ProImmune is best known as a provider of research reagents used in monitoring immune reactions and the discovery of epitopes, the part of an antigenic molecule that is recognised by the immune system.
The launch of this new service – called the REVEAL Immunogenicity System – is designed to help drugmakers identify biologics that will be prone to immunogenicity so they can be discontinued in early (preclinical) development.
The aim is to allow companies to focus only on those biologic drug candidates that are more likely to be more successful, and avoid wasting development money on those which could be compromised by safety issues associated with immunogenic reactions.
The immunogenicity of biological drugs can often be a significant obstacle in the development of successful new therapies, according to ProImmune.
“Unwanted immunogenicity can manifest itself particularly through anti-drug antibody (ADA) responses,” said the company in a statement.
“These responses can lead to allergic reactions, reduction or neutralisation of the activity of the drug and, in some cases, cross-reactive immune responses, which could lead to serious adverse events.”
The system combines cell-free HLA-peptide binding assays for more than 50 class II HLA alleles, as well as T cell proliferation assays.
“This combination enables the creation of a detailed profile of the helper T cell immune response to one or more drug leads.” The role of helper T cells is known to be of critical importance in controlling unwanted ADA responses.
The data generated using REVEAL can also be used to re-engineer biologics to remove unwanted helper T cell epitopes and produce a re-validated drug lead with improved immunogenicity risk, said ProImmune.
ProImmune is providing REVEAL as a customisable, fee-for-service basis.