Oricell’s GPRC5D-Targeted CAR Cleared for US Evaluation in Patients With R/R Multiple Myeloma

The FDA has cleared Oricell’s investigational new drug (IND) application of OriCAR-017, allowing the company to initiate clinical development for patients with relapsed/refractory multiple myeloma (RR MM) in the United States.¹

OriCAR-017 is a GPRC5D-targeted chimeric antigen receptor (CAR) T cell therapy. The therapy is developed with the use of Oricell's Ori®Ab antibodies and Ori®CAR construct proprietary platforms, designed to achieve optimal binding, superior persistence and anti-tumor efficacy. The FDA IND approval for OriCAR-017 follows its IND approval in China in 2023. 

"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 tumors," Peter He, cofounder and Chief Scientific Officer, Oricell, said in a statement.¹

"Exceptional teamwork is what Oricell relies upon. The fact that we were able to complete technical transfer from China to the U.S. in 5 months speaks for the standard of our teamwork." Helen Yang, cofounder and Chief Executive Officer, Oricell, added.¹ "With a great team and support from our stakeholders, we are confident in our ability to delivering best-in-class cell therapies to patients, providing them new hope and possibilities."

READ MORE: Assessing GPRC5D-Targeted CAR T Therapy for R/R Multiple Myeloma

Oricell previously published data on OriCAR-017 in The Lancet Haematology from the phase 1 POLARIS trial (NCT05016778) in 10 patients with RRMM with a median of238 days follow-up (range, 99-345). The investigators found that the therapy had a manageable safety profile, with common Grade 3 or 4 treatment-emergent adverse events including neutropenia, leukopenia, thrombocytopenia and anemia hematologic toxicities, as well as cytokine release syndrome in all participants.²

OriCAR-017 yielded a 100% overall response rate, with 60% stringent complete response (sCR) and 40% very good partial response (VGPR). All patients (100%) achieved MRD negativity (10-5/ml). Of 5 patients that had disease relapse after BCMA CAR T-cell therapy, 2 had sCR and 3 had VGPR. Median progression-free survival had not been reached as of the cutoff date. Two participants experienced disease progression, one with GPRC5D-positive RRMM and the other with GPRC5D-negative RRMM.²

“Advances in the treatment of R/RMM, including the introduction of immunomodulatory drugs, proteasome inhibitors and monoclonal antibodies as well as stem cell transplantation, have prolonged survival in R/RMM patients, the disease remains a clinically incurable plasma cell neoplasm,” He Huang, MD, PhD, professor, Bone Marrow Transplantation Center, The First Affiliated Hospital, School of Medicine, Zhejiang University, said about the data.² “Nevertheless, almost all R/RMM patients eventually experience one or more relapses, with poorer survival outcomes for those with high-risk cytogenetic characteristics or refractory diseases. Data from our study showed that with extraordinary clinical efficacy, OriCAR-017 has been proved to be a novel, safe and effective therapy for patients with R/RMM, especially for those who experienced a relapse after receiving BCMA-targeted therapy. We are looking forward to continuously conducting follow-up clinical studies of OriCAR-017 in concert with Oricell.”

REFERENCES

1. Oricell Announces FDA Clearance of IND Application for OriCAR-017, a novel GPRC5D Targeted CAR-T Cell Therapy Utilizing the Company's Proprietary Platform, for the Treatment of Relapsed/Refractory Multiple Myeloma. News release. Oricell. January 29, 2024. https://www.prnewswire.com/news-releases/oricell-announces-fda-clearance-of-ind-application-for-oricar-017-a-novel-gprc5d-targeted-car-t-cell-therapy-utilizing-the-companys-proprietary-platform-for-the-treatment-of-relapsedrefractory-multiple-myeloma-302046662.html
2. Oricell Publishes Data from POLARIS Clinical Study Evaluating OriCAR-017 in the Treatment of RRMM in. January 31, 2023. https://www.oricell.com/en/newsdetail/id/15.html