Full Press Release Details
Therapeutics and Oncoheroes Biosciences Sign
Agreements to Advance Pediatric Cancer Development
of Dovitinib and Stenoparib
Oncoheroes will fund and advance the clinical
development of both dovitinib and stenoparib in pediatric cancers, utilizing Allarity's DRP companion diagnostics
Allarity has submitted a new drug application
(NDA) for the U.S. approval of dovitinib in renal cell carcinoma (RCC) together with the Dovitinib-DRP companion diagnostic
Cambridge, MA U.S.A.
(January 3, 2022) - Allarity Therapeutics, Inc. (Nasdaq: ALLR) ("Allarity" or the "Company"), a clinical-stage
biopharmaceutical company developing novel oncology therapeutics together with drug-specific DRP companion diagnostics
for personalized cancer care, and Oncoheroes Biosciences, Inc. ("Oncoheroes"), a clinical-stage biotechnology company advancing
new therapies for childhood cancers, today announced that they have entered into licensing agreements under which Oncoheroes will acquire
exclusive, global development rights to Allarity's therapeutic candidates dovitinib, a pan-targeted kinase inhibitor (pan-TKI),
and stenoparib, a PARP inhibitor, and assume responsibility for their further clinical development in pediatric cancers.
Under the terms of the
licensing agreements, Oncoheroes acquires global, exclusive rights to fund and conduct further clinical development of both dovitinib
and stenoparib in pediatric cancers. Oncoheroes will take responsibility for pediatric cancer clinical development activities for both
clinical-stage therapeutics. Allarity will support Oncoheroes' pediatric clinical trials by providing clinical-grade drug inventory
at cost and by facilitating DRP companion diagnostic screening of pediatric patients for each drug. Under the licenses, Oncoheroes
will receive commercialization rights for pediatric cancers, subject to Allarity's first buy-back option for each program, and Allarity
will receive an undisclosed upfront license fee and regulatory milestones for each program. If Allarity does not re-acquire the pediatric
field rights, it will further receive certain clinical/regulatory milestone payments and royalties on sales of stenoparib and dovitinib
in the pediatric cancer market from Oncoheroes. Further financial terms of the licenses were not disclosed.
CEO of Allarity Therapeutics, commented, "We are very pleased to partner with Oncoheroes Biosciences to advance both dovitinib
and stenoparib as potential new therapeutic options for the personalized treatment of children and adolescents with cancer. Oncoheroes
is a leader in advancing new therapeutics to help address historically underserved, rare childhood cancers, and an ideal partner for Allarity
in the pediatric cancer market. Our out-licensing of these pediatric development programs enables Allarity to remain focused on our top
priority programs in adult cancers, while at the same time leveraging Oncoheroes' resources, capabilities, and commitment to clinically
advancing dovitinib and stenoparib in childhood cancers, together with our DRP companion diagnostics, in a true
personalized cancer care approach."
Therapeutics, Inc. | 210 Broadway, #201 | Cambridge,
MA | U.S.A. | NASDAQ: ALLR | www.allarity.com
In December 2021, Allarity
submitted an NDA, to the U.S. Food and Drug Administration (FDA), for marketing approval for dovitinib for the treatment of third line
RCC. In April 2021, the Company submitted a premarket approval (PMA) application for use of its Dovitinib-DRP companion diagnostic
to select and treat patients most likely to respond to dovitinib. In support of its NDA filing, and in accordance with FDA requirements,
the Company is also planning a clinical trial of dovitnib in pediatric patients with osteosarcoma, in partnership with Oncoheroes, where
the patients will be selected with the Dovitinib-DRP companion diagnostic. Allarity's focus on pediatric osteosarcoma development
is based on the results of two previously reported preclinical studies in which treatment with dovitinib, compared to control treatment
(sucrose solution lacking dovitinib), increased the median survival time of mouse models of osteosarcoma by 50% and antitumor growth activity
was observed for dovitinib as a single agent.
Ricardo Garcia, CEO & Founder of Oncoheroes
Biosciences, further commented, "Oncoheroes is a mission-driven company committed to deliver more effective and safer treatments
for children and adolescents with cancer. We are excited to partner with Allarity on these co-development programs. These fit perfectly
with our goal of becoming the partner of choice for life sciences companies with drug candidates that have the potential to treat pediatric
cancers. We are confident that this collaborative model will create powerful synergies to accelerate pediatric drug development and bring
tangible benefits to younger cancer patients."
Allarity is 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.), and additional U.S. and European trial sites, using the Stenoparib-DRP companion diagnostic to guide patient enrollment
and improve therapeutic outcome. In prior clinical testing of more than 60 patients, stenoparib was well tolerated with a demonstrated
acceptable safety profile. Through use of DRP patient selection, Allarity aims to provide a superior clinical benefit to ovarian
cancer patients receiving stenoparib as compared to other approved PARP inhibitors. Moreover, there is increasing evidence pointing to
the potential use of PARP inhibitors in the treatment of various pediatric cancers.
About Allarity Therapeutics
Allarity Therapeutics, Inc. (Nasdaq: ALLR) develops
drugs for personalized treatment of cancer 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 U.S. for the 2nd line treatment of 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 partnered, via
out-license, to Smerud Medical Research International AS. In 2021, Allarity sold the global rights to Irofulven, a DNA-damaging agent
in Phase 2 for prostate cancer, back to Lantern Pharma, Inc. The Company maintains an R&D facility in Hoersholm, Denmark. For more
information, please visit the company's website at www.Allarity.com
Therapeutics, Inc. | 210 Broadway, #201 | Cambridge,
MA | U.S.A. | NASDAQ: ALLR |
About the Drug Response Predictor - DRP Companion
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, and only treating those patients with a sufficiently high DRP score, the
therapeutic response rate can be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant
human cancer cell lines, including transcriptomic information from cell lines combined with clinical tumor biology filters and prior clinical
trial outcomes. DRP is based on messenger RNA from patient biopsies. The DRP platform has proven its ability
to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in 37 out of 47 clinical
studies that were examined (both retrospective and prospective), including ongoing, prospective Phase 2 trials of Stenoparib and IXEMPRA .
The DRP platform, which can be used in all cancer types and is patented for more than 70 anti-cancer drugs, has been extensively
published in peer reviewed literature.
Follow Allarity on social media
Facebook: https://www.facebook.com/AllarityTx/
Twitter: https://twitter.com/allaritytx
About Oncoheroes Biosciences
Oncoheroes is a ground-breaking biotech company
exclusively focused on the discovery and development of better drugs for children and adolescents with cancer. Our vision is to deliver
benefits to young cancer patients and create value in the process. The company is headquartered in Boston, US, with a discovery lab in
Barcelona, Spain. Oncoheroes is actively looking for in-licensing opportunities in the pediatric oncology space while working to generate
new proprietary assets for a number of pediatric cancer indications with high unmet medical needs. For more information please visit:
Follow Oncoheroes on social media
Facebook: https://www.facebook.com/Oncoheroes
Twitter: https://twitter.com/oncoheroesbio
Instagram: https://www.instagram.com/oncoheroesbio
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 "anticipates," "believe," "continue,"
"could," "estimate," "expect," "intends," "may," "might," "plan,"
"possible," "potential," "predicts," "project," "should," "would"