Prescient Therapeutics seeks to provide new tools for clinicians in combating cancer

Prescient Therapeutics Ltd (ASX:PTX) is a clinical stage oncology company developing personalised medicine approaches to cancer, including targeted and cellular therapies.
 

Prescient Therapeutics Ltd (ASX:PTX, OTC:PSTTF) earlier this week began its Phase 2A clinical trial of PTX-100 in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL). CEO James McDonnell talked with Proactive about the initiation.

The company said the first patient has been dosed in the study, following earlier successful results from a Phase 1B trial. PTX-100 is described as a first-in-class inhibitor of geranylgeranyl transferase-1, targeting the Ras pathway—a signalling mechanism implicated in over 20% of cancers.

Prescient highlighted that PTX-100 showed a favourable safety profile and promising response rates in earlier trials. It said many current CTCL treatments come with serious adverse effects, adding to patient fragility, while PTX-100 may offer a more tolerable alternative.

Prescient Therapeutics Ltd (ASX:PTX, OTC:PSTTF)has kicked off its Phase 2a clinical trial evaluating PTX-100 for relapsed or refractory Cutaneous T-Cell Lymphoma (CTCL), having dosed its first patient.

Prescient Therapeutics chief medical officer Dr Marissa Lim said: “The first patient in Prescient’s Phase 2a study has been dosed at the Linear Clinical Research site in Perth, under the care of Dr. Dejan Radeski, a consultant haematologist with a special interest in T-cell lymphoma.

Prescient Therapeutics Ltd has received Fast Track Designation from the United States Food and Drug Administration (FDA) for its lead candidate PTX-100, putting the company closer to potential Accelerated Approval – a central component of its commercialisation strategy.

The designation, which applies to the treatment of adults with relapsed or refractory (r/r) mycosis fungoides – the most common subtype of Cutaneous T Cell Lymphoma (CTCL) – offers Prescient several regulatory advantages. These include increased access to the FDA and the ability to submit New Drug Applications (NDAs) on a rolling basis, expediting the review process for PTX-100.

Steven Yatomi-Clarke didn’t take the obvious route into his role as a biotech leader. A scientist by training, specialising in biochemistry and molecular biology, he brought a talent for interpreting science jargon for investment bankers and an eye for “what not to do” in business to bear on his role as CEO of Prescient Therapeutics Ltd (ASX:PTX).

Yatomi-Clarke has had one foot in science and the other in commerce for his entire career. He chose to lean into his talent for the latter after observing his university Honours supervisor uproot his family and move cities to chase a grant. “I thought, screw this, if that’s your reward for being an expert, no thank you!”

Bioshares has a Speculative Buy Class B recommendation for Prescient Therapeutics Ltd (ASX:PTX, OTC:PSTTF) after the company released positive trial results from its Phase Ib study in patients with T-cell lymphomas.

The results surpassed Prescient’s expectations from both safety and early efficacy perspectives, especially in the difficult-to-treat patient population.

The following is an extract from Bioshares’ investment note:

Prescient Therapeutics Ltd (ASX:PTX, OTC:PSTTF) CEO and managing director Steven Yatomi-Clarke sits down with Jonathan Jackson in the Proactive studio ahead of a presentation of the results of its PTX-100 Phase 1b study at the 15th Annual T-Cell Lymphoma Forum (TCLF) in California from June 6 to 8.

The Phase 1b study targeted patients with relapsed and refractory T-cell lymphomas (r/r TCLs) and successfully met its primary objectives of demonstrating safety and determining pharmacokinetics and pharmacodynamics. Additionally, the study showed a promising preliminary efficacy with a 45% overall response rate, where five out of 11 evaluable patients responded positively to the treatment.

T-cell lymphomas are a rare type of non-Hodgkin lymphoma, classified as an orphan disease with about 30,000 cases. PTX-100 has received Orphan Drug Designation from the US FDA, highlighting the need for more effective treatments for TCLs, particularly for relapsed and refractory cases. The T-Cell Lymphoma Forum is a specialised conference focused on advancements in TCL treatment, bringing together clinicians, scientists and industry professionals.