Dr. Anne De Groot has been invited to speak at the GTC 2nd Immunogenicity and Immunotoxicity Conference January 30-31st in San Diego, CA. This conference is one of four co-located conferences for the Novel Immunotherapeutics Summit 2014 and focuses on important progress made in the ares of therapeutic protein immunogenicity and immunotoxicity evaluation and mitigation. Learn more about how EpiVax provides best in class immunogenicity screening and immuno-modulation.

Don’t miss Dr. De Groot and other invited speakers, like our collaborator Dr. David Scott, in San Diego this January!


T-cell Dependent Immunogenicity of Protein Therapeutics: Preclinical Assessment and Mitigation

Anne De Groot
Founder, CEO & CSO

Protein therapeutics hold a prominent and rapidly expanding place among medicinal products. Purified blood products, recombinant cytokines, growth factors, enzyme replacement factors, monoclonal antibodies, fusion proteins, and chimeric fusion proteins are all examples of therapeutic proteins that have been developed in the past few decades and approved for use in the treatment of human disease. Despite early belief that the fully human nature of these proteins would represent a significant advantage, adverse effects associated with immune responses to some biologic therapies have become a topic of some concern. As a result, drug developers are devising strategies to assess immune responses to protein therapeutics during both the preclinical and the clinical phases of development. While there are many factors that contribute to protein immunogenicity, T cell- (thymus-) dependent (Td) responses appear to play a critical role in the development of antibody responses to biologic therapeutics. A range of methodologies to predict and measure Td immune responses to protein drugs has been developed. This review will focus on the Td contribution to immunogenicity, summarizing current approaches for the prediction and measurement of T cell-dependent immune responses to protein biologics, discussing the advantages and limitations of these technologies, and suggesting a practical approach for assessing and mitigating Td immunogenicity.

Novel Tolerogenic Approaches to Reduce or Obviate Immunogenicity 

David Scott
Professor of Medicine, Vice Chair for Research Department of Medicine (MED)
Uniformed Services University of Health Sciences

Protein biotherapeutics that are of human origin or “humanized” can nonetheless be immunogenic, thus causing adverse reactions and rendering these therapies ineffective, if not dangerous. This can occur with monoclonal antibodies, cytokines and replacement therapies for monogenic diseases. While efforts to modify such proteins by de-immunization hold promise, these are not tolerogenic. After a brief overview of factors controlling immunogenicity, we will review tolerogenic approaches and mechanisms. The history of the use of IgG chimeric fusion proteins and gene therapy, for example, has led that additional insights and application of specific regulatory T cells, which will be a focus. Additional efforts with nanoparticles for tolerance will be cited. These studies have impact on the design of protein therapeutics and specific therapies to reduce the potential for immunogenicity problems and adverse events.

• Overview of immunogenicity factors
• History of IgG fusion proteins as biologics and tolerogens
• Novel biotherapeutic proteins for tolerance
• Future of cellular therapies