Oricell OriCAR-017 CAR-T Therapy Clears IND Hurdle, Paving the Way for Global Impact

SHANGHAI, Aug. 10, 2023 /PRNewswire/ — August 10, 2023, in a groundbreaking development, Oricell Therapeutics Co., Ltd. (“Oricell”) has received the green light for its Investigational New Drug (IND) application of OriCAR-017, a cutting-edge CAR-T cell therapy targeting GPRC5D to combat relapsed or refractory multiple myeloma (R/R MM). This remarkable milestone not only marks the world’s first tier GPRC5D-targeting CAR-T therapy approved in China but also underlines Oricells prowess as a frontrunner in the biotech industry.

About GPRC5D target

GPRC5D, a G protein-coupled receptor that boasts high expression on multiple myeloma cells while maintaining low levels in normal tissues, has emerged as a promising therapeutic target for multiple myeloma. The revolutionary approach of independently targeting GPRC5D, regardless of BCMA expression levels, opens up new possibilities for patients who have exhausted conventional treatments or shown limited response to BCMA-targeting therapies.

Earlier, data from the investigator initiated trial of OriCAR-017 (POLARIS) were presented at the 2022 ASCO (American Society of Clinical Oncology Annual Meeting) and the 2022 EHA (European Hematology Association Annual Meeting), attracting widespread attention due to its efficacy and safety advantages. The study enrolled 10 patients, included five patients who were previously treated with BCMA-targeted CAR T-cell therapy and four patients with extramedullary disease (EMD). According to the latest data, at a median follow-up time of 280 days (217 ~ 459 days), OriCAR-017 is turning heads with an impressive overall response rate (ORR) of 100% and a stringent complete response rate (sCR) of 80%. Additionally, compared to other therapies targeting the same antigen, OriCAR-017 demonstrated significant safety advantages, with only one case of grade 2 cytokine release syndrome (CRS) observed after treatment, while the rest were grade 1. Notably, no instances of immune effector cell-associated neurotoxicity syndrome (ICANS) and no grade 3 or higher skin toxicities or nail changes were reported, nor infection events were observed during long-term follow-up after treatment. Such reassuring safety data paves the way for reduced post-treatment clinical interventions, ultimately lightening the burden on healthcare providers and enhancing patient experiences.

Oricell’s Chairman and CEO, Helen Yang expressed, “OriCAR-017’s approval as China’s first and the world’s leading GPRC5D-targeting CAR-T therapy is a pivotal moment for the biotech landscape. We are bridging the gap in late-line treatments for R/R MM, providing new hope to patients who have failed or responded poorly to different therapies targeting BCMA. The potential global impact of OriCAR-017 is undeniable, as we have been developing a global development plan for OriCAR-017 and are systematically advancing its registration for clinical trials in the United States. We have already obtained the ‘Orphan Drug’ designation from the Office of Orphan Products Development (OOPD) of the U.S. FDA.” Helen is confident about the development prospects of this product and further stated, “with the IND clearance in China and seamless progress in overseas registrations and technology transfer, the stage is set for OriCAR-017 to become a game-changer in the fight against multiple myeloma. As Oricell continues to make strides in ground-breaking innovation, the future of cancer treatment looks more promising than ever before.”

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