Oricell Therapeutics Announces FDA Clearance of IND for OriCAR-017, a GPRC5D-Targeted CAR-T Therapy for Relapsed/Refractory Multiple Myeloma

On January 29, Qrigincell Therapeutics announced that the U.S. Food and Drug Administration (FDA) had officially approved OriCAR-017 for the treatment of patients with relapsed/refractory multiple myeloma (R/R MM).New Drug Clinical Application (IND).

OriCAR-017 is a GPRC5D-targeted chimeric antigen receptor T-cell therapy (CAR-T) developed by Qrigincell Therapeutics using its proprietary innovative technology platform.。

The design and development of this product integrate Qrigincell Therapeutics' self-innovated Ori®Ab antibody platform, Ori®CAR structural platform, and the company’s expertise in CMC. It has demonstrated promising and durable anti-tumor efficacy in early exploratory clinical studies, along with excellent safety. Following the approval of this IND, Qrigincell Therapeutics is set to initiate the clinical development of OriCAR-017 in the United States.

OriCAR-017 has initially demonstrated its excellent safety, efficacy, and durability.

Before the IND was approved by the FDA, OriCAR-017 had already received approval from the China National Medical Products Administration (NMPA) in August 2023 to conduct a registrational clinical trial. In addition, data from the investigator-initiated clinical study (POLARIS) on OriCAR-017 were orally presented at the 2022 ASCO and 2022 EHA meetings, with longer-term follow-up data published in *The Lancet Haematology* in 2023.

Its data showed that, according to the IMWG criteria, all 10 patients met the diagnosis of relapsed/refractory multiple myeloma (R/R MM) and all responded well to OriCAR-017 treatment.On Day 28 after dosing, a 100% overall response rate (ORR) was achieved, with a 100% minimal residual disease (MRD)-negative rate. This was further confirmed to be 100% negative at the 3-month mark, with 80% of patients achieving stringent complete response (sCR). The therapy was well-tolerated, with only one patient experiencing Grade 2 cytokine release syndrome (CRS), while all others experienced Grade 1.No immune effector cell-associated neurotoxicity syndrome (ICANS) was observed in the patient, with no cerebellar disorders and no late-onset infections.

Notably: These patients had more advanced baseline conditions.Among all 10 patients, 40% had extramedullary disease (EMD), 50% had received CAR-T therapy targeting BCMA, 70% had high-risk cytogenetic abnormalities, 70% had an ECOG score of 2, and 80% were at ISS stage II and III.These data further demonstrate the application potential of OriCAR-017 in very late-stage patients.

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