Celcuity Announces Worldwide Licensing Agreement with Pfizer to Develop and Commercialize Gedatolisib

Celcuity Inc. a clinical-stage biotechnology company pursuing an integrated companion diagnostic and therapeutic strategy for treating patients with cancer, announced it has entered into a global licensing agreement with Pfizer Inc. granting Celcuity exclusive rights to Pfizer’s gedatolisib, a Phase 1b pan-PI3K/mTOR inhibitor. Gedatolisib is in clinical development for the treatment of patients with ER+/HER2-negative advanced or metastatic breast cancer.

Under the terms of the licensing agreement, Pfizer provided Celcuity with a worldwide license to develop and commercialize gedatolisib. Celcuity paid an upfront license fee of $5 million of cash and $5 million of Celcuity’s common stock as upfront payment. Pfizer is eligible to receive up to $330 million of development and sales-based milestone payments and tiered royalties on potential sales. Additional financial terms of the agreement were not disclosed.

“We are excited about the opportunity to utilize our CELsignia platform to support the development of a potential first-in-class targeted therapy like gedatolisib,” said Brian Sullivan, CEO and co-founder of Celcuity. “In light of the important role the PI3K/mTOR pathway plays in driving tumor growth when patients become resistant to endocrine therapies, we believe gedatolisib is a highly promising drug candidate to improve outcomes for patients with breast cancer. Supporting development of a potential first-in-class therapy for breast cancer, such as gedatolisib, with our CELsignia platform is a natural extension of our strategy to develop CELsignia CDx for other breast cancer therapies. We believe developing targeted therapies that benefit from the CELsignia platform while also offering companion diagnostics that enable new drug indications, creates a synergistic advantage for each program.”

Approximately 70%-80% of breast cancers in the United States express the estrogen receptor and are thus likely dependent on estrogen signaling to promote tumor growth. Patients with estrogen receptor-positive (ER+)/HER2- metastatic tumors typically receive endocrine therapies, such as tamoxifen, letrozole, or fulvestrant. Most women with ER+/HER2- metastatic breast cancer ultimately develop resistance to these endocrine therapies. One new strategy to treat metastatic ER+/HER2- breast cancer involves blocking pathways enabling partial and complete endocrine resistance by combining gedatolisib and a cyclin-dependent kinases 4 and 6 (CDK 4/6) inhibitor with existing endocrine therapy.

To evaluate the efficacy and safety of this new treatment strategy, gedatolisib is currently being evaluated in combination with palbociclib, an oral CDK 4/6 inhibitor, and either letrozole or fulvestrant in the expansion portion of a Phase 1b clinical trial in patients with ER+/HER2-negative advanced or metastatic breast cancer. A total of 103 patients were enrolled in one of four different arms according to their prior treatment history for metastatic breast cancer. A preliminary analysis of the objective response rates as of the January 11, 2021 data cut-off demonstrated that gedatolisib combined with palbociclib and an endocrine therapy achieved superior objective response rates relative to historical control data. Gedatolisib was also generally well tolerated, with the majority of treatment related adverse events (TRAE) being Grade 1 or 2. The most common Grade 3 or 4 TRAEs were neutrophil count decrease and stomatitis.

Added Art DeCillis, M.D., Celcuity’s Chief Medical Officer, “In light of the data reported as of the January 11, 2021 data cut-off, we intend to initiate, subject to feedback from the FDA, a Phase 2/3 clinical trial evaluating gedatolisib in combination with palbociclib and an endocrine therapy in patients with ER+/HER2- advanced or metastatic breast cancer in the first half of 2022.”