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 leveraging human-relevant new approach methodologies (NAMs) to measure 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.
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
Roadmap to Reducing Animal Testing in Preclinical Safety Studies – New Approach Methodologies (NAMs)
EMA
Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins
EpiVax’s in silico immunogenicity assessment helps drug developers save time and resources by identifying candidates with the lowest immunogenic risk early in development. Our insights enable the prioritization of promising options, supporting regulatory filings, fundraising, due diligence for in-licensing/out-licensing/fundraising, publications, and internal R&D strategies. By assessing both overall and regional immunogenic and tolerogenic potential, clients can optimize critical protein regions and make smarter decisions. Our approach reduces reliance on costly in vitro and in vivo studies—saving up to 20 times the resources on average—while accelerating development and boosting confidence.
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 Analyze™, ISPRI Evaluate™, ISPRI-HCP™, ISPRI Design™, 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 Analyze™
A comprehensive evaluation of a candidate’s overall and regional potential, delivered as a data compilation.
ISPRI Evaluate™
The most comprehensive evaluation of a candidate’s overall and regional immunogenic potential, delivered in a written report.
ISPRI-HCP™
Rapid assessment of the potential for anti-HCP antibody generation to identify HCPs that represent potential risk for immunogenicity.
ISPRI Design™
To prepare for in vitro studies, the EpiVax experts will design peptides for synthesis and testing using our advanced in silico tools.
PANDA®
A comprehensive generic peptide impurity assessment to support ANDA submissions.