T-Cell Lymphoma is a very deadly cancer, but this ASX stock has a treatment in a Phase 2 trial!

Prescient Therapeutics‘ (ASX:PTX) trial of PTX-100 against T-Cell Lymphoma is well and truly underway now with 8 out of 16 trial sites set up. This significant milestone provides significant hope to sufferers of this disease as well as to the company’s investors.

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T-Cell Lymphoma is a deadly disease

T-Cell Lymphoma generally is a type of lymphoma developing from T-lymphocytes or T-cells (which are white blood cells). Lymphomas generally are cancers of the lymphatic system – part of the body’s germ-fighting and disease fighting immune system.

There are numerous subtypes of T-Cell Lymphoma, including Angioimmunoblastic T-Cell Lymphoma, T-cell Lymphoblastic Lymphoma, Anaplastic Large Cell Lymphoma (ALCL) and Cutaneous T-Cell Lymphoma (CTCL). It is the latter of these that PTX is focused on. The term Cutaneous simply means affecting the skin and in CTCL, cancerous T cells travel to and live in the skin where they grow and divide uncontrollably, attacking the skin.

Current treatment options for CTCL are limited, rarely curative and can cause harmful side effects – investors need only look at the results of drugs on the market to see this. There is a clear unmet medical need for new mechanistically distinct agents.

Recap of Prescient Therapeutics’ journey

But this is where Prescient comes in with PTX-100. Prescient’s PTX-100 is unique, acting as a GGTase-1 (geranylgeranyl transferase-1) inhibitor. This is a enzyme in the body that, when aberrant, can drive tumour growth and resistance to therapies. But when it is inhibited, then treatments are more likely to work.

Don’t just take the scientific theory’s word for it. PTX-100 was shown in Phase 1 to have a 43% Overall Response Rate (ORR), a 100% Clinical Benefit Rate (CBR), a Mean Duration of Response (DoR) of 12.4 months, as well as there being no serious adverse events attributable. At first glance, this may not appear like anything to boast about, but it is superior to treatments on the market such as Lymphir. Moreover it is occuring in patients that have seen multiple prior treatments and thus are in a position where any impact would be miraculous.

Now in Phase 2

Following Phase 1, Prescient entered Phase 2 and now 8 of 16 sites are enrolled. This number consists of all US and Australian sites in the trial. The European sites have been slower to come online but this should speed up given PTX-100 was granted EU Orphan Drug Designation.

The Phase 2 trial will consist of two stages. First, a dose optimisation strategy study (Phase 2a) which will enrol 40 patients (one group of 20 will receive 500mg/m2 of PTX-100 and the other 20 will receive 1000mg/m2). A safety review committee will meet to determine the optimum dose (Figure 5). Following this, there will be an efficacy and safety determination (Phase 2b) with 75 CTCL patients.

The primary endpoint will be the objective response rate (meaning the patients with complete or partial responses). Secondary endpoints will include skin responses, progression-free survival, duration of response, time to response, complete response rate, overall survival, time to next treatment, safety, pharmacokinetics, and quality of life.

So when can we see results?

We may see interim data later in 2026, although this may only be interim data from the first few patients. Don’t expect to see ‘complete cures’, but look for a response rate higher than Lymphir which was 36%.

Even if it may take 2-3 years and/or a phase 3 before PTX-100 is on the market, it wouldn’t surprise us to see it receive partnership interest. PTX-100’s status as the only GGTase-1 inhibitor in clinical development anywhere in the world, and one with far more promising results than any TCL drugs on the market, gives it a uniqueness that is attractive to potential pharmaceutical partners. A pharma partnership — whether in the form of a co-development agreement, regional licensing deal, or broader collaboration; would be a transformative catalyst for Prescient’s valuation and share price.

The accumulation of Phase 2a data through is likely to be a prerequisite for serious partnership conversations, as larger pharmaceutical companies typically want to see a clinical proof-of-concept in a Phase 2 setting before committing to a deal. That said, the dual ODD status and the quality of the Phase 1 data may attract early-stage interest, and management has indicated it is actively engaged with potential partners.

Further opportunities down the track

While the current Phase 2a focus is r/r CTCL, Prescient has previously indicated interest in evaluating PTX-100 in other cancers. In our view, PTX-100 could be applicable to any cancer that could be defeated with an RAS therapy. This could be 22% of all cancers , even if it not necessarily specific types of cancers because RAS isn’t present in all cancers within a type, albeit very common in some like pancreatic, lung and colorectal cancers.

Data from the broader Phase 1 programme (which included patients across multiple tumour types) could provide the scientific rationale for an expanded Phase 2 programme. Any announcement of a new indication entering clinical development would represent an incremental catalyst for the company.

Investors should also watch for progress with PTX’s pre-clinical assets OmniCAR and CellPryme which help facilitate CAR-T therapy (Chimeric Antigen Receptor T-Cell therapy). Pitt Street Research’s reports on Prescient Therapeutics, the most recent of which was published earlier today, delve into these platforms in more detail. Pitt Street has valued the company at $0.11-0.16 per share.

Conclusion

T-Cell Lymphoma patients have significant hope as PTX-100’s trial progresses. While there are few (if any) options now, this will all change if everything goes to plan.

Prescient Therapeutics is a research client of Pitt Street Research