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OnCusp’s CUSP06 Receives FDA Fast Track Designation

CUSP06 is being evaluated in a Phase 1 study in patients with platinum-refractory/resistant ovarian cancer and other advanced solid tumors.

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By: Charlie Sternberg

Associate Editor, Contract Pharma

The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to CUSP06, a Cadherin-6 targeting Antibody-Drug Conjugate (CDH6 ADC) and OnCusp Therapeutics Inc.’s lead program, for the treatment of patients with platinum-resistant ovarian cancer (PROC).

“We are extremely pleased that the FDA granted Fast Track Designation to CUSP06,” said Eric Slosberg, PhD, Chief Development Officer of OnCusp Therapeutics. “The early results from our Phase 1 trial have been encouraging, and this designation will expedite our efforts to bring this potentially transformative therapy to patients. Given the need for new therapeutic options in this underserved population, we are committed to working closely with the FDA to accelerate its development.”

The current Phase 1 multicenter study is assessing the safety, tolerability, pharmacokinetics, and initial efficacy of CUSP06 in adults suffering from platinum-refractory/resistant ovarian cancer and other advanced solid tumors (CUSP06-1001). Initial findings from the trial indicate encouraging anti-tumor effects along with a manageable safety profile, which supports the continued advancement of the program.

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