Allarity Therapeutics Inc
and Detsamma Investments Pty Ltd have entered a Clinical Collaboration Agreement.
Detsamma Investments, trading as "FivepHusion," is developing Deflexifol, an optimized all-in-one formulation of the chemotherapeutic agent 5-fluorouracil (5FU) and its biomodulator leucovorin (LV).
Under this agreement, Allarity will support FivepHusion's future clinical development of Deflexifol for solid tumors by using certain of Allarity's drug-specific DRP companion diagnostics to potentially select patients for enrollment and treatment in Deflexifol trials as a monotherapy and in combination with other drugs.
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 the selection of the optimal Deflexifol dose to be utilized in the Phase 3 pivotal trial.
Under the terms of the Clinical Collaboration Agreement, FivepHusion will receive a first option to negotiate and obtain from Allarity a global, exclusive license to use and commercialize the DRP-5FU CDx through Phase 3 registration trials, regulatory approval, and market.
Financial terms of the clinical collaboration, option, and potential license are not disclosed.
Suppose FivepHusion exercises its option right and receives a license to the Allarity DRP companion diagnostic technology related to Deflexifol. In that case, Alliarty will receive certain milestone payments triggered by regulatory approvals of Deflexifol and the attainment of drug sales benchmarks.
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