Allarity Therapeutics (NASDAQ: ALLR), a clinical-stage pharmaceutical company, recently announced preliminary results from its Phase 2 clinical trial assessing the effectiveness of IXEMPRA® in treating metastatic breast cancer (mBC) patients. The patients were pre-screened using Allarity’s drug-specific DRP®-IXEMPRA® companion diagnostic (CDx), a predictive indicator consisting of multiple mRNA biomarkers of drug response or resistance.
Early Trial Results Show Promising Signs of Clinical Benefit
From 36 pre-screened mBC patients, five were DRP® positive and were selected for IXEMPRA® treatment. Of the four evaluable cases, all demonstrated encouraging signs of clinical benefit. This included two partial responders with substantial tumor shrinkages of 66% and 59%, and two patients experiencing stable disease for 24 and 19 weeks, respectively.
Allarity’s DRP®-IXEMPRA® CDx May Revolutionize mBC Treatment
Dr. Marie Foegh, the Chief Medical Officer at Allarity, expressed her enthusiasm over the preliminary trial results. She highlighted that these findings suggest a higher clinical benefit rate from IXEMPRA® treatment when using the DRP®-IXEMPRA® CDx for patient selection. If approved, this innovative diagnostic tool could help identify mBC patients most likely to benefit from IXEMPRA® treatment.
Allarity Continues to Refine Patient Selection and Treatment
The ongoing trial is part of an open-label, single-arm study conducted across multiple European sites. The company recently modified the trial protocol to lower the DRP® cut-off score, aiming to broaden the enrollment of potential responder patients while still excluding those unlikely to respond to the drug. The ultimate goal is to fine-tune the DRP®-IXEMPRA® CDx criteria to identify the patients who could substantially benefit from this treatment.
The Potential of the DRP®-IXEMPRA® CDx to Improve IXEMPRA®’s Benefit-Risk Ratio
The DRP®-IXEMPRA® CDx, a transcriptomic signature comprising 191 mRNA biomarkers, aims to predict tumor sensitivity or resistance to IXEMPRA®. By using this tool to select patients likely to respond to the drug, Allarity hopes to improve IXEMPRA®’s benefit-risk ratio in metastatic or locally advanced breast cancer. Early data suggest that this novel approach might identify patients who could achieve improved response and clinical benefit rates as compared to the standard monotherapy efficacy indicated by the U.S. FDA-approved label for the drug.
Allarity’s Vision for IXEMPRA® in Europe
Allarity has the exclusive rights to develop and commercialize IXEMPRA® in Europe. Their CEO, James G. Cullem, expressed optimism regarding the potential of their ongoing Phase 2 trial, and the company’s commitment to bring this beneficial drug to European mBC patients.
The information provided is based on early trial results and is not yet statistically significant. The DRP®-IXEMPRA® CDx is a clinical stage companion diagnostic candidate and has not been approved by the U.S. FDA or the EMEA.
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