Gritstone Oncology Announces FDA Fast Track Designation for GRANITE-001 for the Treatment of Colorectal Cancer
December 20 2018 - 4:00PM
Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage
biotechnology company developing the next generation of cancer
immunotherapies to fight multiple cancer types, today announced
that the U.S. Food and Drug Administration (FDA) has granted Fast
Track designation to GRANITE-001 for the treatment of colorectal
cancer. GRANITE-001 is a personalized immunotherapy containing
patient-specific neoantigens identified by Gritstone’s proprietary
EDGETM artificial intelligence platform as the most relevant
neoantigens to drive a tumor-specific T-cell attack.
“Colorectal cancer remains a major contributor to cancer deaths
and has not yet proved very amenable to first generation
immunotherapy,” said Andrew Allen, M.D., Ph.D., co-founder,
president and chief executive officer of Gritstone Oncology. “We
believe GRANITE-001 has the potential to be a valuable therapeutic
option for these patients through its highly personalized design.
The ability to leverage tumor markers, or neoantigens, specific to
a patient’s own tumor cells in the development of a personalized
immunotherapy is regarded as the next frontier of cancer therapy.
We look forward to continuing our productive dialogue with the FDA
under their Fast Track program as we seek to advance GRANITE-001
expeditiously for the potential benefit of patients.”
The FDA grants Fast Track designation to facilitate development
and expedite the review of therapies with the potential to treat a
serious condition where there is an unmet medical need. A
therapeutic that receives Fast Track designation can benefit from
early and frequent communication with the agency, in addition to a
rolling submission of the marketing application, with the objective
of getting important new therapies to patients more quickly.
Ongoing Phase 1/2 Clinical
StudyGRANITE-001 in combination with immune checkpoint
blockade is being evaluated in a Phase 1/2 clinical study called
GO-004 for the treatment of patients with common solid tumors,
including metastatic non-small cell lung cancer, microsatellite
stable colorectal cancer, gastroesophageal cancer, and bladder
cancer. The Phase 1 study includes two parts: in part A patients
receive an adenovirus-based prime with escalating doses of an
RNA-based boost vaccinations in combination with anti-PD-1 therapy;
and in part B patients receive the prime and the boost vaccinations
at the selected dose in combination with both anti-PD-1 and
anti-CTLA-4 immuno-modulatory antibodies.
About GRANITE-001GRANITE-001 is
Gritstone Oncology’s lead, personalized tumor-specific
immunotherapy product candidate. It is engineered to elicit a
significant T-cell response (particularly CD8+ cytotoxic T-cells)
against mutation-derived tumor-specific neoantigens, or TSNA,
identified for each patient through the company’s proprietary EDGE™
artificial intelligence platform. GRANITE-001 consists of two
components, first a priming adenoviral vector followed by monthly
boosting with an RNA vector, each containing the same 20
patient-specific TSNA.
About Gritstone
OncologyGritstone Oncology (Nasdaq: GRTS), a
clinical-stage biotechnology company, is developing the next
generation of cancer immunotherapies to fight multiple cancer
types. Gritstone develops its products by leveraging two key
pillars—first, a proprietary machine learning-based platform,
Gritstone EDGE™, which is designed to predict, from a routine tumor
biopsy, the tumor-specific neoantigens (TSNA) that are presented on
a patient’s tumor cells; and second, the ability to develop and
manufacture potent immunotherapies utilizing patients’ TSNA to
potentially drive the patient’s immune system to specifically
attack and destroy tumors. The company’s lead product candidate,
GRANITE-001, is a personalized neoantigen-based immunotherapy
beginning Phase 1 clinical testing. Gritstone’s second product
candidate, SLATE-001, is a shared neoantigen (“off-the-shelf”)
immunotherapy which is advancing towards the clinic. Novel
tumor-specific antigens can also provide targets for bispecific
antibody (BiSAb) therapeutics for solid tumors, and Gritstone’s
BiSAb program is currently in lead optimization. For more
information, please visit gritstoneoncology.com.
Gritstone Forward-Looking Statements This press
release contains forward-looking statements, including, but not
limited to, statements related to the potential benefits of the
FDA’s Fast Track designation for its GRANITE-001 investigational
immunotherapy. 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 14, 2018 and any subsequent current and periodic reports
filed with the Securities and Exchange Commission.
ContactsMedia:Dan Budwick1AB(973)
271-6085dan@1abmedia.com
Investors:Alexandra SantosWheelhouse Life Science Advisors(510)
871-6161asantos@wheelhouselsa.com
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