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CMC Biologics and OncoSynergy Enter into Agreement to Develop and Manufacture Material for IND Enabling Studies and Phase I Clinical Trials
Date:12/17/2013

COPENHAGEN, Denmark; SEATTLE; STRASBOURG, France; and SAN FRANCISCO, Dec. 17, 2013 /PRNewswire/ -- CMC Biologics and OncoSynergy announced today that the two companies entered into an agreement for cell-line development, process development, analytical development and manufacturing of non-GMP material to enable early toxicology testing and cGMP material for IND enabling toxicology studies and Phase I clinical trials. This work will advance OncoSynergy's OS2966 monoclonal antibody program based on its "Targeted Synergy" approach - a transformative strategy allowing broad inhibition of multiple fundamental cancer growth mechanisms with a single drug.

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"We look forward to helping advance OncoSynergy's OS2966 drug platform targeting cancers resistant to currently available therapies," said Gustavo Mahler, Global Chief Operations Officer of CMC Biologics. "This contract highlights CMC Biologics' proven and trusted platform for monoclonal antibody development and manufacturing." 

The project will be executed by CMC Biologics at its Copenhagen development and manufacturing facility. OncoSynergy EU SAS in France will lead the project.

"We are impressed with CMC Biologics' experience and technical competency in biopharmaceutical development and cGMP manufacturing," said OncoSynergy Co-Founder and CEO, Shawn Carbonell, MD, PhD. "Choosing a partner who can provide a complete solution - from expression of the sequence of interest, to providing material suitable for clinical trials - was a critical decision as we advance our lead candidate. They have also shown flexibility to accommodate our unique program needs as a virtual startup company."

About OncoSynergy
OncoSynergy is a privately-held biotechnology company based in San Francisco, California and Strasbourg, France. The mission of OncoSynergy is to radically improve health outcomes for patients by addressing unmet needs in oncology and neurofibromatosis. Its therapies are drug platforms featuring "Targeted Synergy" - multiple mechanisms of action for maximal effectiveness. OncoSynergy's lead drug, OS2966, blocks a critical path for growth and therapy resistance in cancer and is under development for the treatment of glioblastoma. OncoSynergy's therapeutic platforms have been developed at several world-class institutions including by its founders at UCSF and by Martin Karplus of Harvard University - a 2013 Nobel Prize in Chemistryawardee. To learn more, visit www.oncosynergy.com.

About CMC Biologics 
CMC Biologics is a dedicated contract biopharmaceutical manufacturing and development organization with facilities in Copenhagen, Denmark and Seattle, Washington, USA. CMC Biologics specializes in custom services for scale up and cGMP manufacture of protein-based therapeutics for preclinical, clinical trials, and in-market production. The Company's fully integrated services includes cell line development using its proprietary CHEF1® system, process and formulation development, and comprehensive analytical testing. CMC Biologics has fully segregated microbial fermentation and mammalian cell culture suites and offers stirred tank and perfusion production processes. To learn more, visit www.cmcbiologics.com.

Media Contacts:
Stacie D. Byars
CMC Biologics Global Marketing
sbyars@cmcbio.com
+1 (206) 660-2588

Robert Dunkle
OncoSynergy, Inc.
bob@oncosynergy.com
+1 (415) 978-2153


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SOURCE CMC Biologics; OncoSynergy
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