Gritstone Oncology Advances into Phase 2 Expansion Cohorts for its Personalized Neoantigen Immunotherapy GRANITE and its Off-the-Shelf Neoantigen Immunotherapy SLATE
--The Phase 1 portions of the studies are closed for enrollment; patient treatment and follow-up for efficacy and safety continues--
“We are excited to advance the highest doses of GRANITE and SLATE tested in the Phase 1 studies into Phase 2 clinical cohorts and interrogate the ability of our immunotherapies at full dose to elicit robust immune responses against historically cold (or non-immunogenic) tumor types such as metastatic colorectal cancer,” said
The Phase 2 portion of the GRANITE Phase 1/2 study (GO-004) includes a cohort for patients with microsatellite stable colorectal cancer (MSS CRC) who have progressed on FOLFOX/FOLFIRI therapy and a second cohort for patients with gastro-esophageal cancer (GEA) who have progressed on chemotherapy. GRANITE was granted Fast Track designation by the
In the Phase 2 part of the SLATE Phase 1/2 study (GO-005), the company has begun enrolling non-small cell lung cancer patients with relevant KRAS mutations who have progressed on prior immunotherapy, and patients with tumors where a relevant TP53 mutation exists.
About GRANITE and SLATE
Gritstone’s neoantigen-based immunotherapies are engineered to elicit a significant T-cell response (particularly CD8+ cytotoxic T cells) against mutation-derived tumor-specific neoantigens, or TSNA, that are identified by the company using its proprietary Gritstone EDGETM artificial intelligence platform and tumor HLA peptide sequencing. Data demonstrating the neoantigen identification capabilities of EDGE were published in Nature Biotechnology.
GRANITE is Gritstone’s personalized immunotherapy that consists of two components: first, a priming adenoviral vector is used to deliver a cassette of 20 patient-specific TSNA derived from the patient’s own tumor; and second, the same personalized TSNA cassette is delivered using a self-amplifying RNA vector in a repeated boost sequence. GRANITE is being evaluated in combination with immune checkpoint blockade in a Phase 1/2 clinical study, referred to as GO-004. GRANITE was granted Fast Track designation by the
SLATE is Gritstone’s “off-the-shelf” immunotherapy. It uses the priming adenoviral vector and self-amplifying RNA vector to deliver a cassette of 20 shared TSNA, representing mutated gene sequences that are shared across patients (such as TP53 and K-RAS mutations). SLATE is being evaluated in combination with immune checkpoint blockade in a Phase 1/2 clinical study called GO-005.
Gritstone Forward-Looking Statements
This 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
Source: Gritstone Oncology, Inc