Benzinga | Jan 18, 2022 07:39AM EST

Celcuity Receives FDA Fast Track Designation For Gedatolisib In HR+ / HER2- Metastatic Breast Cancer And Provides Corporate Update

* FDA's Fast Track Designation for the pan-PI3K/mTOR inhibitor highlights potential to address the urgent need for new treatment options for breast cancer patients

* On track to finalize Phase 3 clinical trial design for gedatolisib with FDA feedback in first quarter

* Planning to initiate two studies in breast cancer to evaluate gedatolisib in patients selected with a CELsignia test

MINNEAPOLIS, MN / ACCESSWIRE / January 18, 2022 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing an integrated therapeutic and companion diagnostic strategy for treating patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company's lead drug candidate, gedatolisib, for the treatment of patients with HR+/HER2- metastatic breast cancer after progression on CDK4/6 therapy.

"There is an urgent need for better treatment options for HR+/HER2- metastatic breast cancer patients whose disease progressed after treatment with a CDK4/6 inhibitor and endocrine therapy," said Brian Sullivan, CEO and co-founder of Celcuity. "We are very encouraged by the clinical data for gedatolisib and believe that Fast Track designation will facilitate our efforts to advance its development for patients as quickly as possible."

Fast Track designation is granted by the FDA for products that are intended for the treatment of serious or life-threatening disease or conditions and which demonstrate the potential to address an unmet medical need. The designation offers the opportunity for frequent interactions with the FDA to discuss the drug's development plan and to ensure collection of appropriate data needed to support drug approval, as well as eligibility for rolling submission of a New Drug Application.

Celcuity remains on track to obtain feedback from the FDA and to finalize the design and protocol of its Phase 3 clinical trial in the first quarter of 2022. Site identification and feasibility activities for the Phase 3 clinical trial are on-going.

Additionally, Celcuity announced plans to initiate two Phase 2 clinical trials to evaluate gedatolisib in HR+/HER2- breast cancer patients selected with a CELsignia PI3K Pathway Test. One trial will evaluate gedatolisib in combination with fulvestrant in up to 25 patients with metastatic breast cancer. The second trial will evaluate up to 15 patients with early-stage breast cancer with gedatolisib in combination with palbociclib and letrozole. These clinical trials will be initiated at sites which are already participating in a trial that is screening patients with the CELsignia HER2 Pathway Test. Screened patients who provide a tumor biopsy will receive a CELsignia HER2 and PI3K Test. Patients found to have hyperactive HER2 signaling will be eligible to receive treatment with an anti-HER2 therapy and those with hyperactive PI3K signaling will be eligible to receive gedatolisib in combination with other targeted therapies. Patient enrollment is expected to begin for the two trials in late 2022.

Celcuity believes that conducting these CELsignia studies in parallel will enhance screening activities for potentially eligible patients. Based on the prevalence of hyperactive HER2 and PI3K signaling, Celcuity estimates that approximately 40%-45% of patients receiving a CELsignia test would potentially be eligible to enroll in one of the clinical trials. Patients providing tumor for CELsignia testing would thus be twice as likely to be eligible for participation in a CELsignia clinical study, potentially a significant benefit.

"Initiating clinical trials to evaluate gedatolisib in CELsignia selected patients in parallel with other CELsignia studies is very synergistic," stated Brian Sullivan. "First, we believe this will enhance the enrollment activities for each study. Secondly, these studies provide an efficient opportunity for Celcuity to evaluate gedatolisib in CELsignia PI3K test selected patients. Finally, it allows optimization of our overall CELsignia trial strategy. We concluded that the patients eligible for PI3K therapies may significantly overlap with the patients eligible for our clinical trial evaluating the pan-HER inhibitor, dacomitinib, and the c-MET inhibitor, crizotinib. In addition, a gedatolisib based regimen offers, we believe, a significantly more favorable safety profile than the combination of dacomitinib and crizotinib. Since we have another clinical trial evaluating a pan-HER and c-MET inhibitor, we concluded the FACT-3 clinical trial was redundant, and we have decided to discontinue it."