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CMC Biologics and OncoSynergy Enter into an Agreement for Accelerated Process Development and GMP Manufacture of an Investigational Drug to Combat Ebola

16th December 2014

Experimental monoclonal antibody to be used in clinical trials with patients in West Africa infected with the Ebola virus. Recent data from the World Health Organization said the virus has infected 18,000 people, with a fatality rate greater than 60%.

CMC Biologics and OncoSynergy have entered into an agreement for process development and GMP manufacture of OS2966 – a novel potential treatment for Ebola. The investigational drug candidate, designed to inhibit a major cellular adhesion receptor (CD29) that is fundamental for progression of aggressive and resistant cancer tumors, was granted orphan drug designation by the U.S. FDA earlier this year in the treatment of glioblastoma. Previous studies have suggested CD29 is required for Ebola virus infection; blocking CD29 could halt Ebola's spread in the body.

OS2966, a monoclonal antibody, is being investigated in multiple models of highly aggressive cancers and other diseases of high unmet need. Recently, in collaboration with multiple eminent Ebola scientists internationally, OncoSynergy has demonstrated OS2966 blocks the ability of Ebola virus to enter cells in laboratory models. Further studies, including primate models, are ongoing or in development. Proposed West Africa trials will examine safety and dosing and test the effectiveness of OS2966 against Ebola virus disease in humans.

"We are truly honored to be a strategic partner with OncoSynergy to help address this current global health crisis, and deploying resources necessary to produce clinical material as quickly as possible," said Global Chief Operations Officer of CMC Biologics, Gustavo Mahler. "In December last year, we began working with OncoSynergy for development and GMP manufacturing of OS2966 for their IND enabling studies and clinical trials in cancer. Given our strong relationship, we were able to quickly put in place an agreement that enables aggressive timelines and provides a progressive cost-structure that benefits this global health program. Projects like these best define our commitment to the advancement of protein therapeutics to help our customers worldwide."

"Our experience with CMC Biologics' cell line and process development capabilities to develop GMP material for our clinical studies in cancer has been outstanding," said Dr. Shawn Carbonell, founder and CEO of OncoSynergy. "They have exceeded expected expression levels in a high productivity system while producing quality material. Excellent technical capabilities applied to cell line development; rapid, sophisticated product analysis; and streamlined formulation development have resulted in an expedited path to provide material for Ebola clinical trials. This performance, combined with our strong relationship and satisfaction with our project team experience, has given us the confidence to move the Ebola project forward quickly to address the current West African outbreak."

About OncoSynergy
OncoSynergy is a biopharmaceutical startup based in San Francisco, California focused on addressing grave unmet needs in medicine, particularly orphan diseases and cancer. OncoSynergy's lead drug candidate, OS2966, blocks a critical path target that drives cancer resistance to therapy and has demonstrated preclinical efficacy in Ebola models in the laboratory. The FDA has granted orphan drug designation for OS2966 in the treatment of glioblastoma. To learn more, visit www.oncosynergy.com.

About CMC Biologics
CMC Biologics is leading the industry among CMOs in reliability, technical excellence, and quality – Right and On Time. With three facilities in the USA and Europe, the Company provides fully integrated biopharmaceutical development and manufacturing solutions to clients globally. The Company has proven expertise in delivering custom solutions for the scale-up and cGMP manufacture of protein-based therapeutics for pre-clinical and clinical trials, and commercial production. The Company's wide range of integrated services includes cell line development, bioprocess development, formulation and comprehensive analytical testing. Clients can also benefit from CMC Biologics' proprietary CHEF1® expression system for mammalian production. CMC Biologics has fully segregated microbial fermentation and mammalian cell culture suites and offers both fed-batch and perfusion production processes. More detailed information can be found at www.cmcbiologics.com. 


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