The approval allows Oricell to commence clinical development of OriCAR-017 in the US, with immediate effect.
Utilising Oricell’s platforms, including OriAb antibodies, OriCAR construct, and unique CMC know-how, OriCAR-017 is designed to achieve optimal binding, persistence, and anti-tumour efficacy from rejuvenated CAR-T cells.
The FDA’s clearance follows the therapy’s IND approval by the NMPA in 2023.
In the POLARIS study, it was observed that all 10 patients with R/R MM responded to OriCAR-017 therapy per IMWG criteria, achieving a 100% overall response rate (ORR) and 80% stringent complete response.
A 100% minimal residual disease (MRD) negative rate was detected at day 28 and further confirmed at month three.
The therapy was found to be well-tolerated, with no reported cases of Immune effector cell-associated neurotoxicity syndrome (ICANS), cerebellar disorder, delayed infections, and only Grade 1/Grade 2 cytokine release syndrome (CRS) that resolved rapidly.
Among the ten R/R MM patients treated, 40% had extramedullary disease (EMD), 50% previously received BCMA CAR-T treatments, 70% had high-risk cytogenetics, and 70% were assessed with an ECOG performance status of two, with 80% at ISS stage II & III.
Oricell co-founder and chief scientific officer Peter He said: “The evidenced superior safety, efficacy and durability profile of OriCAR-017 is truly exciting and will significantly benefit multiple myeloma patients on a global scale.
“Ten years’ R&D cumulates not only OriCAR-017 but also the robust and integrated technology platforms that generate one-of-its-kind CAR-T products for liquid and solid tumours.”