OnCusp Therapeutics Receives FDA Clearance for the Phase 1 Clinical Trial of CUSP06, Targeting Ovarian Cancer and Other Advanced Solid Tumors

NEW YORK,Aug. 15,2023 --OnCusp Therapeutics,a biopharmaceutical company dedicated to transforming cutting-edge preclinical innovation into clinically validated treatments for cancer patients worldwide,announced today the clearance of its Investigational New Drug (IND) Application for CUSP06 by the U.S. Food and Drug Administration (FDA). CUSP06 is a highly differentiated,global second-in-class cadherin-6 (CDH6)-directed antibody-drug conjugate (ADC) designed for the treatment of multiple solid tumors.

"We are delighted to announce the IND approval for our flagship program,CUSP06,which has demonstrated excellent anti-tumor efficacy across diverse invivo 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.

About CUSP06

CUSP06,a CDH6-targeting 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 specially designed to complement the exatecan payload,enabling a highly 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 a stronger "bystander effect" than competitor ADCs. CUSP06 has a drug-to-antibody ratio of 8. OnCusp obtained the exclusive global rights (ex-China) to lead the development and commercialization of CUSP06 from Multitude Therapeutics. WuXi XDC,a global CRDMO company dedicated to end-to-end bioconjugates services,is the CMC partner for CUSP06.

About OnCusp Therapeutics

OnCusp Therapeutics is a biopharmaceutical company dedicated to transforming cutting-edge preclinical innovation into clinically validated treatments for cancer patients worldwide. OnCusp was founded by a team of accomplished veterans with a proven track record in building a startup biotech to the commercialization stage,leading successful global clinical programs,and creating value in mutually beneficial partnerships. The company is committed to accelerating the advancement of globally competitive oncology assets by leveraging its deep translational and clinical development expertise. OnCusp is headquartered in New York City,with a branch office in Shanghai.