On February 13, 2025 Alphamab Oncology (stock code: 9966.HK) reported 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.
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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.
About JSKN003
JSKN003 is an anti-HER2 bispecific antibody-drug conjugate (bis-ADC), which is developed inhouse with Alphamab’s proprietary Glycan-specific conjugation platform. JSKN003 can bind HER2 on the surface of tumor cells and release topoisomerase I inhibitors (TOPIi) through cellular endocytosis, thereby exert anti-tumor effects. Compared with its ADC counterparts, JSKN003 demonstrated better serum stability and stronger bystander effect, which effectively expands the therapeutic window.
Multiple clinical studies at various stages of JSKN003 are currently being conducted in China and Australia. Clinical research results have demonstrated favorable tolerability and safety profile, with promising efficacy of JSKN003 in heavily pretreated patients with advanced solid tumors, especially in patients with HER2-expressing breast cancer, platinum-resistant ovarian cancer (PROC) or high HER2-expressing solid tumors.
In September 2024, the Company entered a licensing agreement with JMT-Bio Technology Co., Ltd. ("JMT-Bio"), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (stock code: 1093.HK), pursuant to which, JMT-Bio was granted the exclusive license and sublicense rights to develop, sell, offer for sale and commercialize JSKN003, for the treatment of tumor-related indications (the "Field") in mainland China (excluding Hong Kong, Macau or Taiwan) (the "Territory") and become the sole marketing authorization holder for JSKN003 for the Field in the Territory. Alphamab retains the sole right to supply JSKN003.
(Press release, Alphamab, FEB 13, 2025, View Source [SID1234657005])