On March 26, 2024 Alphamab Oncology (stock code: 9966.HK) reported that the first patient has been dosed in Australia in the clinical study (JSKN033-101) of JSKN033, a subcutaneous formulation with HER2 bispecific antibody-conjugated drug and PD-L1 monoclonal antibody, for the treatment of HER2-expressing, advanced or metastatic solid tumors.
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Previous clinical studies have shown that combining antibody-drug conjugates (ADCs) with immunotherapy can enhance treatment efficacy and substantially prolong overall survival. However, this combination approach often leads to prolonged infusion and hospitalization durations, along with increased adverse events. The safety concern will be further exacerbated when chemotherapy regimens are included in the combo regimen. These factors can significantly impact patient medication compliance.
JSKN033, developed on top of the superior solubility and stability of Envaforlimab, is anticipated to offer a novel and effective treatment option for patients and healthcare providers by combining immune-oncology (IO) and ADC therapies. Notably, the nature of subcutaneous injectable will lead to improved safety and convenience. This innovative approach aims to mitigate the challenges associated with IV infusion, thereby enhancing patient adherence and treatment outcomes.
JSKN033-101 is an open-label, muti-center, phase I/II clinical study. The study consists of dose escalation and dose expansion phases: the Phase I dose escalation stage aims to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of JSKN033 in patients with advanced or metastatic HER2-expressing solid tumors, determining the maximum tolerated dose (MTD) and/or Phase II recommended dose (RP2D); the Phase II dose expansion stage will evaluate the efficacy and safety of JSKN033 in HER2-expressing gastrointestinal tumors at the RP2D dose.
About JSKN033
JSKN033 is the global first subcutaneous fixed-dose combination (FDC) independently developed by Alphamab Oncology, consisting of JSKN003 and envafolimab. JSKN003 is a HER2 dual-epitope-targeting glycan-specific antibody-drug conjugate (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 the National Medical Products Administration of China (the "NMPA") as the global-first subcutaneous injection PD-(L)1 inhibitor in November 2021.
(Press release, Alphamab, MAR 26, 2024, View Source [SID1234657014])