Celcuity Secures New Patent for Gedatolisib
Celcuity Inc. (NASDAQ: CELC), a pioneering clinical-stage biotechnology company focused on developing targeted therapies for oncology, has recently celebrated the issuance of U.S. Patent No. 12,350,276. This significant patent governs the clinical dosing regimen for their lead drug candidate, gedatolisib, specifically targeting ER+/HER2- breast cancer patients. With this new patent, Celcuity’s patent exclusivity in the United States has now been extended to 2042.
CEO Statement Reflecting Commitment
Expressing enthusiasm about this milestone, Brian Sullivan, CEO and Co-Founder of Celcuity, stated, "This dosing regimen patent reflects our commitment to enhancing our intellectual property portfolio. With patent exclusivity for gedatolisib now extended into 2042, we expect to have a long runway to optimize development of gedatolisib." This sentiment underscores the company's dedication to building a robust pipeline of innovative treatments for breast cancer patients.
Expanding Intellectual Property Portfolio
The issuance of this latest patent adds to a comprehensive portfolio already comprising five U.S. patents related to gedatolisib’s composition of matter, four focused on various formulations containing gedatolisib, and three pertaining to its methods of use. In total, the global gedatolisib-related portfolio now consists of 13 granted patents in the U.S. and an impressive 290 patents secured in international markets.
Upcoming Clinical Trial Data
As the company moves forward, they anticipate announcing topline data for the PIK3CA wild-type cohort from the VIKTORIA-1 clinical trial in the near future. The third quarter of 2025 is earmarked for this vital update, followed closely by additional topline data for the PIK3CA mutant cohort, expected in the fourth quarter of the same year.
About Gedatolisib and Its Clinical Trials
Gedatolisib is carving a niche in the oncology landscape as it acts as a potent pan-PI3K and mTORC1/2 inhibitor, effectively blocking the PI3K/AKT/mTOR (“PAM”) pathway. This innovative therapy presents a unique mechanism of action and enhanced pharmacokinetics compared to existing therapies that primarily target PI3K?, AKT, or mTORC1 independently or in different combinations.
Currently, Celcuity is actively enrolling patients in its Phase 3 clinical trial, VIKTORIA-1, which assesses gedatolisib in combination with fulvestrant and potentially with palbociclib for patients diagnosed with HR+/HER2- advanced breast cancer. Additionally, a Phase 1/2 clinical trial, known as CELC-G-201, is ongoing, evaluating gedatolisib in conjunction with darolutamide for those suffering from metastatic castration-resistant prostate cancer. The company is also recruiting participants for another Phase 3 trial, VIKTORIA-2, which explores the efficacy of gedatolisib combined with a CDK4/6 inhibitor and fulvestrant as a frontline treatment.
Visit Celcuity for More Information
For further details on Celcuity and its innovative clinical trials, interested parties can visit the company at www.celcuity.com. Here, prospective patients and partners can find a wealth of information about ongoing research and future developments.
Frequently Asked Questions
What is Celcuity Inc. known for?
Celcuity Inc. is recognized for its pioneering work in developing targeted therapies for various types of cancers, focusing primarily on breast cancer treatments.
What is gedatolisib?
Gedatolisib is Celcuity's leading drug candidate, acting as a pan-PI3K and mTORC1/2 inhibitor to effectively block key pathways in cancer progression.
What does the new patent cover?
The new patent covers the clinical dosing regimen for gedatolisib in ER+/HER2- breast cancer patients, extending exclusivity until 2042.
What upcoming data should we expect from Celcuity?
Celcuity is expected to release topline data from the VIKTORIA-1 trial’s PIK3CA wild-type cohort in the third quarter of 2025 and data for the PIK3CA mutant cohort in the fourth quarter.
How can I stay updated on Celcuity's progress?
To stay informed, you can visit Celcuity's official website or follow them on LinkedIn and other social media platforms for the latest news and updates.
