NEW YORK – Allarity Therapeutics on Thursday said that it has enrolled the first patient in a European Phase II clinical trial evaluating the microtubulin inhibitor ixabepilone (Ixempra) as a third-line treatment for certain metastatic breast cancers.
Specifically, Allarity — previously named Oncology Venture — will evaluate the agent, a product for which it in-licensed the European rights from R-Pharm in 2019, for patients whose cancers have a predictive genetic signature, as detected by Allarity's Drug Response Predictor (DRP) companion diagnostic. The DRP platform, an algorithm-based tool that Allarity has developed using genomic information from cell lines, tumor biology, and clinical data, uses messenger RNA from patients' biopsies to predict whether the patient has a high likelihood of responding to the drug. For the Phase II clinical trial, which will take place in Belgium, England, Denmark, Finland, Poland, and Germany, among other European countries, Allarity plans to enroll roughly 60 patients selected with the ixabepilone-specific DRP as a companion diagnostic.
Using the DRP to determine patients' likelihood to respond to in-licensed oncology agents is part of Allarity's bigger-picture strategy; the company has pursued the same approach, for example, with the previously failed kidney cancer drug dovitinib. While ixabepilone does have regulatory approval in the US, the European Medicines Agency (EMA) chose not to approve the drug based on previous trials that did not pre-select patients. Allarity hopes that pre-selecting patients with the DRP will result in improved outcomes versus those seen in earlier trials.
"We are confident that our Phase II study will prove the merits of this drug, together with its DRP companion diagnostic, further clinically validating our DRP biomarker technology," Steve Carchedi, CEO of Horsholm, Denmark-based Allarity, said in a statement.