Merck, Flare Therapeutics enter clinical trial collaboration, supply agreement

Flare Therapeutics entered into a clinical trial collaboration and supply agreement with Merck (MRK). FX-909, a first-in-class orally available small molecule inhibitor of PPARG, the master regulator of the luminal lineage, will be evaluated in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, in a new cohort within the company’s ongoing Phase 1 study in locally-advanced or metastatic urothelial cancer. Under the terms of the supply agreement, Merck will provide its anti-PD-1 therapy KEYTRUDA to be used in combination with FX-909. The Phase 1 study combination cohort is expected to begin enrollment in the first quarter of 2026 and will investigate the safety, tolerability, immunologic effects and preliminary efficacy of escalating doses of FX-909 in combination with standard dose pembrolizumab in patients with advanced urothelial carcinoma.