Gritstone Oncology Announces FDA Fast Track Designation for GRANITE-001

Gritstone Oncology (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.

As quoted in the press release:

GRANITE-001 is a personalized immunotherapy containing patient-specific neoantigens identified by Gritstone’s proprietary EDGE^TM 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.”

Click here to read the full press release.