Gritstone Announces First Patient Enrolled for Phase 2/3 Trial Evaluating Individualized Neoantigen Vaccine GRANITE for First Line (1L) Maintenance Treatment of Metastatic, Microsatellite-Stable Colorectal Cancer (MSS-CRC)
January 13 2022 - 7:00AM
Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology
company developing the next generation of cancer and infectious
disease immunotherapies, today announced that the first patient has
been enrolled for inclusion in the Phase 2/3 GRANITE-CRC-1L trial.
The trial evaluates the individualized neoantigen vaccine GRANITE
in combination with immune checkpoint blockade for the first line
(1L) maintenance treatment of newly diagnosed patients with
metastatic, microsatellite-stable colorectal cancer (MSS-CRC). This
trial has registrational intent and has been discussed previously
with the FDA.
“Building on the success of our GRANITE program, which continues
to demonstrate extended survival in multiple end-stage colorectal
cancer patients, we are excited to launch this randomized,
open-label Phase 2/3 trial to evaluate earlier use of GRANITE as a
maintenance treatment in newly diagnosed patients with metastatic,
microsatellite-stable colorectal cancer,” said Andrew Allen, M.D.,
Ph.D., Co-founder, President and Chief Executive Officer of
Gritstone. “We are pleased with the degree of clinical benefit seen
with GRANITE to date in hard-to-treat, late-line CRC patients, and
are optimistic we will see greater benefit from neoantigen
immunotherapy in earlier lines of treatment where immune responses
are likely stronger and tumor genomic complexity is lower. We
expect to report initial Phase 2 data from the GRANITE-CRC-1L trial
in mid-2023.”
Additionally, the company reported updated overall survival (OS)
data from its Phase 1/2 GRANITE trial evaluating individualized
immunotherapy in combination with nivolumab (OPDIVO®) and
ipilimumab (YERVOY®) in patients with advanced solid tumors,
specifically end-stage metastatic MSS-CRC. Patients with MSS-CRC
who experienced a molecular response (as evidenced by a decrease in
circulating tumor DNA [ctDNA]) continue to have an OS advantage
compared to those patients who did not have a molecular response.
All patients alive at the time of the ESMO 2021 data presentation
remain alive after an additional ~22 weeks of follow-up (January 5,
2022 data cut-off).
Dr. Allen continued, “These results reinforce our original
observation that molecular response is associated with extended
overall survival, the gold standard clinical outcome, in patients
with advanced MSS-CRC. The fact that no new patient has succumbed
to their disease after an additional ~22 weeks of observation and
treatment is encouraging and would not typically be expected in
third line CRC patients, for whom median overall survival is
typically only around 26-30 weeks from initiation of therapy in
multiple Phase 3 trials.”
Gritstone will address these developments and present the
updated OS data (from the Phase ½ trial in patients with advanced
solid tumors) in a presentation at the 40th Annual JP Morgan
Healthcare Conference occurring at 8:15am ET today. To access this
presentation, visit:
http://ir.gritstonebio.com/investors/events.
About GRANITE-CRC-IL Phase 2/3 TrialThe
GRANITE-CRC-1L trial (NCT05141721) is a Phase 2/3, randomized,
open-label study evaluating the GRANITE individualized
immunotherapy regimen as a first line (1L) maintenance treatment in
combination with atezolizumab (TECENTRIQ®) and ipilimumab (YERVOY®)
in newly diagnosed patients with metastatic, microsatellite-stable
colorectal cancer (MSS-CRC) who received fluoropyrimidine,
oxaliplatin and bevacizumab (FOLFOX-bevacizumab) induction therapy.
The Phase 2 portion of the study will measure changes in ctDNA over
time to characterize the clinical activity of maintenance therapy
with GRANITE (GRT-C901/GRT-R902). The Phase 3 portion will further
measure the clinical efficacy of the regimen as assessed by
progression-free survival using iRECIST criteria.
About Phase 1/2 Trial Evaluating GRANITE Against
Advanced Solid TumorsThe purpose of this study was to
evaluate the safety, dose, immunogenicity and early clinical
activity of the GRANITE individualized neoantigen cancer vaccine,
in combination with OPDIVO® (nivolumab) and YERVOY® (ipilimumab),
in patients with end-stage metastatic MSS-CRC, NSCLC,
gastroesophageal adenocarcinoma, and urothelial cancer
(NCT03639714).
About GRANITEGritstone’s
neoantigen-based immunotherapies are engineered to elicit a
significant T-cell response (particularly CD8+ cytotoxic T cells)
against mutation-derived tumor-specific neoantigens that are
identified by the company using its proprietary Gritstone EDGE™
artificial intelligence platform. GRANITE is an individualized
neoantigen-based immunotherapy and uses a priming adenoviral vector
(GRT-C901) and self-amplifying mRNA (samRNA) vector (GRT-R902) to
deliver individualized immunotherapy containing the relevant
neoantigens. GRANITE was granted Fast Track designation by the U.S.
Food and Drug Administration for the treatment of MSS-CRC.
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 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. 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
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
November 3, 2021 and any current and periodic reports filed with
the Securities and Exchange Commission.
Gritstone ContactsMedia:Dan Budwick1AB(973)
271-6085dan@1abmedia.comInvestors:George E. MacDougallDirector,
Investor Relations & Corp CommsGritstone bio,
Inc.IR@gritstone.com
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