FDA Approves Oricell's IND Application for Innovative CAR-T Therapy, OriCAR-017
Oricell Therapeutics, a firm at the clinical development phase in the biotech industry, declared that its application for the exploration of a new pharmaceutical, OriCAR-017, has received approval from the FDA in the United States for usage in individuals suffering from multiple myeloma that is recurrent or resistant to treatment.
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OriCAR-017 stands as a novel therapeutic approach, framed as a chimeric antigen receptor T cell treatment, and is specifically devised to address GPRC5D. Utilizing Oricell's cutting-edge technologies, which include the Ori®Ab antibodies, the Ori®CAR designs, and a distinctive competence in CMC processes, this therapy ensures an enhanced attachment and elevated effectiveness in both persistence and combating tumor cells through revitalized CAR-T cells. Through the issuance of the IND, Oricell now possesses the authorization to commence the introductory phases of clinical trials for OriCAR-017 within the US territory without delay.
The United States Food and Drug Administration (FDA) bestowed an IND clearance for OriCAR-017, a milestone following its previous sanction by the NMPA in 2023. Compelling clinical findings, stemming from an Investigator-Initiated Trial, were disseminated at the 2022 ASCO, the 2022 EHA, and within The Lancet Haematology. This evidence revealed compelling responses amongst the cohort of ten patients dealing with R/R MM, as adjudicated by the IMWG norms. The therapy yielded an unparalleled 100% rate of overall response, with a significant 80% achieving a stringent complete response. Impressively, a 100% negative rate for minimal residual disease was recorded on day 28, with successive validation at the 3-month milestone.
Remarkably, the treatment regimen manifested a high safety margin, evidenced by the absence of Immune effector cell-associated neurotoxicity syndrome, cerebellar complications, or procrastinated infections. Moreover, incidents of CRS were confined to Grade 1 and Grade 2 classifications and demonstrated swift resolution. Within the group of ten patients afflicted with R/R MM, a varied clinical backdrop was noted: 40% presented with extramedullary disease; half underwent previous treatments involving BCMA CAR-T; 70% were identified with high-risk cytogenetics; and a similar proportion presented with an ECOG performance status of 2, with 80% classified within ISS stages II and III.
Peter He, co-creator and the principal scientific leader at Oricell, expressed profound optimism towards the impactful safety, effectiveness, and endurance profiles of OriCAR-017, heralding its potential for global patient benefit within the multiple myeloma landscape. He also underscored the culmination of a decade's research and development efforts that have not only materialized OriCAR-017 but also fortified a robust, integrated platform. This platform is integral to the creation of uniquely innovative CAR-T cell products targeting both hematologic and solid malignancies.
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According to the data provided by the Synapse Database, As of February 5, 2024, there are 29 investigational drugs for the GPRC5D target, including 13 indications, 40 R&D institutions involved, with related clinical trials reaching 43, and as many as 2156 patents.
OriCAR-017 targets GPRC5D and aims to treat multiple myeloma and relapsed/refractory multiple myeloma. The drug is currently in Phase 1/2 of clinical development globally and in China. It has been designated as an orphan drug, indicating its potential to address unmet medical needs in rare diseases.
