China-based Simcere Pharmaceutical Group Limited’s (HKG: 2096) subsidiary Simcere Zaiming announced the first patient dosing of the Phase I SIM0500-101 study in the United States. The trial aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of SIM0500 in patients with relapsed/refractory multiple myeloma (RRMM).

Drug Profile
SIM0500 (previously code-named SCR-8572) is a humanized trispecific antibody (TriAb) targeting GPRC5D, BCMA, and CD3. It was developed using Simcere Zaiming’s proprietary T-cell engager multispecific antibody platform.

Mechanism and Preclinical Results
The drug combines two tumor antigens, GPRC5D and BCMA, and has demonstrated potent T-cell-mediated cytotoxicity against multiple myeloma cells in preclinical studies. It has also shown favorable preliminary safety and efficacy data during dose escalation.

Regulatory and Partnership Milestones
SIM0500 was awarded fast-track status in the US in April of last year. In January this year, Simcere Zaiming entered into a licensing deal with US-based major AbbVie Inc., (NYSE: ABBV).-Fineline Info & Tech