The FDA approved Incysus Therapeutics’ Investigational New Drug (IND) application for the clinical study of a genetically modified γδ T cell in combination with chemotherapy for the treatment of patients with newly-diagnosed glioblastoma (GBM). This approval will allow Incysus to initiate a first-in-human Phase 1 clinical trial of gene-modified γδ T cells for cancer immunotherapy. William Hoe, President and CEO of Incysus notes “this represents a significant milestone for Incysus as we continue to work toward improving patient outcomes. We are pleased to have received FDA approval to conduct this clinical work and look forward to the initiation of the Phase I study.”
The first genetically modified γδ T cell product candidate that the FDA has cleared for a clinical trial, the company and its partner, the University of Alabama at Birmingham (UAB), plan to initiate a Phase I clinical trial in 2019. It will evaluate the safety and activity of the DRI platform, combining standard-of-care chemotherapy with genetically engineered γδ T cells that are resistant to the effects of chemotherapy.
UAB’s O’Neal Comprehensive Cancer Center will manage the study. The Incysus technology enables simultaneous combination of standard-of-care chemotherapy with activated γδ T cells that are genetically-engineered to resist chemotherapy-induced cell death, allowing these T cells to attack the tumor at the time that it is most vulnerable.
Burt Nabors, MD, Director of Division of Neuro-oncology and Translational ScienceSource: Globe Newswire