EpiVax

What EpiVax does

EpiVax is a Providence, Rhode Island-based contract research organization (CRO) founded in 1998 that specializes in computational immunogenicity risk assessment for biologic therapeutics, vaccines, and generic peptide drugs. The company combines proprietary in silico T cell epitope prediction algorithms (EpiMatrix®, JanusMatrix™, ClustiMer™, OptiMatrix™) with human-relevant in vitro assay services (Whole Blood, PBMC, DC:PBMC, Class II HLA Binding) to provide integrated immunogenicity screening, protein reengineering, and regulatory submission support. Its flagship ISPRI™ platform and iVAX™ vaccine design toolkit serve pharmaceutical, biotech, vaccine developer, and generic peptide clients, with the PANDA® service specifically supporting FDA ANDA pathway approvals (16+ supported to date) and the Ancer® platform addressing personalized neoantigen-based cancer vaccine development.

EpiVax generates revenue through five primary streams: tiered fee-for-service computational analyses (ISPRI Downselect™, Quantify™, Evaluate™, HCP™), in vitro laboratory assays, Trusted Expert Advice (TEA) consulting and IRA/ISI regulatory writing services, software licensing of ISPRI™ and iVAX™ platforms (annual subscriptions), and technology licensing of Tregitopes™ and Ancer® for partner development. The company employs 11-50 staff operating from a single Providence headquarters, with sales executed through a dedicated business development team employing consultative, relationship-driven engagement with scientific experts. Marketing relies on scientific thought leadership: 240+ peer-reviewed publications, annual industry seminars (Amsterdam, Japan Westin for 17 years, AI/HI Workshop), and direct enterprise outreach to pharmaceutical R&D leaders.

In April 2026, EpiVax was acquired by SV Health Investors, a healthcare-focused private equity firm, with founders Annie De Groot and Bill Martin transitioning to consulting roles. Under new ownership, the company has expanded its laboratory footprint, launched AI-driven ADA prediction capabilities (74% accuracy within 10% of clinical rates), and broadened its platform into emerging modalities including gene therapy and CAR-T. The firm maintains ongoing FDA co-development relationships through grants and contracts, and counts 18 of the top 20 global pharmaceutical companies among its historical client base.

Name

EpiVax

Legal name

EpiVax, Inc.

Website

https://epivax.com

Company type

Private

Founded year

1998

Operating status

Operating

Headcount range

11–50 employees

Short description

EpiVax is a Providence, RI-based CRO providing computational immunogenicity risk assessment and in vitro assay services for biologic, vaccine, and generic peptide developers, combining proprietary T cell epitope prediction algorithms with regulatory submission support serving top global pharma companies.

Ownership category

akta.pro rank

Product category

Immunogenicity Risk Assessment Services

NAICS

Medical and Diagnostic Laboratories (62151)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Pharmacovigilance, Risk Management & Medical Affairs CROs (HLAGAAAH)

akta.pro secondary industries

Clinical CROs (Phase I–IV) (HLAGAAAA), Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL)

Keywords

• Immunogenicity risk assessment
• T cell epitope prediction
• Computational immunology services
• Biologics deimmunization
• Vaccine design tools

Headquarters

HQ city

Providence

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Fee-for-Service Computational Analysis: EpiVax provides in silico immunogenicity risk assessment services through multiple tiers (ISPRI Downselect™, ISPRI Quantify™, ISPRI Analyze™, ISPRI Evaluate™, ISPRI-HCP™, ISPRI Design™). Clients submit biologic sequences for expert analysis, receiving comprehensive reports on T cell epitope content and immunogenic potential.
2. In Vitro Assay Services: Fee-for-service laboratory testing services including Whole Blood Assay, PBMC Assay, DC:PBMC Assay, Class II HLA Binding Assay, T cell Assay, and Innate Immune Response Assay. Assays are modular and scalable based on development phase and program needs.
3. Consulting Services (Trusted Expert Advice): Personalized consulting services providing one-on-one expert guidance on immunogenicity risk strategy, regulatory engagement, and development decisions. Includes IRA and ISI writing services for regulatory submissions.
4. Software Licensing (ISPRI™/iVAX™): Licensing agreements allowing biotech companies to directly access ISPRI™ and iVAX™ platforms for self-serve immunogenicity screening and vaccine design. Provides secure, seamless integration into preclinical R&D workflows.
5. Technology Licensing (Tregitopes™, Ancer®): Licensing of proprietary technologies including Tregitopes™ (tolerance-inducing peptides) and Ancer® platform for personalized cancer vaccine design to pharmaceutical and biotech partners.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels6 records

