Celcuity Inc.

Celcuity Inc. is a clinical-stage biotechnology company developing targeted therapies for various solid tumor indications. Its primary therapeutic candidate is gedatolisib, a kinase inhibitor that targets the phosphatidylinositol 3-kinase (PI3K), serine/threonine-protein kinase protein kinase B (AKT), and mechanistic target of rapamycin (mTOR) pathway. Gedatolisib comprehensively inhibits the PI3K/AKT/mTOR (PAM) pathway by binding to all class I PI3K isoforms and both mTORC1 and mTORC2 complexes. This mechanism of action and its pharmacokinetic properties distinguish it from other approved and investigational therapies that target PI3Kα, AKT, or mTORC1 individually or in combination. The company has completed enrollment for its Phase 3 clinical trial, VIKTORIA-1, which evaluates gedatolisib alongside fulvestrant, with or without palbociclib, in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). Detailed results for cohort 1 (patients with PIK3CA wild-type (WT) tumors) have been reported, and enrollment for cohort 2 (patients with PIK3CA mutant-type (MT) tumors) is complete. Additionally, Celcuity Inc. is conducting the Phase 3 clinical trial, VIKTORIA-2, which is evaluating gedatolisib in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor and fulvestrant as a first-line treatment for patients with endocrine treatment-resistant HR+/HER2- ABC.