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.

2024-01-29

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SHANGHAI and ROSELAND, N.J., Jan. 29, 2024 /PRNewswire/ -- Oricell Therapeutics (Oricell), a clinical-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for OriCAR-017 for patients with relapsed/refractory multiple myeloma (R/R MM). OriCAR-017 is a chimeric antigen receptor (CAR) T cell therapy targeting GPRC5D. The therapy leverages Oricell's proprietary platforms including Ori®Ab antibodies, Ori®CAR construct and unique CMC know-how to achieve optimal binding and superior persistence and anti-tumor efficacy out of rejuvenated CAR-T cells. The IND enables Oricell to initiate the clinical development for OriCAR-017 in the US immediately. The FDA IND approval for OriCAR-017 follows its NMPA IND approval in 2023 and the publication of clinical results from an Investigator Initiated Trial (POLARIS study) at the 2022 ASCO, 2022 EHA and The Lancet Haematology. The data showed that all ten patients with R/R MM responded to the therapy per IMWG criteria, achieving a 100% overall response rate (ORR), 80% stringent complete response. 100% minimal residual disease (MRD) negative rate was detected at day 28 and further confirmed at month 3. The therapy was well-tolerated, with no Immune effector cell-associated neurotoxicity syndrome (ICANS), no cerebellar disorder, no delayed infections, and only Grade 1/Grade 2 CRS that resolved rapidly. Of the ten R/R MM patients, 40% had extramedullary disease (EMD), 50% received prior BCMA CAR-T treatment(s), 70% had high-risk cytogenetics, and 70% with ECOG 2, 80% at ISS stage II & III. "The evidenced superior safety, efficacy and durability pro 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," said Peter He, Co-founder and Chief Scientific Officer of Oricell. "Exceptional teamwork is what Oricell relies upon. The fact that we were able to complete technical transfer from China to the U.S. in five months speaks for the standard of our teamwork." Helen Yang, Co-founder and Chief Executive Officer of Oricell further stated that, "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." About Oricell Therapeutics Oricell is a clinical-stage biotechnology company, dedicated to developing innovative cell therapies to address unmet medical needs in oncology and immunology around the world. Via Ori®Ab, Ori®CAR technology platforms and unique CMC know-how, Oricell has established unparalleled expertise in antibody screening and tuning, tumor immune microenvironment regulation, T cell infiltration, metabolism and killing ability. For more information, please visit: Forward-Looking Statements This press release contains "forward-looking statements" which are not historical facts, but instead are predictions about future events based on the beliefs as well as assumptions made by and information currently available to the management of Oricell Therapeutics Holdings Limited (the "Company" or "Oricell"). The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause the actual results, performance or achievements of the Company, or industry results, to differ materially from any future results, performance or achievement implied by such forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date of this press release. The Company assumes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.