China-based Simcere Pharmaceutical Group (HKG: 2096) announced that it has received clearance from the US FDA to conduct a clinical study for its SIM0237, an in-house developed bispecific antibody (BsAb) targeting programmed-death ligand 1 (PD-L1) and interleukin-15 (IL-15). The molecule is intended for the treatment of locally advanced, unresectable metastatic solid tumors, as indicated in an IND filing in China earlier this month.
Preclinical Results and Development Potential
Preclinical studies have demonstrated that SIM0237 is superior to the combined use of PD-L1 and IL-15 monotherapy in mice tumor models. These results suggest that SIM0237 has strong potential for clinical development, positioning it as a promising candidate for the treatment of advanced solid tumors.
Future Outlook
With the FDA’s clearance, Simcere is poised to advance SIM0237 into clinical trials, marking a significant step in the development of innovative therapies for patients with advanced cancers. The company aims to leverage the unique mechanism of action of SIM0237 to address significant unmet needs in oncology.-Fineline Info & Tech
