Allarity Therapeutics and FivepHusion Announce Collaboration to Support Clinical Development of Deflexifol with DRP Companion Diagnostics
Allarity Therapeutics, Inc., 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,” 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 today that the two companies have entered into a Clinical Collaboration Agreement. Under this agreement, 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. It combines, in a single infusion, 5FU and LV, a drug that potentiates 5FU anti-tumor activity, to improve the therapeutic activity of 5FU. 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 ~50 patient trial is designed to evaluate the safety, tolerability and pharmacokinetics of Deflexifol in the DEFLOX plus bevacizumab regimen, to enable 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. 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.
Dr. Christian Toouli, CEO and Managing Director of FivepHusion, said, “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 tumours with significant unmet medical need.”
James G. Cullem, CEO of Allarity Therapeutics, added, “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.”