On October 28, 2022 Alphamab Oncology (stock code: 9966.HK) reported the IND application to conduct a Phase Ia/Ib Clinical Trial of Anti-HER2 bispecific ADC was approved by the Center for Drug Evaluation (CDE) of NMPA (Press release, Alphamab, OCT 30, 2022, View Source [SID1234632919]). The study will evaluate the safety and tolerability of JSKN003 in Chinese patients with advanced malignant solid tumors, and to determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D).

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According to the latest report released by the National Cancer Center in 2022, the incidence of cancer in China continues to rise, with more than 11,100 people are diagnosed with tumors every day, among which lung cancer, colorectal cancer, gastric cancer, liver cancer and female breast cancer account for 57.4% of the total new cases. Human epidermal growth factor receptor-2 (HER2) is an effective target for the treatment of a variety of advanced malignant solid tumors, and antibody-drug conjugates (ADCs) have been shown to significantly improve the clinical efficacy. Therefore, exploring novel HER2-targeting antibody-drug conjugates could provide new treatment options for more cancer patients.

JSKN003 is an anti-HER2 bispecific antibody-drug conjugate (ADC), which is developed inhouse with proprietary Glycan-specific conjugation platform. Through enzyme catalysis and click chemistry, the payloads are site-specifically linked to glycan on Fc. The glycan structure is precisely controlled via process engineering which renders consistant DAR with more favorable stability. Compared other ADC drugs, JSKN003 induce faster and more intense endocytosis, which leads to stronger bystander effect in HER2-expressing tumors. Meanwhile the better serum stability ensures much wider therapeutic window. For example, JSKN003 shows better safety profile in preclinical study and comparable tumor killing activity with Enhertu (DS-8201) in both high and low HER2 expression (CDX+PDX model). A phase I clinical dose escalation study in underway in Australia for JSKN003 and the first patient was dosed in September 2022.

About JSKN003
JSKN003 is an anti-HER2 bispecific antibody-drug conjugate (ADC), which is developed inhouse with proprietary Glycan-specific conjugation platform. JSKN003 targets HER2 and triggers a signal in the tumor cell, which then internalizes the antibody together with the payload. After endocytosis, the cytotoxic drug is released and kills the cancer cells. Compared other ADC drugs, JSKN003 induce faster and more intense endocytosis, which leads to stronger bystander effect in HER2-expressing tumors. Meanwhile the better serum stability ensures much wider therapeutic window. A Phase I, multicenter, open-label, dose-escalation, first-in-human trial in Australia is ongoing to assess safety and tolerability in patients with advanced or metastatic solid malignancies and to determine the maximum tolerated dose /RP2D. The phase I clinical study application of JSKN003 in China for treatment of advanced solid tumors was approved by NMPA.