Oricell has been approved to commence clinical development of OriCAR-017 in the United States. This decision was made effective immediately. OriCAR-017, which employs Oricell’s platforms including OriAb antibodies, OriCAR construct, and unique CMC know-how, is engineered to provide optimal binding, persistence, and anti-tumor efficacy from rejuvenated CAR-T cells.
The Food and Drug Administration’s (FDA) clearance follows the therapy’s Investigational New Drug (IND) approval by the NMPA in 2023. The POLARIS study provided significant insights into the potential of OriCAR-017. In the study, all ten patients with R/R MM responded positively to the 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 reconfirmed at month three. The treatment was 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. The study involved ten R/R MM patients, of whom 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.
Clinical Development of Advancing Multiple Myeloma Treatment and Beyond
Oricell’s co-founder and chief scientific officer, Peter He, commented on the superior safety, efficacy, and durability profile of OriCAR-017. He expressed enthusiasm about the significant global benefits this therapy can bring to multiple myeloma patients. Peter He also emphasized that ten years of clinical development and research resulted in not only OriCAR-017 but also robust and integrated technology platforms that generate unique CAR-T products for liquid and solid tumors.
In summary, the approval of OriCAR-017 for clinical development in the U.S. signifies a significant advancement in treating multiple myeloma. The therapy, designed for optimal binding, persistence, and anti-tumor efficacy, has shown promising results in the POLARIS study. Patients responded positively to the treatment, showing a 100% overall response rate and 80% stringent complete response. The therapy was well-tolerated, with no severe cases of ICANS, cerebellar disorder, delayed infections, and only mild CRS. The potential of OriCAR-017 for both liquid and solid tumors further broadens its application and impact in oncology.
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