On July 15, 2024, Qrigincell Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to the company's CAR-T cell injection targeting GPRC5D (OriCAR-017) for the treatment of relapsed/refractory multiple myeloma (RRMM). Obtaining this designation will facilitate the acceleration of OriCAR-017’s clinical trials and marketing registration process. Previously, the FDA had granted OriCAR-017 Orphan Drug Designation (ODD) and approved its Investigational New Drug (IND) application.OriCAR-017 is a chimeric antigen receptor (CAR) T-cell therapy targeting the GPRC5D antigen, offering new hope for patients with relapsed and refractory multiple myeloma. This therapy leverages QrigincellTherapeutics' proprietary technology platform and demonstrates outstanding performance in antibody affinity, antigen-binding activity and persistence, anti-tumor efficacy, and safety. It has successively received IND approval from China’s National Medical Products Administration (NMPA) and the U.S. FDA. Currently, clinical trials in both China (NCT06182696) and the U.S. (NCT06271252) are actively progressing.
At the 2024 ASCO Annual Meeting in early June this year, Oricell Therapeutics orally presented the 24-month long-term follow-up data of OriCAR-017. The data showed that OriCAR-017 demonstrated deep and durable responses in RRMM patients who had failed treatments with anti-CD38, proteasome inhibitors (PI), immunomodulatory drugs (IMID), and BCMA CAR-T, with a favorable safety profile. This result further indicates that OriCAR-017 has the potential to become a new treatment option for RRMM patients.All 10 patients responded well to the treatment, with an overall response rate of 100%, including a stringent complete response rate of 80%. Notably, all patients achieved 100% minimal residual disease negativity by Day 28, which was confirmed at Month 3. In terms of safety, no cytokine release syndrome (CRS) of Grade ≥3 was observed, and there were no serious adverse events or treatment-related deaths. Additionally, no immune effector cell-associated neurotoxicity syndrome (ICANS) or dose-limiting toxicity (DLT)-related toxicities were reported, nor were there any reports of cerebellar disorders or other neurotoxicities. No late-onset infections occurred.[Read Full Text]Currently, Qrigincell Therapeutics has established operational teams in both China and the United States, and is fully committed to advancing the global clinical development of its product pipeline.About FDA Fast Track DesignationThe FDA’s Fast Track designation in the U.S. aims to accelerate the development and approval process of new drugs for serious diseases, addressing unmet medical needs.Typically, new drugs that obtain this qualification may be the first treatment option for specific severe diseases or have significant clinical advantages over existing therapies. They can provide new treatment choices for patients who respond poorly to or cannot tolerate current therapies, allowing them to benefit.
The Fast Track Designation will provide the company with more opportunities to engage in frequent interactions with the U.S. FDA regarding the subsequent development plan of the OriCAR-017 project, discuss clinical data of the investigational drug, and enjoy accelerated approval and priority review status. Additionally, the company can also proceed with submissions.New Drug Production and Marketing Registration Application orBiologics License Application(NDA/BLA), the rolling submission of new drug research materials to the FDA provides strong support for subsequent clinical development and accelerated new drug marketing.
About Oricell TherapeuticsQrigincell 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. Leveraging its proprietary Ori®Ab antibody screening and engineering platform, Ori®CAR structural platform, and expertise accumulated in the CMC domain, Qrigincell Therapeutics has developed multiple product pipelines for treating hematological malignancies and solid tumors. These have demonstrated favorable safety and efficacy in exploratory clinical studies. Relevant clinical research data have been presented at international conferences such as the 2021 ASCO, 2022 ASCO, 2022 EHA, 2024 ASCO, as well as in the international academic journal *The Lancet Haematology*.
Forward-Looking StatementsThis press release contains "forward-looking statements" that are not historical facts but constitute predictions about future events based on the beliefs, assumptions, and current knowledge of Oricell Therapeutics Holdings Limited ("the Company"). Terms such as "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. These 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 outcomes to differ materially from any future results, performance, or achievements indicated in these forward-looking statements. Any forward-looking statements contained in this press release reflect the situation only as of the date of this press release. The Company expressly states,This news announcement aims to release R&D clinical progress information for medical and health professionals only, not for advertising purposes.Our CompanyThe use of any unapproved drugs or indications is not recommended.
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