Alphamab Oncology announced that the first patient has been successfully dosed in the Phase III clinical study (Study ID: JSKN003-306) of anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003. The study aims to compare the efficacy of JSKN003 versus investigator-selected chemotherapy for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

JSKN003 is an anti-HER2 biparatopic ADC, which is developed inhouse with Alphamab's proprietary Glycan-specific conjugation platform. Compared with its ADC counterparts, JSKN003 demonstrated better serum stability and stronger bystander effect, which effectively expands the therapeutic window. In 2022, JSKN003 initiated monotherapy dose-escalation and dose-expansion clinical studies in Australia and China (Study IDs: JSKN003-101, JSKN003-102). Results from the pooled analysis of both studies demonstrated a favorable tolerability and safety profile, with promising efficacy of JSKN003 in heavily pretreated patients with platinum-resistant recurrent ovarian cancer. Notably, efficacy was observed in both HER2-expressing (IHC 1+/2+/3+) and HER2-negative (IHC 0) patients.

JSKN003-306 is a randomized, open-label, parallel-controlled, multi-center Phase III clinical study for patients with platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, regardless of HER2 expression levels. The study aims to compare the efficacy and safety of JSKN003 versus investigator-selected chemotherapy in this patient population.