Celcuity Secures Key Patent for Gedatolisib Through 2042

New Patent Secures Future for Celcuity Inc.

Celcuity Inc. (NASDAQ: CELC), a pioneering clinical-stage biotechnology firm dedicated to developing targeted therapies for oncology, has recently achieved a significant milestone. The company has announced the issuance of U.S. Patent No. 12,350,276, which protects the clinical dosing regimen for its lead drug candidate, gedatolisib, aimed at treating ER+/HER2- breast cancer patients. This new patent extends Celcuity's patent exclusivity in the United States until 2042, reinforcing the company's commitment to advancing its innovative therapies.

Strengthening the Intellectual Property Portfolio

Brian Sullivan, the CEO and Co-Founder of Celcuity, expressed great enthusiasm about the patent issuance, emphasizing that this addition to their intellectual property portfolio underscores their dedication to protecting their innovations. The extended exclusivity for gedatolisib is expected to provide Celcuity ample opportunity to optimize its development strategies, potentially leading to enhanced treatment protocols and better patient outcomes.

A Comprehensive Patent Portfolio

This latest patent is part of a robust portfolio that Celcuity has built around gedatolisib. Previously, five U.S. patents covering its composition were issued, along with four patents related to various formulations and three focused on methods of using gedatolisib. Altogether, Celcuity now possesses 13 granted gedatolisib-related patents in the United States and 290 in international markets, establishing a formidable presence in the oncology sector.

Clinical Trials and Future Expectations

Looking ahead, Celcuity is set to announce crucial topline data for the PIK3CA wild-type cohort of the VIKTORIA-1 clinical trial in the upcoming months. The company is also expecting to release data for the PIK3CA mutant cohort later this year. These trials are critical to demonstrating the efficacy of gedatolisib among different patient populations and advancing its clinical applications.

About Celcuity Inc.

Founded to transform the landscape of oncology treatment, Celcuity Inc. is focused on developing targeted therapies for multiple solid tumor indications. The company’s key therapeutic candidate, gedatolisib, is known for its potent inhibition of the PI3K and mTORC1/2 pathways, delivering a comprehensive blockade of the PI3K/AKT/mTOR signaling pathway. Unlike other treatments that target PI3K? or mTORC1 alone, gedatolisib addresses multiple elements within the pathway, setting it apart from both current and investigational therapies.

Ongoing Clinical Trials

Currently, Celcuity is actively enrolling patients in major clinical trials including the Phase 3 trial known as VIKTORIA-1. This trial evaluates the combination of gedatolisib and fulvestrant, with or without palbociclib, specifically targeting patients diagnosed with HR+/HER2- advanced breast cancer. Furthermore, a Phase 1/2 clinical trial is underway testing gedatolisib alongside darolutamide for patients with metastatic castration-resistant prostate cancer. Such studies are essential for assessing the potential of gedatolisib in various treatment settings, ultimately aiming to enhance patient care in oncology.

Conclusion

The recent patent issuance represents a critical step forward for Celcuity, not only in terms of ensuring the longevity of its key assets but also in demonstrating a steadfast commitment to innovation in cancer therapy. As the company continues to make strides in clinical research, the future appears promising for Celcuity and its ambition to revolutionize oncology treatment with gedatolisib.

Frequently Asked Questions

What is the significance of the new patent issued to Celcuity?

The newly issued patent ensures exclusive rights for the dosing regimen of gedatolisib, extending protection into 2042, which allows Celcuity to further develop the drug without generic competition.

What is gedatolisib?

Gedatolisib is a potent inhibitor targeting the PI3K and mTOR pathways, utilized in advancing treatment options for specific breast cancer patients.

How does the patent enhance Celcuity's market position?

By securing patent exclusivity, Celcuity reinforces its market presence and shows commitment to its innovative therapies, potentially attracting investors and collaborators.

When will results from ongoing trials be announced?

Celcuity plans to announce topline data for the PIK3CA wild-type cohort in the third quarter and the mutant cohort in the fourth quarter of 2025.

What are the implications of the patent for future oncology treatments?

The patent could serve as a foundation for developing further therapies and techniques to enhance treatment efficacy for oncology, benefiting a broader patient population.

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