OnCusp Therapeutics receives FDA Fast Track Designation for CUSP06 for the treatment of platinum-resistant ovarian cancer

CAR-T Digest - August 2020

12 Feb 2025: OnCusp Therapeutics receives FDA Fast Track Designation for CUSP06 for the treatment of platinum-resistant ovarian cancer

The FDA granted Fast Track Designation to OnCusp Therapeutics’ lead program, CUSP06, a Cadherin-6 targeting ADC, for treating platinum-resistant ovarian cancer
Early Phase 1 trial data indicate promising anti-tumor activity and a manageable safety profile
CUSP06 consists of a high-affinity CDH6 antibody, a protease-cleavable linker, and an exatecan payload, a potent topoisomerase-1 inhibitor
OnCusp holds exclusive global rights (excluding China) to develop and commercialize CUSP06, licensed from Multitude Therapeutics in 2022
The ongoing Phase 1 study is evaluating CUSP06 in patients with platinum-refractory/resistant ovarian cancer and other advanced solid tumors