Shanghai Securities News China Securities Network News On January 29, 2024, Oricell Therapeutics Holdings Limited (hereinafter referred to as "QrigincellTherapeutics") announced that the U.S. Food and Drug Administration (FDA) had officially approved the Investigational New Drug (IND) application for OriCAR-017, used to treat patients with relapsed/refractory multiple myeloma (R/R MM). OriCAR-017 is a chimeric antigen receptor T-cell (CAR-T cell) therapy targeting GPRC5D developed by QrigincellTherapeutics using its self-innovated technology platform. The design and development of this product integrates the advantages of QrigincellTherapeutics' self-innovated Ori®Ab antibody platform, Ori®CAR structure platform, and CMC. In early exploratory clinical studies, it has demonstrated good and lasting anti-tumor efficacy, as well as excellent safety. With the approval of this IND, QrigincellTherapeutics is about to initiate clinical development of OriCAR-017 in the United States.
It is reported that before the IND was approved by the FDA, OriCAR-017 had already been approved by the China National Medical Products Administration (NMPA) in August 2023 to carry out registration clinical trials. In addition, the data from the investigator-initiated clinical study (POLARIS) on OriCAR-017 were orally presented at the 2022 ASCO and 2022 EHA, respectively, and longer-term follow-up data were published in The Lancet Haematology in 2023.
Data Show That, According to IMWG Criteria, All 10 Patients Meet the Diagnosis of Relapsed/Refractory Multiple Myeloma (R/R MM) and Respond Well to OriCAR-017 Treatment. An Overall Response Rate (ORR) of 100% Was Achieved at Day 28 Post-infusion, with a 100% Minimal Residual Disease (MRD) Negative Rate, Further Confirmed as 100% Negative at Month 3. Among Them, 80% of Patients Achieved Stringent Complete Response (sCR). The Therapy Was Well Tolerated, with Only One Patient Experiencing Grade 2 Cytokine Release Syndrome (CRS), and the Remaining Were Grade 1. No Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), Cerebellar Disorders, or Late-Onset Infections Were Observed.
Notably: The baseline conditions of these patients were relatively advanced. Of the 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 potential application of OriCAR-017 in extremely advanced-stage patients.
He Xiaowen, Co-founder and Chief Scientific Officer of Qrigincell Therapeutics, stated, "The clinical data of OriCAR-017 has preliminarily demonstrated its excellent safety, efficacy, and durability. It is expected to become a new treatment option for patients with advanced multiple myeloma globally. After a decade of relentless efforts, we have gradually developed a series of highly synergistic platform technologies, covering antibody development, CAR structure design, and more, with hundreds of patents applied for. The clinical data of OriCAR-017 validates our technical capabilities, and in the future, we will continue to work hard to provide more CAR-T cell therapy options for clinical use." (Ding Jinling)