FivepHusion, an advanced clinical-stage biotechnology company, today announces a commercial transaction with University of Wollongong (UOW) for an exclusive option over its ResectAssist™ Drug Delivery Platform. This innovative, drug-eluting biodegradable implant enables targeted administration of a diverse range of approved and investigational drugs directly into solid tumours with high unmet medical needs.

Key highlights of the deal and ResectAssist™ technology:

  • FivepHusion has secured an exclusive option to acquire the ResectAssist™ Platform technology and IP portfolio on agreed financial terms,
  • ResectAssist™ is a differentiated and adaptable next-generation drug delivery platform enabling intra-tumoural delivery of a diverse range of small molecule chemistries, biologics, antibody-drug conjugates, mRNA and other drug modalities,
  • Drugs are delivered directly into solid tumours via standard endoscopy, facilitating focused high dose therapy, maximising efficacy and minimising side effects,
  • The lead drug candidate, ResectAssist™-FOLFIRINOX, is in development for unresectable locally-advanced pancreatic cancer (LAPC), and is designed to downgrade these tumours to being resectable with curative intent,
  • Commercial opportunities include the US$4B pancreatic cancer market, and an exciting range of upside prospects to optimally deliver other approved and biopharma-partnered investigational drugs for a broad range of solid tumour indications.

Dr Christian Toouli, CEO & Managing Director of FivepHusion said, “This transaction formalises a long-term collaboration with the University of Wollongong to secure an exciting pipeline development opportunity that will ultimately follow the development and commercialisation of Deflexifol®. We are looking forward to rapidly developing the ResectAssist™ Platform into a clinical trial program to optimise treatment for cancer patients.”

The clinical rationale and commercial strategy for the ResectAssist™ Platform is closely aligned with FivepHusion’s mission to optimise cancer therapeutics to improve patient treatment outcomes and quality of life. The UOW ResectAssist™ Program involves an expert multi-disciplinary team led by Associate Professor Kara Perrow and Professor Morteza Aghmesheh. ResectAssist™ is an innovative single-use drug-eluting implant in development for inoperable LAPC and other cancers. Using standard endoscopy procedures, the lead candidate, ResectAssist™-FOLFIRINOX, is designed to locally deliver high dose FOLFIRINOX chemotherapy (5-fluorouracil, leucovorin, irinotecan and oxaliplatin) directly into LAPC tumours, facilitating a substantially safer, more tolerable and significantly more efficacious treatment. The intent of ResectAssist™ treatment is to convert inoperable LAPC to resectable and potentially curable.

Prof. Morteza Aghmesheh, ResectAssist™ Program Co-Founder, and an Honorary Clinical Professor at UOW said, “There is a significant unmet medical need for the treatment of pancreatic cancer patients, and in particular those with unresectable disease. The ResectAssist™ technology is designed to optimally deliver the FOLFIRINOX regimen, the most efficacious but also the most toxic therapy, facilitating maximum anti-cancer efficacy without typical systemic side effects.”

Pancreatic cancer is the 5th leading cause of cancer death in Australia and 7th worldwide, and projected to become the 2nd leading cause of cancer-related deaths by 2030. It has the lowest solid tumour survival rate, with two thirds of patients dying within the first year of diagnosis and <10% of patients surviving by 5 years. Pancreatic cancer patients have limited treatment options. While tumour resection remains the only curative option, >80% of patients present with unresectable disease, including ~30% with locally-advanced, non-metastatic disease. FivepHusion is aiming to initially develop ResectAssist™-FOLFIRINOX to treat these patients.

ResectAssist™-FOLFIRINOX represents the first of a potential pipeline of drug candidates that may be delivered via the ResectAssist™ technology for the treatment of LAPC and other solid tumours with high unmet medical need. The platform is also designed to deliver a diverse range of other drug payloads, including hydrophobic and hydrophilic compounds, biologics (including antibodies and antibody-drug conjugates), peptides and mRNA therapeutics.

A/Prof. Kara Perrow, ResectAssist™ Program Co-Founder and Program Leader commented, “The ResectAssist™ Platform enables delivery of a diverse range of drug payloads directly into solid tumours via standard endoscopy procedures. We are excited to collaborate with FivepHusion to develop this technology to treat pancreatic cancer and a broad range of other tumours.”

The market for the ResectAssist™-FOLFIRINOX drug candidate is very attractive, as there is a significant unmet medical need in pancreatic cancer and limited competition, with a projected global market of ~US$4B by 2029. The adaptability of the ResectAssist™ technology plus common use of the FOLFIRINOX drug regimen across cancer indications provides opportunities to also pursue development for other cancers, leading to upside market opportunities. Moreover, the utility of the ResectAssist™ Platform to deliver other proven and experimental drug candidates across innovative modalities and mechanisms enables exciting opportunities to develop a pipeline of drugs, and to partner with other biopharma companies, to deliver anti-cancer drugs to treat an even broader range of solid tumours.

About FivepHusion

FivepHusion (www.fivepHusion.com) is an advanced clinical-stage, globally focused biotechnology company whose purpose is to optimise cancer therapy to improve patient treatment outcomes and quality of life.

The FivepHusion lead asset is Deflexifol®, a proprietary, novel, and optimised co-formulation of the chemotherapeutic agent 5-fluorouracil (5-FU) and its biomodulator leucovorin (LV), a drug that significantly enhances 5-FU anti-cancer activity. These drugs are commonly used globally to treat various solid tumours including colorectal, pancreatic, gastric and breast cancers. However, due to their chemical incompatibility, current formulations of 5-FU and LV suffer from limitations in their safety, tolerability, effectiveness and pharmacological compatibility. These disadvantages contribute to limited treatment response rates, unpleasant side effects and toxicities, and a reduced quality of life experienced by cancer patients.

FivepHusion is developing Deflexifol® via the FDA 505(b)(2) and EMA Article 10b regulatory pathways as a next-generation replacement of standard of care formulations of 5-FU and LV for the first-line treatment of metastatic colorectal cancer, and other tumours with a projected global incidence of >6 million patients. Anticipated revenues for Deflexifol® reach peaks of >US$1B. Deflexifol® is also being developed as a new therapy for cancers with high unmet medical need, including paediatric ependymoma; a rare and deadly brain cancer which afflicts very young children. A phase 1b clinical trial investigating Deflexifol® as a treatment for paediatric ependymoma and other paediatric brain cancers is ongoing.

ResectAssist™ is an innovative drug delivery platform technology enabling targeted delivery of anti-cancer drugs directly into solid tumours, maximising efficacy and minimising side effects of proven and investigational drugs. The lead candidate, ResectAssist™-FOLFIRINOX, is in development to treat unresectable locally-advanced pancreatic cancer.

Deflexifol® is a trademark of FivepHusion. ResectAssist™ is a trademark of the University of Wollongong.

Forward-Looking Statements

This announcement (and any attachments) may contain certain forward-looking statements that are based on any number of assumptions and estimates which may prove incorrect and relate to circumstances and events that may not take place. Forward-looking statements involve known and unknown risks, uncertainties, and other factors (such as significant business, economic and competitive uncertainties and contingencies, and regulatory and clinical development risks and uncertainties) which may cause the actual future plans, results or the performance of FivepHusion and its development pipeline opportunities Deflexifol® and ResectAssist™ to differ materially from the plans, results or performance expressed or implied by such forward-looking statements. Past performance is not a reliable indicator of future performance. There can be no assurance that any forward-looking statements will be realised. FivepHusion does not make any representation or give any warranty as to the likelihood of achievement or reasonableness of any forward-looking statements.