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Allarity Therapeutics, Inc. (NASDAQ: ALLR), a clinical-stage pharmaceutical company developing novel oncology therapies as well as drug-specific DRP® companion diagnostics for personalized cancer care, today announced that the Food and U.S. Drug Administration (“FDA”) has provided the Company with Refusal to File (“RTF”) letters regarding the New Drug Application (“NDA”) for dovitinib, and its pre-approval request for placing on the market (“PMA”) for the DRP®– Companion diagnostic to dovitinib, for the third-line treatment of metastatic renal cell carcinoma (“mRCC”).
During a preliminary review, the FDA determined that the NDA, submitted on December 22, 2021, and the PMA application, submitted on April 2, 2021, were not sufficiently complete to permit substantive reviews. In the letter regarding the NDA, the reasons cited by the FDA for the RTF decision primarily include, but are not limited to, the fact that the clinical trial data submitted do not support a conclusion of efficacy based on a non-inferiority data set. Since the PMA and NDA were filed as related applications, the RTFs also apply to the DRP®– Companion diagnosis of Dovitinib.
Allarity intends to seek immediate guidance from the FDA, which could include requesting a Type A meeting with the agency to clarify and respond to the issues identified in the RTF letters and seeking additional guidance regarding the information , data and specific deliverables that the agency would need. for a resubmitted NDA and PMA to be considered complete. The Company anticipates that a new prospective clinical trial will be required to overcome outstanding FDA objections.
“We remain very confident in the clinical profile of dovitinib, as well as the DRP®-Dovitinib diagnostic companion, and we remain committed to advancing this product candidate as a potential new treatment option for people with mRCC,” said Allarity CEO Steve Carchedi. “We are fully committed to working with FDA staff as quickly as possible to resolve outstanding issues and clarify the path forward to successfully file our applications.”
On Allarity Therapeutic
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 being developed for regulatory advancement in 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 www.Allarity.com
About the Drug Response Predictor – DRP® Companion diagnosis
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 relies 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 treatment 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 more than 70 cancer drugs, has been widely published in peer-reviewed literature.
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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 predictions 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 www.sec.gov, as well as discussions of potential risks, uncertainties and other important factors in the Company’s subsequent filings with 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.
Jens Knudsen Chief Financial Officer [email protected]
Chuck Padala LifeSci Advisors +1 (646) 627-8390 [email protected] US Media Contact:
Mike Beyer Sam Brown, Inc. +1 (312) 961-2502 [email protected]
EU media contact:
Thomas Pedersen Carrotize PR and communication +45 6062 9390 [email protected]
- Press release Allarity – Dovitinig RTFs
Source: Allarity Therapeutics, Inc.