Health and Healthcare

Gritstone Oncology Receives Key FDA Update

Chris Lange

Published: December 21, 2018 10:20 am

Last Updated: January 11, 2020 1:22 pm

Gritstone Oncology Inc. (NASDAQ: GRTS) shared on Friday that it received good news in the form of a key update from the U.S. Food and Drug Administration (FDA).

Specifically, the FDA has granted Fast Track designation to Granite-001 for the treatment of colorectal cancer.

Granite-001 is a personalized immunotherapy containing patient-specific neoantigens identified by Gritstone’s proprietary EDGE artificial intelligence platform as the most relevant neoantigens to drive a tumor-specific T-cell attack.

The FDA grants Fast Track designation to facilitate development and expedite the review of therapies with the potential to treat a serious condition where there is an unmet medical need.

Andrew Allen, M.D., Ph.D., co-founder, president and CEO of Gritstone, commented:

Colorectal cancer remains a major contributor to cancer deaths and has not yet proved very amenable to first generation immunotherapy. 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.

Shares of Gritstone were last seen up 3% at $15.15 on Friday, in a 52-week range of $11.22 to $32.90. The stock has a consensus analyst price target of $24.67.