On March 6, 2024 OnCusp Therapeutics, Inc., a clinical stage biopharmaceutical company dedicated to transforming cutting-edge preclinical innovation into clinically validated treatments for cancer patients worldwide, reported that the first patient has been dosed in the Phase 1 study evaluating CUSP06 for the treatment of platinum-refractory/resistant ovarian cancer and other advanced solid tumors (Press release, OnCusp Therapeutics, MAR 6, 2024, View Source [SID1234640879]).

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CUSP06 is engineered to increase potency, heighten the "bystander effect," elevate linker stability, and overcome drug resistance. Thus, it is a potentially safer and more effective therapeutic option for patients with advanced solid tumors that express Cadherin-6 (CDH6). Preclinical data further suggest that CUSP06 may demonstrate best-in-class activity in the clinic.

"We are thrilled to announce the initiation of the Phase 1 clinical trial for CUSP06, our first ADC program to enter the clinic, and look forward to seeing our robust preclinical findings reflected in clinical settings," stated Bing Yuan, PhD, Co-Founder and CEO of OnCusp Therapeutics. "This marks a pivotal moment for OnCusp as we transition into a clinical-stage company, reaffirming our dedication to delivering innovative therapies to patients in need."

Eric Slosberg, PhD, Co-Founder and Chief Development Officer of OnCusp Therapeutics, said "CDH6 is an ideal target for an ADC approach, as it is overexpressed in many cancer types such as ovarian, renal, cholangiocarcinoma, uterine, and other malignancies, but has limited expression in non-tumor tissues. We look forward to exploring the effect of CUSP06 in patients with both high and low CDH6 expressing tumors."

The Phase 1 multicenter study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CUSP06 in adults with platinum-refractory/resistant ovarian cancer and other advanced solid tumors (NCT06234423). Phase 1a will determine safety and the recommended dose for expansion and the Phase 1b portion will focus on further characterizing safety and efficacy in selected tumor types.

"Ovarian cancer is the third most common and the most lethal gynecologic cancer worldwide," said Alexander Spira, MD, PhD, FACP, FASCO, CEO and Clinical Director for NEXT Oncology Virginia and a Principal Investigator for the Phase 1 study of CUSP06. "There is significant unmet medical need in the treatment landscape, especially in the platinum-resistant setting. We are excited to participate in this clinical trial and evaluate the potential of CUSP06 in treating ovarian cancer and other advanced solid tumors."

About CUSP06

CUSP06, a CDH6 ADC, is composed of a proprietary antibody with high CDH6 binding affinity, a protease-cleavable linker, and an exatecan payload (a potent and clinically validated topoisomerase-1 inhibitor). The linker is designed to complement the exatecan payload, enabling a stable and homogenous ADC. The payload is a weak substrate for BCRP/P-gp, which are drug efflux pumps that drive chemoresistance to many therapies. In preclinical data, this linker-payload has been shown to have an increased "bystander effect" compared to competitor ADCs. CUSP06 has a drug-to-antibody ratio of eight. OnCusp obtained the exclusive global rights (outside of China) to lead the development and commercialization of CUSP06 from Multitude Therapeutics.