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Allarity Therapeutics and FivepHusion Announce Collaboration to Support Clinical Development of Deflexifol™ with DRP® Companion Diagnostics
BOSTON and SYDNEY (July 31, 2023) — Allarity Therapeutics, Inc. (Nasdaq: ALLR) (“Allarity”), a clinical-stage pharmaceutical company developing novel
About this update from Allarity Therapeutics, Inc.
[{"type":"text","content":" BOSTON and SYDNEY (July 31, 2023) — Allarity Therapeutics, Inc. (Nasdaq: ALLR) (“Allarity”), 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, ...