• Philadelphia, PA (October 28, 2020) – Oncoceutics, Inc. announced today that the first patient has been treated in a first-in-human clinical trial of the company’s next-generation imipridone ONC206 at the National Institutes of Health (“NIH”). The Phase I trial, for adults with recurrent primary central nervous system (CNS) neoplasms, is led by Mark Gilbert, MD, Chief of the Neuro-Oncology Branch, Center for Cancer Research (CCR), National Cancer Institute (NCI), and Brett Theeler, MD, Clinical Collaborator at the Neuro-Oncology Branch, CCR, NCI (NCT04541082).

    ONC206 is the second agent in the Oncoceutics pipeline to enter clinical trials.  ONC206 is part of the family of drug candidates called “imipridones”, a term that refers to small molecules that possess the same core chemical structure as the company’s first-generation molecule ONC201. ONC206 is protected by composition of matter patents issued in the US, EU, Eurasia, Israel, China, and Japan.

    Dr. Gilbert’s laboratory has previously demonstrated that ONC206 exerts therapeutic effects in preclinical models of CNS tumors, including brain tumors, that currently have no effective treatment. ONC206 has also proven effective in several biomarker-enriched tumor types outside of the CNS that have been studied extensively by other research groups. Preclinical studies suggest that ONC206 is likely to be orally bioavailable, penetrate the blood-brain barrier, demonstrate a well-tolerated safety profile, and selectively antagonize dopamine receptor D2 (DRD2). While DRD2 is also targeted by ONC201, ONC206 exhibits distinct biological effects and chemical properties that position its clinical development in indications beyond those of the parent compound.

    “I am excited to see next-generation imipridone ONC206 enter the clinic,” said Minesh Mehta, MD, Deputy Director and Chief of Radiation Oncology, Miami Cancer Institute and member of the board of directors of Oncoceutics. “ONC206 has the potential to become an impactful new therapy for patients with untreatable CNS tumors and broadens the clinical utility of imipridones beyond its founding member, ONC201, which has already shown promise in helping patients.”

    “Our study will evaluate the safety and clinical activity of ONC206 in patients with CNS malignancies,” said Dr. Gilbert. “This clinical trial was designed to incorporate biomarker information derived from our molecular studies of ONC206 in an effort to enable future patient selection.”

    For patients interested in enrolling in this clinical study, please call NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), email NCIMO_Referrals@mail.nih.gov, and/or visit the website: https://trials.cancer.gov.

    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, and the National Brain Tumor Society, and a series of private and public partnerships. Visit Oncoceutics.com or contact Press@oncoceutics.com for more information.

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