In the development of biologic therapeutics, understanding and mitigating potential immunogenicity is not just important— it’s essential.
Immunogenicity, or the ability of a therapeutic or its impurities to elicit an undesired immune response, can impact both the safety and efficacy of a product. Sometimes these impacts can be significant enough to force the termination of otherwise promising therapies in clinical or post-approval stages. For these reasons, regulatory agencies have taken great interest in preclinical immunogenicity assessments and have asked drug developers to use a structured approach to measuring immunogenicity risk of therapeutics in published guidance. Therefore, addressing immunogenicity concerns early and throughout the development process to mitigate risk is key to ensuring a therapeutic’s ultimate success.
The details of the assessment and mitigation process are critical components to include in the Immunogenicity Risk Assessment section of your IND, to develop a clinical bioanalytical and immunogenicity monitoring strategy, and to start the compilation of your Integrated Summary of Immunogenicity section of your BLA or ANDA. They can also help to streamline R&D strategy and support partnership, licensing, and fundraising opportunities earlier in the process.
FDA
Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products
Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry
Clinical Pharmacology Considerations for Peptide Drug Products
EMA
Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins
EpiVax has been at the forefront of immunogenicity assessment for over 25 years, helping clients navigate the complexities of therapeutic development and strengthen their drug development pipelines with a set of industry-leading, multi-dimensional preclinical immunogenicity assessment approaches.
EpiVax’s core immunogenicity assessment capabilities encompass the identification, characterization, and mitigation of T cell epitope content within biologic sequences. T cell epitopes within a therapeutic’s (or impurity’s) primary sequence are crucial in driving or modulating ADA responses. Thereby, identifying, characterizing, and potentially reducing the presence of T cell epitopes or T cell response to therapeutics and their impurities prior to further development for clinical use are critical to a more accurate, actionable preclinical immunogenicity assessment.
These capabilities have been compiled into the integrated set of tools available in the ISPRI™ toolkit. EpiVax has made the toolkit available for groups to access directly through the internet (ISPRI™ Access), to have fee-for-service analyses and deimmunization performed by the EpiVax team (ISPRI Downselect™, ISPRI Quantify™, ISPRI Evaluate™, ISPRI-HCP™ and PANDA™ Analyses), and through commercial development collaborations.
ISPRI™ Website
Access to a suite of tools allowing for self-serve immunogenicity assessments and deimmunization.
ISPRI Downselect™
A high throughput option to guide lead candidate selection.
ISPRI Quantify™
A fast assessment including the most critical data points for easy decision making.
ISPRI Evaluate™
The most comprehensive evaluation of a candidate’s overall and regional immunogenic potential.
ISPRI-HCP™
Rapid assessment of the potential for anti-HCP antibody generation to identify HCPs that represent potential risk for immunogenicity.
PANDA®
A comprehensive generic peptide impurity assessment to support ANDA submissions.