Suzhou, China, December 11, 2023 - Alphamab Oncology (stock code: 9966.HK) announced that the independently developed global first subcutaneous injection HER2 bispecific antibody-conjugated drug (JSKN033) has received approval from the Australian Bellberry Clinical Research Ethics Committee to conduct clinical studies (JSKN033-101) for the treatment of HER2-expressing advanced or metastatic solid tumors.
JSKN033-101 is an open-label, muticenter, 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.
JSKN033 is a subcutaneous injection compound consisting of JSKN003 and envafolimab, independently developed by Alphamab. JSKN033 is expected to provide effective innovative therapy for patients and doctors through IO and ADC combo and have better safety profile and convenience due to the nature of SubC injectables.
About JSKN033
JSKN033 is the global first subcutaneous injection HER2 bispecific antibody-conjugated drug developed by Alphamab, which is composed of JSKN003 and envafolimab. JSKN003 is a HER2 dual-epitope-targeting antibody-conjugated drug composed of three parts: bispecific antibodies targeting two non-overlapping epitopes of the HER2 extracellular domain, 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 China NMPA as the global first subcutaneously administered PD-L1 inhibitor and marketed in China.
About Alphamab Oncology
Alphamab Oncology is a biopharmaceutical company dedicated to the discovery, development manufacturing and commercialization of world-class innovative biotherapeutics for cancer treatment. On December 12, 2019, Alphamab Oncology was listed on the Main Board of Hong Kong Stock Exchange, with the stock code:9966.
To make cancer manageable and curable，Alphamab Oncology has always been guided by clinical value and patient needs, and focuses on the development of innovative, safe and affordable anti-tumor drugs to benefit patients in China and around the world.
We have created a biological macromolecule drug discovery, research and development, manufactured technology platform with independent intellectual property rights such as protein/antibody engineering, antibody screening, multi-module/multi-functional antibody modification.
With multiple in-house proprietary technology platforms, Alphamab Oncology has established a globally competitive and differentiated pipeline which consists of tumor single domain antibody/monoclonal antibodies, multi-functional antibodies, and antibody-drug conjugates. Among them, The world's first subcutaneous PD-L1 inhibitor injection (Envafolimab) has been obtained the market approval by the Chinese National Medical Products Administration, several varieties have entered the critical clinical stage in China and the United States, 2 varieties were selected into the national special project of " New Drug Development", and 3 varieties were granted 4 orphan drug qualifications by FDA.
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