On January 14, 2025 Alphamab Oncology (stock code: 9966.HK) reported that the first patient has been successfully dosed in Fudan University Shanghai Cancer Center in the phase I/II clinical study (Study ID: JSKN033-102) of JSKN033, a high-concentration subcutaneous co-formulation consisting of anti-HER2 bispecific antibody-drug conjugate (ADC) and PD-L1 immune checkpoint inhibitor, for the treatment of advanced metastatic malignant tumors.
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JSKN033 is the global first high-concentration subcutaneous co-formulation consisting of ADC and PD-L1 immune checkpoint inhibitor in first-in-human clinical trial, which is independently developed by the Company. By combining immunotherapy and ADC, JSKN033 is anticipated to significantly enhance efficacy. Leveraging the superior solubility and stability of Envafolimab, this formulation makes ADC subcutaneous injectable and leads to improved safety and convenience. The first-in-human phase I/II clinical study of JSKN033 conducted in Australia demonstrated favorable safety profile and encouraging anti-tumor activity.
JSKN033-102 is an open-label, multicenter, Phase Ⅰ/Ⅱ clinical study designed to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics and anti-tumor activity of JSKN033 in Chinese patients with advanced metastatic malignant tumors, and to determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D). This study has previously been included in the "Pilot Program for Optimizing the Review and Approval of Clinical Trials for Innovative Drugs".
About JSKN033
JSKN033 is the global first high-concentration subcutaneous co-formulation consisting of ADC (JSKN003) and immune checkpoint inhibitor (Envafolimab), which is independently developed by the Company. JSKN003 is a an anti-HER2 bispecific ADC, comprising of three components: a bispecific antibody targeting two non-overlapping epitopes of HER2 extracellular domains, a cleavable linker, and a topoisomerase I inhibitor. Envafolimab is a Fc fusion protein consisting of humanized anti-PD-L1 single domain antibody and human IgG1 Fc fragment, which has been approved by Chinese authorities as the global-first subcutaneous injection PD-(L)1 inhibitor in November 2021. By combining immunotherapy and ADC, JSKN033 is anticipated to significantly enhance efficacy. Leveraging the superior solubility and stability of Envafolimab, this formulation makes ADC subcutaneous injectable and leads to improved safety and convenience. The phase I/II clinical study of JSKN033 for the treatment of advanced or metastatic solid tumors is currently being conducted in China and Australia.
(Press release, Alphamab, JAN 14, 2025, View Source [SID1234657007])