In-licensing

Oncoheroes Biosciences and Allarity Therapeutics Sign Exclusive Pediatric Licensing Agreement for Dovitinib and Stenoparib

  • Oncoheroes will lead the pediatric clinical development of dovitinib and stenoparib in childhood cancers, utilizing Allarity’s DRP® companion diagnostics

  • Oncoheroes is Allarity’s partner of choice to fulfill FDA’s requirements mandated by the RACE for Children Act

  • The RACE for Children Act authorizes the FDA to require pediatric clinical studies when a molecular target of an adult cancer drug is relevant to a children’s cancer

Boston, MA., January 3, 2022 —Oncoheroes Biosciences, Inc. (“Oncoheroes”), and Allarity Therapeutics, Inc. (Nasdaq: ALLR) (“Allarity”) have signed a worldwide, exclusive pediatric licensing agreement for dovitinib, a pan-targeted kinase inhibitor (pan-TKI), and stenoparib, a PARP inhibitor, both being developed by Allarity.

Under the terms of the licensing agreements, Oncoheroes acquires global, exclusive rights to both clinical-stage therapeutic compounds for pediatric cancer clinical development. Allarity will support Oncoheroes’ pediatric clinical trials by providing access to its DRP® companion diagnostic for the selection of patients that are most likely to respond to both drugs. Financial terms of the licenses were not disclosed.

“Oncoheroes is a leader in pediatric oncology and Allarity’s ideal pediatric-focused partner to advance both dovitinib and stenoparib as potential new therapeutic options for children and adolescents with cancer,” explained Steve R. Carchedi, CEO of Allarity Therapeutics. “We are very pleased to support Oncoheroes’ pediatric clinical development of our therapeutic candidates together with our DRP® companion diagnostics, in a true personalized cancer care approach.”

 Dovitinib is a pan-tyrosine kinase inhibitor targeting fibroblast growth factor receptor (FGFR), vascular endothelial growth factor receptor (VEGFR) and other receptor tyrosine kinases (RTKs). The drug was originally licensed by Allarity from Novartis and is currently under NDA submission to the U.S. FDA  for treatment of renal cell carcinoma.

“This agreement fits very well with the requirements set forth in the Research and Accelerate Cures and Equity (RACE) for Children Act, requiring companies to test adult oncology drugs in pediatric patients too, when there is a scientific rationale,” said Ricardo Garcia, Oncoheroes’ co-founder and CEO. “ Allarity’s drug candidate dovitinib, initially developed for renal cell carcinoma, might provide significant benefit to osteosarcoma pediatric patients and Oncoheroes is excited to make this happen”.

 The use of dovitinib in osteosarcoma patients is based on the results of preclinical studies suggesting a significant role of dovitinib in preventing metastases formation in the lungs. More in general, the potential of this class of multi-tyrosine kinase inhibitors for pediatric bone sarcomas, is suggested by several clinical studies demonstrating significant responses in subsets of patients.

Stenoparib is a unique, small molecule dual targeted inhibitor of Poly ADP-Ribose Polymerases (PARP 1 and 2) and telomerase maintenance enzymes (Tankyrase 1 and 2), currently in a Phase 2 clinical trial for advanced ovarian cancer at Dana-Farber Cancer Institute (Boston, MA).

“Previous preclinical and clinical studies have demonstrated the potential of PARP inhibitors in pediatric oncology. We are excited to bring this class of molecules into Oncoheroes’ portfolio,” explained Cesare Spadoni, Oncoheroes’ co-founder and COO.  “Stenoparib has the potential to be tested across many different pediatric cancers, including brain tumors. More importantly, for both licensed molecules, we would have a powerful tool in the DRP® companion diagnostic to select potential responders.”

 

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: oncoheroes.com

 

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 3rd line renal cell carcinoma; IXEMPRA® (Ixabepilone), a microtubule inhibitor approved in the U.S. for the treatment of 2nd 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 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: allarity.com

Oncoheroes Biosciences Inc. and Boehringer Ingelheim International GmbH sign exclusive licensing agreement for volasertib

Oncoheroes Biosciences Inc (“Oncoheroes”) and Boehringer Ingelheim International GmbH (“Boehringer Ingelheim”) have signed a worldwide, exclusive licensing agreement for volasertib, an investigational anti-cancer compound that was originally discovered and developed by Boehringer Ingelheim. Under the terms of this agreement Boehringer Ingelheim assigns to Oncoheroes the intellectual property of volasertib, with exclusive rights to research, develop, sell and sublicense the compound. Oncoheroes is committed to further develop and commercialize volasertib for pediatric cancer indications.

Volasertib is an inhibitor of Polo-like-kinase 1 (PLK1), an enzyme known to be involved in cancer progression in a number of diseases. The compound was being developed by Boehringer for the treatment of a specific form of leukemia but clinical development activities were halted after a large Phase III study with adult patients failed to meet its primary endpoints. Meanwhile, independent academic groups had generated strong data in support of further developing the drug for rhabdomyosarcoma and a few other pediatric cancer indications. By signing this licensing agreement, Oncoheroes and Boehringer Ingelheim make it possible to continue the clinical development of volasertib to the benefit of younger cancer patients.

Oncoheroes is a Boston-based biotech company exclusively focused on the development of innovative medicines to treat cancer in children and adolescents. The company was co-founded by Ricardo Garcia and Cesare Spadoni, two parents touched by childhood cancer and determined to change the outlook for these young patients.

“This is probably the first example of an investigational compound being specifically repurposed to investigate it as a treatment for a form of childhood cancer. We are committed to identify more such opportunities and also develop our own innovative treatments for children and adolescents with cancer”, jointly stated Ricardo Garcia and Dr Cesare Spadoni, Oncoheroes’ Chief Executive Officer and Chief Operating Officer, respectively.

The financial details of this deal are not disclosed. Oncoheroes has already established links with international pediatric oncology networks and is actively working to start clinical development activities as soon as possible.

Learn more at our informative webinar on October 15th

About Oncoheroes Biosciences Inc.

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 and working to generate new proprietary assets for a number of pediatric cancer indications with high unmet medical needs. The company was co-founded by Ricardo Garcia (serial entrepreneur), Cesare Spadoni (drug development professional), Marc Goldberg (savvy Life Science VC investor) and Marco Muñoz (seasoned fundraiser). The management team is formed by drug development and industry professionals in the US and Europe and the company has already established strong links with the major international pediatric oncology network as well as the childhood cancer community at large.

About Boehringer Ingelheim

Improving the health of humans and animals is the goal of the research-driven pharmaceutical company Boehringer Ingelheim. The focus in doing so is on diseases for which no satisfactory treatment option exists to date. The company therefore concentrates on developing innovative therapies that can extend patients’ lives. In animal health, Boehringer Ingelheim stands for advanced prevention. 

Family-owned since it was established in 1885, Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies. Some 50,000 employees create value through innovation daily for the three business areas human pharmaceuticals, animal health and biopharmaceuticals. In 2018, Boehringer Ingelheim achieved net sales of around 17.5 billion euros. R&D expenditure of almost 3.2 billion euros, corresponded to 18.1 per cent of net sales. 

As a family-owned company, Boehringer Ingelheim plans in generations and focuses on long-term success. The company therefore aims at organic growth from its own resources with simultaneous openness to partnerships and strategic alliances in research. In everything it does, Boehringer Ingelheim naturally adopts responsibility towards mankind and the environment. 

More information about Boehringer Ingelheim can be found on www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com