Immunosafety Technical Committee (ITC)

Mission Statement

The HESI Immuno‑Safety Technical Committee (ITC) works to identify and address scientific questions related to immune safety and to strengthen the translation of immune safety findings into human health risk assessment.

It’s Key Objectives are to:

  • Advance immuno‑safety science by bringing together technical and scientific expertise from academia, regulatory agencies, and industry.
  • Support sound scientific decision‑making by contributing to the development of guidelines and regulations for immune safety testing.
  • Educate and engage stakeholders in safety science to promote the understanding, appropriate interpretation, and responsible use of immune safety data.

Regulatory Strategies and Risk Assessment Workstreams

  • Advancing regulatory acceptance of NAM-based immunosafety assessment for biologics and immunomodulators

    The Regulatory Gaps workstream is focused on addressing immune safety challenges associated with T-cell–modulating biologics, including T-cell engagers in autoimmune and immune-mediated diseases. As these therapies rapidly advance, the project examines whether existing regulatory frameworks and safety assessment paradigms are fit for purpose, particularly for complex immune mechanisms that are not well captured by traditional animal models.

    A central component of this effort is the evaluation of New Approach Methodologies (NAMs), including advanced in vitro and in silico tools, as scientifically credible and regulatory-relevant approaches for immune safety assessment of biologics. The workstream is identifying specific contexts of use where NAMs can inform decision-making, generating case studies, and defining key data gaps that must be addressed to build regulatory confidence.

    This work will culminate in an FDA co-sponsored workshop that convenes industry, academic, and regulatory stakeholders to align on immune safety considerations, discuss emerging evidence, and advance fit-for-purpose regulatory strategies. The overarching goal is to support timely, ethical, and science-based evaluation of T-cell–directed therapies in an evolving immunotherapy landscape.

  • Carcinogenicity Weight of Evidence (WOE)

    This workstream is developing a regulator-aligned Weight-of-Evidence (WoE) framework to evaluate the carcinogenic potential of immunomodulatory therapeutics. Aligned with ICH S1B(R1), ICH S8, and the 2023 FDA Immunotoxicology Guidance, the framework integrates multiple data streams—including clinical labeling, mechanistic insights, carcinogenicity risk assessment (CRA) data, structured case studies, and FDA reviewer perspectives—to support hazard identification and decision-making.

    By systematically analyzing approved drugs, cancer-related signals, and clinical indicators of immune status, the project aims to clarify when additional carcinogenicity testing may or may not be warranted. The ultimate goal is to improve consistency, transparency, and predictability in cancer-risk evaluation for immune-modulating therapies.

  • Best Practices for Cytokine Release Assays (CRA)

    This project is developing a practical, mechanism-driven framework to guide the appropriate use of cytokine release assays (CRAs) for preclinical hazard identification of protein-based biologics. Focused specifically on immune-mediated hazard identification—not broad safety screening or risk assessment—the effort ensures that CRA data are applied in a scientifically rigorous and fit-for-purpose manner.

    The scope includes monoclonal antibodies, Fc-modified antibodies, and bispecific or trispecific engagers, as well as other biologics with clear immune activation potential, while excluding cell- and gene-based therapies. A central deliverable is a science-based decision tree to determine when CRAs are warranted based on therapeutic modality, mechanism of action, and risk context. Supported by real-world case studies illustrating both appropriate use and limitations, the project aims to improve consistency in CRA application, clarify regulatory expectations for hazard identification, and strengthen communication of immune risk.

Translational Immunosafety Workstreams

  • Translating Non-Clinical Immune Findings to Clinical Outcomes

    This workstream evaluates the clinical predictive value of nonclinical immune safety findings through retrospective translational analyses. By systematically linking preclinical immune signals to observed human clinical outcomes, the project seeks to determine which nonclinical findings are clinically meaningful, which are not, and how they should inform development and regulatory decision-making.

    Currently in a feasibility and scoping phase, the team is assessing data availability and interoperability across public, regulatory, clinical, and industry sources, using a beta-test set of discontinued pharmaceuticals with planned expansion to biologics and immune engagers. The objective is to develop translational frameworks that strengthen early risk assessment, reduce late-stage attrition, and improve regulatory confidence. Ultimately, the project aims to address a critical gap in immune safety assessment by clarifying how preclinical immune signals should be interpreted in a clinical context.

