Selexis SA and Turgut Pharmaceuticals advance partnership with third commercial license agreement

December 21, 2017 6:36 AM

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Selexis SA and Turgut Pharmaceuticals (Turgut Ilaclari A.S.) announced that they have entered into a third commercial license agreement that provides Turgut with access to Selexis SUREtechnology Platform™ and SURE CHO-M Cell Line™ for the development of a high-quality biosimilar product for the treatment of two ultra-rare diseases: paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).

The new agreement builds on two commercial license agreements established between the companies in July 2016 to develop biosimilar products to treat inflammatory diseases and certain cancers using the SURE CHO-M Cell Lines.

“At Selexis, we value our role in contributing to the success of partners like Turgut Pharmaceuticals who are working to bring additional therapeutic options to patients who are facing complex, and sometimes life-threatening, diseases,” said Marco Bocci, PhD, DPharm, Selexis vice president, licensing and business development. “Based on biosimilarity data from the two previous projects, this newly signed commercial license agreement is a testament of the predictability of the SUREtechnology Platform and cell line when applied to development of biosimilars.”

Selexis’ proprietary SUREtechnology Platform facilitates the rapid, stable, and cost-effective production of virtually any recombinant protein, including biosimilars, and provides seamless integration of the biologics development continuum, spanning discovery to commercialization. Often, the biggest challenge with CHO-generated biosimilar products is ensuring enough similarity in glycan profile to the originator. Utilizing the SUREtechnology Platform, Selexis has successfully generated numerous biosimilars, including marketed products, that have glycan profiles matching originator products.

Serdar Alpan, MD, PhD, Head of Biotechnology Group, Turgut Pharmaceuticals stated that, after two successful biosimilar monoclonal antibody development projects, Turgut Pharmaceuticals’ global standard biotechnology platform is now starting the development of the third biosimilar monoclonal antibody. “Our collaboration with Selexis and its SUREtechnology Platform is an important component of our established biotechnology platform and we are expecting to extend our collaboration with new industrial cell line developments,” he said.

The Selexis SURE CHO-M Cell Line is a proprietary high-performance mammalian cell line that is derived from CHO-K1 cells and used for the production of therapeutic recombinant proteins and monoclonal antibodies. The growth and production properties of the Selexis SURE CHO-M Cell Line are well defined, and the feed strategy has been optimized, allowing for faster and more efficient scale-up to bioreactors. Therapeutics that are generated using Selexis SURE CHO-M cells are in both clinical trials and marketed products.

PNH is a condition where red blood cells are created without a protective protein, which causes them to burst. The disease is characterized by destruction of red blood cells, thrombosis, and impaired bone marrow function.

aHUS is a rare, life-threatening, genetic disease that can damage vital organs such as the kidneys, heart, and brain. In patients with aHUS, blood clots form in small blood vessels throughout the body, a process known as systemic thrombotic microangiopathy, or TMA.

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