Pharma Focus Asia

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

Thursday, March 16, 2023

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.

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 Centre 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 tumours to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic and anti tumour activity of JSKN003. JSKN003-102 trial and ongoing JSKN003-101 complement with each other, laying the foundation for the global development of JSKN003.

JSKN003 is an anti-HER2 bispecific antibody-drug conjugate (ADC), which is developed inhouse with proprietary Glycan-specific conjugation platform. JSKN003 targets HER2 and triggers a signal in the tumour cell, which then internalises the antibody together with the payload. After internalisation, the cytotoxic drug is released and kills the tumour cells. Compared other ADC drugs, JSKN003 induce faster and more intense endocytosis, which leads to stronger bystander effect in HER2-expressing tumours. Meanwhile the better serum stability ensures much wider therapeutic window. JSKN003 is currently undergoing phase I clinical research in China and Australia.

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