Clinical-stage biotech company Celcuity announced Thursday that it had entered into a global licensing agreement with Pfizer to develop and commercialize gedatolisib, the latter company’s first-in-class PI3K/mTOR inhibitor for the treatment of breast cancer.
Clinical-stage biotech company Celcuity announced Thursday that it had entered into a global licensing agreement with Pfizer to develop and commercialize gedatolisib, the latter company’s first-in-class PI3K/mTOR inhibitor for the treatment of breast cancer.
The news of the agreement immediately followed the announcement of results from a Phase Ib clinical trial, which showed gedatolisib was well tolerated and generated anti-tumor activity in patients with ER+/HER2-negative advanced or metastatic breast cancer. The study allocated 103 patients into one of four different treatment arms stratified by prior metastatic breast cancer treatment history.
In a preliminary analysis of the study, the objective response rates demonstrated that gedatolisib, when added to treatment with palbociclib and endocrine therapy (letrozole or fulvestrant), helped patients achieve superior objective response rates (ORR) compared with historical control data.
Approximately 60% of the evaluable patients in the trial experienced an ORR at the time of data cut-off. A clinical benefit associated with therapy, defined as a confirmed objective response or stable disease for at least 24 weeks, was observed in 75% of evaluable patients.
Additionally, the investigators found that gedatolisib was generally well tolerated among the patients. Most of the treatment-related adverse events (TRAE) were Grade 1 or 2, with the most frequent Grade 3 or 4 TRAEs being stomatitis and decreases in neutrophil count.
“We are very encouraged by this preliminary data for gedatolisib from our ongoing Phase 1b trial in patients with breast cancer,” according to a statement made by Brian Sullivan, Celcuity’s Co-Founder and Chief Executive Officer. “The robust response rate and the observed tolerability profile are particularly compelling given the need for a therapeutic regimen that can address endocrine therapy resistance.“
Celcuity says it plans to launch a Phase II/III trial to further evaluate gedatolisib plus with palbociclib and endocrine therapy in patients with ER+/HER2-advanced or metastatic breast cancer pending feedback from the U.S. Food and Drug Administration. If the FDA gives the go-ahead, the trial is expected to start in the first half of next year.
In the new licensing agreement with Pfizer, Celcuity is provided a worldwide license to develop and commercialize its PI3K/mTOR inhibitor. Celcuity provided Pfizer an upfront cash payment of $5 million as well as a $5 million upfront payment of Celcuity’s common stock to cover the licensing fee. Under terms of the agreement, Pfizer will be eligible to receive up to $330 million in development and sales-based milestone payments, in addition to tiered royalties on potential sales of the product.
“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,” Sullivan added. The company’s CELsignia analyzes key pathways involved in cancer cells’ signaling to enable insight into targeted therapies. “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.”
Sullivan noted that supporting the development of gedatolisib with its CELsignia platform represents “a natural extension” of the company’s strategy for developing CELsignia CDx for additional breast cancer treatments. “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,” he said.
