Posted by Michael Wonder on 23 Dec 2018
Gritstone Oncology announces FDA fast track designation for GRANITE-001 for the treatment of colorectal cancer
20 December 2018 - Gritstone Oncology today announced that the U.S. FDA has granted fast track designation to GRANITE-001 for the treatment of colorectal cancer.
GRANITE-001 is a personalised immunotherapy containing patient-specific neo-antigens identified by Gritstone’s proprietary EDGE artificial intelligence platform as the most relevant neo-antigens to drive a tumour-specific T-cell attack.
GRANITE-001 in combination with immune checkpoint blockade is being evaluated in a Phase 1/2 clinical study called GO-004 for the treatment of patients with common solid tumours, including metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, gastrouesophageal cancer, and bladder cancer.
