Pharma Focus Asia

Alphamab Oncology Marks Milestone as First Patient Receives Dose in Australian Clinical Trial for Subcutaneous Formulation JSKN033

Tuesday, March 26, 2024

Alphamab Oncology (9966.HK) has recently announced the commencement of dosing for the first patient in Australia for their clinical trial (JSKN033-101) of JSKN033. This compound is a subcutaneous formulation that combines a HER2 bispecific antibody-conjugated drug with a PD-L1 monoclonal antibody, with the aim of treating advanced or metastatic solid tumors expressing HER2.

Previous studies have demonstrated the potential benefits of combining antibody-drug conjugates (ADCs) with immunotherapy for improving treatment efficacy and extending overall survival. However, such combinations often result in prolonged infusion times, leading to extended hospital stays and increased adverse events, particularly when chemotherapy is included. These challenges can significantly impact patient compliance with medication.

JSKN033, which builds upon the solubility and stability of Envaforlimab, seeks to address these challenges by integrating immune-oncology (IO) and ADC therapies in a subcutaneous formulation. This delivery method promises improved safety and convenience compared to traditional intravenous infusion, potentially enhancing patient adherence and treatment outcomes.

The ongoing JSKN033-101 study is an open-label, multi-center, phase I/II trial that includes dose escalation and expansion phases. The Phase I stage aims to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of JSKN033 in patients with advanced HER2-expressing solid tumors, focusing on determining the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D). The Phase II expansion will further assess efficacy and safety in HER2-expressing gastrointestinal tumors at the RP2D.

JSKN033 is the first subcutaneous fixed-dose combination (FDC) developed independently by Alphamab Oncology. It combines JSKN003, a HER2 dual-epitope-targeting glycan-specific antibody-drug conjugate (ADC), with envafolimab, a subcutaneous injection PD-(L)1 inhibitor that received approval from the National Medical Products Administration of China in November 2021.



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