Prescient Therapeutics (ASX:PTX) has taken a significant step forward in its oncology pipeline, announcing that European regulators have authorised the company to begin a Phase 2a clinical trial of PTX-100 in patients with relapsed or refractory Cutaneous T-cell Lymphoma (CTCL).
The approval, granted through the European Clinical Trials Information System (CTIS), clears the way for trial site activation and patient recruitment in Italy.
PTX-100 is a first-in-class inhibitor of geranylgeranyl transferase-1 (GGT-1), a key enzyme involved in cancer cell growth pathways. By blocking the activation of Rho, Rac, and Ral signalling pathways, the therapy induces cancer cell death and disrupts oncogenic Ras-driven processes. It is believed to be the only GGT-1 inhibitor currently in clinical development worldwide
The therapy has shown encouraging early performance. PTX-100 demonstrated safety and preliminary efficacy in previous Phase 1 studies and recently completed a Phase 1b expansion cohort in T-cell lymphomas. The U.S. FDA has granted the drug Orphan Drug Designation for all T-cell lymphomas and Fast Track Designation for adults with relapsed or refractory mycosis fungoides. The global Phase 2 program aims to enrol up to 40 patients in its Phase 2a component.
Prescient CEO James McDonnell said the authorisation marks a meaningful milestone not only for the company but for patients facing limited treatment options. “This authorisation marks a significant milestone for Prescient and for patients living with CTCL. It reflects months of dedicated work by our clinical team and brings us closer to delivering a new treatment option for a disease with high unmet need,” he said.
Alongside its targeted therapies, Prescient continues to advance its next-generation cell therapy platforms, CellPryme-M, CellPryme-A, and OmniCAR, designed to enhance the potency, precision, and durability of engineered T-cell therapies. These complementary technologies remain in preclinical and early clinical development.