, president and chief executive officer of Gritstone. “As
we look to the future, we believe CORAL has the potential to
address coronavirus immunity challenges that are likely to emerge,
particularly around novel Spike variants of concern. Building on
this NIAID/IDCRC first-in-human study, we are planning to examine
the expected broad immunity elicited by our vaccine by delivering
it as a boost for people who have received first-generation
vaccines in a Phase 2 study starting later this year. We hope that
strong CD8+ T cell immunity generated against key non-Spike gene
fragments will provide protection against future Spike
variants.”
Dr. Allen continued, “Additionally, the repeated
emergence of new coronavirus epidemics/pandemics over the last 20
years supports the desire for a pan-coronavirus vaccine to prevent
or mitigate future pandemics. Certain non-Spike genes, some of
which are included in our vaccine, tend to be conserved in
coronaviruses over time and across variants. This observation may
catalyze the development of a pan-coronavirus vaccine.”
About Gritstone OncologyGritstone
Oncology, 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 machine learning-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
and manufacture potent immunotherapies utilizing these antigens to
potentially drive the patient’s immune system to specifically
attack and destroy disease-causing 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. The company also has a bispecific antibody
(BiSAb) program for solid tumors in lead optimization. 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, as well as 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 gritstoneoncology.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 Annual Report on Form 10-K filed on March
11, 2021 and any current and periodic reports filed with the
Securities and Exchange Commission.
Gritstone ContactsMedia:Dan
Budwick1AB(973) 271-6085dan@1abmedia.com
Investors:Alexandra Santos Wheelhouse Life Science
Advisors(510) 871-6161asantos@wheelhouselsa.com
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