Qilu Regor’s RGT-264 Phosphate Tablets Approved for Phase I Study

China-based biotech Qilu Regor Therapeutics Inc has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase I study. The study will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of its RGT-264 phosphate tablets in patients with advanced solid tumors.

RGT-264 Profile
RGT-264 is a novel small molecule selective inhibitor of hematopoietic progenitor cell kinase 1 (HPK1), also known as MAP4K1. The drug demonstrates high activity and selectivity, with significant targeting of various susceptible immune kinases. HPK1 is an immune regulation-related protein and a key negative regulator of T cell activation induced by T cell receptor (TCR) signaling. Inhibiting HPK1 kinase activity is a promising strategy for tumor immunotherapy. Currently, no HPK1 inhibitor has been approved for marketing globally.

Future Development
The Phase I study marks a significant step forward in the clinical development of RGT-264. Qilu Regor Therapeutics aims to explore the potential of this innovative HPK1 inhibitor in treating advanced solid tumors, potentially offering a new therapeutic option for patients with these challenging conditions.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry