ADCC-enhancement for innovative cancer therapy, produced via ProBioGen’s accelerated CMC development path.
Berlin, Germany, and South San Francisco, CA, USA, October 1, 2015 / B3C newswire / -- ProBioGen AG and Tizona Therapeutics, Inc. have signed a commercial license and service agreement for cell line and process development. Under the Agreement ProBioGen will develop Tizona’s immuno-oncology antibody up to GMP manufacturing, applying ProBioGen’s proprietary GlymaxX® cell line to boost the antibody’s ADCC anti-tumor activity. The program will follow ProBioGen’s integrated and accelerated development path which allows selecting superior, stable producer clones with robust and excellent process features in a significantly reduced time, facilitating the earlier onset of clinical trials. Manufacturing of clinical study material will be conducted at ProBioGen’s new facility which will house two additional 1,000L single-use bioreactors in its GMP suites.
Volker Sandig, ProBioGen’s CSO commented “We were impressed by the scientific approach and quality of work which Tizona has invested into this product candidate already, and we are looking forward to combining our expertise with that of Tizona for this very promising product candidate.”
René Brecht, VP Process Science and Manufacturing at ProBioGen added “Our accelerated CMC development path allows us to choose clones with optimal product and manufacturing characteristics right from the beginning, resulting in simplified scale-up and reduced time lines.”
Tizona’s COO, Jeremy Bender, commented: We were seeking a high quality service provider with a proven track record and a robust ADCC enhancement technology for our project, and ProBioGen’s package of technical and scientific expertise, timelines, financial terms and, importantly, people behind it, were a compelling combination.”
About ProBioGen AG
ProBioGen is a specialist for developing and manufacturing complex therapeutic glycoproteins. Combining both state-of-the-art development platforms together with intelligent product-specific technologies yields biologics with optimized properties.
Rapid and integrated cell line and process development, comprehensive analytical development and following reliable GMP manufacturing is performed by a highly skilled and experienced team. All services and technologies are embedded in a total quality management system to assure compliance with international ISO and GMP standards (EMA/FDA).
ProBioGen was founded 1994, is privately owned, and located in Berlin, Germany.
About Tizona Therapeutics
Tizona Therapeutics, Inc., based in South San Francisco, CA, USA, is a preclinical stage biotechnology company that is developing multiple, innovative immuno-oncology and autoimmune therapies. Tizona Therapeutics, Inc. was founded by MPM Capital and leading scientists from Dana Farber Cancer Institute, the University of Pittsburgh, Johns Hopkins, Memorial Sloan Kettering Cancer Center, and Brigham and Women’s Hospital.
About GlymaxX®
The GlymaxX® technology, developed by ProBioGen, prevents the addition of the sugar “fucose” to the N-linked antibody carbohydrate part by antibody producing cells. The absence of fucose enhances ADCC (antibody-dependent cell-mediated cytotoxicity) activity for antibodies directed against cancer and infectious diseases. The GlymaxX® technology is based on the stable introduction of a gene for an enzyme which deflects the cellular pathway of fucose biosynthesis.
Moreover, GlymaxX® cell lines can be two cell lines in one: They can either produce afucosylated antibodies, or, by adding fucose to the medium, stably produce fully fucosylated antibodies. The GlymaxX® technology is universally applicable, simple and potent, and can be rapidly applied to any existing antibody producer cell line, any new cell line development or to entire expression platforms. ProBioGen offers this technology royalty-free to third parties.
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