OnCusp Initiates Phase 1 CUSP06 Trial for Platinum-Resistant Ovarian Cancer and Solid Tumors

March 6, 2024 - Biopharmaceutical firm OnCusp Therapeutics has initiated a Phase 1 clinical trial for CUSP06, an innovative CDH6-directed antibody-drug conjugate (ADC). The trial's first patient has been dosed, marking a significant step in the company's journey to bring a new treatment option to patients with platinum-resistant ovarian cancer and other advanced solid tumors.

CUSP06 has been meticulously designed to enhance therapeutic potency, maximize the bystander effect, bolster linker stability, and counteract drug resistance, positioning it as a promising candidate for improved safety and efficacy in treating CDH6-expressing tumors. Preclinical studies indicate that CUSP06 could lead the field in clinical performance.

Bing Yuan, PhD, CEO of OnCusp Therapeutics, expressed enthusiasm about the trial's commencement, highlighting the company's evolution into a clinical-stage entity and its commitment to developing groundbreaking therapies. Eric Slosberg, PhD, the company's Chief Development Officer, emphasized CDH6 as a prime target for ADC therapies due to its overexpression in various cancers while sparing non-tumor tissues.

The multicenter Phase 1 study, registered as NCT06234423, aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of CUSP06 in adult patients. The trial is bifurcated into Phase 1a for dose determination and Phase 1b for a deeper examination of safety and efficacy in specific tumor profiles.

Alexander Spira, MD, PhD, a Principal Investigator for the CUSP06 trial and Clinical Director at NEXT Oncology Virginia, underscored the urgency of finding effective treatments for ovarian cancer, which is both prevalent and deadly. The Phase 1 study represents a significant effort to address the treatment gap in platinum-resistant cases.

CUSP06's formulation includes a proprietary high-affinity antibody targeting CDH6, a protease-cleavable linker, and an exatecan payload, a potent topoisomerase-1 inhibitor. The ADC's design minimizes chemoresistance by being a weak substrate for BCRP/P-gp efflux pumps. OnCusp Therapeutics holds the exclusive rights outside China for CUSP06's development and commercialization, following a partnership with Multitude Therapeutics.

OnCusp Therapeutics, co-founded by Drs. Yuan, Slosberg, and Andy Fu, is based in New York City and is focused on converting innovative preclinical research into cancer treatments. The company has secured a $100 million Series A financing round led by Novo Holdings, OrbiMed, and F-Prime Capital, underscoring its potential in the global oncology market.

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