Prescient Therapeutics (ASX:PTX) has announced the US Food and Drug Administration's (FDA) Office of Orphan Products Development has granted Orphan Drug Designation for PTX-100 for the treatment of T-cell lymphomas (TCL).
Prescient Therapeutics is a clinical stage oncology company developing personalised medicine approaches to cancer, including targeted and cellular therapies.
The designation encompasses all TCLs and their subtypes, and confers several developmental benefits and 7 years of market exclusivity to Prescient.
PTX-100 is a first-in-class prenylation inhibitor that disrupts oncogenic Ras pathways in cancer cells, and is currently being tested in a Phase 1b expansion cohort study in TCLs.
Prescient Therapeutics is also developing OmniCAR, a universal immune receptor for controllable T-cell activity and multi-antigen targeting with a single cell product; CellPryme-M, a 24-hour process to enhance adoptive cell therapy; and CellPryme-A, an adjuvant therapy designed to be administered alongside cellular immunotherapy.