Weekly Digest - December 2024

Weekly Digest - December 2024

26 Dec 2024: IND application for a phase I/II clinical study of anti-HER2 bispecific ADC subcutaneous co-formulation JSKN033 was approved

  • Alphamab Oncology has received approval from the CDE of the NMPA for a Phase I/II clinical trial (JSKN033-102) of JSKN033, a high-concentration subcutaneous co-formulation combining immunotherapy (KN035) and ADC (JSKN003)

  • The JSKN033-102 study is an open-label, multicenter trial aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of JSKN033 in patients with advanced metastatic tumors

  • This innovative formulation aims to improve safety and convenience by making ADC subcutaneously injectable, leveraging the superior solubility and stability of Envaforlimab, the first subcutaneous PD-L1 inhibitor

  • The first-in-human Phase I/II study of JSKN033 in Australia (JSKN033-101) showed a favorable safety profile and promising anti-cancer activity in heavily treated patients. At the 2024 SITC Annual Meeting, data revealed that of the ten evaluable patients, three had a partial response (PR) and five had stable disease (SD), resulting in an 80% disease control rate (DCR)

     
     

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