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Today (July 15), Qrigincell Therapeutics announced that the U.S. FDA has granted Fast Track designation to the company's CAR-T cell injection (OriCAR-017) targeting GPRC5D for the treatment ofRelapsed/Refractory Multiple Myeloma (RRMM).Qrigincell Therapeutics' press release stated,Obtaining this qualification will facilitate the advancement of OriCAR-017 in clinical trials and expedite its market registration process. Previously, the FDA granted OriCAR-017 Orphan Drug Designation and approved its Investigational New Drug (IND) application.
Public confidence shows that OriCAR-017, a chimeric antigen receptor (CAR) T-cell therapy targeting the GPRC5D antigen, has brought new hope for patients with relapsed and refractory multiple myeloma. The therapy, based on QrigincellTherapeutics' self-developed technology platform, demonstrates excellent performance in antibody affinity, antigen-binding activity and persistence, anti-tumor efficacy, and safety. It has successively obtained IND approval from China's NMPA and the U.S. FDA. Currently, clinical trials in both China and the U.S. are proceeding actively.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 agents (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.The total remission rate reached 100%., where the stringent complete remission rate was 80%. Notably, all patients achieved a 100% minimal residual disease (MRD)-negative status by Day 28, which was confirmed at Month 3. In terms of safety, no Grade ≥3 cytokine release syndrome (CRS) 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 delayed infections.Qrigincell Therapeutics is a clinical-stage biotechnology company currently focused on developing innovative cell therapies to address unmet medical needs in the global fields of oncology and immunology. Qrigincell Therapeutics has developed multiple product pipelines for the treatment of hematologic malignancies and solid tumors.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.
[1] Express | Oricell Therapeutics Announces FDA Grants Fast Track Designation to GPRC5D CAR-T for the Treatment of RRMM.Retrieved July 15，2024. From https://mp.weixin.qq.com/s/q6bh5WONe-26ZYe2xoUSRg
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