Philadelphia, PA (February 15, 2019) – Oncoceutics, Inc. announced today the outlicense of the rights to the company’s lead compound, ONC201, for Japan to Ohara Pharmaceutical Co., Ltd. In addition, Ohara will receive a right of first refusal on the license of ONC201 for additional areas, including most of Asia and West Africa, and a right of first refusal for the company’s next generation compound, ONC206, in these territories.
In return for the license and future rights, Ohara will make a multi-part payment to Oncoceutics including upfront payments, milestone payments, payment for purchase of the drug for re-sale, and royalties. In addition, Ohara will make a significant equity investment into Oncoceutics. Ohara will also be responsible for the execution of clinical trials required to obtain Marketing Authorization in Japan and the commercialization of ONC201 in the Japanese market.
ONC201 is a novel small molecule with a unique mechanism of action that has demonstrated anti-cancer activity and safety in preclinical models and in several ongoing clinical trials, including clinical trials in adult and pediatric patents with high-grade gliomas. The trials focus on gliomas that harbor a H3 K27M mutation that can be identified by immunohistochemistry or gene sequencing, including the FDA-approved companion diagnostic FoundationOne CDx. H3 K27M-mutant glioma is a molecularly-defined disease with a dismal prognosis.
Oncoceutics’ clinical trials are being carried out at numerous leading cancer centers across the United States, including: Massachusetts General Hospital, Dana Farber Cancer Institute, NYU Langone, MD Anderson Cancer Center, Levine Cancer Institute, Miami Cancer Institute, University of California San Francisco, and the University of Michigan. In addition, Emory University, University California Los Angeles, Columbia University and several other institutions are in the process of joining the program. Recently, the FDA granted Fast Track Designation to ONC201 for the Treatment of Adult Recurrent H3 K27M-mutant High-Grade Glioma.
“We are delighted to be partnering with Ohara Pharmaceutical Co., Ltd. whose mission and focus set them apart in the Japanese market and make them the ideal collaborators to bring ONC201 to Japanese patients with H3 K27M-mutant gliomas and other indications,” said Wolfgang Oster, MD, PhD, Chief Executive Officer and Chairman of Oncoceutics. “This agreement sets the stage for developing ONC201 towards entry into global markets and providing a therapeutic option to patients in Japan who are affected by a serious disease. Oncoceutics will work closely with Ohara to expand the use of ONC201 into other cancers that are similarly responsive to the pathways engaged by ONC201. We are thrilled by the shared vision between the two companies to introduce a truly novel therapeutic paradigm to a broad selection of tumors that abuse dopamine signaling to promote their growth.”
“We are excited to be working with the exceptional team at Oncoceutics to bring this novel medicine and medical concept to Japan for patients with cancer for whom there are no other options,” said Seiji Ohara, President of Ohara Pharmaceuticals., Ltd. “The introduction of new treatment paradigms have often led to breakthroughs in diseases that have no therapeutic standards. The anticipated market entry for ONC201 in Japanese pediatric and adult oncology patients is consistent with Ohara’s strategy to challenge and address unmet medical needs. We are excited with the opportunity of the two companies to collaborate and develop ONC201 to address a broad selection of cancers responsive to ONC201.”
Oncoceutics, Inc. is a clinical-stage drug discovery and development company with a novel class of compounds, called “imipridones,” that selectively target G protein-coupled receptors for oncology. The first lead compound to emerge from this program is ONC201, an orally active small molecule DRD2 antagonist. The company is supported by grants from NCI, FDA, Musella Foundation, XCures, Cancer Commons, and a series of private and public partnerships.
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Ohara Pharmaceutical Co., Ltd. is one of the few Japanese pharmaceutical companies that engage in both the orphan drug and generic drug business. Its 3-year “Challenge 2020” business plan commenced in fiscal 2018, with one key objective of this plan being to challenge and address unmet medical needs. The company develops and markets orphan drugs mainly in the field of pediatric oncology and also operates an innovative generic drug business which takes careful consideration to prevent medical accidents. Ohara Pharmaceutical plans to further expand these businesses into emerging countries, primarily in the Asian region.