Celcuity Enters into a Clinical Trial Collaboration and Supply Agreement with Bayer to Provide Nubeqa (darolutamide) for Planned Phase 1b/2 Clinical Trial

MINNEAPOLIS, Aug. 22, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today 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.

“We are excited that Bayer is providing darolutamide for this important Phase 1b/2 clinical trial,” said Brian Sullivan, Chief Executive Officer and co-founder of Celcuity. “Darolutamide is structurally unique to other ARI’s, with an excellent efficacy and differentiated tolerability profile coupled with minimal drug-drug interactions, making it an ideal combination partner for gedatolisib. Our goal is to address the significant need for new therapeutic options for patients with metastatic castration resistant prostate cancer.”

About Gedatolisib
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.

About Celcuity
Celcuity is a clinical-stage biotechnology company pursuing development of targeted therapies for oncology. The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTOR inhibitor. 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. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer is currently enrolling patients. More detailed information about the VIKTORIA-1 study can be found at ClinicalTrials.gov. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is planned to begin enrolling patients in the first quarter of 2024. The company’s CELsignia companion diagnostic platform is uniquely able to analyze live patient tumor cells to identify new groups of cancer patients likely to benefit from already approved targeted therapies. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at Celcuity.com. Follow us on LinkedIn and Twitter.