  • Translational Relevance of NHP Immunotoxicities

    This workstream critically evaluates when non-human primates (NHPs), particularly cynomolgus macaques, are predictive models for human immunotoxicity and when their use may be scientifically uninformative. While NHPs are often selected due to target cross-reactivity, comparable immune architecture, and pharmacologic activity, translational performance varies substantially by mechanism, immune context, and endpoint. The project examines genomic homology, immune cell phenotypes, cytokine signaling kinetics, Fc receptor biology, cytotoxic function, TDAR responses, and immunogenicity patterns to identify where immune biology is conserved versus meaningfully divergent. Case studies, ranging from underprediction of immune-related adverse events with checkpoint inhibitors to successful anticipation of systemic immune activation with CD40 agonists, anchor a structured assessment of predictive success and failure.

    A central deliverable is a mechanism-based Weight-of-Evidence framework to guide species selection and study design. This framework integrates comparative genomics, cross-species in vitro pharmacology, historical translational data, and contextual factors such as age, immune tone, and genetic diversity. It also incorporates emerging New Approach Methodologies (NAMs)—including human in vitro cytokine release assays, cytotoxicity platforms, and immune-competent microphysiological systems—to inform when NHP studies add value and when alternative approaches may be more appropriate. The goal is to support responsible 3Rs implementation while preserving scientific rigor and regulatory confidence in immuno-safety decision-making.

  • Comparative Immune Biology

    This workstream addresses how to select the most appropriate species and models for immune safety assessment of biologics in a scientifically justified and translationally relevant manner. By comparing immune system biology across species, the project evaluates when traditional models—including nonhuman primates—are informative and when alternative approaches or weight-of-evidence strategies may be more appropriate. Integrating scientific and regulatory perspectives, the effort considers species-specific immune pathways, target biology, historical translational performance, and emerging predictive immune models. The goal is to support more consistent, defensible, and regulator-aligned species selection decisions while strengthening translational relevance and promoting responsible use of animal models.

  • CRA in Cynomolgus Monkeys

    This workstream evaluates baseline cytokine variability in cynomolgus monkeys to better distinguish natural biological fluctuation from true test-article–related immune effects in immunotoxicology studies. Drawing on retrospective, cross-institutional data and industry experience, the project defines variability ranges, identifies key drivers, and clarifies interpretive pitfalls that can confound cytokine analysis. The findings are contextualized within evolving regulatory expectations, including increased emphasis on 3Rs principles, constrained nonhuman primate availability, and the growing use of virtual control strategies. By strengthening confidence in cytokine interpretation, the project supports more accurate immune safety assessments, improved regulatory dialogue, and responsible refinement of NHP study design.

Methods development Workstreams

  • Complex In Vitro Models (CIVMs) in Immuno-Safety

    This workstream is advancing the development and application of complex immune-competent in vitro systems to model T cell–dependent antibody responses (TDAR) for immunotoxicology. Through a webinar series, an industry survey, and a collaborative manuscript effort, the team is defining the biological and technical requirements necessary to recapitulate TDAR-like responses in vitro, including key cellular components (APCs, T cells, B cells), germinal center biology, and functional readouts. Collectively, this project aims to strengthen the scientific foundation for TDAR CIVMs, support earlier and more human-relevant immune safety assessment, and inform future qualification of these models within evolving regulatory frameworks.

  • Predictive Immunogenicity Reference Panel

    The HESI–AAPS Predictive Immunogenicity Reference Panel Pilot Study is a cross-sector benchmarking initiative aimed at establishing standardized reference materials for in vitro T-cell immunogenicity assays. Engaging 10 laboratories across industry and government, the pilot evaluated anti-PCSK9 monoclonal antibodies as candidate reference controls, assessing their stability and functional performance following freeze-drying and lyophilization while identifying key sources of inter-laboratory variability. The fully drafted manuscript, “Benchmarking the Future of In Vitro Immunogenicity Testing: A Multi-Laboratory Pilot Study to Establish Reference Controls and Inform Harmonized Assay Strategies,” will be submitted to an AAPS journal and is intended to serve as the foundation for a larger, externally funded ring trial that will expand evaluation to peptide-based controls. Collectively, this work demonstrates the feasibility and value of standardized reference materials, advancing assay harmonization, improving comparability and reliability, and strengthening the scientific basis for immunogenicity risk assessment of therapeutic proteins.

