Oricell Therapeutics Announces FDA IND Approval for OriCAR-017, a GPRC5D-Targeting CAR-T Therapy for Relapsed/Refractory Multiple Myeloma

Jan 29, 2024 07:29 CST Updated 07:29

Oricell Therapeutics

Developer of Tumor Immunocyte Products

Shanghai, New Jersey, January 29, 2024 – Oricell Therapeutics Holdings Limited (referred to as “Qrigincell Therapeutics”) announced that the U.S. Food and Drug Administration (FDA) has officially approved the Investigational New Drug (IND) application for OriCAR-017, intended for the treatment of patients with relapsed/refractory multiple myeloma (R/R MM).OriCAR-017 is a GPRC5D-targeted chimeric antigen receptor T-cell therapy (CAR-T) developed by Qrigincell Therapeutics using its proprietary technology platform.The design and development of this product integrate Qrigincell Therapeutics' self-innovated Ori®Ab antibody platform, Ori®CAR structure platform, and the company’s expertise in CMC. It has demonstrated good and durable anti-tumor efficacy in early exploratory clinical studies, as well as excellent safety.With the approval of this IND, Qrigincell Therapeutics is about to launch the clinical development of OriCAR-017 in the United States.

OriCAR-017 has preliminarily demonstrated its excellent safety, efficacy, and durability.

Before the IND was approved by the FDA, OriCAR-017 had already received approval from the China National Medical Products Administration (NMPA) in August 2023 to conduct registration clinical trials. In addition, data from the investigator-initiated clinical study on OriCAR-017 (POLARIS) were orally presented at the 2022 ASCO and 2022 EHA meetings, with longer-term follow-up data published in The Lancet Haematology.

Its data show that, according to the IMWG criteria, all 10 patients met the diagnosis of relapsed/refractory multiple myeloma (R/R MM) and responded well to OriCAR-017 treatment. The overall response rate (ORR) was 100% at Day 28 post-infusion, with a 100% minimal residual disease (MRD) negativity rate, which was further confirmed to be 100% negative at Month 3, with 80% of patients achieving stringent complete response (sCR). The therapy was well-tolerated, with only one patient experiencing Grade 2 cytokine release syndrome (CRS), while the rest were Grade 1. No immune effector cell-associated neurotoxicity syndrome (ICANS), cerebellar disorders, or delayed infections were observed.

Notably: The baseline condition of these patients was relatively advanced, with all 10 patients having40% of patients have extramedullary disease (EMD),50% received CAR-T cell therapy targeting BCMA, and 70% of patients had high-risk cytogenetic abnormalities.70% of patients had an ECOG score of 2.80% of patients were ISS Stage II and III. These data further demonstrate the application potential of OriCAR-017 in very late-stage patients.

Dr. He Xiaowen, Co-founder and Chief Scientist of Qrigincell Therapeutics, stated

"The clinical data of OriCAR-017 has preliminarily demonstrated its excellent safety, efficacy, and durability, and it is expected to become a new treatment option for patients with advanced multiple myeloma globally. After a decade of relentless efforts, we have gradually developed a series of highly synergistic platform technologies, covering antibody development, CAR structure design, and more, with hundreds of patents applied for. The clinical data of OriCAR-017 validates our technical capabilities, and in the future, we will continue to work hard to provide more CAR-T cell therapy options for clinical use."

Ms. Yang Huanfeng, Co-founder and CEO of Qrigincell Therapeutics, stated

"An exceptional advantage of Qrigincell Therapeutics lies in its outstanding team collaboration and execution capabilities. It only took us five months to complete the technology transfer of this product from China to the United States, and we will continue to drive the product’s early market entry through highly efficient clinical development for the benefit of patients. Here, I would also like to extend special thanks to our investors for their tremendous help and support. On the path to internationalization, Qrigincell Therapeutics has already taken a crucial step forward. I firmly believe that Qrigincell Therapeutics will bring more and better cell therapies to patients in the future, and we will tirelessly strive to cure cancer patients."

OriCAR-017 Demonstrates Significant Efficacy and Better SafetyAbout Oricell Therapeutics

About Oricell Therapeutics

Qrigincell Therapeutics is a clinical-stage biotechnology company dedicated to becoming an innovation-driven global leader in the field of tumor immunotherapy. The company is currently focused on developing innovative cell therapies to address unmet medical needs in the global fields of oncology and immunology. Through its proprietary Ori®Ab antibody screening and engineering platform, Ori®CAR structure platform, and expertise accumulated in the CMC domain, Qrigincell Therapeutics has developed multiple product pipelines for treating hematologic malignancies and solid tumors. These have demonstrated favorable safety and efficacy in exploratory clinical studies, with related clinical research data published at conferences such as the 2021 ASCO, 2022 ASCO, 2022 EHA, and in the international academic journal *The Lancet Haematology* in 2023.

Since its establishment, the company has raised over 200 million US dollars in funding, with participation from Qiming Venture Partners, Quan Capital, RTW, QIA, and others. The latest round of financing was the Series B1 funding completed in February 2023, jointly led by RTW and QIA.

For more information, please visit: www.oricell.com

Contact Email: ir@oricell.com

Forward-Looking Statements

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