Alphamab Oncology (HKG: 9966) has announced that the first patient has been dosed in a Phase I clinical study for its JSKN003-KN026 antibody drug conjugate (ADC) in Australia. The open, multi-center, dosage escalation Phase I study is designed to assess the safety, tolerability, and preliminary efficacy of JSKN003 in advanced solid tumors, alongside the determination of the recommended Phase II dosage (RP2D).
Drug Overview and Mechanism
JSKN003 is a HER2-targeted antibody drug conjugate. The conjugates prepared by the click reaction have better serum stability compared to those based on the maleimide-Michael reaction. Bi-epitope HER2 targeting enables JSKN003 to have stronger endocytosis-inducing and bystander killing effects, resulting in strong antitumor activity in HER2-expressing tumors with low drug-loaded toxicity.
Regulatory Progress
An Investigational New Drug (IND) filing for JSKN003 in solid tumors was accepted for review in China last month. This marks a significant step forward in the global development of JSKN003, positioning Alphamab Oncology to address significant unmet needs in the treatment of advanced solid tumors.
Future Outlook
The initiation of the Phase I clinical study in Australia underscores Alphamab Oncology’s commitment to advancing innovative treatments for cancer. With its unique mechanism and ongoing clinical trials, JSKN003 is poised to contribute to the development of next-generation therapies for patients with HER2-expressing tumors.-Fineline Info & Tech
