By Chris Wack

Jounce Therapeutics Inc. said the U.S. Food and Drug Administration has cleared its investigational new drug 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 million milestone payment to Jounce.

Jounce said 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 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.

Under the terms of their September 2020 agreement, Gilead invested $35 million in Jounce's common stock and made an $85 million upfront payment to Jounce. Jounce has led the development of JTX-1811 through IND clearance, after which Gilead now has the sole right to develop and commercialize the program.

After receiving the $25 million milestone payment, Jounce may receive up to an additional $660 million in future clinical, regulatory and commercial milestone payments and will also be eligible to receive royalties ranging from high single digit to mid-teens based upon worldwide sales.

Jounce shares were up 9% to $7.60 in premarket trading.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

06-15-21 0936ET