#United States #Princeton #FDA Fast Track #OnCusp Therapeutics #CUSP06

OnCusp Therapeutics Makes Progress in Ovarian Cancer Treatment

On February 12, 2025, OnCusp Therapeutics, Inc., a clinical stage biopharmaceutical company, announced a significant milestone in cancer therapy with the U.S. Food and Drug Administration's (FDA) decision to grant Fast Track Designation (FTD) to its groundbreaking drug candidate, CUSP06. This Antibody-Drug Conjugate (ADC) is specifically tailored to treat patients with platinum-resistant ovarian cancer (PROC). This designation is a testament to OnCusp's commitment to addressing the urgent need for innovative therapies in oncology.

Significance of Fast Track Designation

Fast Track Designation is a crucial regulatory status that aims to accelerate the development of drugs intended for serious conditions with unmet medical needs. Having received this designation, OnCusp Therapeutics can expect more frequent interactions with the FDA, potential eligibility for Accelerated Approval, and Priority Review, all of which will help hasten the availability of CUSP06 for patients suffering from this challenging cancer type.

Dr. Eric Slosberg, Chief Development Officer at OnCusp, expressed his enthusiasm over the FDA’s decision, stating, "The early results from our Phase 1 trial have been encouraging, and this designation will expedite our efforts to bring this potentially transformative therapy to patients. Given the need for new therapeutic options in this underserved population, we are committed to working closely with the FDA to accelerate its development."

The CUSP06 Clinical Trial

Currently, the CUSP06 program is being evaluated in an ongoing Phase 1 multicenter trial (CUSP06-1001), which focuses on its safety, tolerability, pharmacokinetics, and preliminary efficacy in adults with platinum-refractory or resistant ovarian cancer and other advanced solid tumors. Early data has shown promising anti-tumor activity, as well as a manageable safety profile, lending further support for the drug's continued development.

CUSP06 is a CDH6-targeting ADC comprised of a proprietary antibody with high binding affinity for Cadherin-6, a protease-cleavable linker, and an exatecan payload, known for its potency as a topoisomerase-1 inhibitor. The design of this drug aims to counteract the mechanisms that lead to drug resistance, which is a significant obstacle in treating ovarian cancer patients.

Background on Platinum-Resistant Ovarian Cancer

Ovarian cancer remains a leading cause of gynecologic cancer-related deaths in the United States, with around 20,000 new cases diagnosed annually. While platinum-based chemotherapy is the standard first-line treatment, a staggering 80% of patients who respond initially will eventually develop resistance, typically within two years. Platinum-resistant ovarian cancer is marked by disease progression within six months after completing platinum therapy and is associated with a dismal prognosis, presenting median survival rates of only 9-12 months.

Despite advancements in treatment, the 5-year survival rate for patients with platinum-resistant cancer hovers around 15%, highlighting a critical need for new therapeutic approaches that can break through current limitations. In this context, the development of CUSP06 presents a vital opportunity to improve options for patients grappling with this challenging diagnosis.

A Commitment to Innovation

OnCusp Therapeutics, based in Princeton, New Jersey, is dedicated to transforming cutting-edge preclinical innovations into effective treatments for cancer patients. Since its inception, the company has established a team of seasoned professionals in the biotechnology field, nurturing an environment conducive to innovation and collaboration. In a notable financing round in January 2024, OnCusp secured $100 million in funding from prominent investors, demonstrating strong support for its mission and paving the way for its promising projects.

By accelerating the development process for CUSP06, OnCusp Therapeutics is poised to make a noteworthy impact on the landscape of ovarian cancer treatment, aiming to provide new hope to those in need.