Shanghai-based tumor immunotherapy specialist OriginCell Therapeutics has announced that its investigational autologous chimeric antigen receptor (CAR)-T cell therapy, OriCAR-017, has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA). The therapy targets GPRC5D, a receptor highly expressed in multiple myeloma (MM) cells, and is being developed for the treatment of recurrent/refractory (r/r) MM.
Targeting GPRC5D in Multiple Myeloma
G protein-coupled receptor family C group 5 member D (GPRC5D) is a 7-transmembrane protein that is highly expressed in MM cells but rarely found in normal tissues. It is independently expressed from BCMA on CD138+ cells, making it a promising target for the treatment of MM. OriginCell’s OriCAR-017 is the first CAR-T therapy targeting GPRC5D, developed through the company’s proprietary OriAb and OriCAR technology platforms.
Clinical Trial Results and Future Outlook
The Phase I POLARIS study of OriCAR-017 in China has demonstrated a strong safety and efficacy profile. The therapy achieved a 100% objective response rate (ORR) and a 100% negative rate of minimal residual disease (MRD) at the 10-5 level, assessed at 28 days. Notably, all subjects, including those who had previously failed BCMA CAR-T treatment, achieved continuous remission with no disease progression or additional anti-tumor treatment as of the cut-off date. These results highlight the potential of OriCAR-017 to address unmet needs in the treatment of r/r MM.-Fineline Info & Tech
