Allarity Therapeutics and Lonza Collaborate to Manufacture Dovitinib, a Renal Cell Carcinoma Candidate

• Integrated solution for process development and manufacturing of drug substance and drug product will facilitate the advancement of clinical development
• The agreement meets Allarity’s needs for current and future commercial production of dovitinib and will support the Company’s planned NDA filing in 2021
  
  
  
  

Basel, Switzerland and Hoersholm, Denmark, 23 September 2021 – Allarity Therapeutics A/S, a clinical-stage precision medicine company actively advancing a pipeline of in-licensed oncology therapeutics for patients with difficult-to-treat cancers, and Lonza, a CDMO partner to the biopharma industry, today announced an agreement to develop and manufacture dovitinib. The agreement aims to commence manufacturing of dovitinib in 2022 to meet Allarity’s projected needs for bringing dovitinib to market following anticipated regulatory approvals.

Dovitinib represents Allarity’s most advanced clinical asset, targeting metastatic renal cell carcinoma (RCC) with possible use in other indications, such as liver cancer, breast cancer and various solid tumors. This pan-tyrosine kinase inhibitor targets fibroblast growth factor receptor, vascular endothelial growth factor receptor and other receptor tyrosine kinases.

Steve Carchedi, CEO, Allarity commented: “Entering this agreement with Lonza is an important step in our long-term preparations to take dovitinib towards commercialization. Allarity now has a robust agreement covering the production and ongoing supply of dovitinib that we will need in the years to come.”

Under the terms of the agreement, Lonza will leverage its capabilities for commercial manufacturing of small-molecules and oral solid dosage forms to provide Allarity with cGMP compliant drug product supply and regulatory support towards commercialization. Allarity will leverage Lonza’s global network, technical capabilities, and integrated solution covering both drug substance and drug product. The drug substance manufacturing and particle size reduction by micronization will be performed at Lonza’s facility in Visp (CH). The drug product manufacturing will take place at the Tampa, FL (US) facility.

Christian Dowdeswell, VP and Global Head, Commercial Development – Small Molecules, Lonza, added: “Our collaboration with Allarity Therapeutics demonstrates our commitment to supporting companies with their development pipeline. Our unique and comprehensive set of capabilities supporting drug substance through to drug product development and manufacturing enable Allarity to focus on dovitinib commercialization.”

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.

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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 Lonza

Lonza is the preferred global partner to the pharmaceutical, biotech and nutrition markets. We work to enable a healthier world by supporting our customers to deliver new and innovative medicines that help treat a wide range of diseases. We achieve this by combining technological insight with world-class manufacturing, scientific expertise and process excellence. Our unparalleled breadth of offerings enables our customers to commercialize their discoveries and innovations in the healthcare sector.

Founded in 1897 in the Swiss Alps, today, Lonza operates across five continents. With approximately 15,000 full-time employees, we comprise high-performing teams and individual talent that make a meaningful difference to our own business, as well as to the communities in which we operate. The company generated sales of CHF 2.5 billion with a CORE EBITDA of CHF 847 million in H1 2021. Find out more at .

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Allarity Therapeutics Contact Details

Mike Beyer

US Media contact

Sam Brown, Inc.

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Thomas Pedersen

EU Media contact

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Certified Adviser

Svensk Kapitalmarknadsgranskning AB

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Lonza Contact Details

Victoria Morgan

Head of External Communications

Lonza Group Ltd

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Dr. Martina Ribar Hestericová

Trade Media Lead

Lonza Group Ltd

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Dirk Oehlers

Investor Relations

Lonza Group Ltd

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Additional Information and Disclaimer (Lonza)

Lonza Group Ltd has its headquarters in Basel, Switzerland, and is listed on the SIX Swiss Exchange. It has a secondary listing on the Singapore Exchange Securities Trading Limited (“SGX-ST”). Lonza Group Ltd is not subject to the SGX-ST’s continuing listing requirements but remains subject to Rules 217 and 751 of the SGX-ST Listing Manual.

Certain matters discussed in this news release may constitute forward-looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward-looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ materially in the future from the forward-looking state-ments included in this news release due to various factors. Furthermore, except as otherwise re-quired by law, Lonza Group Ltd disclaims any intention or obligation to update the statements con-tained in this news release.

Forward-Looking and MAR Statements (Allarity Therapeutics)

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 makes nor undertakes any obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.

This information is information that Allarity Therapeutics A/S is obliged to make public pursuant to the EU Market Abuse Regulation (MAR). The information was submitted for publication on September 23, 2021.

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