Philadelphia, PA (June 4, 2019) – Oncoceutics, Inc. announced a publication in the Journal for ImmunoTherapy of Cancer demonstrating ONC201 immunostimulatory activity in advanced cancer patients when given the recommended phase II dose (RP2D) of 625 mg orally every one week. The publication, which describes a Phase I trial conducted by Mark Stein, MD, at the Rutgers Cancer Institute of New Jersey (CINJ) to evaluate weekly oral administration of the company’s lead compound ONC201, also confirmed previous studies, which demonstrated that the drug was well-tolerated. Weekly dosing stimulated intratumoral infiltration and activation of natural killer (NK) cells. The immune stimulatory effects that were observed under weekly dosing were significantly improved over a schedule that used ONC201 every 3 weeks.
These results confirm findings reported in 2018 in the Journal of Clinical Investigation in a study led by Wafik El-Deiry, MD, PhD, FACP that described intratumoral NK cell accumulation and activation in preclinical models. Dr. El-Deiry is the Director of the Joint Program in Cancer Biology at Brown University and the Lifespan Cancer Institute, Associate Dean for Oncologic Sciences at the Warren Alpert Medical School, Brown University, and the Scientific Founder of Oncoceutics.
In addition, the new study showed that weekly oral administration of ONC201 did not result in dose-limiting toxicities, discontinuations, or dose modifications. No Grade 3/4 side effects occurred that were attributed to study drug. The pharmacokinetic profile of weekly ONC201 exceeded preclinical therapeutic thresholds and resulted in intratumoral integrated stress response activation and apoptosis. This was consistent with previously published studies, which also demonstrated that ONC201 was well-tolerated by cancer patients.
“Immune activation further explains the durable tumor regressions reported with ONC201,” said Varun Vijay Prabhu, PhD, Associate Vice President of R&D at Oncoceutics, “The safety profile of ONC201 has allowed dose intensification with weekly administration.”
“NK cell activation and other immune stimulatory effects contribute to the overall anti-tumor effect of ONC201 and provide a rationale for combination with immune-checkpoint therapies,” said Dr. El-Deiry. “Based on these findings, we have worked towards initiating a Phase Ib/II trial to evaluate ONC201 in combination with nivolumab.”
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 the NCI, FDA, The Musella Foundation, and a series of private and public partnerships. Visit Oncoceutics or contact Press@oncoceutics.com for more information.