Alphamab Oncology (HKG: 9966) has released preliminary data from a Phase I clinical study on its JSKN003-KN026 antibody drug conjugate (ADC) in Australia, focusing on advanced solid tumors. This open-label, multi-center, dosage escalation study is designed to evaluate the safety, tolerability, and preliminary efficacy of the molecule in treating these tumors.
Study Progress and Initial Findings
As of October 26, 2023, with a median follow-up time of 4.2 months (95% CI: 2.3 to 5.8), 20 patients (62.5%) were still undergoing treatment. While progressive free survival (PFS) and duration of remission (DoR) data are not yet mature, the objective response rate (ORR) is under further observation. Among the 30 patients who underwent at least one tumor assessment, an ORR of 46.7% (95% CI: 28.3% to 65.7%) was noted, along with a disease control rate (DCR) of 90.0% (95% CI: 73.5% to 97.7%).
HER2 Expression and Treatment Response
In terms of HER2 expression, the ORR for HER2 low expression breast cancer (BC) patients was 40.0% (95% CI: 12.2% to 73.8%), whereas for HER2 high expression BC patients, the ORR was significantly higher at 75.0% (95% CI: 19.4% to 99.4%).
JSKN003 ADC: Mechanism and Advantages
JSKN003 is a HER2-targeted ADC that utilizes a click reaction for conjugation, which offers better serum stability compared to the maleimide-Michael reaction method. Its bi-epitope HER2 targeting capability enhances endocytosis-inducing and bystander killing effects, leading to potent antitumor activity against HER2-expressing tumors with minimal drug-related toxicity.
Ongoing Studies in China
Parallel to this, a Phase I/II study and a Phase III study are currently in progress in China, further investigating the potential of JSKN003 in treating HER2-expressing tumors.- Flcube.com
