Celcuity and Pfizer Enter Global Licensing Agreement to Develop Gedatolisib, a Pan-PI3K/mTOR Inhibitor for ER+/HER2- Metastatic Breast Cancer

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On April 8, according to foreign media reports, cell analysis company Celcuity announced that it had reached a global licensing agreement with Pfizer, under which Pfizer granted exclusive rights to gedatolisib (a Phase 1b pan-PI3K/mTOR inhibitor) to Celcuity. Gedatolisib is currently in clinical development for the treatment of patients with ER+/HER2-negative advanced or metastatic breast cancer.

Under the terms of the license agreement, Pfizer granted Celcuity a global license to develop and commercialize gedatolisib. Celcuity paid an upfront consideration consisting of $5 million in cash and $5 million in Celcuity common stock. Pfizer is eligible to receive up to $330 million in development and sales milestone payments, as well as tiered royalties on potential sales. Other financial terms of the agreement were not disclosed.

Patients with estrogen receptor-positive (ER+)/HER2-negative metastatic tumors typically receive endocrine therapy, such as tamoxifen, letrozole, or fulvestrant. Most women with ER+/HER2- metastatic breast cancer eventually develop resistance to these endocrine therapies. A novel strategy for treating metastatic ER+/HER2- breast cancer involves combining gedatolisib and a cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor with existing endocrine therapies to block pathways associated with partial and complete endocrine resistance.

To evaluate the efficacy and safety of this novel therapeutic strategy, an expansion cohort of a Phase 1b clinical trial is currently underway in patients with ER+/HER2- advanced or metastatic breast cancer, assessing gedatolisib in combination with the oral CDK4/6 inhibitor palbociclib plus either letrozole or fulvestrant. A total of 103 patients were enrolled into four distinct cohorts based on their prior treatment history for metastatic breast cancer. Preliminary analysis of objective response rates (ORR) as of January 11, 2021, demonstrated that gedatolisib combined with palbociclib and endocrine therapy achieved superior ORR compared to historical control data. Gedatolisib was also generally well tolerated, with most treatment-related adverse events (TRAEs) being Grade 1 or 2. The most common Grade 3 or 4 adverse events were neutropenia and stomatitis.

Art DeCillis, M.D., Chief Medical Officer of Celcuity, stated, “Based on the reported data with a cutoff date of January 11, 2021, we plan to initiate a Phase 2/3 clinical trial in the first half of 2022, subject to FDA feedback, evaluating gedatolisib in combination with palbociclib and endocrine therapy in patients with ER+/HER2- advanced or metastatic breast cancer.”

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