Alphamab Oncology has dosed the first subject in the randomised Phase III JSKN003-306 trial of its anti-human epidermal growth factor receptor 2 (HER2) biparatopic antibody-drug conjugate (ADC), JSKN003, for ovarian cancer.
The trial is designed to assess the ADC’s efficacy against investigator-selected chemotherapy in subjects with platinum-resistant recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
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The open-label, multi-centre, parallel-controlled trial will include subjects with these cancers, irrespective of HER2 expression levels.
JSKN003 targets HER2 on tumour cells and releases topoisomerase I inhibitors to produce anti-tumour effects.
Developed using the company’s Glycan-specific conjugation platform, it has shown enhanced serum stability and a ‘stronger’ bystander effect against other ADCs, potentially widening the therapeutic window.
JSKN003 was initiated used as a single-agent in the dose-escalation and dose-expansion trials in Australia and China in 2022.
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By GlobalDataThe pooled analysis from these studies indicated a ‘favourable’ safety and tolerability profile.
In September last year, Alphamab signed a licensing agreement with a subsidiary of CSPC Pharmaceutical Group, JMT-Bio Technology.
JMT-Bio received exclusive development, sale, and commercialisation rights to the therapy for tumour-related indications in mainland China, with Alphamab holding the right to supply the therapy.
Alphamab’s integrated platform combines research and development, along with manufacturing capabilities for biologics, supported by an intellectual property portfolio.
With a focus on ADC, single-domain, and bispecific antibodies, the company claims to have a globally competitive pipeline.
In 2021, Chinese authorities granted approval to the company’s subcutaneously injectable programmed cell death protein 1 (PD-1) inhibitor, Envafolimab.
Alphamab has three assets in Phase III or pivotal clinical trials and several bispecific ADC new drug candidates in early clinical stages.
It has also established multiple strategic collaborations with partners such as Arrivent, Glenmark, and CSPC.
