EQS-News: Precision Medicine Could Get Even More Precise With Allarity Therapeutics Next-Generation Diagnostics Platform

Once brought into its pipeline, Allarity uses its DRP® platform to develop companion diagnostics alongside each drug to improve the treatments in a personalized medicine approach. Earlier this year, the company refocused its pipeline strategy toward combination therapies in an effort to improve treatment outcomes while also creating more funding and partnership opportunities.

Allarity Therapeutics Inc. (NASDAQ: ALLR) is a clinical-stage pharmaceutical company focused on oncology treatments. After decades of research, the company has created what it describes as a powerful next-generation companion diagnostics platform, called Drug Response Predictor (DRP®), and is now developing a portfolio of promising cancer treatments.

Companion diagnostic tests help doctors quickly and accurately identify which treatments a particular person is most likely to respond to so that they can develop a personalized treatment plan that has the highest odds of being successful for that cancer patient.

Earlier versions of these tests would look at a single gene or a small handful of genes known to be predictors of treatment response. This can provide a limited view of the patients potential response. Take, for example, the epidermal growth factor receptor (EGFR) expressed in some colorectal cancers.

A test identifying this biomarker might identify the patient as a candidate for anti-EGFR therapy. However, tumors with EGFR alongside KRAS or NRAS mutations are often resistant to anti-EGFR therapy. But if the test isnt looking at that biomarker of resistance, it could misidentify them as a candidate for the therapy when they really arent.

To account for those limitations, the next generation of diagnostic tests is broadening the scope. Foundation Medicine Inc.s FoundationFocus CDx, for example, was the first companion diagnostic assay approved by the Food and Drug Administration (FDA). It analyzes 324 genes to predict responsiveness to treatments for five types of cancer. Similarly, Myriad Genetics Inc. (NASDAQ: MYGN) launched its new Precise Tumor test earlier this year that analyzes over 500 tumor-related genes.

However, these are still constrained by the limits of the biomarkers science has identified so far. That means biomarkers of resistance or responsiveness that researchers dont know about yet could impact the accuracy of the results.

Allaritys Drug Response Predictor (DRP®) platform is a unique bioanalytical platform that can create drug-specific predictive diagnostics for a wide range of cancer treatments. Unlike other companion diagnostics on the market, Allaritys DRP® looks at the entire 25,000-plus genes expressed in a cancer cell not just the ones science has already identified as biomarkers of responsiveness.

Over the past two decades, the company has developed this platform through dozens of clinical trials and the analysis of thousands of human tumor biopsy samples to create the robust platform. The result is a platform that can bridge the gap between how cancer cells respond to a given drug in vitro versus how actual patient tumors respond. It can then create drug-specific biomarker signatures, a set of 50 to 400 genes that predict how a patients cancer is likely to respond to a specific treatment.

A DRP® companion diagnostic delivers its results in the form of a score on a color-coded spectrum where green means the patient is a high match, likely to respond to a drug, and red means the patient is unlikely to respond because they have too many genes predicting resistance to that treatment. In other words, the DRP® not only identifies likely candidates for a drug but also rules out unlikely responders so doctors can more effectively narrow in on the best treatment options for each patient.

This precision has yielded promising results in clinical trials. Across the dozens of clinical trials done to develop this platform, DRP® has shown it offers twofold to fivefold improvements in overall response rate or time to progression compared to patients not selected with the DRP® companion diagnostic. The DRP® platform has been extensively published in peer-reviewed scientific journals and is patented.

This genome-wide scope covering all 25,000-plus cancer genes gives Allarity the ability to develop a companion diagnostic for every drug it brings into its pipeline as well as partner with other companies to develop tests for the drugs in their pipelines.

The Massachusetts-based pharmaceutical has minimized the risks associated with drug development by only having acquired drug candidates from other companies, including big pharma, that have already demonstrated safety and efficacy in early trials. Most of Allaritys pipeline programs are former big pharma assets that have progressed past Phase 1 studies or later Phase 2/3 studies.

Stenoparib, for example, is being evaluated as a treatment for ovarian cancer. Allarity licensed it from Eisai Co. Ltd. (OTCMKTS: ESALY). It now planning to evaluate stenoparib in combination with dovitinib, a drug candidate with multiple indications that Allarity licensed from Novartis AG (NYSE: NVS).

Allarity Therapeutics, Inc. (Nasdaq: ALLR) develops drugs for personalized treatment of cancer guided by its proprietary and highly validated companion diagnostic technology, the DRP® platform. The Company has a mature portfolio of five drug candidates: stenoparib, a PARP inhibitor in Phase 2 development for ovarian cancer; dovitinib, a post-Phase 3 pan-tyrosine kinase inhibitor; IXEMPRA® (Ixabepilone), a microtubule inhibitor approved in the U.S. for the treatment of second-line metastatic breast cancer and in Phase 2 development in Europe for the same indication; and 2X-111, a liposomal formulation of doxorubicin in Phase 2 development for metastatic breast cancer and/or glioblastoma multiforme (GBM), which is the subject of discussions for a restructured out-license to Smerud Medical Research International AS. LiPlaCis®, a liposomal formulation of cisplatin and its accompanying DRP® is being developed via a partnership with Chosa ApS, an affiliate of Smerud Medical Research International, for late-stage metastatic breast cancer. The Company is headquartered in the United States and maintains an R&D facility in Hoersholm, Denmark.

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Thomas Pedersen

tsp@carrotize.com

https://allarity.com/