Shares of Celcuity (CELC) skyrocketed on a license deal with Pfizer (PFE). The company today announced it has entered into a global licensing agreement with Pfizer 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 agreement, Pfizer will provide Celcuity with a worldwide license to develop and commercialize geatolisib. Celcuity paid an upfront license fee of $5 million of cash and $5 million of common stock. Pfizer is eligible to receive up to $330 million of development and sales-based milestone payments.
This new treatment is currently in evaluation in combination with palbociclib, an oral CDK 4/6 inhibitor, and either letrozole or fulvestrant in the expansion portion of Phase 1b clinical trial.
In addition to this announcement the company has also released preliminary phase 1b data for Gedatolisib.
The preliminary efficacy and safety analysis showed:
- 53 of the 88 evaluable patients (60%) had an objective response.
- 66 of the 88 evaluable patients (75%) had a clinical benefit, defined as either a confirmed objective response or stable disease for at least 24 weeks.
- 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 associated with gedatolisib were stomatitis and rash. Gedatolisib was discontinued in 10% of patients.
- 22 patients were continuing to receive gedatolisib in combination with the other study drugs, 17 of whom have been on study treatment for more than two years.