Philadelphia, PA (December 15, 2020) "“ Oncoceutics, Inc. announced today the outlicense of the rights to the company"™s lead compound, ONC201, for Greater China to China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. ("CR Sanjiu").
In return for the license and future rights, CR Sanjiu will make a multi-part payment to Oncoceutics including upfront payments, milestone payments, and royalties. CR Sanjiu will also be responsible for the execution of clinical trials required to obtain Marketing Authorization in China and the commercialization of ONC201 in the Chinese market.
ONC201, the company"™s lead development candidate, is a novel small molecule with a unique mechanism of action that has demonstrated anti-cancer activity and safety in several ongoing clinical trials, including clinical trials in adult and pediatric patients 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. Recently, FDA granted to ONC201: Fast Track Designation for the treatment of adult recurrent H3 K27M-mutant high-grade glioma, Orphan Drug Designation for the indication of glioblastoma and H3 K27M-mutant glioma, and Rare Pediatric Disease Designation for treatment of H3 K27M-mutant glioma.
"We are thrilled to form this partnership with CR Sanjiu whose dedication to innovative therapies and make them the ideal collaborators to bring ONC201 to Chinese patients with H3 K27M-mutant gliomas and other indications," said Lee Schalop, MD, Chief Executive Officer of Oncoceutics. "This agreement continues the development of ONC201 to be available in global markets, so patients in China who are affected by a serious disease have this therapeutic option. Oncoceutics will work closely with CR Sanjiu to expand the use of ONC201 into other cancers that are similarly responsive to the pathways engaged by ONC201. We are excited 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 confident that with the remarkable team at Oncoceutics, we can bring this novel therapy to China for patients with cancer for whom there are no other options," said Qiu Huawei, President of CR Sanjiu. "ONC201 represents a medical breakthrough for Chinese pediatric and adult oncology patients and is consistent with CR Sanjiu"™s strategy to develop and introduce innovative therapies in diseases with no therapeutic standards. We are excited to work with Oncoceutics and develop ONC201 to treat a broad range of cancers responsive to ONC201."
About Oncoceutics
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. ONC201 is an orally active small molecule DRD2 antagonist and ClpP agonist in late-stage clinical development for H3 K27M-mutant glioma with additional indications under clinical investigation. ONC206 is the second clinical-stage imipridone that is under clinical investigation for central nervous system tumors. The company is supported by grants from NCI, FDA, The Musella Foundation, Michael Mosier Defeat DIPG Foundation, Dragon Master Foundation, The ChadTough Foundation, the National Brain Tumor Society, and a series of private and public partnerships. Visit Oncoceutics.com or contact Press@oncoceutics.com for more information.
About CR Sanjiu
China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. is a well-established pharma company in China that engages in both OTC and prescription drugs. The company develops and markets drugs in a wide range of therapeutics, including: oncology, anti-infectives, respiratory, orthopedics, and digestives. It is looking to expand its prescription drug capabilities in oncology by working with international companies. CR Sanjiu is a subsidiary of the larger pharmaceutical group, CR Pharma, which has capabilities across drug manufacturing, commercialization, distribution, and retail.