In 2025, EpiVax advanced the science of immunogenicity assessment through AI-driven ADA prediction, enhanced in silico tools, expanded in vitro assays and consulting offerings, and new regulatory frameworks supporting biologics and generic peptides.
Advancing Immunogenicity Science: EpiVax in 2025
A Year of Momentum at EpiVax
2025 was a year of growth for EpiVax. The company met major milestones, accomplished key technological advances, and expanded service offerings. From newsworthy leadership appointments and platform enhancements to new scientific insights and global collaboration, the past year reflected our continued focus on supporting the development of safer, more effective biologics and vaccines as a trusted partner for drug developers navigating increasingly complex modalities and regulatory expectations.
Expanding Scientific and Technical Leadership
EpiVax was thrilled to welcome Vibha Jawa, PhD, FAAPS as Chief Scientific Officer, marking a new phase of the company’s evolution. Dr. Jawa brings more than 20 years’ experience guiding immunogenicity strategy across biologics, vaccines, and gene therapies, with prior leadership roles at Bristol Myers Squibb, Merck, and Amgen. As CSO, Dr. Jawa leads scientific strategy, internal research, and external engagement, helping the team expand its expertise into new modalities and development stages while continuing to refine its cutting-edge approaches to immunogenicity assessment.
Earlier in the year, Guilhem Richard, PhD, was appointed Chief Technology Officer, building on more than a decade of contributions to EpiVax’s computational platforms. Dr. Richard led the development of Ancer®, a platform for personalized neoantigen-based cancer vaccines, and now oversees innovation across the company’s immunoinformatics tools, including AI- and ML-driven approaches enhancing the precision of immunogenicity risk assessment for clients and collaborators.
Advancing the ISPRI™ Platform
EpiVax’s ISPRI™ Platform continues to set the standard for in silico immunogenicity assessment. Used by leading pharmaceutical developers for decades, ISPRI integrates computational tools that help biotech teams evaluate and optimize biologics during discovery and preclinical development. 2025 was a big year for ISPRI, with major updates to our core tools, expanded support for emerging modalities, and the release of a new AI-driven approach to anti-drug antibody (ADA) prediction. The platform is continually updated to reflect advances in computational immunology and feedback from users working across a range of therapeutic modalities.
ISPRI saw significant enhancements to Class I analysis alongside broader improvements across modalities and reporting. We introduced new Class I tools to support the development of gene therapies, CAR-T, and other endogenously expressed therapeutics. We also provided a revised workflow which provides a more intuitive way to quantify and compare Class I epitope content. Users can now generate Class I Epitope Maps, offering a zoomed out, sequence-level view of predicted epitope distribution to support clearer interpretation of risk. The addition of Class I Foreign Epitope Maps further strengthened this assessment by enabling easy comparison against non-self content.
Simultaneously, the ISPRI development team expanded support for emerging biologic formats, reflecting the rapid expansion of new multispecific modalities in recent years. Now, users will find a Multispecific Antibody Characterization tool with the option to analyze up to 8 chains, giving developers more flexibility to assess more complex constructs.
Additionally, the Machine Generated Immunogenicity Compilation (MaGIC) within ISPRI has been updated to accommodate single-chain antibodies and non-antibody proteins. Additional reporting and visualization updates, including expanded JanusMatrix™ scoring and enhanced CDR highlighting, were introduced to improve usability and facilitate more efficient data comparison across analyses.
AI-Driven Approaches to ADA Risk
The most significant advance of this year was the release of the new, AI-Driven ADA prediction model for monoclonal antibodies. The model is now available in ISPRI in a pre-release format – open to clients for testing and feedback while the prior model is still available. The new model’s training incorporates a significantly broadened set of clinically characterized antibodies. The model framework captures complex patterns and relationships in immunogenicity data, including total, conserved, and foreign T cell epitope content and observed ADA, contributing to an improved predictive accuracy. The model demonstrated a significant correlation between observed and predicted ADA rates (r = 0.57, p < 0.001). Notably, 74% of predictions fell within 10% of reported clinical ADA rates, highlighting the model’s ability to provide reliable quantitative insights into ADA risk.
