China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd has announced receiving approval from the US FDA to conduct a Phase II clinical study for its drug candidate SKB264, an antibody drug conjugate (ADC) targeting trophoblast cell-surface antigen 2 (TROP2), in combination with the PD-1 inhibitor pembrolizumab. The initial development target is selected advanced solid tumors. The global multi-center study, including sites in China, the United States, Canada, Europe, and Australia, was already initiated in China in July.
Drug Profile
As an ADC, SKB264 directly delivers a cytotoxic payload to tumor cells via targeting the TROP2 antibody. This mechanism aims to reduce off-target toxicity while enhancing efficacy and safety. The drug is currently undergoing Phase II and III clinical trials for multiple tumor types globally, based on its preliminary data.
Partnership and Future Plans
In May 2022, Kelun Pharma entered into a USD 1.41 billion licensing agreement with Merck Sharp & Dohme Corp, granting the US major development and commercial rights to SKB264 outside of Greater China. The two companies are collaborating to assess the combination of SKB264 and pembrolizumab in advanced solid tumors. This partnership underscores Kelun-Biotech’s commitment to advancing innovative cancer therapies through global collaboration.-Fineline Info & Tech
