Celcuity Inc. presented data from preclinical studies evaluating gedatolisib and other PI3K/AKT/mTOR inhibitors in prostate cancer cell lines. The poster was presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), which is being held February 16-18, 2023. The presentation titled "Therapeutic effect of gedatolisib, a pan-PI3K/mTOR inhibitor, on prostate cancer models with PI3K or PTEN mutational status" demonstrated gedatolisib's superior potency and efficacy across different prostate cancer cell lines relative to other PI3K/AKT/mTOR inhibitors of PTEN or PI3K status.

About Gedatolisib: Gedatolisib is an investigational, pan-PI3K and mTOR inhibitor with low nanomolar potency for all Class I PI3K isoforms and mTORC1 and mTORC2. Its mechanism of action and pharmacokinetic properties are highly differentiated from other therapies that target PI3K or mTOR alone or together. Inhibiting all four Class I PI3K isoforms and mTOR limits the potential development of drug resistance compared to isoform-specific PI3K or mTOR specific inhibitors.

A robust response rate and a manageable side effect profile were reported for a Phase 1b clinical trial that evaluated gedatolisib in combination with palbociclib and endocrine therapy in patients with HR+/HER2- advanced breast cancer. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer is currently enrolling patients.