Clinical stage biopharmaceutical company OnCusp Therapeutics Inc announced on Wednesday that it has received Fast Track Designation (FTD) from the US Food and Drug Administration (FDA) for CUSP06, a Cadherin-6 targeting Antibody-Drug Conjugate (CDH6 ADC) and the company's lead programme, for the treatment of patients with platinum-resistant ovarian cancer (PROC).

An ongoing Phase 1 multicentre study is evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of CUSP06 in adults with platinum-refractory/resistant ovarian cancer and other advanced solid tumours (CUSP06-1001). Early data from the trial showed promising anti-tumour activity and a manageable safety profile, supporting further development of the programme.

Eric Slosberg, PhD, OnCusp Therapeutics' chief development officer, said: "We are extremely pleased that the FDA granted Fast Track Designation to CUSP06. 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."