China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) announced that its antibody drug conjugate (ADC) SKB264, targeting trophoblast cell-surface antigen 2 (TROP2), has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study in advanced solid tumors. The trial will assess SKB264 in combination with other therapies.
Drug Profile
SKB264 delivers a cytotoxic payload directly to tumor cells via the TROP2 antibody, aiming to reduce off-target toxicity and enhance efficacy. The ADC has received three NMPA clinical trial approvals:
- Monotherapy for advanced solid tumors.
- Combined with Kelun’s anti-PD-L1 drug KL-A167 for advanced/metastatic non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC).
- Monotherapy in the second-line setting for advanced/metastatic TNBC (Phase III).
Partnership with Merck
On May 16, 2022, Kelun Pharma signed a $1.36 billion licensing deal with Merck Sharp & Dohme Corp. (MSD), granting MSD global development and commercial rights to an undisclosed biologic candidate speculated to be SKB264. Kelun received $30 million from MSD last month, marking the partnership’s full initiation.-Fineline Info & Tech
