Researchers Identify Biomarkers and Combination Therapies that Hone Path to ONC201 Clinical Success

ONC201 is a small molecule inducer of the TRAIL gene under current investigation as a novel anticancer agent. The small molecule drug has a unique mechanism of action that causes significant anti-tumor activity in a variety of types of human cancer.

In an article published OnlineFirst on February 13, 2015 in Cancer Research, a journal published by the American Association for Cancer Research (AACR), Professor Wafik El-Deiry, MD, PhD, FACP, Co-Program Leader of Molecular Therapeutics, Deputy Cancer Center Director for Translational Research at Fox Chase Cancer Center, and Joshua Allen, PhD, VP Development of Oncoceutics Inc., a drug discovery and development company targeting the most potent suppressor pathways in human cancer, describes the identification of several predictive markers of ONC201 response in tumor cells and promising drug combinations that may be investigated in future combinatorial clinical studies.

Large genetic and pharmacological screens of kinase siRNAs in were conducted in combination with a subcytotoxic dose of ONC201 in a panel of human cancer cells to elucidate its mechanism and identify synergistic combination therapies.  I doing do, the scientists identified several kinases that ablated tumor cell sensitivity, including the MAPK pathway inducer KSR1. The findings lay out a path that maximizes the probability of clinical success for ONC201, a first-in-class molecule that has shown a high level of efficacy in both in vitro and in vivo pre-clinical models against a number of difficult-to-treat tumors with minimal side effects, including brain, breast, lymphatic, leukemic, colon and lung cancer.

Broad spectrum of therapeutic potential
“We are delighted to report the results of these highly translational preclinical studies of ONC201 that can readily be incorporated into ongoing clinical programs. While ONC201 exhibits a broad spectrum of activity as a monoagent, these studies offer molecular tools to enhance our ability to demonstrate its therapeutic potential,” Allen said.

“These results provide important information that will guide how ONC201 is used in the clinic. The biomarkers and combination therapies identified in these studies can potentially be used in the future to tailor therapy for individual patients,” explained El-Deiry.

Clinical trials
Following acceptance by the U.S. Food and Drug Administration (FDA) of Oncoceutics' Investigational New Drug (IND) application for ONC201 in 2014, the company is currently enrolling patients in clinical trials which began in January 2015.

Last Editorial Review: February 20, 2015

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