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Personalized Neoantigen Vaccine Candidate Launches Metastatic Colorectal Cancer Study

January 13, 2022 • 8:25 am CST
(Vax Before Cancer)

California-based Gritstone bio, Inc. announced that the first patient had been enrolled in the Phase 2/3 GRANITE-CRC-1L trial.

This clinical trial evaluates the individualized neoantigen vaccine GRANITE combined with immune checkpoint blockade for the first line (1L) maintenance treatment of newly diagnosed patients with metastatic, microsatellite-stable colorectal cancer (MSS-CRC).

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. FDA for treating MSS-CRC.

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 identified by the company using its proprietary Gritstone EDGE™ artificial intelligence platform.

“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 CEO of Gritstone, in a press release issued on January 13, 2022.

“We expect to report initial Phase 2 data from the GRANITE-CRC-1L trial in mid-2023.”

Gritstone bio, Inc. is a clinical-stage biotechnology company located in Emeryville, CA, developing the next generation of immunotherapies against multiple cancer types and infectious diseases.