On February 2019, Oncoceutics, Inc., reported the expansion of its diverse collaborations across the National Institutes of Health (NIH) involving its imipridone family of anti-cancer compounds (Press release, Oncoceutics, FEB 22, 2019, View Source [SID1234553818]).
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ONC206 has been studied extensively for several years in models of central nervous system cancers, including high grade gliomas as evaluated by the laboratory of Mark Gilbert, MD, Chief of the Neuro-Oncology Branch, Center for Cancer Research (CCR), National Cancer Institute (NCI). These studies convincingly demonstrate that ONC206 exerts significant therapeutic effects on preclinical models of brain cancers that are commonly recognized as incurable. The properties of ONC206 that include penetrance of the blood brain barrier, feasibility of oral administration, demonstration of a benign safety profile in preclinical studies, and selective antagonization of dopamine receptor D2 (DRD2) further demonstrate the potential therapeutic value of the new class of imipridone compounds. While DRD2 is targeted by ONC206, as well as the first clinical-stage imipridone ONC201, the receptor pharmacology of ONC206 is unique, offering therapeutic options beyond ONC201.
Based upon NCI’s positive data from preclinical studies of ONC206, Dr. Mark Gilbert and his team in the Neuro-Oncology Branch, CCR, NCI in Bethesda, MD, are interested in conducting the first-in-human trial of ONC206 following Oncoceutics’ completion of IND-enabling studies and the execution of an appropriate agreement. This clinical trial will incorporate biomarker information derived from the molecular mechanism of ONC206 to select patients and to profile its activity in patients with central nervous system malignancies.
"I am excited to see ONC206, as the second imipridone, on the verge of entering the clinic," Minesh Mehta, MD, Deputy Director And Chief Of Radiation Oncology, Miami Cancer Institute and member of the board of directors of Oncoceutics. "This translational effort will introduce ONC206 as an impactful new therapy for patients with untreatable brain tumors and broadens the clinical utility of imipridones beyond its founding member, ONC201, which is already helping patients."