ProBioGen today announced that a Novartis clinical candidate using its antibody-dependent cellular cytotoxicity (ADCC) technology, GlymaxX, has reached Phase III.

ProBioGen's mission is to contribute towards the development of medicines against complex diseases. Therefore, ProBioGen wants to particularly emphasize that GlymaxX is also being used in late stage clinical trials of several other pharmaceutical partners and numerous top pharma companies alongside many biotech's have in-licensed GlymaxX and are also tapping its potential. GlymaxX is available under a non-exclusive license.

As the candidate has reached Phase III, ProBioGen is eligible to receive a milestone payment from Novartis. Further financial details are not disclosed.

"Having our GlymaxX technology in yet another phase III trial with a top pharma player is an important milestone for us. This shows again the great potential of GlymaxX in generating highly efficacious molecules for patients in need", said Dr. Gabriele Schneider, Chief Business Officer at ProBioGen.

About GlymaxX

ProBioGen developed the GlymaxX technology to optimize antibody activity, notably the enhanced antibody-mediated cell killing of cancerous or infected cells (known as "ADCC" activity). GlymaxX is based on the stable introduction of a gene into producer cells that encodes for an enzyme that blocks the cells' fucose biosynthesis pathway and hence the formation of the sugar "fucose". Consequently, in the antibody-producer cells no fucose is added to the antibody's N-linked carbohydrate part. This absence of fucose in antibodies is known to greatly enhance ADCC.

As a unique feature, differentiating it from other approaches, GlymaxX can be applied to both novel or already existing antibody producer cell lines, and entire antibody expression and discovery platforms. GlymaxX does not negatively affect cellular productivity or other product characteristics. Furthermore, a GlymaxX cell line can be flexibly used to produce differently fucosylated products, depending on the upstream process: In fucose-free medium the antibody is literally afucosylated.

The same GlymaxX cell line grown in fucose-containing medium however, uses the provided fucose and produces fully fucosylated antibody. Thus, one GlymaxX cell line can be employed to produce several products: For instance ADCC-enhanced GlymaxX antibodies or wildtype-like, fully fucosylated mAbs, e. g. for a parallel Antibody-Drug-Conjugate (ADC) project. Moreover, GlymaxX has also been used to adjust the fucose level as wanted and by biosimilar-developing companies to match the originators glycoprofile. Overall, GlymaxX is simple, rapid, potent, and universally applicable to different CHO hosts and all other eukaryotic cell species. ProBioGen offers its GlymaxX technology royalty-free and non-exclusively as a service or as an individual license.

About ProBioGen

ProBioGen is a Berlin-based specialist for developing and manufacturing complex therapeutic glycoproteins.

Combining both state-of-the-art development services, based on ProBioGen's CHO.RiGHT? expression and manufacturing platform, 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 has been operational for more than 25 years. At three locations in Berlin, nearly 300 employees contribute to the creation of new therapies in medicine and groundbreaking innovations worldwide through their creative and meticulous work. ProBioGen's growth strategy is driven by the expansion of the service value chain through organic growth and potential acquisition. Diversification is a complement driver, while the focus is strict on enabling the development of biopharmaceuticals for tomorrow.