China-based pharmaceutical innovator Simcere Pharmaceutical Group (HKG: 2096) has announced the receipt of an additional clinical trial approval from the National Medical Products Administration (NMPA) for its investigational bispecific antibody (BsAb), SIM0237. This molecule, targeting both PD-L1 and IL-15, is set to be evaluated as a novel treatment for non-muscular invasive bladder cancer (NMIBC), expanding the therapeutic landscape for this condition.
Mechanism of SIM0237
SIM0237 is a bispecific molecule combining a PD-L1 monoclonal antibody (mAb) with an inactivated IL-15/IL-15R α sushi fusion protein. It is designed to block the PD-1/PD-L1 immunosuppressive pathway by binding to PD-L1 and simultaneously activate the immune system through IL-15. This dual-action approach aims to achieve a synergistic effect, alleviating immunosuppression while activating immune anti-tumor dual pathways, offering a comprehensive strategy for cancer immunotherapy.
Pre-Clinical Success and Global Approvals
Pre-clinical studies have demonstrated that SIM0237 achieved superior efficacy compared to monotherapies targeting PD-L1 or IL-15 alone in mouse tumor models. Building on these promising results, the drug has already secured clinical trial approvals in China and the United States in October and December 2022, respectively, for the treatment of advanced solid tumors. The recent NMPA approval further extends the potential applications of SIM0237, highlighting its versatility and the broad therapeutic potential of bispecific antibodies in oncology.-Fineline Info & Tech
