Allarity Therapeutics Accelerates Trial Enrollment To Bring FDA-Approved Breast Cancer Treatment To European Market – Interim Results Could Be Released In Second Half Of 2023

Recently, Allarity Therapeutics, Inc. ALLR announced plans to speed up its Phase 2 clinical trial for IXEMPRA®, the clinical-stage pharma company’s metastatic breast cancer treatment. Already approved by the Food and Drug Administration (FDA) for patients in the United States, the company is sponsoring this current trial as part of its work to get IXEMPRA® and IXEMPRA-DRP® the companion diagnostic approved as a treatment in Europe. With the accelerated recruitment of patients, Allarity aims to release interim data from the trial in the second half of 2023. 

The Phase 2 Trial Combines IXEMPRA® With Allarity’s Precision Diagnostic Technology

Originally developed by Bristol Myers Squibb BMY, IXEMPRA is a small molecule targeted inhibitor of microtubules, the structures that help form the cancer cell’s cytoskeleton and regulate cell growth. IXEMPRA® attaches to these microtubules to block the process of dividing and multiplying, ultimately causing the cancer cell to die. As such, it’s meant to both kill existing cancer cells and slow the growth of new ones. 

It was already approved by the FDA for the U.S. market in 2007, where it is marketed by its current owner R-PHARM U.S., LLC, thanks to its ability to increase progression-free survival rates and overall response rates in patients with metastatic breast cancer. Allarity owns exclusive development rights for the drug in Europe, where it is not currently approved. 

What really sets the Phase 2 trial apart from others, however, is Allarity’s patented Drug Response Predictor (DRP®) platform, which the company has used to develop a companion diagnostic to help identify which patients are most likely to benefit from IXEMPRA®, Allarity owns exclusive development rights for the drug in Europe. This is key because as promising as any new cancer treatment may be, the reality is that many patients may not respond or at least not respond as strongly as they would to a different treatment. Most cancer drugs approved by the FDA have a response rate of 40% or less, meaning fewer than half of patients will see a significant reduction in tumor size.

The good news is that cancer researchers are identifying more and more biomarkers that can predict whether or not an individual patient’s cancer will respond to a particular drug. That includes biomarkers that indicate if a cancer is especially resistant to a drug and biomarkers that suggest if it might be especially vulnerable to it. 

However, there’s no single gene or biomarker that definitively proves a drug will or will not work. Instead, dozens if not hundreds of genes and biomarkers are at play and a single patient can often have a mix of both resistant and susceptible biomarkers. 

That cancer complexity is why Allarity developed the DRP® platform. Using drug-specific DRP® companion diagnostics,  doctors will be able to not only rule out drugs that a patient is unlikely to respond to but hone in on the course of treatment with the best chance of producing the best results. This can save thousands of dollars for patients by avoiding ineffective treatments and improve their odds of remission by getting them on the right treatment for their particular cancer as soon as possible.

Already deployed in over 47 cancer trials, the DRP® platform technology has yielded a high success rate with more than 80% predictive accuracy thanks to its systems biology analysis approach.  Starting with analysis of messenger RNA taken from cancer cell lines treated with a given drug, the DRP® platform generates an initial gene expression signature that predicts whether a tumor will (or will not) respond to the drug.  The DRP® platform then refines this predictive signature through a proprietary clinical relevance filter comprising drug response/resistance data from thousands of biopsy samples from actual patients in prior oncology clinical trials.  The result is a unique DRP® signature (or companion diagnostic) based on 50 to 400 biomarkers. That signature can then be compared to messenger RNA data from a specific patient’s tumor to generate a DRP® score, a measure of how likely the patient is to respond to that drug.

In the IXEMPRA® trial, for example, Allarity is enrolling patients with at least a 33% DRP® score for the breast cancer therapy. In addition to measuring the efficacy of the therapy, the trial will also be used to further validate the predictive accuracy of the DRP® companion diagnostic by comparing response rates to patients’ initial DRP® scores. 

As the company implements the amended trial protocol to speed up enrollment, by having lowered the IXEMPRA-DRP® companion diagnostic cut-off score, for enrollment, from 67% to 33%, and by expanding its CRO partnerships, meaning more sites will participate in the trial, it’s working to advance towards hopeful approval for the European market, where Allarity holds exclusive option rights to the drug.

Featured photo by National Cancer Institute on Unsplash

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