  • Predictive Immunogenicity in-silico T-cell activation

    This project is a coordinated effort to generate the first harmonized dataset directly linking predicted peptide–MHC binding to measured T-cell activation under standardized conditions. Recognizing that MHC binding is necessary but not sufficient for immunogenicity, the project will conduct a proof-of-principle pilot study evaluating approximately 500 non-microbial peptides across 20–30 fully HLA-typed donors, with defined peptide selection criteria and centralized CRO execution to minimize variability and ensure data quality. The resulting dataset is intended to inform and benchmark in silico predictive models, reduce methodological and comparability barriers, and provide a publishable, precompetitive resource to strengthen translational immunogenicity risk assessment. The proposal has been drafted and will undergo further scope confirmation, refinement of peptide selection and data-integration strategy, and alignment on CRO engagement prior to committee review and approval.

  • Evaluating NK Function Assays

    This project is developing the manuscript, “Current Approaches to Evaluating Natural Killer (NK) Cell Function in Non-Clinical Immune Safety Assessments,” which provides a comprehensive framework for integrating NK cell evaluations into immunotoxicology and drug safety studies. By synthesizing NK cell biology, established and emerging functional assays, advanced technologies such as single-cell RNA sequencing and mass cytometry, published case studies, and relevant regulatory perspectives, the work clarifies when and how NK functional assessments should inform non-clinical decision-making. The manuscript offers practical recommendations to improve methodological consistency, strengthen data interpretation, and align NK testing with translational and regulatory needs, ultimately enhancing prediction of immune-related risk and supporting more robust immune safety evaluations.

Education & Outreach Workstreams

  • Background

    This cross-functional initiative aims to enhance the visibility and impact of ITC science. Key efforts include: (1) proactive engagement with professional societies through sessions, working groups, and presentations; and (2) broad dissemination of ITC-generated knowledge via open access publications, social media campaigns, webinars, podcasts, and other communication channels. The goal is to expand awareness of immuno-safety science, drive participation, and foster collaboration across sectors.

  • Immuno safety course

    This on-demand educational course is designed to support continuing education for scientists, regulators, and stakeholders working in immunotoxicology. Developed and delivered by ITC experts, the course covers key tools, concepts, and case examples relevant to immune safety evaluation. It is intended to strengthen scientific literacy and promote consistent application of immuno-safety principles across programs.

  • Immunosafety Manuscript

    This manuscript, targeted for publication in the Journal of Immunology (AAI), provides a concise overview of the emerging field of immuno-safety science and its relevance at the intersection of basic and translational immunology. The piece advocates for the early and proactive integration of immune safety principles into immunology education, research design, and therapeutic development. The goal is to raise awareness within the broader immunology community and foster greater alignment between discovery science and safe clinical application.

Outreach

HESI Immuno-Safety Career Symposium

Speaker Bios

Blog Posts

ITC

Launching ITC Immunosafety in 2026: the Science, the People, and the Future of Safety Assessment

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Committee Events

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HESI Staff

Leadership Team

  • Marc Pallardy, PhD

    Université Paris-Saclay

  • HervĂ© Lebrec, PhD

    Sonoma Biotherapeutics

  • Curtis Maier, PhD

    GSK

Center for Translational Sciences

The Immuno-Safety Technical Committee (ITC) is part of the Center for Translational Sciences. This HESI Center serves as a focal point for staff to share strategic approaches, scientific developments, management best practices and innovations with other related HESI committees.

Other Committees in the Center for Translational Sciences are:

For questions about the Center contact:

 

Contact Us

Health and Environmental Sciences Institute (HESI)

hesi@hesiglobal.org
Phone: +1-202-659-8404
Fax: +1-202-659-8403

740 15th Street NW, Suite 600
Washington, DC 20005

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