Celcuity Inc. announced that it has entered into a clinical trial collaboration and supply agreement with Bayer AG for Celcuity's Phase 1b/2 clinical trial of gedatolisib and Nubeqa®? (darolutamide) in patients with metastatic castration resistant prostate cancer (mCRPC). As part of the supply agreement, Bayer will provide Nubeqa to Celcuity at no cost.

Celcuity expects to initiate a Phase 1b/2 clinical trial in the first quarter of 2024 to evaluate gedatolisib, the company's pan-PI3K/mTOR inhibitor, in combination with darolutamide, an androgen receptor inhibitor, in patients with mCRPC who progressed on their first line of androgen receptor treatment for mCRPC. Gedatolisib is a potent inhibitor that selectively targets all Class I isoforms of PI3K and mTOR. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together.

Inhibiting all four PI3K isoforms, as gedatolisib does, limits the potential confounding effect of isoform interaction that may occur with isoform-specific PI3K inhibitors. Inhibiting mTOR also addresses potential resistance mechanisms that can result when PI3K isoforms are targeted in the absence of mTOR inhibition.