PTX will unveil trial results at the American Society of Hematology (ASH) annual meeting. Pic: Getty Images.
Health & Biotech
Clinical stage oncology company Prescient Therapeutics will showcase the results of its Phase 1b study in relapsed and refractory T cell lymphomas (TCL) at the largest and most comprehensive haematology conference in the world.
Prescient Therapeutics (ASX:PTX) has announced that its abstract for results for the Phase 1b study have been accepted for poster presentation at the prestigious American Society of Hematology (ASH) annual meeting in San Diego, California on December 9-12.
In its 65th year, the ASH annual meeting will be attended by international pharmaceutical and biotech companies; physicians and researchers gathering to discuss the latest advancements and innovations in haematological diseases. Last year more than 25,000 people attended the meeting.
PTX is a clinical stage oncology company developing personalised medicine approaches to cancer, including targeted and cellular therapies.
The company continues to make solid progress on all fronts, with positive results from its clinical programs underlining its position as an emerging global leader in the next generation of personalised cancer therapies.
PTX has two distinct types of cancer therapies;
PTX managing director and CEO Steven Yatomi-Clarke, says “it is a huge honour” to have the abstract presented at the world’s most prestigious haematology conference.
“This is a validation of the quality and relevance of the clinical data we are generating in T cell lymphomas, which is an area of unmet clinical need,” he says.
“It is also a testament to the hard work by the Prescient team and our clinical collaborators.
“Prescient looks forward to presenting this data at ASH and will release this data to the market concurrently.”
Earlier this month, PTX also presented at the Cell & Gene Meeting on the Mesa, an annual conference bringing together senior executives and top decision-makers.
Mr Yatomi-Clarke discussed how Prescient’s platforms can make cell therapies more effective, safer and adaptable.
The CellPryme platform in particular is seeing strong interest from the sector, as a less disruptive way of improving outcomes of third party cell therapy programs.
PTX’s lead targeted therapy PTX-100 is licensed from Yale University and is a first in class compound that blocks an important cancer growth enzyme known as geranylgeranyl transferase-1 (GGT-1).
PTX-100 has shown the ability to disrupt oncogenic Ras pathways by inhibiting the activation of Rho, Rac and Ral circuits in cancer cells which leads to apoptosis, or death of the cell.
PTX says RAS is a gene family that consists of 36 human genes, the discovery of which fundamentally transformed the understanding of cancer biology.
While RAS genes are a normal part of the human genome, they can transform normal human cells into cancerous ones if their gene function becomes mutated.
More than 30% of all human cancers are driven by mutations of the RAS family of genes.
PTX-100 has a unique ability to disrupt this cancer pathway by blocking GGT-1. It is believed to be the only GGT-1 inhibitor in the world that is in clinical development.
PTX announced earlier this year it was seeking the go-ahead from the US Food and Drug Administration (FDA) for an accelerated approval study after its Phase 1b clinical trial showed encouraging results.
While the primary goal of the study was to evaluate safety, PTX-100 has shown positive clinical activity in the difficult-to-treat patient population.
The study demonstrated several positive clinical responses especially when considered against responses expected from current standards of care.
Under current standards, less than a third of the patient population would be expected to respond to current therapies. For those that do respond, the expected duration of that response is only three to four months.
However, the PTX-100 study, albeit based on a small number of trial participants, showed a response rate of 40% for almost nine months.
Responses also include two patients with relapsed and refractory peripheral TCL (PTCL) that have had complete eradication of cancer. Such responses are not generally expected in PTCL.
PTX-100 has exhibited an excellent safety profile at the highest dose of 2,000 mg/m2, with very few serious adverse events.
The next step for a clinical study would typically be to roll into a Phase 2 study to determine efficacy of the treatment in a wider cohort. However regulatory advisers recommended PTX enrol additional patients into the study (seven or so) with different types of TCL to enable a more robust data package.
Prescient is planning a Phase 2 trial in TCL, which will be conducted subject to satisfactory Phase 1b outcomes. Prescient will seek to apply for this Phase 2 trial to be a registration study (meaning that it could potentially be the study enabling approval).
Prescient is also planning another manufacturing campaign for PTX-100 to ensure that there is enough of the drug for future trials. Prescient will also be working with the FDA to determine the best dose and schedule for PTX-100 in the next trial.
PTX-100 was granted Orphan Drug Designation by the US FDA for all TCLs in March this year, which was a broader designation than PTX had requested and confers seven years of market exclusivity.
TCL is an area of oncology with a sizable and under-served target market. PTCL is the most common TCL with ~5,600 cases per year in the US.
PTX says most patients eventually relapse, making them eligible for therapies such as Folotyn – which costs more than US$840k per year of treatment.
PTX’s other targeted therapy PTX-200 is a novel PH domain inhibitor that inhibits an important tumour survival pathway known as Akt, which plays a key role in the development of many cancers, including breast and ovarian cancer, as well as leukaemia.
PTX-200 is currently in a Phase 1b/2 trial in relapsed and refractory AML, where it has resulted in 4 complete remissions so far.
PTX-200 previously generated encouraging Phase 2a data in HER2-negative breast cancer and Phase 1b in recurrent or persistent platinum resistant ovarian cancer.
PTX also has two cell therapy platforms which aim to overcome the challenges of Chimeric Antigen Receptor T Cell (CAR-T) Therapy, which has revolutionised cancer treatment.
CAR-T is a form of personalised immunotherapy which alters a patient’s own T cells to seek and destroy cancer cells.
Prescient’s CellPryme is a high-performance cell therapy enhancement platform that can improve CAR-T efficacy and consists of two distinct components: CellPryme-M and CellPryme-A.
OmniCAR is a next-generation, universal CAR platform that is controllable, with “plug and play” capabilities to enable a wider range of cancers to be targeted.
This article was developed in collaboration with Prescient Therapeutics, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
Health & Biotech
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