US-based Celcuity has announced a new clinical trial collaboration and supply agreement with Bayer to provide its cancer drug Nubeqa (darolutamide) for a planned Phase Ib/II clinical trial.

Celcuity plans to initiate a Phase Ib/II clinical in Q1 2024 investigating the company’s pan-PI3K/mTOR inhibitor, gedatolisib, in combination with Nubeqa. Irregular activation of the PI3K/Akt/mTOR pathway contributes to the pathology of many cancer types.

The combination therapy is being studied for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). As per the deal, Bayer will provide Nubeqa for the trial free of cost.

The US Food and Drug Administration first approved Bayer’s Nubeqa for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) in July 2019. More recently, the agency approved the drug in combination with docetaxel for treating adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) on 5 August 2022.

The Phase Ib/II CELC-G-201 study will recruit up to 54 participants who progressed after treatment with an androgen receptor inhibitor (ARI) as first-line treatment for mCRPC. The company plans to randomly assign 36 participants to receive 600mg of Nubeqa in combination with either 120mg gedatolisib in arm one or 180mg gedatolisib in arm two. Later, in Phase II, 12 more participants will be enrolled to study the radiographic progression-free survival (rPFS) at six months of patients who received the recommended Phase II dose.

Celcuity is also investigating gedatolisib as a treatment for breast cancer. Earlier this month, the biotech announced the enrolment for its Phase III VIKTORIA-1 clinical trial (NCT05501886) with plans to recruit patients at nearly 200 sites in 20 countries. The study aims to evaluate gedatolisib as a combination therapy with AstraZeneca’s Faslodex (fulvestrant), an endocrine therapy, with or without Pfizer’s Ibrance (palbociclib), a CDK4/6 inhibitor, in adults with HR+/HER2- advanced breast cancer.

In a 22 August press release, Celcuity CEO Brian Sullivan said: “Darolutamide is structurally unique to other ARIs, with 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.”