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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)

— Phase 2/3 GRANITE-CRC-1L trial has registrational intent —

— Updated data from Phase 1/2 trial in end-stage metastatic MSS-CRC further support the association of circulating tumor DNA (ctDNA) reduction with extended overall survival —

— GRANITE has received Fast Track designation by the U.S. Food and Drug Administration for the treatment of MSS-CRC –

Excerpt from the Press Release:

EMERYVILLE, Calif., Jan. 13, 2022 (GLOBE NEWSWIRE) — 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.”

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