Oncoceutics Expands DRD2 Research Collaborations With NIH

Philadelphia, PA (March 14, 2017) – Oncoceutics, Inc., announced a number of new research collaborations with various groups within the National Institutes of Health (NIH) to study DRD2 as a novel therapeutic target in oncology.

DRD2, a member of the dopamine receptor family that is part of the G protein-coupled receptor (GPCR) superfamily, is a well-known drug target but one that has not been explored previously as a target for clinical oncology. As a result of recent work by Oncoceutics with its cancer drug candidate called ONC201 that selectively antagonizes DRD2 and is in Phase II clinical trials, Oncoceutics has generated interest by multiple institutions within the NIH to study basic, translational, and clinical research opportunities for both ONC201 and other related drug candidates called imipridones.

In addition to Oncoceutics’ relationship with the NIH’s National Cancer Institute (NCI) that goes back many years, the company has recently expanded its collaborations throughout NIH institutions to include:

• Preclinical and clinical evaluation of ONC201 in advanced breast and endometrial cancers by a team led by Stanley Lipkowitz, MD, PhD, Chief of Women’s Malignancies Branch at the NCI;

• DRD2 receptor pharmacology and signaling studies of imipridones by the laboratory of David Sibley, PhD, Chief of the Molecular Neuropharmacology Section at the National Institute of Neurological Disorders and Stroke (NINDS); and

• Translational evaluation of ONC206 (a related drug candidate also under development by Oncoceutics) as a potent and selective DRD2 antagonist for neuro-oncology by a team of investigators led by Mark Gilbert, MD, at the Neuro-oncology branch that itself is a collaboration between NCI and NINDS.

In addition, the NCI continues to support clinical investigation of ONC201 as a single agent in recurrent glioblastoma through a small business innovation research (SBIR) grant, and discussions are underway with the NCI regarding the clinical evaluation of ONC201 in combination with targeted agents.

“The unique pharmacology and mechanism of action associated with ONC201 and other imipridones that has come to light in the past year opens up an exciting new arena for basic and clinical investigations,” said Joshua Allen, PhD, Vice President of Research and Development at Oncoceutics. “We are delighted to work with these expert multi-disciplinary teams to continue to elucidate the elegant and complex basic biology of this receptor, how imipridones uniquely target this receptor, and how we assimilate this information to maximize the clinical benefit offered by imipridones to cancer patients.”

“True medical breakthroughs in oncology and other diseases are driven by the introduction of novel classes of therapeutic targets,” added Keith Flaherty, MD, Director of Developmental Therapeutics at Massachusetts General Hospital. “We have seen this in recent history with oncogene targeted therapies that have been followed by immune checkpoint inhibitors, and the question is what realm of therapeutic targets will be the next to drive a quantum leap. G protein-coupled receptors are a befitting family of druggable receptors that are dysregulated in cancer and control broadly important signal transduction pathways.”

About Oncoceutics

Oncoceutics, Inc. is a clinical-stage drug discovery and development company with a novel class of compounds that selectively target G protein-coupled receptors for oncology. The first lead compound to result from this program is ONC201, an orally active DRD2 small molecule antagonist that is well-tolerated and effective against advanced cancers. The company has completed a successful Phase I study in solid tumors and has begun additional Phase I/II and Phase II clinical programs in both solid and hematological malignancies. Oncoceutics and collaborative groups have received more than $7 million in grants over the last two years, including grants from the National Cancer Institute, the U.S. Food and Drug Administration, the Pennsylvania Department of Health, and The Musella Foundation. In addition, outside interest in the company’s portfolio has resulted in several R&D alliance agreements between Oncoceutics and leading comprehensive cancer centers, including The University of Texas MD Anderson Cancer Center and the Fox Chase Cancer Center. The company has established a robust intellectual property position, including several issued patents.

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