What’s Next for ISPRI™
Technology enhancements certainly won’t slow down in 2026, as the ISPRI development team is working on several major updates. We have made significant progress developing the second generation of our JanusMatrix™ algorithm to predict epitope tolerance. This updated tool, along with a JanusMatrix-adjusted EpiMatrix® score, will enable refined predictions of foreign T cell epitope content prediction, omitting putative tolerated and tolerogenic epitopes.
Our team is also looking forward to the release of an AI-powered companion within the platform, dubbed EpiBot, to take away the guesswork and streamline the use of ISPRI. This tool will be designed to guide users toward the appropriate analyses for their needs based on user feedback. In addition, we are pursuing a redesigned EpiMatrix 2.0 T cell epitope mapping tool, leveraging large language model-based approaches.
Expanding EpiVax Services
In vitro immunogenicity assays play a central role in supporting development decisions and regulatory readiness, particularly as therapeutic modalities grow more complex and agencies encourage reduced reliance on in vivo models in favor of human-relevant approaches. In 2025, the EpiVax team turned their attention to strengthening and expanding our in vitro service portfolio to better support developers across a wider range of programs, phases, and use cases. This work reflects a broader dedication to ensuring that the data our clients receive can be applied consistently as programs advance, supporting strong immunogenicity strategies and efficient use of resources. The expanded innate and adaptive assay offerings will be officially announced in early 2026, including Cytokine Storm, PBMC, DC:PBMC, and HLA Binding assays.
In parallel, our popular Trusted Expert Advice (TEA) consulting service has also seen exciting updates to facilitate the success of biologics and vaccine developers. EpiVax now offers expert consulting for Immunogenicity Risk Assessment (IRA) and Integrated Summaries of Immunogenicity (ISI) writing, helping teams compile comprehensive submission packages. Our seasoned consultants review data generated across all phases of development to create defensible narratives on predicted and observed immunogenic risk, mitigation efforts, bioanalytical/ clinical strategies, and statements on the safety and efficacy impact of the product. This service is designed to streamline the daunting submission process and instill confidence as programs progress toward approval.
Other Scientific Contributions and New Insights
EpiVax is constantly conducting internal research to advance the field’s understanding of immunogenicity. 2025 was no different, with the release of several publications providing new data on how EpiVax tools and methodology can inform peptide drug development, immune regulation, animal health, and more.
Supporting Regulatory Readiness for Generic Peptides
EpiVax continued to advance the safety and regulatory readiness of generic peptide drugs in 2025 through close collaboration with the FDA and CUBRC. Earlier in the year, the team published Immunogenicity of Generic Peptide Impurities: Current Orthogonal Approaches, an updated review of EpiVax’s Peptide Abbreviated New Drug Application (PANDA®) Screening Program. The PANDA® Program applies stepwise methods for assessing adaptive and innate immunogenicity risks in generic peptides and their related impurities, including in silico T cell epitope prediction, HLA binding assays, and human T-cell assays, accompanied by comprehensive reports summarizing findings and recommending next steps to support regulatory submissions.
A key milestone this year was the submission of the PANDA® methods as a Model Master File (MMF) to the FDA. This submission provides FDA reviewers with detailed descriptions of the underlying models and validation data supporting PANDA, allowing sponsors to reference an established, regulator-reviewed framework rather than resubmitting the same technical documentation with each ANDA. By aligning PANDA with the FDA’s MMF initiative, EpiVax helps reduce review burden, improve consistency in regulatory evaluation, and accelerate the path to approval for generic peptide therapies.
