ProBioGen AG, a premier service & technology provider for complex therapeutic antibodies and glycoproteins, announced that the company achieved an undisclosed milestone payment from Merus N.V. (NASDAQ: MRUS) based on Merus’ use of MCLA-158, a bispecific antibody utilizing the GlymaxX® antibody-dependent cell-mediated cytotoxicity (ADCC)-enhancing technology in Merus’ Phase I clinical trial. The trial is in patients with solid tumors with an initial focus on metastatic colorectal cancer who will be administered MCLA-158, which uses ProBioGen’s GlymaxX® technology for greater cell-killing potential. GlymaxX® is a stable modification, applicable to any producer cell, leading them to produce antibodies without the sugar fucose. Such GlymaxX®-modified, afucosylated antibodies recruit and activate immune effector cells much more effectively, possess a much higher tumor cell killing activity and potentially require much lower doses with accordingly lower side effects.
Merus’ use of the GlymaxX® ADCC enhancement technology in MCLA-158 is the result of an agreement executed between ProBioGen and Merus in 2016. Under the terms of that agreement, Merus obtained non-exclusive rights to use the GlymaxX® technology for Merus’ Bioclonics® pipeline of bispecific antibodies designed to treat various forms of cancer to enhance their ADCC activity.
ProBioGen offers access to GlymaxX® royalty-free as part of cell line development service projects or as individual technology licenses.
About ADCC
ADCC (Antibody-Dependent Cell-Mediated Cytotoxicity) activity is an important antibody function, leading to the selective killing of target cells, i.e. cancerous cells or pathogen-infected cells. Several therapeutic antibody drugs on the market rely on ADCC as a mechanism of action. ADCC enhancement has the potential to increase the therapeutic effect and/or to greatly reduce antibody dosage requirements, resulting in fewer side-effects and treatment costs.
About GlymaxX®
ProBioGen developed the GlymaxX® technology to optimize antibody activity, notably the enhanced antibody-mediated cell killing or cancerous or infected cells (known as "ADCC" activity). GlymaxX® is based on the stable introduction into producer cells of a gene for an enzyme which blocks the cells’ fucose biosynthesis pathway and hence the formation of the sugar "fucose". Consequently, no fucose is added to the antibody’s N-linked carbohydrate part of the in antibody producer cells. 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 by 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 by biosimilar-developing companies to adjust a specific fucose content in order 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 AG
ProBioGen is a premier, Berlin-based specialist for developing and manufacturing complex therapeutic glycoproteins. Combining both state-of-the-art development platforms, 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, comp...
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