Celvuity Jumps on Pfizer Deal

Celcuity Inc. (NASDAQ:CELC) took off skyward soon after Friday’s opening bell.




This, after the company reported a worldwide licensing agreement with Pfizer (NYSE:PFE) to develop and commercialize gedatolisib. The company also reported preliminary data from Phase 1b Trial of gedatolisib plus ibrance and endocrine therapy for patients with ER+/HER2- metastatic breast cancer.




The company, a clinical-stage biotechnology company pursuing an integrated companion diagnostic and therapeutic strategy for treating patients with cancer, said that as of the January 11 data cut-off date, 53 of the 88 evaluable patients (60%) had an objective response. 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 related to gedatolisib were stomatitis and rash.




“We are very encouraged by this preliminary data for gedatolisib from our ongoing Phase 1b trial in patients with breast cancer,” said CEO Brian Sullivan. “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.




“We look forward to sharing additional data from the study at a future medical conference in 2021. Developing a therapeutic such as gedatolisib allows us to more fully leverage our CELsignia cellular analysis platform.”




In light of these encouraging results, Celcuity is planning 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




CELC shares sprang $6.29, or 44%, to $20.60.

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