Australian biotechnology company FivepHusion is raising pre-IPO capital to develop their lead drug asset Deflexifol®, which has the potential to become a ‘blockbuster’ anti-cancer drug.
FivepHusion is optimising cancer therapy to improve patient treatment outcomes and quality of life. Their goal is to deliver a product that will be progressively adopted as the global ‘gold standard’ for the treatment of various adult and childhood solid cancers.
Improving patient outcomes and quality of life
Cancer prevalence is increasing worldwide due to population aging and expansion, and changes in individuals’ exposure to risk factors. Remarkably, for some decades the standard treatments for various common cancers have remained unchanged for the majority of patients.
This is particularly true for bowel cancer, the third most common cancer globally. Most bowel cancer patients will receive the chemotherapy 5-fluorouracil (5-FU) and its biomodulator, leucovorin (LV), a drug that enhances 5-FU anti-cancer activity. These drugs have been the standard treatment for bowel cancer since the 1960s and 1990s, respectively. Despite working together synergistically, standard formulations of 5-FU and LV are chemically incompatible and cannot be administered together. This results in sub-optimal co-exposure and effectiveness of these drugs, and may contribute to the poor treatment outcomes currently experienced by many patients.
FivepHusion is developing Deflexifol as a “next-generation” enhanced and superior version of 5-FU and LV standard treatment, with clinical development initially focused on metastatic colorectal (stage 4 bowel) cancer. Deflexifol is a proprietary ‘all-in-one’ co-formulation of 5-FU and LV that offers superior safety, tolerability and effectiveness.
Deflexifol optimises 5-FU/LV co-administration, facilitating a 10-fold increase in 5-FU/LV co-exposure in the body. Forty years of independent scientific research and two successfully completed clinical trials run by FivepHusion suggest Deflexifol may offer improved response rates and prolonged life expectancy for patients with metastatic colorectal cancer. Deflexifol has also demonstrated greater tolerability, allowing for an increase in 5-FU dosing of up to 40%, which may further improve patient outcomes.
A new treatment option for childhood brain cancers
The potential for Deflexifol to treat childhood brain cancers has also been investigated in an Australian national clinical trial supported by the Kids with Cancer Foundation, Robert Connor Dawes Foundation and Sydney Children’s Hospital Foundation.
The first component of the trial recently completed and confirmed a safe and tolerable dose of Deflexifol in children. The second component of the trial will investigate the effectiveness of Deflexifol in treating recurrent or refractory paediatric ependymoma, an aggressive childhood brain cancer with no currently approved drug therapies.
Ependymoma predominantly affects young children. Current standard treatment is surgery and radiotherapy, with no other treatment options available. Unfortunately, relapse occurs in around one-third of patients. Backed by independent US data and the recently completed clinical trial, FivepHusion believes Deflexifol has strong potential to become the first approved drug specifically targeting ependymoma, alongside possible effectiveness against other types of brain tumours.
Capital raising to fund a blockbuster market opportunity
Deflexifol is positioned to become the new ‘go-to’ standard of care for the treatment of patients with metastatic colorectal cancer, and to potentially become the first approved drug for childhood ependymoma.
In addition to its application in the treatment of colorectal cancer, Deflexifol has the potential to enhance the treatment of all cancers currently treated with standard 5-FU/LV, which includes gastric and pancreatic cancer, amongst others. It is estimated that globally, more than 8 million people a year are diagnosed with cancers that are treated with 5-FU/LV.
Deflexifol is protected by a portfolio of patents granted in major pharmaceutical markets such as the USA, Europe, China and India, and a pipeline of new patent filings facilitating expected exclusivity for Deflexifol until at least 2045.
FivepHusion is currently undertaking a pre-IPO capital raising to progress Deflexifol development towards late-stage trials in colorectal cancer and ependymoma. An IPO is planned for 2026 to support late-stage clinical development through to market launch.
As a next generation, optimised formulation of standard of care drugs (backed by decades of independent clinical data), Deflexifol has fewer developmental risks and a faster route to market than most other new anti-cancer drugs in development. Consequently, Deflexifol has the potential to be on the market as early as 2029.
The progressive global adoption of Deflexifol in metastatic colorectal cancer has the potential to deliver sales revenues approaching US$1+ billion, which will be further supplemented as Deflexifol becomes adopted as a treatment for additional cancer indications.
For more one FivepHusion see fivephusion.com or contact CEO and Managing Director Christian Toouli.
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