Sino-US company OnCusp Therapeutics Inc. has announced that it has received Fast Track Designation (FTD) from the US Food and Drug Administration (FDA) for its CUSP06. CUSP06 is a Cadherin-6 targeting antibody-drug conjugate (CDH6 ADC). The targeted indication for this therapy is platinum-resistant ovarian cancer (PROC).
Drug Details
CUSP06, the CDH6 ADC, is composed of a proprietary antibody with high CDH6 binding affinity. It also includes a protease-cleavable linker and an exatecan payload. Exatecan is a potent and clinically validated topoisomerase-1 inhibitor. The linker is designed to complement the exatecan payload. This enables a stable and homogenous ADC. The payload is a weak substrate for BCRP / P-gp. These are drug efflux pumps that drive chemoresistance to many therapies.
Development and Licensing
The drug is currently being assessed in a Phase I study for platinum-refractory / resistant ovarian cancer and other advanced solid tumors. CUSP06 was obtained from China’s Multitude Therapeutics through a licensing deal in 2022. The agreement covers development and commercialization globally, excluding Greater China.-Fineline Info & Tech
