• Current positive results with 3 variants, including alpha variant B.1.1.7 (“British” variant), beta variant B.1351 (“South African” variant) and gamma variant P.1 (“Brazilian” variant), follows prior pre-clinical tests indicating efficacy of the novel PARP inhibitor stenoparib against SARS-Cov-2
  
  
  • Allarity Therapeutics is initiating further testing of stenoparib against delta variant B.1.617.2 (“Indian” variant)
    
    

Press Release

Hørsholm, Denmark (August 5, 2021) – Allarity Therapeutics A/S (“Allarity” or the “Company”) today announced positive results from the further pre-clinical testing of the antiviral activity of its PARP inhibitor, stenoparib, against Coronavirus variant B.1.1.7 (British variant). The Pathogen and Microbiome Institute at Northern Arizona University (NAU), a leading U.S. infectious disease research center, conducted the tests.

The current in-vitro studies, focusing on SARS-CoV-2 lineage B.1.1.7, follow previous, positive pre-clinical test results with stenoparib as a treatment of SARS-CoV-2 first announced on August 26, 2020, and since published in the peer-review journal mBio (mbio.asm.org) on January 19, 2021. The previously announced data showed that stenoparib inhibits SARS-CoV-2 as a single agent, and in addition that stenoparib, in combination with remdesivir, was also active in inhibiting the virus. The concentration of stenoparib required for virus inhibition was lower in the combination study with remdesivir than in the single agent study.

The new results show that stenoparib is also effective in inhibiting the alpha variant in a dose-dependent manner in Vero E6 cells, both when measuring virus with PCR and with plaque counts. In combination with remdesivir, researchers observed a 95% reduction in virus. This reduction was measured as an average of plaque counts in three experiments. The results at NAU are confirmed by initial pre-clinical results from additional laboratory testing conducted at Viroclinics-DDL Diagnostics Laboratory (Rotterdam, The Netherlands), which show stenoparib activity against the alpha (B.1.1.7), beta (B.1351), and gamma (P.1) variants, as well as the original strain of SARS-CoV-2.

Currently, the delta variant (lineage B.1.617.2) has become the dominant strain of SARS-CoV-2, and near-term tests of stenoparib against this variant are being initiated by Allarity. The Pathogen and Microbiome Institute’s ongoing testing of stenoparib is a component of the early steps of a potential therapeutic expansion of this drug, an orally administered Phase 2 anticancer agent, to anti-viral applications. Stenoparib is one of very few drugs that has been shown, based on ongoing or completed pre-clinical tests by 2 independent laboratories, to be a potential treatment for patients infected with SARS-Cov-2 or several of its currently known variants.

Allarity is planning to submit preclinical findings to the U.S. National Institutes of Health (NIH) as part of the new U.S. federal government program The Antiviral Program for Pandemics (APP) that has replaced the project “Warp Speed” grant program under the new Biden presidential administration. Funding opportunities include those under the newly announced Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern within the U.S. National Institute of Allergy and Infectious Diseases (NIAID). AViDD aims to develop safe and effective antivirals to combat SARS-CoV-2, the virus that causes COVID-19, as well as to build sustainable platforms for targeted drug discovery and development of a robust pipeline of antivirals against viruses with pandemic potential. The NIH has recently stated its interest in identifying and supporting new orally-administered, single pill drugs that can impede Coronavirus function before the onset of the respiratory inflammatory response that causes fatality from viral infection.

Steve Carchedi, CEO of the Company, said, “Allarity Therapeutics remains committed to developing novel treatments that change the course of disease in areas of high unmet need. Our ongoing research and development work with stenoparib as a potential anti-viral treatment for COVID-19 is no exception, particularly as new variants emerge as an ongoing problem. We are proud to be among the companies leading development of possible new treatments for COVID-19 and its currently known variants.”

Allarity Therapeutics plans to advance stenoparib into human clinical trials as a potential therapy for COVID-19 and is working opportunistically on securing funding to advance such trials. In addition to investigating whether stenoparib has therapeutic potential as a possible treatment of SARS-CoV-2, including the alpha, beta, gamma and delta variants, Allarity Therapeutics is also currently evaluating stenoparib for the treatment of advanced ovarian cancer in a Phase 2 clinical trial at the Dana-Farber Cancer Institute (Boston, MA U.S.A.) using a DRP® companion diagnostic to guide patient enrollment and improve therapeutic outcome, and is currently expanding this study with additional trial sites in the U.S. and Europe. Stenoparib is a novel small molecule (oral), targeted inhibitor of Poly ADP-Ribose Polymerase (PARP), a key DNA damage repair enzyme active in cancer cells.

Allarity holds global, exclusive rights to stenoparib under an existing license with Eisai Co., Ltd. (Tokyo, Japan), in the fields of cancer therapy as well as anti-viral therapy.

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 in post-Phase 3 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, currently being developed by Smerud Medical Research International; 2X-111, a liposomal formulation of doxorubicin under manufacturing for Phase 2 in breast cancer, currently being developed by Smerud Medical Research International ; and Irofulven, a DNA damaging agent in Phase 2 for prostate cancer, currently being developed by Lantern Pharma, Inc.

About Northern Arizona University
Northern Arizona University is a higher-research institution providing exceptional educational opportunities in Arizona and beyond. NAU delivers a student-centered experience to its nearly 30,000 students in Flagstaff, statewide and online through rigorous academic programs in a supportive, inclusive and diverse environment. Dedicated, world-renowned faculty help ensure students achieve academic excellence, experience personal growth, have meaningful research opportunities and are positioned for personal and professional success.

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.

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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.

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Investor Contacts:
        InvestorRelations@allarity.com

U.S. Media Contact:

        Mike Beyer
        Sam Brown, Inc.
        +1 312-961-2502
        mikebeyer@sambrown.com

EU 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 August 5, 2021.