"We are delighted to announce the IND approval for our flagship program, CUSP06, which has demonstrated excellent anti-tumor efficacy across diverse in vivo cancer models with both high and low CDH6 expression," stated Dr. Bing Yuan, Chairman and CEO of OnCusp Therapeutics. "This achievement is a testament to the dedication and expertise of our exceptional team. As our first asset to receive FDA approval for clinical trials, this marks a transformative milestone for OnCusp and reaffirms our commitment to developing game-changing treatments for cancer patients."

CDH6 is overexpressed in a myriad of cancers such as ovarian, renal, uterine, thyroid, lung, and cholangiocarcinoma. CUSP06 is a highly differentiated CDH6 ADC that is thoughtfully engineered to enhance potency, amplify the "bystander effect," improve linker stability, and potentially overcome drug resistance. It has exhibited a robust safety profile and developability in IND enabling studies.

The Phase 1 clinical trial will assess the safety and tolerability of escalating doses of CUSP06 to determine the maximum tolerated dose and/or recommended dose for expansion in patients with platinum-refractory/resistant ovarian cancer and other advanced solid tumors.