We are doing a webinar on the 13th May at 10am EDT/ 3pm BST.
Register for the webinar here.
Therapeutic proteins and emerging gene and cell-based therapies are important approaches in the development of drugs to treat many severe and chronic diseases. However, their development and optimal clinical application can be complicated by the induction of unwanted immune responses. This immune response, characterized by the development of specific anti-drug antibodies (ADA), can alter drug pharmacokinetics and pharmacodynamics leading to impaired efficacy and can occasionally lead to safety adverse events, and it is in this context that regulatory agencies require the immunogenicity risk to be thoroughly explored and characterized.
There has been a growing interest over the past decade in developing methods to assess the risk of unwanted immunogenicity during preclinical drug development, with the aim of mitigating the risk during the drug design phase. To this end, a range of in silico and in vitro tools have been developed to identify the risks inherent to the product itself, and, where possible, guide the removal of liabilities, for example through removal of T cell epitopes, removal of deamidation sites etc. These evaluations can be used to narrow down from a larger panel of drug candidates to select a lead candidate to progress to manufacturing and clinical development.
In this webinar, we discuss some of the approaches to therapeutic protein immunogenicity risk assessment, with particular attention paid to the use of in silico tools and different in vitro assays to mitigate risk and design drugs with a better chance of success in the clinic. Through case studies we illustrate complementary approaches that can be applied to different classes of proteins.
Rob Holgate, PhD
Senior Director Protein Engineering
Rob has over 20 years’ experience in Drug Discovery and early stage Development. After obtaining his PhD in Molecular Medicine at UCL, he moved to The University of York as a post-doctoral researcher. He subsequently worked at Cambridge Antibody Technology (now part of AZ) where he was a Senior Scientist within Antibody Engineering then Team Leader of the High Throughput Expression team. Rob joined Antitope (now Abzena) in 2008 as a Research Manager and now leads Abzena’s Discovery and Protein Engineering group overseeing Abzena’s antibody discovery, antibody humanization, protein deimmunisation and bespoke engineering projects.
Group Leader Bioassays
Alyson Rust has over 14 years’ extensive experience within the field of biologic immunogenicity at Abzena and is currently Group Leader of Bioassay, Cambridge, UK. Since joining Abzena Alyson has developed, and optimised an array of ex vivo assays to aid in the pre-clinical immunogenicity risk assessment and safety of biologics. These have included T-cell epitope mapping strategies to support the de-immunisation of biologics in the early-stage development process. Alyson leads the Bioassay team delivering high quality projects and reports on the immunogenicity risk of biological candidates to reflect regulatory guidelines. Prior to Abzena, Alyson held positions at Lorantis (Cambridge-based Biotech) and Aventis.