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BERGISCH GLADBACH, Germany and Evry, France, September 21, 2016 – Genethon, a leader in the field of gene therapy treatments for rare diseases, and Miltenyi Biotec, a global pioneer in cell processing and related technologies in cell therapy, have announced the execution of an exclusive license to the patents and trademarks for the development and commercialization of Vectofusin-1® by Miltenyi Biotec. As part of this agreement, Miltenyi Biotec has also acquired the right to grant sublicenses to its customers.
Vectofusin-1 is a novel viral transduction enhancer that promotes the adhesion and fusion between viral and cellular membranes. The use of Vectofusin-1 diminishes technical limitations the gene therapy field is confronted with, by enhancing target cell transduction levels and reducing the amount of viral particles required. This opens up possibilities to develop reliable gene therapy protocols with optimized efficiency, higher safety standards and reduced cost.
Research-grade Vectofusin-1 for basic and translational research will be available as early as November 2016. Miltenyi Biotec has also initiated a development program in order to produce clinical GMP-grade Vectofusin-1 for the manufacturing of cellular therapies on its automated, integrated cell processing platform called CliniMACS Prodigy®. This program includes the set-up of quality control assays as well as the generation of stability, biocompatibility and toxicology data in order to provide standardized, generic ex vivo cell processing protocols. The release of the GMP-grade product is scheduled for early 2017. The addition of Vectofusin-1 to Miltenyi Biotec’s product portfolio allows to advance the development of a broad range of technologies in the field of cellular and gene therapy.
Miltenyi Biotec’s fully-automated CliniMACS Prodigy cell processing system has recently been advanced to include an integrated protocol for lentiviral transduction with the aim of developing a clinically compliant process for the manufacture of T cells encoding chimeric antigen receptors (CARs). The engineered CAR-T cells can then be used to kill target cells, for example cancer cells, in an antigen-dependent manner. With the use of a soluble reagent such as Vectofusin-1, alternative retroviral vectors that require the use of transduction enhancers, can be implemented effectively in this fully-automated, closed system.
Genethon, created by the AFM-Téléthon, is dedicated to making innovative gene therapy treatments available to patients affected with rare genetic diseases. Having played a pioneering role in deciphering the human genome, Genethon is today, with more than 200 scientists, physicians, engineers and regulatory affairs specialists, one of the leading organizations for the development of gene therapy treatments. Genethon has also built one of the largest sites worldwide for GMP production of gene therapy products, Genethon BioProd. The pipeline of Genethon includes products currently in international clinical trials and at preclinical stages, for muscular dystrophies, immune deficiencies, blood, ocular and liver diseases. These products are developed either with Genethon as sponsor, or in partnership with private companies and academic institutions. For more information please visit www.genethon.fr/en/
Miltenyi Biotec is one of the world’s leading providers of products and services for biomedical research as well as cell and gene therapy. The company is committed to enabling the delivery of new treatment options to patients with unmet medical needs. Miltenyi Biotec’s portfolio of innovative solutions and enabling technologies have set new standards in the industry. The company has more than 1,700 employees in 25 countries and its products have been used in more than 50,000 cell therapy procedures.
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