Allarity Therapeutics Submits New Drug Application (NDA) to US FDA for Dovitinib for Third-Line Treatment of Renal Cell Carcinoma (RCC)

Marks Allarity’s first regulatory marketing authorization application
for one of its priority oncology pipeline programs

The NDA is supported by the premarket approval (PMA) submission previously filed by Allarity
to the FDA for the companion diagnostic Dovitinib-DRP® to select RCC patients
most likely to respond to medication

Press release

Cambridge, MA United States (December 22, 2021) — Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (Nasdaq: ALLR) today announced the submission of a marketing authorization application for dovitinib for the third-line treatment of patients with renal cell carcinoma (RCC).

The Company’s NDA filing is supported by its prior PMA submission to the FDA for the use of Dovitinib-DRP®, the Company’s validated companion diagnostic for the drug, to select and treat the most susceptible RCC patients to respond to dovitinib.

Allarity CEO Steve Carchedi said:This NDA submission for dovitinib, in conjunction with the companion diagnostic Dovitinib-DRP®, is a historic milestone for our company and an important milestone for patients with advanced renal cell carcinoma awaiting new treatment options. . Over the past decade, we have worked diligently to advance our pipeline of novel oncology therapies with our unique DRP® diagnostic technology to realize the promise of personalized cancer care for patients. We look forward to the approval of dovitinib and to showcasing the clinical value of DRP® companion diagnostics to oncologists and their patients. »

Dovitinib is a small molecule, pan-tyrosine kinase inhibitor licensed from Novartis, and is Allarity’s lead clinical therapeutic candidate. The drug has already shown clinical activity in a number of cancer indications including RCC, gastrointestinal stromal tumors (GIST), endometrial cancer, metastatic breast cancer and hepatocellular carcinoma (HCC). ). The Company plans to further assess the therapeutic benefit of dovitinib in one or more of these additional indications, either as monotherapy or in combination with other oncology treatments.

“As a clinical oncologist looking for new therapies for my patients with RCC, I am excited about the NDA filing of Allarity with its companion diagnostic Dovitinib-DRP(R),” said Professor Roberto Pili, MD, associate dean for cancer research and integrative oncology at the University at Buffalo Jacobs School of Medicine and Biomedical Sciences. “These patients, and their treating oncologists, are in dire need of new precision medicines, coupled with validated companion diagnostics, to help select and treat the most likely responders. I look forward to working with Allarity to advance this new approach to personalized cancer care for patients with RCC. »

Allarity’s unique, clinically validated DRP® companion diagnostic platform predicts whether a particular cancer patient is likely to respond to treatment with dovitinib, in addition to a wide range of cancer drugs. Assessments of the DRP® drug response for an individual patient are made based on a biopsy of the patient’s tumor. The Dovitinib-DRP® companion diagnostic is intended to be used to identify patients with advanced renal cell carcinoma (RCC) who, by their tumor’s gene expression signature, are identified as having a high likelihood of responding to dovitinib. By identifying and treating only patients with RCC most likely to respond to dovitinib and avoiding treatment of patients with RCC who may not respond to the drug, Allarity aims to improve treatment options for patients and their oncologist. treating in order to improve the therapeutic benefit.

About Allarity Therapeutics

Allarity Therapeutics, Inc. (Nasdaq: ALLR) develops medicines for personalized cancer treatment guided by its proprietary and highly validated companion diagnostic technology, the DRP® Platform. The Company has a mature portfolio of five drug candidates, including: Stenoparib, a PARP inhibitor in phase 2 development for ovarian cancer; Dovitinib, a pan-TKI submitted for NDA review by the FDA for the 3rd line treatment of renal cell carcinoma; IXEMPRA® (Ixabepilone), a microtubule inhibitor approved in the United States for the treatment of second-line metastatic breast cancer and in phase 2 development, in Europe, for the treatment of the same indication; LiPlaCis®, a liposomal formulation of cisplatin in phase 2 development for metastatic breast cancer; and 2X-111, a liposomal formulation of doxorubicin in phase 2 development for metastatic breast cancer and/or glioblastoma multiforme (GBM). The LiPlaCis® and 2X-111 programs are in partnership, via an external license, with Smerud Medical Research International AS. In 2021, Allarity resold the worldwide rights to Irofulven, a phase 2 DNA-damaging agent for prostate cancer, to Lantern Pharma, Inc. The company has an R&D facility in Hoersholm, Denmark.
For more information, please visit the company’s website at

