Jazz Pharmaceuticals and partner Redx Pharma have announced that the U.S. FDA has cleared their IND application for an experimental pan-RAF inhibitor, launching clinical trials and triggering a $5M milestone payout to Redx.
The precision inhibitor, JZP815, is designed for the treatment of solid tumors and hematologic malignancies that contain mutations in the MAPK pathway. Ireland-based Jazz snatched up the asset in a 2019 deal with Redx, plunking down $3.5 million upfront with the promise of up to $203 million in additional milestone payments and royalties.
Promising preclinical data from the pan-RAF program was recently presented at the American Association for Cancer Research conference this past April. The therapy has a differentiated mechanism of action, and Jazz expects to assess its utility in treating several types of difficult-to-treat solid tumors where there remains significant unmet patient needs.
Redx appears to be on a roll — JZP815 will be the fifth compound discovered by the UK biotech to enter the clinic. Jazz and Redx also have a separate collaboration agreement to discover and develop drug candidates in the RAS-RAF-MAP kinase (MAPK) pathway, where Redx is again responsible for research and preclinical development activities up to IND application to the FDA.