ALLR - Precision Medicine Could Get Even More Precise With Allarity Therapeutics’ “Next-Generation†Diagnostics Platform
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Once brought into its pipeline , Allarityuses its DRP® platform to develop companion diagnostics alongsideeach drug to improve the treatments in a personalized medicineapproach. Earlier this year, the company refocusedits pipeline strategy toward combination therapies in aneffort to improve treatment outcomes while also creating more fundingand partnership opportunities.
Allarity Therapeutics Inc. (NASDAQ: ALLR) isa clinical-stage pharmaceutical company focused on oncologytreatments. After decades of research, the company has created what itdescribes as a powerful next-generation companion diagnosticsplatform, called Drug Response Predictor (DRP®), and is nowdeveloping a portfolio of promising cancer treatments.
Companion Diagnostics Are Helping DoctorsDeliver The Right Cancer Treatment To The Right Patient At The RightTime
Companiondiagnostic tests help doctors quickly and accurately identify whichtreatments a particular person is most likely to respond to so thatthey can develop a personalized treatment plan that has the highestodds of being successful for that cancer patient.
Earlier versions ofthese tests would look at a single gene or a small handful of genesknown to be predictors of treatment response. This can provide alimited view of the patient’s potential response. Take, for example,the epidermal growth factor receptor (EGFR) expressed in somecolorectal cancers.
A test identifying this biomarker might identify the patient asa candidate for anti-EGFR therapy. However, tumors with EGFR alongsideKRAS or NRAS mutations areoften resistant to anti-EGFR therapy . But if the test isn’tlooking at that biomarker of resistance, it could misidentifythem as a candidate for the therapy when they really aren’t.
To account forthose limitations, the next generation of diagnostic tests isbroadening the scope. Foundation Medicine Inc.’s FoundationFocusCDx, for example, was the first companion diagnostic assay approved bythe Food and Drug Administration (FDA). It analyzes 324 genes topredict responsiveness to treatments for five types of cancer.Similarly, Myriad Genetics Inc. (NASDAQ: MYGN) launched its new Precise Tumortest earlier this year that analyzes over 500 tumor-relatedgenes.
However,these are still constrained by the limits of the biomarkers sciencehas identified so far. That means biomarkers of resistance orresponsiveness that researchers don’t know about yet could impactthe accuracy of the results.
Allarity’s Proprietary Drug Response Predictor PlatformReported To Deliver Even More Precision
Allarity’s Drug Response Predictor (DRP®)platform is a unique bioanalytical platform that can createdrug-specific predictive diagnostics for a wide range of cancertreatments. Unlike other companion diagnostics on the market,Allarity’s DRP® looks at the entire 25,000-plus genes expressed ina cancer cell — not just the ones science has already identified asbiomarkers of responsiveness.
Over the past two decades, the company hasdeveloped this platform through dozens of clinical trials and theanalysis of thousands of human tumor biopsy samples to create therobust platform. The result is a platform that can bridge the gapbetween how cancer cells respond to a given drug in vitro versus howactual patient tumors respond. It can then create drug-specificbiomarker signatures, a set of 50 to 400 genes that predict how apatient’s cancer is likely to respond to a specific treatment.
A DRP® companiondiagnostic delivers its results in the form of a score on acolor-coded spectrum where green means the patient is a high match,likely to respond to a drug, and red means the patient is unlikely torespond because they have too many genes predicting resistance to thattreatment. In other words, the DRP® not only identifies likelycandidates for a drug but also rules out unlikely responders sodoctors can more effectively narrow in on the best treatment optionsfor each patient.
This precision has yielded promising results in clinicaltrials. Across the dozens of clinical trials done to develop thisplatform, DRP® has shown it offers twofold to fivefold improvementsin overall response rate or time to progression compared to patientsnot selected with the DRP® companion diagnostic. The DRP® platformhas been extensively published in peer-reviewed scientific journalsand is patented.
This genome-wide scope covering all 25,000-plus cancer genesgives Allarity the ability to develop a companion diagnostic for everydrug it brings into its pipeline as well as partner with othercompanies to develop tests for the drugs in their pipelines.
A Low-Risk Pipeline Of Promising OncologyDrug Candidates?
The Massachusetts-based pharmaceutical has minimized the risksassociated with drug development by only having acquired drugcandidates from other companies, including big pharma, that havealready demonstrated safety and efficacy in early trials. Most ofAllarity’s pipeline programs are former big pharma assets that haveprogressed past Phase 1 studies or later Phase 2/3 studies.
Stenoparib, for example,is being evaluated as a treatment for ovarian cancer. Allaritylicensed it from Eisai Co. Ltd. (OTCMKTS: ESALY). It nowplanning to evaluate stenoparib in combination with dovitinib, a drugcandidate with multiple indications that Allarity licensed from Novartis AG (NYSE: NVS).
Allarity Therapeutics, Inc.(Nasdaq: ALLR) develops drugs for personalized treatment of cancerguided by its proprietary and highly validated companion diagnostictechnology, the DRP® platform. The Company has a mature portfolioof five drug candidates: stenoparib, a PARP inhibitor in Phase 2development for ovarian cancer; dovitinib, a post-Phase 3 pan-tyrosinekinase inhibitor; IXEMPRA® (Ixabepilone), a microtubule inhibitorapproved in the U.S. for the treatment of second-line metastaticbreast cancer and in Phase 2 development in Europe for the sameindication; and 2X-111, a liposomal formulation of doxorubicin inPhase 2 development for metastatic breast cancer and/or glioblastomamultiforme (GBM), which is the subject of discussions for arestructured out-license to Smerud Medical Research International AS.LiPlaCis®, a liposomal formulation of cisplatin and itsaccompanying DRP® is being developed via a partnership with ChosaApS, an affiliate of Smerud Medical Research International, forlate-stage metastatic breast cancer. The Company is headquartered inthe United States and maintains an R&D facility in Hoersholm,Denmark.
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