9 December 2017 - Rhizen Pharmaceuticals today announced that the U.S. FDA has granted fast track Designation for RP6530 (tenalisib), the Company’s highly selective and orally active dual PI3K delta/gamma inhibitor, for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma.
RP6530 (tenalisib) is a highly selective and orally active dual PI3K delta/gamma inhibitor with efficient translation of activity through enzyme, cell, and whole blood-based studies. Besides inhibiting growth of immortalised cancerous cell lines and primary patient leukaemic/lymphoma cells, RP6530 plays a significant role in modulation of tumour microenvironment at clinically achievable concentrations. In preclinical studies, RP6530 reprograms macrophages from an immunosuppressive M2-like phenotype (pro-tumour) to an inflammatory M1-like state (anti-tumour), which can potentially enhance the activity of checkpoint inhibitors or overcome resistance to these drugs.