On February 14, 2018 Oncoceutics Inc. and Calvert Research, LLC reported that the two companies have entered into a second product development and investment partnership agreement, this time to further develop and enable the submission of an investigational new drug (IND) application for ONC206, Oncoceutics’ next generation molecule (Press release, Oncoceutics, FEB 14, 2018, View Source [SID1234558372]).

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As a part of this second agreement, Calvert Research will enlist the capabilities of its CRO affiliate, Calvert Laboratories, Inc. to conduct certain GLP animal safety and pharmacology studies on ONC206 in its GLP certified facilities. In addition, Calvert Research has made a second equity investment in Oncoceutics. This agreement follows the same successful investment-development partnership model established between Oncoceutics and Calvert Research in 2013 that lead to Oncoceutics being able to open an IND application for ONC201, its lead molecule.

ONC206 is a member of a family of drug candidates called "imipridones" that possess the same core structure of ONC201 and that have demonstrated the same favorable drug characteristics, including efficacy in pre-clinical models against cancer with high levels of safety. Given these attractive attributes, Oncoceutics filed a pre-IND application with the FDA describing its plans for a clinical trial with ONC206 and received positive written feedback to the pre-IND submission from the FDA. Based on the FDA written response, Oncoceutics has defined all of the studies required to have an IND accepted by the FDA. These include manufacturing ONC206 in quantity and at quality sufficient to treat people, and the toxicology work necessary to open an investigational new drug application (IND) that will be completed by Calvert Laboratories. Oncoceutics expects to complete all studies by the end of 2018 and to file the IND and begin first-in-human studies for ONC206 in 2019.

Previously, Oncoceutics has announced that the United States Patent and Trademark Office (USPTO) has issued a patent providing the company with composition of matter protection for ONC206.

"We are pleased to enter into a second investment partnership agreement with Calvert Research, a firm that possesses excellent capabilities in the field of GLP-compliant animal safety studies," said Martin Stogniew Ph.D., Chief Development Officer of Oncoceutics. "By bringing the second member of the imipridone family towards a clinical trial, we are continuing our transformation of Oncoceutics from a company with one drug in development into a company developing a portfolio of drugs."