Nurix's GS-6791/NX-0479 IND Cleared by FDA for Inflammatory Conditions

Nurix Therapeutics, Inc., a clinical-stage biopharmaceutical firm, has announced a significant development in its collaboration with Gilead Sciences. The U.S. Food and Drug Administration (FDA) has given the green light to the Investigational New Drug (IND) application for their IRAK4 degrader, GS-6791/NX-0479. This approval paves the way for the commencement of a Phase 1 clinical trial, scheduled to start in the second quarter of 2025.

GS-6791/NX-0479 is an advanced, selective oral degrader targeting IRAK4, a critical regulator in inflammatory processes through IL-1R and TLR signaling pathways. According to Dr. Gwenn M. Hansen, the Chief Scientific Officer at Nurix, IRAK4's dual role as both a kinase and scaffolding protein necessitates innovative approaches like targeted protein degradation for effective pathway inhibition. In preclinical trials, GS-6791/NX-0479 has shown rapid and substantial IRAK4 degradation in various human cell types in vitro, alongside sustained degradation in non-human primates. This suggests its potential for effectively treating inflammatory conditions like rheumatoid arthritis and atopic dermatitis.

Nurix's collaboration with Gilead has been a productive one, with GS-6791/NX-0479 being one of the promising candidates in their growing pipeline of degrader-based medicines. Dr. Arthur T. Sands, President and CEO of Nurix, emphasized the success of their partnership with Gilead, highlighting Nurix's capability to develop potentially best-in-class medications targeting inflammation and autoimmune disorders. Nurix's pipeline also includes a STAT6 degrader in collaboration with Sanofi and a proprietary BTK degrader, NX-5948, aimed at treating similar conditions.

The partnership between Gilead and Nurix dates back to June 2019, focusing on discovering, developing, and commercializing up to five innovative targeted protein degradation therapies for cancer and other complex diseases. Nurix received an initial payment of $45 million, with success-based preclinical milestones amounting to $15 million, a $20 million licensing fee, and the potential for $425 million in clinical, regulatory, and commercial milestones per program. Following the FDA's IND clearance, Nurix has received a $5 million milestone payment from Gilead, bringing the total earnings under this collaboration to $135 million. Nurix is also set to receive up to $420 million in future milestones related to the IRAK4 program, with the option to co-develop and co-detail up to two programs in the U.S. after completing applicable Phase 1 trials.

GS-6791/NX-0479 targets IRAK4, crucial in TLR and IL-1R signaling, making it an ideal candidate for targeted protein degradation. This approach holds promise for treating rheumatoid arthritis and other inflammatory diseases. Gilead Sciences, which licensed the program in 2023, is responsible for advancing its clinical development.

Nurix Therapeutics is committed to pioneering targeted protein degradation medicines aimed at enhancing treatment options for cancer and inflammatory diseases. With a robust pipeline including degraders of Bruton’s tyrosine kinase (BTK) and Casitas B-lineage lymphoma proto-oncogene B (CBL-B), Nurix is at the forefront of innovative drug design. The company is also working on multiple preclinical programs through collaborations with major pharmaceutical companies like Gilead Sciences, Sanofi, and Pfizer. Headquartered in San Francisco, California, Nurix leverages a fully AI-integrated discovery engine and ligase expertise to translate targeted protein degradation science into clinical progress, aiming to establish these treatments as pivotal in patient care.