About the Drug Response Predictor – DRP® Companion Diagnostic

Allarity uses its drug-specific DRP® to select patients who, based on the genetic signature of their cancer, have a high likelihood of responding to the specific drug. By screening patients before treatment and treating only patients with a sufficiently high DRP® score, the rate of therapeutic response can be significantly increased. The DRP® method is based on the comparison of susceptible and resistant human cancer cell lines, including transcriptomic information from the cell lines combined with clinical tumor biology filters and results from previous clinical trials. DRP® is based on messenger RNA from patient biopsies. The DRP® platform has been proven to provide statistically significant prediction of clinical outcome of drug therapy in cancer patients in 37 of 47 clinical studies reviewed (both retrospective and prospective), including ongoing prospective Phase 2 trials on Stenoparib and IXEMPRA®. The DRP® platform, which can be used in all types of cancer and is patented for over 70 cancer drugs, has been widely published in peer-reviewed literature.

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Forward-looking statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide Allarity’s current expectations or forecasts of future events. The words “plans”, “believes”, “continues”, “could”, “estimates”, “expects”, “intends”, “may”, “could”, “plans”, ” possible”, “potential”, “predicted”, “plans”, “should”, “would” and similar expressions may identify forward-looking statements, but the absence of such words does not mean that a statement is not prospective. These forward-looking statements include, but are not limited to, statements relating to the Company’s NDA submission for dovitinib and its PMA submission for the drug-specific DRP® companion diagnostic for dovitinib, any statements relating to ongoing clinical trials on stenoparib for the treatment of advanced ovarian cancer, or ongoing clinical trials (in Europe) for IXEMPRA® for the treatment of metastatic breast cancer, and statements regarding the efficacy of the companion diagnostic platform Company’s DRP® to predict whether a particular patient is likely to respond to a specific drug. All forward-looking statements contained in this press release are based on management’s current expectations regarding future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. statements. These risks and uncertainties include, but are not limited to, the risk that the results of a clinical study will not necessarily predict the final results and that one or more of the clinical results could change materially as a result of examinations. more complete data and as patients become available, the risk that the results of a clinical study will be subject to interpretation and that additional analyzes will be necessary and/or may contradict these results, obtaining regulatory approval for dovitinib or any of our other therapeutic candidates or, if approved, the successful commercialization of such products, the risk of termination or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that results of previously conducted studies may not be repeated or observed in ongoing or future studies involving our product candidates t therapeutics, and the risk that the current COVID-19 pandemic will impact the Company’s current and future clinical trials and the Company’s schedule of preclinical studies and other operations. For a discussion of other risks and uncertainties, and other important factors, each of which could cause our actual results to differ materially from those contained in the forward-looking statements, see the section titled “Risk Factors” in our statement of registration of Form S-1. filed with the Securities and Exchange Commission, available on the Securities and Exchange Commission’s website at , together with discussions of potential risks, uncertainties and other important factors in the Company’s subsequent filings with of the Securities and Exchange Commission. All information contained in this press release is as of the date of publication, and the Company assumes no obligation to update such information except as required by law.


Company Contact:

Jens Knudsen
Financial director

Investor Relations:

Chuck Padala
LifeSci Advisors
+1 (646) 627-8390

US Media Contact:

Mike Beyer
Sam Brown, Inc.
+1 (312) 961-2502

EU media contact:

Thomas Pedersen
Carrotize PR & Communications
+45 6062 9390


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