NEW YORK – Allarity Therapeutics will contribute its drug-specific companion diagnostics to the development of FivepHusion's Deflexifol, a combined formulation of 5-fluorouracil and leucovorin, as a treatment for solid tumors, the companies announced Monday.
FivepHusion plans to begin a Phase Ib/IIa trial in the second half of 2023 of Deflexifol with oxaliplatin and Genentech's Avastin (bevacizumab) in patients with newly diagnosed unresectable metastatic colorectal cancer. In the 50-patient trial, investigators will evaluate the safety, tolerability, and pharmacokinetics of Deflexifol in the three-drug regimen and will select a dose for a Phase III pivotal trial in the same setting. As a secondary endpoint, the company, which is headquartered in Sydney, will assess objective response and overall survival.
Boston-based Allarity will work with FivepHusion to incorporate evaluation of companion diagnostics developed on its gene expression-based drug response predictor (DRP) platform. In a study of DRP-5FU, a DRP designed to predict efficacy of 5-fluorouracil for metastatic colorectal cancer, the DRP-5-FU biomarker was able to predict benefit for patients treated after the year 2000, while results for patients treated before 2000 did not reach statistical significance.
In the trial, Allarity and FivepHusion will evaluate the use of DRP companion diagnostic to select cancer patients most likely to respond to Deflexifol.
"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," FivepHusion CEO Christian Toouli said in a statement.
The partners did not disclose certain terms of the alliance, but if FivepHusion exercises its option right and receives the Allarity DRP companion diagnostic technology related to Deflexifol, Allarity would receive milestone payments triggered by regulatory approvals of the drug and achievement of sales benchmarks.