Why are clinical advances by this small-cap ASX biotech in FY23 so significant?

Highlights

• Prescient marked several achievements and progress in FY23, to advance its journey in the cancer treatment space.
• Preparations are underway to commence the Phase-2 trial of PTX-100.
• CellPryme data demonstrates ability to enhance existing CAR-T therapies.

Prescient Therapeutics Limited (ASX: PTX) has been witnessing significant achievements and progress towards its goal of developing targeted cancer treatments. In the latest financial year ended 30 June 2023, the company made progress on multiple fronts, despite macroeconomic heat winds.  

One of the major highlights of the period was the ongoing encouraging patient outcomes and strong safety profile in the Phase 1b study of PTX-100 in patients with relapsed T-cell lymphoma (TCL).

The company also boosted its financial foothold with the execution of a share purchase plan and top-up placement (raising AU$11.3 million) and exercise of listed share options (AU$5.3 million) during the period.  Curent cash sits at over $19 million, which is adequate to fund the company through to value accretive milestones and beyond.

Encouraging clinical results from PTX-100 study

PTX-100 saw highly encouraging data from the ongoing Phase 1 clinical trial involving patients with refractory and relapsed TCLs. The trial results highlighted the safety profile of PTX-100 as limited serious adverse events were reported. The company shared that two patients experienced a total eradication of cancer. Also, seven out of ten patients had durations of response exceeding that expected using standard of care.

Now, PTX aims to create a robust data package with the intent to interact with clinicians and regulators. The team is working to commence the Phase 2 trial within the same population.

Also, PTX-100 secured an Orphan Drug Designation from the US FDA to treat TCLs. Benefits of Orphan Drug Designation include seven years of exclusivity in the US post approval, which extends commercial protection for PTX-100.

CellPryme makes strong impression

CellPryme is a proprietary platform that assists in enhancing emerging and existing cell therapies. It includes CellPryme-M (for manufacturing) and CellPryme-A (as an adjuvant therapy).

The company previously unveiled CellPryme-M. It is a novel manufacturing enhancement that improves adoptive cell therapy by performance shifting T and NK cells towards a more desirable central memory T cell (Tcm) phenotype that last longer and kill cancer more effectively.

Further improvement has been made in CellPryme-M, which enhanced the platform’s performance. The exposure protocol during cell manufacture was improved, leading to a stable amount of CAR expression on T-cells and a further increase in Tcm cells.

CellPryme-A was introduced during the year. The adjuvant therapy addresses the hostile tumour microenvironment that lowers the effectiveness of cellular immunotherapies.

The company showcased data for CellPryme at several conferences, making a strong impression with many cell therapy developers, says the company.

Over the coming year, Prescient Therapeutics intends to focus on expanding and advancing PTX-100 trials and progress towards the human trial for its next-gen CAR-T programs.