YuanBio’s GPRC5D-Targeted CAR-T Therapy OriCAR-017 Granted FDA Fast Track Designation for Relapsed/Refractory Multiple Myeloma

On July 15, 2024, Qrigincell Therapeutics announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track Designation (FTD) to the company’s GPRC5D-targeted CAR-T cell injection (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 Orphan Drug Designation (ODD) to OriCAR-017 and approved its Investigational New Drug (IND) application.

About OriCAR-017

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. The therapy, based on QrigincellTherapeutics' proprietary technology platform, demonstrates exceptional performance in antibody affinity, antigen-binding activity and persistence, anti-tumor efficacy, and safety. It has received IND approval from both the China National Medical Products Administration (NMPA) and the U.S. FDA. Clinical trials are currently advancing in both China (NCT06182696) and the U.S. (NCT06271252).

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, 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 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 other neurotoxicities. No late-onset infections occurred. [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.

Editor: Mu Mian

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