SEATTLE, SAN FRANCISCO, COPENHAGEN (Denmark), and STRASBOURG (France), December 16, 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 coststructure 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.”
Recent Comments