An advanced French research laboratory is offering to pharmaceutical companies a new tool to evaluate the immune response risks a therapeutic protein candidate may induce in order to determine the epitopes associated with such immunogenicity.

“What it means is we can test real-time and live the cell-to-cell contact for a protein exactly as it will happen in a human being,” said Emmanuel Maille, general manager for business development for Protéus Services for Industry (N mes, France), focused on commercializing a testing technique called Immuno’Line.

“There is no other simulation like it in the world that can deliver data on how the entire human immune system will react to a new drug,” he said, at the EuroBio conference in Lille, France, last week. Maille said Protéus is negotiating with its first customer, “a very advanced French firm,” and has approached several other pharmas.

“Considering the high costs and high risks of drug development, our system offers the advantage of being representative of a significant and large population so that a target drug can arrive at its clinical stage with lower risk and a greater assurance for the developers of the outcome,” said Maille.

Developed by the French Commission for Atomic Energy (CEA) through its Institute of Biology and Technologies (IBITEC; Saclay, France), Immuno’Line is based on a combination of in vitro human cellular assays and immuno-enzymatic assays to predict the immunogenic potential of candidate proteins prior to clinical development. The techniques enable the identification of the regions of a protein that are linked to an immunogenicity.

In a second phase, proprietary protein engineering techniques developed by Protéus can modify the identified regions in order to reduce the risks of immune response before administration to humans.

“By providing experimental information on immunogenicity of candidate therapeutic proteins long before their clinical development, we offer to the pharmaceutical industry the ability to anticipate on this major risk factor in drug development of biopharmaceuticals,” said Daniel Dupret, chief executive of Protéus.

Founded in 1998, Proteus holds a patented gene shuffling technology aimed at generating and optimizing proteins.

CEA’s Life Science Division researches the complexities of biological structures and mechanisms.

— John Brosky