Jounce Therapeutics Inc. (NASDAQ: JNCE) lost 2.55% after the FDA cleared its anti-CCR8 antibody, JTX-1811, Investigational New Drugs application for Gilead Sciences Inc. (NYSE: GILD) has rights to produce and market. The IND clearance will trigger a milestone payment of $25 million to Jounce.
Jounce developed JTX-1811
JTX-1811 is a monoclonal antibody developed by Jounce and intended to reduce immunosuppressive tumor-infiltrating T regulatory (TITR) cells exclusively. In Gilead’s pipeline, it is known as GS-1811. CCR8, a chemokine receptor abundant in TITR cells, is the target of JTX-1811. Once JTX-1811 binds to CCR8, it enhances an antibody-dependent cellular cytotoxicity process that targets TITR cells for depletion.
Richard Murray, Jounce CEO and President said that the JTX-1811 IND approval is a significant and confirming step forward for Jounce in its cancer immunotherapy treatment strategy. Murray said that they have now advanced numerous unique and diverse immunotherapy research candidates into clinical trials, increasing its ability to help cancer patients with limited options. Notably, this is Jounce’s fourth internally generated antibody in the last five years, demonstrating the value of the company’s discovery to the early stages of the development engine. Murray added that they would continue advancing JTX-1811 as Gilead takes the program into the clinic.
Gilead invested $35 million in JTX-1811.
Gilead invested $35 million in September 2020 in Jounce’s common shares and made an upfront payment of $85 million Jounce. Jounce oversaw the development of JTX-1811 to IND approval, following which Gilead now holds exclusive development and commercialization rights to the program. Following this $25 million milestone payment, Jounce may be entitled to up to $660 million in regulatory, future clinical, and commercial milestone payments and royalties ranging from the low single digits to the mid-teens based on worldwide sales. Any payment to Jounce for a milestone is subject to specific restrictions outlined in the license agreement.