Alphamab Oncology Announces the First Patient Dosed in the Phase I Trial of Anti-HER2 bispecific ADC JSKN003

Alphamab Oncology announced that the first patient has been dosed with 2.1mg/kg in a Phase I clinical study (JSKN003-102) of JSKN003, an Anti-HER2 bispecific ADC.

ADC drugs have the advantages of highly specific targeting of antibody and anti cancer activity of cytotoxin. ADC shave developed rapidly as tumor therapeutics in recent years. Optimizing tumor specificity, linker conjugation chemistry together with improving in vivo stability are the focus of ADC development. JSKN003 is an ADC based on Her2 bispecific antibody KN026. Through enzymatic catalyzed reaction and click chemistry, the payloads are linked to precisely controlled glycan on Fc, when make consistant DAR value close to 4. The better serum stability of JSKN003 ensures much wider therapeutic window. For example, JSKN003 shows better safety profile in preclinical study and comparable tumor killing activity with Enhertu (DS-8201) in both high and low HER2 expression tumor models(CDX+PDX model).

JSKN003 was approved by the Bellberry Human Research Ethics Committee in Australia(JSKN003-001), and the first patient was dosed in September 2022. At present, JSKN003-001 is ongoing smoothly at dose escalation stage, and currently at 5.2mg/Kg level. In October 2022, JSKN003 was approved for Phase I clinical trial by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration. JSKN003-102 is a Phase Ia/Ib clinical trial in Chinese patients with HER2-expressing advanced solid tumors to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic and anti tumor activity of JSKN003. JSKN003-102 trial and ongoing JSKN003-101 complement with each other, laying the foundation for the global development of JSKN003.