Biokin has filed a new drug application (NDA) with China's Centre for Drug Evaluation (CDE) for its EGFR/HER3 bispecific antibody drug conjugate (ADC) izalontamab brengitecan in recurrent or metastatic nasopharyngeal carcinoma following progression on PD-1/L1 inhibitor and platinum-based chemotherapy. The submission follows a positive interim analysis of a Phase III trial meeting co-primary endpoints of objective response rate (ORR) and overall survival (OS) compared against investigator's choice chemotherapy. Previously, Phase I data showed 45.8% ORR and 100% disease control rate (DCR) in 24 patients.

The candidate represents the first bispecific ADC completing Phase III development, utilising proprietary camptothecin derivative ED04 as payload, with drug-to-antibody ratio (DAR) of 8 through stable linker technology. Biokin granted ex-China rights to Bristol Myers Squibb through a USD 8.4 billion agreement.

PharmCube's NextBiopharm® database lists a total of 15 EGFR/HER3 bispecific ADC programs globally, led by Biokin's. Click here to request a free trial for NextBiopharm®.