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Prescient Therapeutics prepares for ‘pivotal’ year of PTX-100 development to treat T-cell lymphomas

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By Imelda Cotton - 
Prescient Therapeutics ASX PTX-100 development treat T-cell lymphomas
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Clinical stage oncology company Prescient Therapeutics (ASX: PTX) has reported a solid end to financial year 2023 which it says has set the stage for a pivotal 12 months to come and beyond.

Front and centre of the company’s strategy is commercialising its targeted cell therapies, primarily lead candidate PTX-100 to treat T-cell lymphomas (TCLs).

TCLs develop when white blood cells (lymphocytes) grow out of control. They collectively represent an area of unmet (or poorly met) patient need, especially in people with relapsed or refractory disease.

There are around 5,600 PTCL cases per year in the US, and the disease has an average 5-year survival rate of 32%. Approximately 68% of patients relapse after treatment or are refractory (resistant) to conventional chemotherapy, making them eligible for therapies such as Folotyn – which costs each patient more than US$840,000 per year of treatment.

Potential game changer

Prescient’s announcement earlier this year of a robust response rate – including complete eradication of cancer in two patients — along with longer-than-expected durability of responses, has positioned the asset as a potential game changer for TCL, which has long been considered a sizeable and under-served oncology market.

Prescient said there had been no serious adverse events related to PTX-100 to date.

This compares to currently available TCL therapies which are typically characterised by a high occurrence of serious toxicities, response rates of less than 30% and a short duration of responses (up to four months).

A final data readout from a recently-expanded Phase 1b trial is due in the next quarter and will hopefully be followed by a much larger Phase 2 trial, which would be a huge catalyst for Prescient.

Shortest path to market

Of Prescient’s diverse pipeline of cancer-treating assets spanning targeted therapies and cell therapy platforms (including CellPryme and OmniCAR), PTX-100 is reported to have the shortest path to market.

Each of the assets is at a different stage of development and has the potential to be licensed by third parties, collaborated on, or commercialised in-house by Prescient.

Prescient said the potential for the Phase 2 trial to serve as an approval study, subject to regulatory interactions, would be a milestone event for the company which could “open the door to a rapid commercialisation opportunity for PTX-100”.

This could also see Prescient as the only ASX company with a cancer drug in a pivotal trial.

Orphan drug designation

In March, PTX-100 was granted orphan drug designation by the US FDA for all TCLs. This was a pleasant surprise for Prescient as it was a broader designation than the company had requested.

Orphan drug designation has considerable benefits including seven years of market exclusivity in the world’s largest healthcare market from the granting of regulatory approval, a partial tax credit and waived user fees.

Cell therapy platforms: CellPryme and OmniCAR

Outside of personalised targeted therapies PTX-100 and PTX-200, Prescient has two cell therapy platforms which aim to overcome the challenges of CAR-T therapy.

The CellPryme and OmniCAR platforms are distinct but complementary.

Either or both technologies can be incorporated into third party cell therapy programs.

Prescient’s cell therapy enhancement platform CellPryme is working to solve a key problem in CAR-T. Current therapies are making too many effector and effector memory T-cells, which are prone to exhaustion, when they need to be making more central memory T-cells (Tcm).

CellPryme-A is an adjuvant therapy provided to patients that dramatically increases the proliferation of CAR-T cells inside the patient, and enables them to penetrate the protective barriers around the tumours, which otherwise protects the tumour from the immune system .

The platform’s benefits are even greater when used in conjunction with PTX’s CellPryme-M, which is a cell manufacturing enhancement that boosts cell therapy performance by shifting T and natural killer (NK) cells towards a more “youthful” central memory phenotype that last longer and kill more effectively.

CellPryme-M is a 24-hour, non-disruptive process during cell manufacturing that improves T cell persistence, and increases their ability to find and penetrate tumours.

Prescient’s OmniCAR platform is also aiming to address key challenges of current generation CAR-T therapies by making treatments safer, more effective, controllable and longer lasting.

The OmniCAR platform gives clinicians unprecedented control over T-cells – allowing oncologists to switch them off once they’re infused to immediately stop treatment.

World-class collaborators

Prescient adopts a “work with the best” philosophy; their technologies emanate from prestigious centres including Yale, the University of Pennsylvania, Oxford University, the Moffitt Cancer Centre and the Peter MacCallum Cancer Centre.

The company is united with their collaborators to develop truly differentiated therapies that have the capacity to help cancer patients live longer, better quality lives.