Jounce Therapeutics Gets FDA Clearance for Cancer Treatment IND

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 [e-mail]

(END) Dow Jones Newswires

June 15, 2021 09:36 ET (13:36 GMT)

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