China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has announced that its antibody drug conjugate (ADC) SKB264, targeting trophoblast cell-surface antigen 2 (TROP2), has obtained approval from the National Medical Products Administration (NMPA) to enter a Phase II clinical study in advanced or metastatic non-small cell lung cancer (NSCLC). The study will evaluate SKB264 both as a monotherapy and in combination with pembrolizumab, with or without chemotherapy.
Drug Profile
As an ADC, SKB264 delivers a cytotoxic payload directly to tumor cells by targeting the TROP2 antibody. This mechanism aims to reduce off-target toxicity while enhancing efficacy and safety. The drug is currently undergoing Phase II clinical trials for multiple tumor types in China and the US, positioning it as a potential new treatment option for patients with advanced cancers.
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 company development and commercial rights to SKB264 outside of Greater China. Last month, Kelun further strengthened its collaboration with Merck through a USD 936 million deal for another macro biologic. The partnership aims to assess the combination of SKB264 and pembrolizumab in advanced solid tumors, highlighting the potential of this ADC in addressing significant unmet medical needs.-Fineline Info & Tech
