Pharma Focus America

IASO Bio's GPRC5D CAR-T Therapy RD118 Receives Regulatory Approval from NMPA for Treating Multiple Myeloma

Saturday, June 29, 2024

IASO Bio, a biopharmaceutical company specializing in innovative cell therapies and antibody products, has recently announced the approval of their investigational new drug (IND) application for RD118 by the National Medical Products Administration (NMPA). RD118 is a chimeric antigen receptor T-cell (CAR-T) therapy designed to target G protein-coupled receptor class C group 5 member D (GPRC5D) for the treatment of relapsed/refractory multiple myeloma (RRMM).

GPRC5D is highly expressed on multiple myeloma cells and minimally expressed in normal tissues, making it a promising and safe therapeutic target. RD118 utilizes a proprietary fully human single-domain antibody for precise targeting and minimal immunogenicity. It incorporates a fusion of 4-1BB and CD3ζ signaling domains to enhance tumor cell elimination. The therapy has demonstrated potent cytotoxic activity in laboratory studies and effective tumor suppression in preclinical models. Additionally, it exhibits strong expansion and persistence capabilities in clinical settings.

IASO Bio has initiated an investigator-initiated clinical trial to evaluate RD118's safety and efficacy in patients with RRMM or plasma cell leukemia who have undergone previous lines of therapy, including proteasome inhibitors and immunomodulators. Early findings from the trial indicate promising safety profiles and therapeutic benefits, including positive responses in patients previously treated with BCMA CAR-T therapy.

Professors Jianqing Mi and Chunrui Li, principal investigators of the clinical trial, highlight the potential of GPRC5D-targeted therapy to provide new treatment avenues, especially for patients who have relapsed post-BCMA CAR-T treatment or exhibit low BCMA expression levels. Ms. Jinhua Zhang, Founder and Chairman of IASO Bio, underscores the significance of RD118 in advancing treatment options for multiple myeloma and expresses commitment to further research efforts to optimize its clinical application.

IASO Bio's IND approval for RD118 represents a significant advancement in personalized medicine for hematologic malignancies, offering renewed hope for patients facing challenging treatment scenarios in multiple myeloma.



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