Alphamab Oncology (HKG: 9966) presented compelling data from a Phase I clinical trial of its HER2-targeted antibody-drug conjugate (ADC), JSKN003, at the AACR 2024 annual meeting. Conducted in Australia, the study focused on advanced solid tumors with HER2 expression. JSKN003, which utilizes a click reaction for conjugation, showcased superior serum stability compared to traditional maleimide-Michael reaction-based conjugates. Its bi-epitope HER2 targeting mechanism enhances endocytosis and bystander killing effects, leading to potent antitumor activity with minimal drug-related toxicity.
The Phase I trial, an open-label, multi-center study, aimed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of JSKN003, as well as to establish the recommended Phase II dosage. The trial demonstrated that JSKN003 was well-tolerated and safe in patients with advanced/metastatic solid tumors who had previously received multiple lines of systemic treatment, with encouraging preliminary anti-tumor activity.
A total of 32 patients, diagnosed with various cancers including breast, ovarian, and bladder, were enrolled. Over 62.5% of these patients had undergone at least three lines of systemic treatment prior to the study. As of March 15, 2024, the objective response rate (ORR) and disease control rate (DCR) among the 32 patients were 56.3% (95% CI: 37.7%, 73.6%) and 90.6% (95% CI: 75.0%, 98.0%), respectively. Notably, the ORR for IHC 1+, 2+, and 3+ patients were 66.7% (6/9), 37.5% (6/16), and 85.7% (6/7), respectively. The ORR for HER2-positive breast cancer patients reached 100% (5/5), while for those with low HER2 expression, it was 50% (5/10). The study reported no deaths or treatment terminations due to treatment-related adverse events (TRAEs), and no dose-limiting toxicity (DLT) events occurred.- Flcube.com
