In another significant milestone towards its goal of setting the new gold standard for Chemotherapy with its flagship Deflexifol™, FivepHusion has entered into a strategic collaboration with Allarity Therapeutics (Nasdaq: ALLR) to evaluate the potential of Allarity’s DRP®-5FU companion diagnostic to support the clinical development of Deflexifol™.
Allarity’s Drug Response Predictor (DRP®) companion diagnostic technology has demonstrated the ability to predict the likely response of late-stage colorectal cancer patients to chemotherapy treatments using the standard-of-care anti-cancer drug 5-fluorouracil (5FU). FivepHusion’s Deflexifol™ co-formulates 5-FU together with leucovorin (LV), a drug that makes 5-FU’s anti-tumour activity more potent.
Through the use of the DRP®-5FU companion diagnostic, FivepHusion may be able to determine which patients will be most likely to respond to treatment using Deflexifol™, allowing the Company to personalise its treatment for patients and provide this potentially revolutionary drug to those who are mostly likely to benefit.
The clinical collaboration between the two companies will begin with FivepHusion’s planned Deflexifol™ phase 1b/2a trial for the 1st line treatment of unresectable metastatic colorectal cancer (mCRC), a trial designed to determine the optimal Deflexifol™ dose when combined with the standard of care drug oxaliplatin (together referred to as DEFLOX) and another drug named bevacizumab.
This trial is designed to evaluate the safety, tolerability and pharmacokinetics of escalating doses of Deflexifol™ to inform the Deflexifol™ dose to be used in the DEFLOX + bevacuzimab regimen in a planned Phase 3 pivotal trial in 1st line mCRC.
Via the phase 1b/2a trial, Allarity and FivepHusion will evaluate whether Allarity’s DRP® technology can identify those mCRC patients that are more and less likely to respond to DEFLOX treatment, and potentially Deflexifol™ monotherapy.
Allarity will perform a blinded analysis of tumour biopsies from consenting trial participants using its DRP® companion diagnostics. Allarity will not receive any patient data and will have no knowledge of the actual clinical response that the patients experienced with treatment. This will allow the companies to undertake a retrospective analysis of the DRP® companion diagnostics’ predictive power by comparing the technologies’ predicted response to the actual clinical response in the trial.
Through to Market
The outcome of this trial collaboration is designed to provide FivepHusion with insights into the DRP® companion diagnostics’ ability to select patients responsive to DEFLOX plus bevacizumab and/or Deflexifol™ monotherapy, with the Company receiving from Allarity a first option to obtain a global, exclusive license to use and commercialise the DRP®-5FU CDx and potentially other related DRP companion diagnostics
If FivepHusion chooses to pursue a further collaboration, the technology could be used to select and enroll mCRC patients in an international Phase 3 registration study for Deflexifol™, with FivepHusion retaining the rights to use and commercialise the DRP® technology and take the drug through this trial and subsequent regulatory approvals to market.
Additionally, Allarity will provide FivepHusion with the preparation and submission of relevant USA and European regulatory approvals, giving FivepHusion yet another ally as it works to bring its potentially revolutionary product to market, with the Company recently securing partnerships with healthcare advisory firm Tree-Hill Partners and leading biopharmaceutical solutions organisation Syneos Health.
Having recently reported Deflexifol™’s improved safety and tolerability over standard-of-care treatment in a phase 1b clinical trial in end-stage cancer patients, this collaboration with Allarity further expands FivepHusion’s potential to change the game with its flagship drug.
FivepHusion’s Chief Executive Dr Christian Toouli stated “We are excited to collaborate with Allarity Therapeutics to evaluate the drug-specific DRP® companion diagnostic technology as part of our upcoming Deflexifol™ phase 1b/2a trial in 1st line treatment of unresectable metastatic colorectal cancer.”
“This collaboration has the potential to develop an exciting precision medicine companion diagnostic for oncologists, facilitating the administration of Deflexifol™ to likely patient responders as a superior treatment for a range of solid tumours with significant unmet medical need.”