Alphamab Oncology’s JSKN003 ADC Achieves Positive Safety and Efficacy Outcomes in Phase I Studies

Alphamab Oncology (HKG: 9966), a leading player in the oncology space, has reported encouraging results from its Phase I clinical studies of JSKN003, a HER2-targeted antibody-drug conjugate (ADC), at the 2024 European Society of Medical Oncology (ESMO) Congress. The studies, conducted in Australia and China, targeted advanced and metastatic solid tumors, highlighting the drug’s potential in oncology treatment.

In the Australian Phase I study, JSKN003 was administered to 50 patients with platinum-resistant ovarian cancer (PROC) across five dose levels. The treatment demonstrated a favorable safety profile, with no treatment-related adverse event (TRAE)-induced fatalities. Of the 44 patients who received at least one baseline tumor assessment, an impressive 88.6% experienced tumor shrinkage, and the objective response rate (ORR) was 56.8% (95% CI: 41.0 to 71.7). The Chinese Phase I/II study involved 29 patients with HER2-positive advanced solid tumors, excluding breast cancer, who received JSKN003 intravenously every three weeks. The treatment maintained a good safety profile, with no TRAEs leading to death. Among the 28 patients with assessable efficacy, the ORR was 75.0%, and the disease control rate (DCR) was 89.3%.

JSKN003’s innovative molecular design, utilizing a click reaction, is believed to enhance serum stability compared to traditional conjugates that rely on the maleimide-Michael reaction. Its dual epitope HER2 targeting mechanism provides a stronger induction of endocytosis and bystander killing effects, leading to robust anti-tumor activity in HER2-expressing tumors while minimizing the toxicity of the drug payload. – Flcube.com

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