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Positive Preclinical Performance Of greenovation Biotech GmbH`s Lead Candidate moss-?Gal


6/12/2014 9:11:59 AM

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FREIBURG, Germany, DALLAS, Texas, USA, June 12, 2014 - greenovation Biotech GmbH and Baylor Research Institute today announced positive preclinical results of greenovation’s plant-made version of human Alpha-Galactosidase (?Gal) for use as enzyme-replacement-therapy (ERT) in patients suffering from Fabry disease.

Fabry disease is a rare lysosomal storage disease (LSD) caused by hereditary ?Gal-deficiency due to genetic mutations. ?Gal-deficiency causes a progressive disease due to accumulation of a sphingolipid called globotriaosylceramide (Gb3) in patients’ cells in virtually all organs. Kidney and heart disease as well as stroke are the most life threatening complications for Fabry patients.

Regular infusion of a recombinant version of ?Gal (enzyme replacement therapy: ERT) has become the standard treatment in patients with Fabry disease as it corrects for the deficiency. Recent long-lasting international supply shortage of ?Gal product resulted in tremendous problems among patients as up to now there is no treatment available but ERT. This underlines the urgent need for securing continuous global supply of a high quality ?Gal product.

Influencing and efficiently engineering the structure of so-called N-glycans, small sugar-moieties on the enzyme´s surface, which are crucial for the correct uptake of the therapeutic molecule from the bloodstream into the target cells, is one of several unique features offered by greenovations BryoTechnology™. The company's proprietary technology has been developed for production of customized protein biopharmaceuticals in moss. In case of its “moss-?Gal”, a moss-made version of human ?Gal , greenovation successfully managed to decorate the therapeutic enzyme with solely uptake-active N-glycans.

According to Dr. Raphael Schiffmann, an internationally acknowledged expert in the field of LSD, greenovations moss-?Gal revealed in Fabry mouse model its potential to be “a viable product for ERT in Fabry disease.”

Dr. Thomas Frischmuth, CEO of greenovation, stated: "We are proud to closely collaborate with the internationally renowned LSD expert Professor Schiffmann and his team. The promising preclinical results of our moss-?Gal lead candidate in the Fabry mouse model are very exciting and will assure a quick entry into clinical evaluation. Currently, we are producing GMP drug substance of our lead candidate to be used in a clinical first in man study later this year”

About greenovation Biotech GmbH
greenovation Biotech GmbH is a specialty biopharmaceutical company developing customized protein biopharmaceuticals using its proprietary eukaryotic Physcomitrella-based BryoTechnologyTM-platform.

Clonal stable moss lines are developed for a sustainable, cGMP-compliant manufacturing of protein biopharmaceutical candidates. Key features of BryoTechnologyTM: photoautotrophic process ? easy to cultivate in animal-derived-component-free and antibiotic-free purely mineral media ? rapid genome customization to express demanding proteins ? genetically stable genomic integration ? eukaryotic post-translational modifications ? straightforward genetic glyco-engineering ? highly homogeneous glycosylation pattern ? targeted elimination of plant-type glyco-forms ? protein excretion into the media.

Large scale production using the photoautotrophic moss lines is performed in certified, disposable bag-based reactors of the wave-type. Supply as well as full physico-chemical and biological characterization of GMP material for clinical use has been established at greenovation's specialized partner companies.

greenovation has two pre-clinical programs under development, in the area of orphan lysosomal storage diseases (LSD): Moss Alpha-Galactosidase (moss-?Gal) for treating patients with Fabry Disease and Moss Glucocerebrosidase for treating patients suffering from Gaucher's Disease. With the moss-?Gal program greenovation plans entering into a clinical phase I/IIa trial in the second half of 2014.

About Baylor Research Institute
Established in 1984 in Dallas, Texas, Baylor Research Institute (BRI) promotes and supports research to bring innovative treatments from the laboratory workbench to the patient bedside. To achieve this bench-to-bedside concept, BRI focuses on basic science, clinical trials, healthcare effectiveness and quality of care research. Today, BRI is conducting more than 930 active research protocols with 400 research investigators, spanning more than 22 medical specialties, and has research and development projects in areas ranging from human immunology and orphan metabolic diseases to diabetes, cardio-vascular disease and many other unmet medical needs.

Contact:
greenovation Biotech GmbH
Manon Bartusel, Tel. +49 (0)761 470 99 0
e-mail mbartusel@greenovation.com

BaylorHealth
Kristine Hughes, Tel. +1-214-820-7556
e-mail: kristine.hughes@baylorhealth.edu
For more information, please visit www.greenovation.com

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