On June 15, 2021 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported the U.S. Food and Drug Administration’s (FDA) clearance of its Investigational New Drug (IND) application for JTX-1811, an anti-CCR8 antibody, for which Gilead Sciences, Inc. (Nasdaq: GILD) has exclusive rights to develop and commercialize (Press release, Jounce Therapeutics, JUN 15, 2021, View Source [SID1234584014]). The IND clearance triggers a $25.0 million milestone payment to Jounce.
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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."
Under the terms of the September 2020 agreement, Gilead invested $35.0 million in Jounce’s common stock and made an $85.0 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 this $25.0 million milestone payment, Jounce may receive up to an additional $660.0 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. Any milestone or royalty paid to Jounce is subject to certain reductions as described in the license agreement