Allarity Therapeutics – a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP companion diagnostics for personalized cancer care – and Detsamma Investments Pty. Ltd. trading as “FivepHusion,” which is an advanced clinical-stage biotechnology company developing Deflexifol, an optimized all-in-one formulation of the chemotherapeutic agent 5-fluorouracil (5FU) and its biomodulator leucovorin (LV), announced recently that the two companies have entered into a Clinical Collaboration Agreement.
Under this deal, Allarity will support FivepHusion’s future clinical development of Deflexifol for the treatment of solid tumors by using certain of Allarity’s drug-specific DRP companion diagnostics, including its validated DRP-5FU companion diagnostic, to potentially select patients for enrollment and treatment in clinical trials of Deflexifol as a monotherapy and in combination with other drugs.
Deflexifol is a novel anti-cancer drug reformulation designed to address the safety and efficacy limitations of standard-of-care 5FU chemotherapy. In a single infusion, it combines 5FU and LV, a drug that potentiates 5FU anti-tumor activity, to improve the therapeutic activity of 5FU. And FivepHusion expects to start a phase 1b/2a study investigating Deflexifol in combination with oxaliplatin (“DEFLOX”) and bevacizumab in the 1st line treatment of unresectable metastatic colorectal cancer (mCRC) patients in H2 2023. This approximate 50-patient trial is designed to evaluate the safety, tolerability, and pharmacokinetics of Deflexifol in the DEFLOX plus bevacizumab regimen to enable the selection of the optimal Deflexifol dose to be utilized in a Phase 3 pivotal trial in 1st line treatment of unresectable mCRC. A secondary endpoint is the assessment of objective response (eight-week scan) and overall survival of patients treated with DEFLOX plus bevacizumab.
Allarity’s DRP-5FU is a companion diagnostic (CDx) that has been retrospectively validated and shown to predict patient response to 5FU treatment in late-stage colorectal cancer. And clinical data showing the predictive ability of the DRP-5FU CDx in colorectal cancer were presented at the annual congress of the European Society for Medical Oncology (ESMO) in Barcelona on September 29, 2019, and were later the same year published in the scientific journal Annals of Oncology.
Under the terms of the Clinical Collaboration Agreement, Allarity is going to initially support FivepHusion’s planned Phase 1b/2a trial of DEFLOX plus bevacizumab in 1st line treatment of unresectable mCRC, which will be conducted at trial sites in Australia. Allarity will receive patient biopsies from the trial and analyze them using the DRP companion diagnostics technology to identify patients most likely to respond or not respond to the DEFLOX plus bevacizumab regimen. And this analysis will be conducted blindly (without knowledge of any patient data and/or actual clinical response to the drug), so as to enable the retrospective analysis of the DRP companion diagnostics predictive power following the completion of the Phase 1b/2a trial. FivepHusion will receive a first option to negotiate and obtain from Allarity a global, exclusive license to use and commercialize the DRP-5FU CDx (together with other DRP CDx relevant to drug combinations including Deflexifol) through Phase 3 registration trials, regulatory approval, and to market.
Following the conclusion of the Phase 1b/2a study, FivepHusion will determine whether the ability of the DRP companion diagnostics technology to select patients responsive to DEFLOX plus bevacizumab and/or Deflexifol monotherapy warrants prospective use of the companion diagnostic(s), to select and enroll mCRC patients, in an international, Phase 3 registration study for the drug. Allarity will receive patient biopsies from the trial and analyze them using the DRP companion diagnostics technology to prospectively identify patients most likely to respond or not respond to Deflexifol. Allarity will further assist FivepHusion in the preparation and submission of any regulatory approvals, including Investigational Device Exemptions (IDEs) and Pre-Market Approvals (PMAs), required to use the DRP companion diagnostics technology in such a Phase 3 trial and to use and market the CDx following any regulatory approval of Deflexifol.
The financial terms of the clinical collaboration, option, and potential license are not disclosed. If FivepHusion exercises its option right and receives a license to the Allarity DRP® companion diagnostic technology related to Deflexifol, Alliarty will receive certain milestone payments triggered by regulatory approvals of Deflexifol and attainment of drug sales benchmarks.
KEY QUOTES:
“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 unresectable metastatic colorectal cancer. This collaboration has the potential to develop an exciting precision medicine companion diagnostic for oncologists, facilitating administration of Deflexifol to likely patient responders as a superior treatment for a range of solid tumors with significant unmet medical need.”
— Dr. Christian Toouli, CEO and Managing Director of FivepHusion
“Allarity is thrilled to work together with FivepHusion to support the clinical advancement of their lead Deflexifol program by evaluating the potential of DRP® companion diagnostics to select cancer patients most likely to respond to this novel and improved formulation of the widely-used chemotherapeutic 5FU. Together with the FivepHusion team, we look forward to advancing true personalized cancer care by using DRP® companion diagnostics to help provide Deflexifol to patients that will most likely benefit from this promising therapeutic candiate.”
— James G. Cullem, CEO of Allarity Therapeutics
