Gritstone Oncology

Gritstone bio, Inc. is a clinical-stage biotechnology company focused on developing vaccine-based immunotherapies for cancer and infectious diseases. Founded in August 2015 as Gritstone Oncology, the company was established by Andrew Allen, MD, PhD, along with Mark Cobbold, MD, PhD, and Roman Yelensky, PhD. Dr. Allen, who served as President and CEO until late 2024, previously co-founded Clovis Oncology and served as its Chief Medical Officer, bringing extensive experience in drug development. The company's founding was inspired by the need for more effective cancer treatments, particularly for solid tumors that are non-responsive to existing immunotherapies, often termed 'cold' tumors.

Gritstone's core business revolves around its proprietary platforms designed to train the immune system to recognize and eliminate diseased cells. A key component is the Gritstone EDGE™ platform, which uses artificial intelligence and machine learning to analyze tumor tissue and predict tumor-specific neoantigens (TSNAs)—novel protein fragments on cancer cells that can be targeted by the immune system. This allows for the development of both personalized and "off-the-shelf" cancer vaccines. The company's revenue model is based on collaborations, licensing agreements, and potential future commercialization of its product candidates. A significant partnership includes a collaboration with Gilead Sciences to develop a therapeutic vaccine for HIV.

The company's product pipeline is divided into two main areas: oncology and infectious diseases. In oncology, Gritstone has two primary programs. GRANITE is a personalized cancer vaccine tailored to each patient's unique tumor mutations. It is being evaluated in a Phase 2/3 study as a maintenance treatment for patients with metastatic microsatellite-stable colorectal cancer (MSS-CRC). The second program, SLATE, is an "off-the-shelf" vaccine that targets a set of neoantigens shared across subsets of cancer patients, particularly those with KRAS mutations. Both programs utilize a prime-boost vaccine regimen involving a chimpanzee adenovirus (ChAd) vector and a self-amplifying mRNA (samRNA) vector to stimulate a potent T-cell response. In infectious diseases, the CORAL program is developing a next-generation samRNA vaccine for COVID-19, designed to offer broader and more durable protection against viral variants. The company also has a therapeutic HIV vaccine in development with Gilead. Despite filing for Chapter 11 bankruptcy in October 2024, Gritstone emerged in April 2025 with a sharpened focus on its oncological research and development.

Keywords: neoantigen vaccine, cancer immunotherapy, personalized medicine, samRNA, ChAd vector, colorectal cancer, solid tumors, KRAS mutation, infectious disease vaccine, Gritstone EDGE, GRANITE, SLATE, CORAL, clinical-stage biotechnology, T-cell response, tumor-specific neoantigens, HIV vaccine, immuno-oncology, Andrew Allen, COVID-19 vaccine