• Philadelphia, PA (February 14, 2018) – Oncoceutics Inc. and Calvert Research, LLC announced 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.

    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.”

    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 recently 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 significant grants over the last two years, from institutions such as 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 and collaborations between Oncoceutics and leading cancer research institutions, including The University of Texas MD Anderson Cancer Center, the NIH/NCI, Harvard and the Fox Chase Cancer Center.  The company has established a robust intellectual property position, including several issued patents.

    About Calvert Research

    Calvert Research (a subsdidiary of its parent company , Calvert Holdings, Inc.) is a strategic advisory and equity investment firm with decades of experience in preclinical drug development.  Our extensive knowledge base covers all aspects related to advancing preclinical stage drug candidates toward first time in human clinical testing.  We leverage our expertise by utilzing the services or our CRO affiliate, Calvert Laboratories (a wholly owned subsidiary of Calvert Holdings) to design and execute IND-enabling studies for our portfolio companies.  We also share both the capital risk, and the development risk of our partners by investing a portion of the normal cost of such IND enabling preclinical study services conducted at Calvert Laboratories by our partner’s into an equity stake in their company. www.calvert-research.com

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