The initial Phase I/II SKN033-101 trial conducted in Australia has shown a ‘favourable’ safety profile in subjects heavily treated. Credit: PeopleImages.com – Yuri A/Shutterstock.

China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has approved Alphamab Oncology’s investigational new drug application (IND) for the multicentre Phase I/II JSKN033-102 trial of JSKN033.

The therapy is a high-concentration subcutaneous co-formulation that includes an anti-human epidermal growth factor receptor 2 (HER2) bispecific antibody-drug conjugate (ADC) and a PD-L1 immune checkpoint inhibitor.

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By combining immunotherapy with ADC, JSKN033 has the potential to significantly improve ‘efficacy’.

The approved open-label trial is aimed at assessing the safety, tolerability, anti-tumour activity, and pharmacokinetic/pharmacodynamic properties of the therapy in individuals with advanced metastatic malignant tumours. It will also determine the maximum tolerated dose (MTD) and/or the recommended Phase II dose (RP2D).

The initial Phase I/II JSKN033-101 trial conducted in Australia has shown a ‘favourable’ safety profile and ‘positive’ anti-cancer activity in subjects heavily treated.

JSKN033 is said to be the first to enter first-in-human clinical trials. Building on the solubility and stability of a subcutaneously injectable humanised PD-L1 inhibitor, Envaforlimab, JSKN033 combines immunotherapy (KN035) with ADC (JSKN003).

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Envaforlimab is a single domain antibody fused with a human immunoglobulin class G 1 (IgG1) crystallisable fragment (Fc) fragment, which received approval for subcutaneous injection in November 2021.

With cancer being a leading cause of death worldwide and in China, and with rising incidence and mortality rates, there is a critical need for treatments.

In December last year, the company reported that the therapy had obtained the Australian Bellberry Clinical Research Ethics Committee approval for conducting trials (JSKN033-101) to treat HER2-expressing advanced or metastatic solid tumours.