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Simcere Zaiming Announces Enrollment of First Patient in GPRC5D-BCMA-CD3 Tri-Specific Antibody SIM0500 Clinical Trial

Release time:2024-05-25

On May 24, 2024, Simcere Zaiming, a pioneering oncology firm and subsidiary of Simcere Pharmaceutical Group Ltd., revealed the initiation of dosing with the GPRC5D-BCMA-CD3 tri-specific antibody, SIM0500, in the first patient of a global Phase 1 clinical trial. This milestone event took place at the Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC, China.

The international, multi-center, open-label Phase I study is spearheaded by Professor Qiu Lugui of the Hospital of Hematology, Chinese Academy of Medical Sciences. The trial aims to recruit approximately 130 adult patients diagnosed with multiple myeloma.

Authorization for the study has been granted by both China's National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA), allowing the research to proceed in both China and the United States. Furthermore, in 2024, the FDA awarded SIM0500 a Fast Track designation.

SIM0500 is an innovative humanized GPRC5D-BCMA-CD3 tri-specific antibody, conceived and developed autonomously via Simcere Zaiming's T-cell engager polyspecific antibody technology platform. The antibody uniquely combines a low-affinity/high-target-activating CD3 antibody with two tumor-associated antibodies (GPRC5D, BCMA). This novel T-cell-activating agent specifically targets MM tumor cells, offering enhanced tumor suppression activity through the synergistic effects of multiple targets.

Preclinical study data has showcased SIM0500's favorable tolerance and promising tumor-killing efficacy, even at minimal dosages. In animal models, the absence of tumor recurrence post-treatment cessation was noted. SIM0500 stands as a potentially best-in-class candidate, poised to offer novel therapeutic options to surmount drug resistance encountered in existing multiple myeloma treatments.