ORicell’s OriCAR-017, a CAR T cell therapy targeting GPRC5D for relapsed/refractory multiple myeloma, has received FDA IND approval, allowing immediate US clinical development initiation.
Clinical data from the POLARIS study, presented at major conferences in 2022, indicated a 100% overall response rate and 80% stringent complete response in ten patients, with a 100% minimal residual disease negative rate at day 28, confirmed at month 3.
The therapy demonstrated excellent tolerability, resolving rapidly without ICANS or cerebellar disorders, even in patients with extramedullary disease, prior BCMA CAR-T treatment, high-risk cytogenetics, and ECOG 2 status.
Oricell’s Co-founder and Chief Scientific Officer, Peter He, expressed enthusiasm about the remarkable safety, efficacy, and durability demonstrated by OriCAR-017. He anticipates substantial global benefits for multiple myeloma patients.
He emphasized that a decade of research and development has not only yielded OriCAR-017 but has also led to the creation of robust, integrated technology platforms generating unique CAR-T products for both liquid and solid tumors.
He further talked about the crucial role of exceptional teamwork at Oricell. He highlighted the accomplishment of transferring technology from China to the U.S. within five months, underscoring the high standard of collaboration.
Helen Yang, Oricell’s Co-founder and Chief Executive Officer, echoed the sentiment, expressing confidence in delivering top-notch cell therapies to patients. With a dedicated team and support from stakeholders, Oricell aims to offer patients new hope and possibilities through its innovative approach.
Source: 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.
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