The application of the PANDA framework to a real-world generic was described in another 2025 publication, written in collaboration with FDA and CUBRC thought leaders, examining peptide-related impurities in generic teriparatide. Using the PANDA orthogonal methods, the study evaluated the immunogenic risk of both process- and product-related impurities and identified specific sequences with the potential to elicit immune responses not observed in the reference drug. These findings reiterated the value of combining in silico predictions with targeted in vitro assays to distinguish clinically relevant risk and demonstrated how PANDA can be used to generate actionable, regulator-ready data to support immunogenicity-relevant bioequivalence assessments for generic peptide drugs.
Additional Research Contributions
EpiVax also contributed to a range of research in other areas this year, spanning vaccine immunogenicity, neoantigen discovery, and immune biobanking, including:
Connecting with the Global Immunology Community
EpiVax played an active role in convening and contributing to scientific dialogue across the immunology space. Through a combination of co-organized workshops and international symposia, the team engaged with academic, industry and regulatory experts to examine how advances in biotechnology and computational approaches are reshaping the future of biologic and vaccine development.
The AI / HI Workshop, held in our hometown of Providence, RI, explored how artificial and human intelligence interact to advance translational medicine; from developing new therapies to interpreting complex immune responses. Thought leaders from academia, industry and government joined the conversation, sharing personal insights and practical applications.
In Japan, we hosted the Westin Immunogenicity Seminar for the 17th year, focused on emerging modalities and AI-powered immunogenicity assessment. We also brought experts together in Europe for the 11th annual Amsterdam Immunogenicity & Tolerance Seminar, which featured rich discussions around tolerance mechanisms, Treg and Breg biology, and emerging approaches to monitoring immune responses.
A standout moment came at the premier Tregs as Medicine: Tolerance and InTolerance Symposium in Tokyo, which celebrated the impact of regulatory T cells on biologics and vaccines while honoring the foundational work that made it all possible. The event marked the 30th anniversary of Distinguished Professor Shimon Sakaguchi’s landmark Journal of Immunology publication, uncovering the concept of peripheral immune tolerance. Professor Sakaguchi delivered the keynote address, followed by a curated program of expert speakers exploring how advances in Treg biology have shaped new approaches to treating autoimmune disease, cancer, and other immune-mediated conditions. The Nobel Prize in Medicine was awarded to Sakaguchi just a few days later, underscoring the lasting global significance of his discovery.
Expert speakers at the Tregs as Medicine: Tolerance and InTolerance Symposium, including Distinguished Professor Shimon Sakaguchi (center).
Supporting Health Beyond the Lab
EpiVax continued its commitment to giving back through employee-led initiatives and long-standing nonprofit partnerships. Through the Vax Gives Back program, employees directed corporate giving toward local and global organizations supporting health, food security, education, and disaster response. We also upheld our annual holiday tradition of matching donations made by our clients and partners, amplifying the impact of their generosity to causes that matter most to them.
EpiVax remains proud to support GAIA Vaccine Foundation and Clínica Esperanza/Hope Clinic (CEHC), two organizations whose missions closely align with our own. GAIA focuses on expanding access to vaccines and preventative care in underserved communities worldwide, pairing scientific rigor with community-based programs that emphasize education and trust. CEHC serves uninsured and underinsured populations in Rhode Island by providing culturally responsive, linguistically appropriate care with a focus on prevention and long-term community health. Both organizations achieved meaningful progress across the public health sectors they serve this year, read more about their accomplishments here.
What Comes Next
2025 was a landmark year for EpiVax, full of major accomplishments in science, technology and partnerships. We celebrated strategic leadership growth, rolled out significant updates to our computational tools, and contributed new data to the field. Across the globe, we connected with the immunology community through events and collaborations, while continuing to support lifesaving nonprofit programs.
As we step into 2026, we are excited about what’s to come—new computational capabilities, advanced laboratory services, expanded consulting opportunities, and more— all with the goal of helping developers advance safer, more effective biologics and vaccines. We’re eager to build on the progress made in 2025 and continue turning scientific insights into meaningful impact for human and animal health.
