On June 6, 2022 OriCell Therapeutics Co., Ltd (OriCell), a leading innovative biopharmaceutical company pioneering novel oncology cell therapies for the unmet medical needs in in hematology and oncology, reported the positive results from Phase I POLARIS study, an investigator-sponsored study evaluating Ori-CAR017, an autologous GPRC5D-directed CAR-T cell, in patients with relapsed/refractory multiple myeloma at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting (Press release, OriCell Therapeutics, JUN 6, 2022, View Source [SID1234615675]).
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Single Infusion of OriCAR-017 Demonstrates an Early, Deep and Durable Responses at All Dose Levels in Heavily Pretreated RRMM Patients, including Patients Who Relapsed from BCMA CAR-T Therapy.
Overall Response Rate(ORR) was 100% with Complete Response (CR)/ stringent Complete Response (sCR) rate of 60%，including Five patients with prior BCMA CART therapy achieved 2 sCR, 2 VGPR and 1PR. Patient medium follow up time 175 days (range 35-281). All patients were progression free without additional therapy at data cutoff. Results Highlights a Major Advance for OriCAR-017 Future Potential in RRMM Setting, regardless prior BCMA Targeted Therapy.
No Dose Limiting Toxicities (DLTs) or Serious Adverse Events (SAE) was observed. No Immune effector Cell Associated Neurotoxicity Syndrome(ICANS). Only Grade 1/2 Cytokine Release Syndrome(CRS). Most common Grade 3/4 AE was cytopenia, mainly due to lymphodepleting chemotherapy.
"We are delighted to share the FIH data from our Phase I POLARIS study, we strongly believe these data has demonstrated our advantages from the proprietary platforms for CAR-T optimization structure. Next step, we will be focusing on filling an IND with the NMPA and FDA for Ori-CAR017." said Dr. Helen Yang, Chairman and CEO of OriCell. "We look forward to continue developing novel cell therapies, to provide patient with better treatment option in the future."
Prof. He Huang, M.D., Bone Marrow Transplantation Center, The First Affiliated Hospital, School of Medicine, Zhejiang University said: "Multiple Myeloma (MM) remains incurable with extremely low overall survival for relapsed/refractory patients. Therapies using newer targets are urgently needed. The data presented at ASCO (Free ASCO Whitepaper) 2022 demonstrated that OriCAR-017 is a safe and effective treatment for patients with RRMM who received multiple lines of therapy, especially those who relapsed after BCMA-targeted therapy. I look forward to advancing the research of Ori-CAR017, a first-in-class autologous GPRC5D-directed CAR-T cell, with OriCell, so that patients can benefit from clinical results as soon as possible."