Iaso Bio Announces NMPA IND Approval for RD118, a Fully Human Anti-GPRC5D CAR-T Therapy for Relapsed/Refractory Multiple Myeloma
IASO Biotechnology
Cancer Treatment New Drug Developer
June 28, 2024, Nanjing, Shanghai, China, San Jose, California, USA — IASO Bio, a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative cell therapies, announced that the companyThe investigational new drug (IND) application for the self-developed fully human GPRC5D-targeted chimeric antigen receptor T-cell (CAR-T cell) injection (research code: RD118) has received tacit approval from the National Medical Products Administration (NMPA) for the proposed treatment of relapsed/refractory multiple myeloma (RRMM).。
About RD118
RD118 is a personalized, autologous infusion gene-modified T-cell immunotherapy product targeting GPRC5D, capable of identifying and eliminating malignant tumor cells expressing GPRC5D. The GPRC5D target is highly expressed in multiple myeloma cells and is only expressed in plasma cells and hair follicle cells in normal tissues, making it an emerging safe and effective target for the treatment of multiple myeloma.
The target recognition domain of RD118 was developed from IASO Bio's proprietary fully human single-domain antibody platform, offering advantages such as high affinity, high specificity, and low immunogenicity. Intracellularly, it incorporates a fusion of the 4-1BB (CD137) and CD3ζ signaling domains. RD118 has undergone in-depth development in antibody screening and structural optimization. The candidate molecule demonstrates excellent in vitro cytotoxic activity and in vivo tumor suppression capabilities, along with favorable in vivo expansion and persistence, showcasing strong developmental potential.
In an investigator-initiated exploratory clinical study (IIT study, Clinicaltrials.gov registration numbers: NCT05759793, NCT05219721), the safety and efficacy of RD118 injection for the treatment of patients with relapsed/refractory multiple myeloma or plasma cell leukemia were preliminarily explored. The principal investigators were Professor Jianqing Mi from Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, and Professor Chunrui Li from Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology.
The trial enrolls patients with multiple myeloma or plasma cell leukemia who have previously received at least three lines of therapy (must include at least one proteasome inhibitor and one immunomodulatory agent). Subjects who have previously received BCMA CAR-T therapy are also eligible for enrollment. The trial involves a dose range of 1.0~3.0 ×10.6RD118 at a dose of CAR-T cells/kg has been explored. As of November 20, 2023, the dose escalation phase has been basically completed, and the enrolled subjects have been infused. The safety and efficacy of the infused subjects are good, and subjects previously treated with BCMA CAR-T can also benefit.
Professor Mí Jiānqīng from Ruijin Hospital, Shanghai Jiao Tong University School of MedicineSaid: "Research shows that malignant plasma cells in almost all multiple myeloma patients can express GPRC5D. Targeted therapy against GPRC5D can effectively control the progression of multiple myeloma and extend patient survival, making GPRC5D a gradually competitive target. Additionally, GPRC5D has been shown to be expressed on the surface of myeloma cells independently of BCMA, and its expression is not affected by the absence of BCMA. For patients who relapse after anti-BCMA CAR-T cell therapy, treatment with GPRC5D-targeted CAR-T cells remains largely effective. This further indicates that anti-GPRC5D CAR-T cell therapy is a potential candidate treatment method."
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Professor Chunrui Li from Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyCommented: "The development of CAR-T cell therapy has significantly transformed the treatment landscape for multiple myeloma. Currently, the primary target for treating multiple myeloma is BCMA, whose heterogeneous expression on most malignant plasma cells can lead to varying depths of therapeutic response among different patients. The results of this IIT study indicate that RD118 has demonstrated promising efficacy and manageable safety in patients with target escape after BCMA-targeted therapy, as well as in patients with low or unstable BCMA expression. This could provide a new treatment pathway for RRMM patients, offering significant clinical value. In future clinical research, we will continue to explore appropriate treatment sequences and strategies targeting GPRC5D."
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Ms. Jin Hua Zhang, Founder and Chief Executive Officer of IASO BioStated: "GPRC5D, as a target expressed on multiple myeloma cells, similar to BCMA, is one of the important targets for treating multiple myeloma. Multiple myeloma is a complex disease that requires various treatment strategies to address different patient conditions. RD118, a product targeting GPRC5D for the treatment of multiple myeloma developed by IASO Bio, has demonstrated significant potential and therapeutic prospects in exploratory clinical studies, offering doctors and patients a new treatment option. We are highly optimistic about the future of RD118 and will continue to conduct in-depth research to ensure its safety and efficacy in clinical applications. At the same time, we will continue to collaborate with medical experts and research institutions worldwide to advance developments in this field and bring more benefits to patients."
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