Celcuity Secures Patent Extension for Gedatolisib Through 2042, Strengthening Breast Cancer Drug Portfolio
Key Insights
Celcuity received US Patent No. 12,350,276 covering the clinical dosing regimen for gedatolisib in ER+/HER2- breast cancer (search) patients, extending patent exclusivity to 2042.
The company's worldwide gedatolisib patent portfolio now includes 13 granted US patents and 290 patents in foreign jurisdictions, providing comprehensive intellectual property protection.
Topline data from the VIKTORIA-1 Phase 3 trial evaluating gedatolisib in HR+/HER2- advanced breast cancer (search) is expected in Q3 and Q4 2025 for different patient cohorts.
Minneapolis-based Celcuity Inc. has received a significant patent extension for its lead oncology drug candidate gedatolisib, with the United States Patent and Trademark Office issuing Patent No. 12,350,276 covering the clinical dosing regimen for ER+/HER2- breast cancer (search) patients. The patent extends Celcuity's exclusivity protection in the US through 2042, providing the clinical-stage biotechnology company with an extended development runway for its targeted cancer therapy.
"This dosing regimen patent reflects our commitment to enhancing our intellectual property portfolio," said Brian Sullivan, CEO and co-founder of Celcuity. "With patent exclusivity for gedatolisib now extended into 2042, we expect to have a long runway to optimize development of gedatolisib."
Comprehensive Patent Portfolio Expansion
The newly issued patent represents a substantial addition to Celcuity's intellectual property strategy. The USPTO had previously granted five US patents directed to gedatolisib's composition of matter, four patents covering various formulations comprising gedatolisib, and three patents focused on methods of using the drug candidate.
The worldwide gedatolisib-related patent portfolio has now expanded to comprise 13 granted patents in the United States and 290 patents granted in foreign jurisdictions, providing comprehensive global protection for the company's lead therapeutic candidate.
Advanced Clinical Development Program
Gedatolisib is characterized as a potent, pan-PI3K (search) and mTORC1/2 (search) inhibitor that comprehensively blockades the PI3K/AKT/mTOR (search) (PAM) pathway. According to Celcuity, its mechanism of action and pharmacokinetic properties differentiate it from other currently approved and investigational therapies that target PI3Kα, AKT, or mTORC1 alone or in combination.
The company is currently conducting multiple Phase 3 clinical trials to evaluate gedatolisib's therapeutic potential. The VIKTORIA-1 trial is evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer (search) and is currently enrolling patients.
Anticipated Clinical Milestones
Celcuity expects to announce topline data for the PIK3CA wild-type cohort of the VIKTORIA-1 clinical trial in the third quarter of 2025, followed by topline data for the PIK3CA mutant cohort in the fourth quarter of 2025. These results will provide crucial efficacy and safety data for the company's regulatory strategy.
Additionally, the company is conducting VIKTORIA-2, a Phase 3 clinical trial evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer (search), which is currently recruiting patients.
Expanding Therapeutic Applications
Beyond breast cancer, Celcuity is exploring gedatolisib's potential in other solid tumor indications. The company is conducting CELC-G-201, a Phase 1/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer (search).
The patent extension provides Celcuity with enhanced commercial protection as it advances its comprehensive clinical development program across multiple oncology indications, positioning the company to potentially capture significant market opportunities in targeted cancer therapy.