Prescient Therapeutics starts Phase 1b clinical trial of its unique inhibitor PTX-100

On 11 July 2019, Prescient Therapeutics Limited (ASX: PTX) announced the commencement of a Phase 1b trial of its second targeted anti-cancer drug PTX-100 in patients with multiple cancers. The trial would reportedly be led by one of the world’s leading cancer researchers and a renowned oncologist, Professor H. Miles Prince AM, based in Melbourne.

The study takes an innovate ‘basket’ approach to assess the drug on multiple cancers with a view to addressing specific mutations, rather than tumour origin. The report read that it is designed with the objective to “rapidly identify the optimal dose and treatment schedule of PTX-100 in a variety of malignancies including myeloma, T-cell lymphomas, gastric and pancreatic cancers with Ras and RhoA mutations.”

In addition to the above-stated objective, Prescient Therapeutics informed that the study would include the several cancer biomarkers to identify patients most likely to respond to PTX-100 therapy. The start of this Phase 1b trial of PTX-100 comes after the encouraging response of previous clinical study conducted at Pennsylvania State University and Indiana State University. In Phase 1 of the study, PTX-100 was proven well tolerated that achieved stable disease in patients with advanced solid tumours.

About PTX-100

PTX-100 is one of the lead drug candidates of Prescient Therapeutics that works by blocking a common cancer growth enzyme, geranylgeranyl transferase (GGT), which plays a key role in malignant cell transformation. It is designed as targeted cancer therapy for the treatment of solid tumours based on the mechanism to disrupt the oncogenic Ras pathways by inhibiting the activation of Rho, Rac and Ral circuits in cancer cells, leading to the death of cancer cells.

This first-in-class anti-cancer drug candidate PTX-100 now enters the open-label, non-randomized Phase 1b trial that would reportedly evaluate the pharmacokinetics and pharmacodynamics of the drug as well as safety and efficacy of two different doses in patients with advanced malignancies.

Prescient Therapeutics informed that the trial would enrol up to 24 patients, where each patient will receive the drug by intravenous infusion over 60 minutes on days one to five of a 14-day cycle for four cycles unless toxicity is observed. This outlines the trial’s target to identify the optimal time and dose-dependent effect of multiple doses of PTX-100. Further, it was reported that the researchers would monitor the mutational status of patients’ malignancies and, using a small sample size, seek to correlate this status with clinical activity.

Moreover, all these patients would receive the treatment under the lead investigator Professor H. Miles Prince and his team at the Epworth Hospital in Melbourne.

What makes PTX-100 unique in the fast-growing cancer biotech space?

PTX-100 is positioned as a differentiated and unique inhibitor that disrupts the Ras pathway downstream. Ras has long been identified as an important target driving cancer that is mutated in about 30% of all human cancers and leads to a staggering 3 million new cancers diagnosed each year globally with Ras mutations.

Ras Pathway (Source: Company Presentation)

In this scenario, PTX-100 blocks the cancer growth enzyme GGT-1, which inactivates Rho, Rac and Ral circuits in cancer cells downstream of Ras, unlike other conventional studies that targeted at direct Ras inhibition. This makes PTX-100 target not only cancers with Ras mutations but also cancers with Rho mutations, taking the place of an only drug candidate to be the RhoA inhibitor in clinical development worldwide.

Prescient’s ultimate target is to break the industry trend of ‘one-size-fits-all’ through its precision medicine approach, which offers a potentially faster development route.

Prescient Therapeutics Managing Director and CEO Steven Yatomi-Clarke said, “Commencing this novel study is a significant milestone for Prescient. Not many companies can boast a drug that is first-in-class entering the clinic. PTX-100 is a truly differentiated and unique inhibitor, and this further demonstrates Prescient’s ability to progress important new therapies for cancer patients. It is another big step forward in the company’s goal of building a robust pipeline of personalized therapies against cancer.”

It is worth noting that study is conducted under the lead investigator Professor H. Miles Prince who is an internationally renowned oncologist, with a highly respected reputation in cancer research, and has worked successfully on the development of many cancer drugs. Professor Price has significant involvement in major clinical research programs ranging from the use of stem cells to the mechanism of the immune systems control of blood and cancer growth, backed by his holding of several Australian, American and European research grants. He has published over 300 journal articles and has recently been appointed as a Director of Molecular Oncology and Cancer Immunology at the Epworth Hospital in Melbourne.

Under the leadership of Professor Prince, the study will apply the ‘basket’ design approach to assess drug in multiple cancers. This strategy has been successfully pioneered by several US companies like Loxo Oncology, Inc (acquired by Eli Lilly and Company for US$8 Billion in January 2019) as a faster way to identify cancer patients who will potentially benefit from the therapy.

Lead Investigator Professor Prince stated “Molecularly targeted therapy is the way forward in treating cancers. We know the pathway that is targeted by PTX-100 is critical to the survival of the cancers included in this study. As a cancer specialist, I want to see PTX-100 added to the tool-box of targeted treatments.”

PTX-100 was invented by Prescient Chief Scientific Officer, Professor Said Sebti, and Professor Andrew Hamilton, now President of New York University. Prescient successfully secured the licence for PTX-100 from Yale University.

Prescient’s remarkable progress in Phase 1 of the study has drawn investors to watch the results of ongoing Phase 1b trial of PTX-100 that have the possible potential to make a big boom in the oncology industry closely focusing on Ras pathways.

PTX last traded at $0.039 on 11 July 2019, with a daily trading volume of 1,143,394 shares.

To know more about Prescient Therapeutics Limited, click here. 


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