Allarity Therapeutics Initiates Phase 2 Trial of IXEMPRA® in Europe for the Treatment of Metastatic Breast Cancer

Press release      

Hørsholm, Denmark (4 March 2021) – Allarity Therapeutics A/S (“Allarity” or the “Company”) today announced that it has enrolled the first patient in its European Phase 2 clinical trial of IXEMPRA^® (ixabepilone) for the treatment of metastatic breast cancer.

The U.S. Food and Drug Administration (FDA) approved IXEMPRA^®, a microtubulin inhibitor, in 2007 for the treatment of metastatic breast cancer. Allarity holds exclusive European option rights to IXEMPRA^® from the pharmaceutical company R-Pharm U.S., LLC, which previously acquired global rights to the drug from Bristol-Myers Squibb (BMS). Allarity has previously developed and validated a Drug Response Predictor (DRP^®) companion diagnostic specific for the drug.

“We are pleased to announce the enrollment of the first patient in our DRP^®-guided Phase 2 clinical trial for IXEMPRA^®, one of our prioritized pipeline programs. Phase 2 development of this asset in the European Union (EU) positions us to advance the drug toward a registrational approval and commercialization in this major oncology market, a necessary step for making it available to individuals living with metastatic breast cancer in Europe,” commented Steve R. Carchedi, CEO of Allarity Therapeutics. “We are confident that our Phase 2 study will prove the merits of this drug, together with its DRP^® companion diagnostic, further clinically validating our DRP^® biomarker technology.”

Allarity is currently conducting a DRP^®-guided Phase 2 clinical trial to evaluate IXEMPRA^® for the treatment of third-line metastatic breast cancer, with numerous trial sites planned in Europe, including Belgium, England, Denmark, Finland, Poland and Germany. The Company’s protocol plans for an enrollment target of 60 IXEMPRA® DRP^®-selected patients. By using DRP^® for patient selection, Allarity aims to provide a superior clinical benefit to patients receiving IXEMPRA^®, as compared to historical clinical data from breast cancer patients treated with IXEMPRA^® but not selected with DRP^®. Principal Investigator Guy Jerusalem, M.D., Ph.D., Head of Medical Oncology and Director of the Breast Clinic at the University Hospital Center in Liege, Belgium, enrolled the first DRP^®-selected patient.  

“I am pleased to see the first patient enrolled in our European Phase 2 trial for IXEMPRA^®,” added Marie Foegh, M.D., D.Sc., CMO of Allarity Therapeutics. “We look forward to further evaluating the clinical and therapeutic value of our IXEMPRA^® DRP^® companion diagnostic, and to providing individuals with  metastatic breast cancer another therapeutic option through our personalized medicine approach.”

About the Drug Response Predictor – DRP^® Companion Diagnostic
Allarity uses its drug specific DRP^® to select those patients who, by the genetic signature of their cancer, are found to have a high likelihood of responding to the specific drug. By screening patients before treatment, the response rate can be significantly increased. The DRP^® method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and prior clinical trial outcomes. DRP^® is based on messenger RNA from the patient’s biopsies. DRP^® has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in nearly 40 clinical studies that were examined, including an ongoing, prospective Phase 2 trial. The DRP^® platform can be used in all cancer types and is patented for more than 70 anti-cancer drugs.

About Allarity Therapeutics
Allarity Therapeutics (Nasdaq First North Growth Market Stockholm: ALLR.ST) develops drugs for personalized treatment of cancer guided by its proprietary drug response predictor technology, the DRP^® platform. The company has a mature portfolio of six drug candidates, including compounds in the pre-registration stage. The product portfolio includes: Stenoparib (2X-121), a PARP inhibitor in Phase 2 for ovarian cancer; Dovitinib, a pan-TKI advancing towards a U.S. NDA filing for renal cell carcinoma; IXEMPRA^® (Ixabepilone), a microtubulin inhibitor approved in the U.S. for the treatment of breast cancer;  LiPlaCis^®, a liposomal formulation of cisplatin in Phase 2 trials for breast and prostate cancer;  2X-111, a liposomal formulation of doxorubicin under manufacturing for Phase 2 in breast cancer; and Irofulven, a DNA damaging agent in Phase 2 for prostate cancer.

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Forward-looking statements
This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of Allarity’s control and which could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning Allarity’s plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. Allarity undertakes no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.  Allarity’s clinical programs may be delayed or impacted by the ongoing global COVID-19 pandemic.

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Investor Contact:
            InvestorRelations@allarity.com

Media Contact:
            Thomas Pedersen
            Carrotize PR & Communications
            +45 6062 9390
            tsp@carrotize.com

Certified Adviser:
Svensk Kapitalmarknadsgranskning AB, Email: ca@skmg.se. Tel: +46 11 32 30 732

This information is information that Allarity A/S is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication on 4 March 2021.

Attachment

• Allarity Press Release_First Patient Enrolled in Ixempra Trial