On August 4, 2025 Alphamab Oncology (stock code: 9966.HK) reported that the Investigational New Drug (IND) application for JSKN022, an independently developed innovative bispecific antibody-drug conjugate (ADC) targeting PD-L1 and integrin αvβ6, has been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The Company plans to initiate a clinical study of JSKN022 for the treatment of advanced malignant solid tumors.
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JSKN022 is an innovative bispecific ADC developed in-house with Alphamab’s proprietary glycan-specific conjugation platform. The molecule simultaneously targets and binds to both PD-L1 and integrin αvβ6 on the surface of tumor cells. After binding to either target, JSKN022 enters the lysosome through target-mediated endocytosis. The cleavable linker is specifically hydrolyzed by proteolytic enzymes such as cathepsin B, releasing cytotoxic topoisomerase I inhibitor (T01), which then induces apoptosis of PD-L1 and/or integrin αvβ6 positive tumor cells. In addition, the inhibitor can penetrate the cell membrane and enter the antigen-negative tumor cells to exert bystander effects. These combined effects can effectively inhibit the growth of tumor cells.
At present, no ADC targeting integrin αvβ6 or PD-L1 has been approved for marketing worldwide, with all related investigational candidates remaining in clinical development stages. Preclinical data demonstrate that JSKN022 exhibits potent antitumor activity in both in vitro and in vivo models against tumor cells expressing integrin αvβ6 and/or PD-L1. JSKN022 will potentially bring in novelty in the therapeutic approach for cancers that are refractory or resistant to PD-1/PD-L1 inhibitors, including non-small cell lung cancer, head and neck squamous cell carcinoma, and colorectal cancer.
This Phase I clinical study will evaluate the safety, tolerability, pharmacokinetics (PK)/pharmacodynamics (PD), and antitumor activity of JSKN022 in patients with advanced malignant solid tumors who have failed standard therapies, and determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D).
About JSKN022
JSKN022 is a first-in-class ADC targeting both PD-L1 and integrin αvβ6. Based on independently developed Envafolimab, Alphamab integrates immuno-oncology (IO) mechanisms with ADC approaches. This novel drug molecule utilizes glycan-specific conjugation technology to enhance both stability and homogeneity. The topoisomerase I inhibitor T01 is site-specifically conjugated to antibodies via a cleavable linker, enhancing therapeutic efficacy. JSKN022 is expected to provide a novel therapeutic option for cancers that are refractory or resistant to PD-1/PD-L1 inhibitors. The IND application for the clinical study of JSKN022 for the treatment of advanced malignant solid tumors has been accepted by CDE.
(Press release, Alphamab, AUG 4, 2025, View Source [SID1234656999])