Jounce Therapeutics Receives FDA Clearance of Investigational NDA for Anti-CCR8 Antibody

Jounce Therapeutics Inc., a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, announced the U.S. FDA's clearance of its Investigational New Drug (IND) application for JTX-1811, an anti-CCR8 antibody, for which Gilead Sciences, Inc. has exclusive rights to develop and commercialize. The IND clearance triggers a $25.0 million milestone payment to Jounce.

JTX-1811, which will be referred to as GS-1811 in Gilead’s pipeline, is a monoclonal antibody created by Jounce and designed to selectively deplete immunosuppressive tumor-infiltrating T regulatory (TITR) cells. The target of JTX-1811 is CCR8, a chemokine receptor enriched on TITR cells. When JTX-1811 binds to CCR8, it targets TITR cells for depletion by enhancing an antibody-dependent cellular cytotoxicity mechanism. 

“The clearance of the JTX-1811 IND marks an important and validating milestone for Jounce in our approach to cancer immunotherapy treatment. We have now been able to bring multiple novel and diversified immunotherapy development candidates into clinical development, further enhancing our opportunity to bring benefit to cancer patients who have few options. Specifically, this is our fourth internally-developed antibody in five years and is testament to the power of our discovery to early development engine” said Richard Murray, PhD, Chief Executive Officer and President of Jounce Therapeutics. “We look forward to JTX-1811’s continued advancement as Gilead progresses this program into the clinic.”