- Celcuity Inc CELC has entered into a global licensing agreement with Pfizer Inc PFE, granting Celcuity exclusive rights to Pfizer's gedatolisib.
- The pan-PI3K/mTOR inhibitor is currently in Phase 1b trial to treat patients with ER+/HER2-negative advanced or metastatic breast cancer.
- Celcuity paid an upfront license fee of $5 million cash and $5 million of Celcuity's common stock.
- 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.
- 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 trial in patients with ER+/HER2-negative advanced or metastatic breast cancer.
- 103 patients were enrolled in one of four different arms according to their prior treatment history for metastatic breast cancer.
- Separately, preliminary data from the gedatolisib Phase 1b trial's expansion portion demonstrated the drug was well tolerated, and anti-tumor activity was noted.
- 53 of the 88 evaluable patients (60%) had an objective response. 75% of the patients had a clinical benefit, defined as either a confirmed objective response or stable disease for at least 24 weeks.
- On the safety front, gedatolisib was also generally well tolerated, with most treatment-related adverse events being mild or moderate.
- The most common serious/severe related to gedatolisib were stomatitis and rash.
- Price Action: CELC shares are up 27.2% at $18.2, while PFE shares are up 0.1% at $36 in the premarket session on the last check Friday.
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