Roche licenses humanising antibody technology
Biotechnology that makes antibody-based drugs more effective by
making them resemble natural human antibodies more closely.
The key to the technology is a process called GlycoMAb, which focuses on the attachment of sugar groups to protein drugs, a process called glycosylation. Human proteins have a pattern of sugar groups attached to them that play a significant role in the way the antibody behaves.
GlycoMAb increases the specific biological activity of therapeutic monoclonal antibodies by modulating the way they are glycosylated during production in cell culture.
GlycoMAb works by genetically engineering the antibody-producing cells with a gene encoding an oligosaccharide-modifying enzyme. The modified cells produce new molecular variants of the antibody, with different types of oligosaccharides attached to the antibody. The resulting oligosaccharides (called 'bisected non-fucosylated' oligosaccharides) are not produced in the standard cell lines used for antibody production in the biotechnology and pharmaceutical industries.
Meanwhile, the ability to make proteins with glycosylation patterns that resemble the human form has been one of the primary hurdles to overcome when using non-mammalian production systems, and the reason that proteins are still made in mammalian cells.
Specifically, GlycoMAb is based on the active modulation of antibody glycosylation during production leading to antibody products with increased ADCC (antibody-dependent cellular cytotoxicity). This immunological mechanism is crucial for the in vivo target-cell killing activity of antibodies.
And aside from improving the activity of antibodies, the technology could also have production benefits by creating antibodies with improved potency that can be delivered at lower doses. This is particularly significant as there are predictions that manufacturing capacity for biological drugs may not be able to serve the needs of the dozens of new protein-based therapeutics flowing through the drug industry pipeline.
Indeed, Glycart estimates that based on success rates from the past, a significant number of antibodies could be approved in the coming years with a potential need of 400 per cent of today's capacity.
Under the terms of the new licensing agreement, Roche will have the option to develop and market worldwide all antibodies generated by Glycart from an undisclosed product candidate. In return, the Swiss biotech company will receive an upfront fee, research funding, milestone payments and royalties on product sales.
Jo Jean-Mairet, Glycart's chief executive, said that he hoped the forging of a relationship with Roche would bring the GlycoMAb technology to the attention of other companies and lead to new partnerships.
In the first quarter of this year, 49 per cent of Roche's sales came from biotechnology products, originating in the main from its US subsidiary Genentech.
