‘Above and beyond approved therapies’: How Prescient Therapeutics is at the forefront of cancer fighting
Health & Biotech
Health & Biotech
Prescient Therapeutics is on a mission to improve outcomes for cancer patients, and it is making progress with a diverse portfolio of later and early-stage assets.
Prescient Therapeutics (ASX:PTX) CEO Steven Yatomi-Clarke says PTX is developing novel, personalised cancer therapies in areas of unmet medical needs.
“We do not go where everyone else is crowding. These are diseases that are poorly met or unmet by current therapies,” he says.
Yatomi-Clarke says PTX uses two approaches in cancer treatment including:
“We have a simple business model of getting the best technology from the best institutes and then developing them with the best people in the world,” he says.
“We have a decent cash runway of $20 million+ going out a couple of years, which is important in this environment and is enough to deliver value-accretive milestones.”
He says PTX has lots of shots on goal with a diverse portfolio of later stage and emerging assets which is important not only for value creation but also risk mitigation.
Prescient’s lead targeted therapy PTX-100 is licensed from Yale University. It 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 disrupts 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.
“RAS is a gene family that consists of 36 human genes, the discovery of which fundamentally transformed the understanding of cancer biology,” Yatomi-Clarke says.
He says 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. PTX-100It is believed to be the only GGT-1 inhibitor in the world that is in clinical development.
In a significant development, PTX-100 was granted Orphan Drug Designation by the US FDA for all T-cell lymphomas (TCL) in March this year. This was a broader designation than the company had requested and confers seven years of market exclusivity.
Yatomi-Clarke says PTX-100 is showing promising signs in T-cell lymphoma (TCL), an area of oncology with a sizable and under-served target market.
A final data readout from the recently expanded Phase 1b safety trial is due next quarter, which will hopefully be followed by a much larger Phase 2 trial, with the potential for that trial to serve as an approval study.
Yatomi-Clarke says Peripheral T-Cell Lymphoma (PTCL) is the most common TCL with ~5,600 cases per year in the US.
Most patients eventually relapse, making them eligible for therapies such as Folotyn – which costs more than US$840,000 per year of treatment but doesn’t work particularly well.
“It only works on about a quarter of patients,” Yatomi-Clarke says.
Results from the Phase 1B trial have so far been promising with no serious adverse events related to PTX-100. Two patients in the trial saw complete eradication of cancer for relapsed and refractory PTCL, and a further five patients had duration of responses exceeding the standard of care.
“You can see why clinicians are becoming interested in this drug because over and above the safety they’re seeing an efficacy signal beyond what one would expect from the approved therapies,” he says.
Phase 1b data readout is forecast for the end of CY23 with PTX preparing for a phase 2 study next year, which Yatomi-Clarke says would be the biggest catalyst in the biotech’s history.
“We’ll be having discussions with the US-FDA about the potential for this Phase 2 study to be a registration study, which is normally the domain of larger Phase 3 studies required to get approval to market a drug,” he says.
“Whilst we cannot predict this outcome, it could be a rapid path to commercialisation. There are no companies in oncology on the ASX in a registration study at this time.”
Yatomi-Clarke says investors only need to look at Neuren (ASX:NEU), which has seen its share price leap 130% in the past year after a US FDA approval in March, to understand what it could mean for PTX.
PTX’s other targeted therapy drug PTX-200 has had four complete remissions so far during in its current Phase 1b/2 trial in relapsed and refractory acute myeloid leukaemia (AML).
The novel PH domain inhibitor 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 previously generated encouraging Phase 2a data in HER2-negative breast cancer and Phase 1b in recurrent or persistent platinum resistant ovarian cancer.
PTX has two cell therapy platforms which aim to overcome the challenges of Chimeric Antigen Receptor (CAR-T therapy), which has revolutionised cancer treatment.
CAR-T is a form of personalised immunotherapy using a patient’s own T cells that are enhanced to seek and destroy cancer cells.
In the CAR-T process, blood is collected from the patient and T-cells are isolated and genetically altered to express cancer-recognising receptors (CARs) that enable them to recognise and kill cancer cells. Millions of CAR-T cells are grown and then administered back to the patient.
“It is really revolutionising medicine and especially in certain types of blood cancers,” Yatomi-Clarke says.
He says while there are several marketed CAR-T drugs they’re not without challenges.
“The first iteration of any new technology is fraught with issues – whether it be the very first mobile phone, or desktop computer. That’s where CAR-T is now,” he says.
“Our two cell therapy platforms seek to address all of these limitations and make this whole area of medicine safer, effective and more accessible.”
Yatomi-Clarke says PTX’s cell therapy enhancement platform CellPryme is its most advanced CAR-T platform therapy.
He says CellPryme works in two ways – CellPryme-M (standing for manufacturing) makes more youthful cells.
“It basically means the immune cells last longer and kill for longer, basically doubling the performance of a CAR-T therapy,” he says.
“We can drop this manufacturing enhancement into a third-party therapy to improve its performance.”
CellPryme-A (standing for adjuvant) can be given to patients directly as an adjuvant therapy boosting tumour killing and host survival of conventional CAR-T cell therapies.
“It works with a very different mechanism and produces many more CAR-T cells expanding in the body and as a result is able to breach the barriers the cancer produces around itself to prevent immune cells getting in,” he says.
“Both CellPryme-M and CellPryme-A can plug into and improve third party programs.
“Both are ready for the clinic now and we’re speaking to third parties about exploring that. Certainly in the case of CellPryme-M we’re hoping that can lead to some commercial agreements in the future.”
While earlier in development, OmniCAR is a potentially revolutionary platform technology for CAR-T therapy.
OmniCAR employs technology licensed from UPenn, the pioneer and world leader in CAR-T, as well as Oxford University.
Yatomi-Clarke likens the platform to a modular Lego set for utilisation of CAR-T cells.
“Current generation CAR-T are like a static construct and OmniCAR seeks to modularise that. Similar to a Lego set, you don’t just make one thing but can turn the blocks into many things,” he says.
“That’s what we’re seeking to do with OmniCAR in a plug and play approach.
“Think of the CAR-T cells as soldiers with only one weapon that can’t be controlled. OmniCAR turns these cells into soldiers you can arm with any weapons who can hit several targets at once and you can control them in real time.”
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.