Core offering

EpiVax is a Contract Research Organization (CRO) that provides immunogenicity risk assessment for biologic therapeutics, biosimilars, vaccines, and personalized cancer immunotherapies. It delivers fee-for-service in silico analyses via the ISPRI™ platform, in vitro human cell-based assays (NAMs), and expert consulting — helping pharmaceutical and biotech developers predict, mitigate, and document immune responses for IND, BLA, and ANDA regulatory submissions.

Product overview

EpiVax offers an integrated portfolio of computational and experimental solutions for immunogenicity risk assessment spanning therapeutic and vaccine development. The core ISPRI™ (Immunogenicity Screening and Protein Reengineering Interface) platform provides in silico T cell epitope prediction and analysis tools including EpiMatrix®, JanusMatrix™, ClustiMer™, and OptiMatrix™ for identification, characterization, and deimmunization of biologic candidates. Service tiers include ISPRI Downselect™ (high-throughput screening), ISPRI Quantify™ (rapid lead candidate assessment), ISPRI Evaluate™ (comprehensive written evaluation), ISPRI-HCP™ (host cell protein assessment), and ISPRI Design™ (in vitro study preparation). The PANDA® (Peptide Abbreviated New Drug Application) Screening program supports generic peptide ANDA submissions through orthogonal in silico and in vitro methods. For vaccines, the iVAX™ toolkit enables computational vaccine design while Ancer® provides personalized neoantigen-based cancer vaccine development. The EpiCC™ tool assesses vaccine efficacy through epitope content comparison. Laboratory services include Whole Blood, PBMC, and DC:PBMC assays plus Class II HLA Binding Assay for in vitro validation. Consulting offerings include Trusted Expert Advice (TEA) for strategic immunogenicity guidance and IRA/ISI Writing Services for regulatory submissions. All offerings leverage the company's proprietary T cell epitope prediction technology validated across 28 years and 240+ peer-reviewed publications.

Differentiator

Problem solved

Functional benefit

Brands

• ISPRI: Interactive Screening and Protein Reengineering Interface - comprehensive in silico toolkit for immunogenicity risk assessment and optimization of biologic drugs
• iVAX
• PANDA
• Ancer
• EpiCC
• EpiMatrix
• JanusMatrix
• Tregitopes

Products and services

• ISPRI™ (Interactive Screening and Protein Reengineering Interface) EpiVax's flagship in silico toolkit for immunogenicity risk assessment and optimization of biologic drugs during drug discovery and preclinical development. Available through software licensing agreements, it integrates tools for T cell epitope identification, characterization, and deimmunization. Used by leading global pharmaceutical companies for decades.
• PANDA® Screening (Peptide Abbreviated New Drug Application) Comprehensive generic peptide immunogenicity assessment service supporting FDA ANDA pathway approval. Multi-step process includes in silico analysis evaluating immunogenic potential of impurities using proprietary tools and in vitro validation assessing innate and adaptive immunogenic potential through orthogonal approaches. EpiVax has supported 16 successful ANDA approvals to date.
• iVAX™ Integrated web-based toolkit for computational vaccine design enabling discovery and optimization of T cell epitope triggers key to protective immune responses. Applied to epitope mapping, antigen selection, immunogen design, and prediction of vaccine efficacy for biothreats, emerging infectious diseases, and cancers.
• Ancer® End-to-end automated neoantigen identification and personalized cancer vaccine design platform integrating multiple advanced algorithms to rapidly design custom therapies for individual cancer patients using their tumor genome sequence as the starting point.
• EpiCC™ (Epitope Content Comparison) Epitope Content Comparison tool enabling assessment of T cell epitope homology between vaccine and related protein sequences or pathogens. Higher EpiCC™ scores correlate with greater vaccine protection against challenge strains. Powers Zoetis' award-winning Circo-Match™ tool for predicting PCV2 vaccine effectiveness.
• PreVAX™ Vaccine immunogenicity assessment service using the iVAX™ toolkit where immunoinformatics experts analyze antigen sequences and compile comprehensive reports on whole protein and regional immunogenic potential to compare, prioritize, select and optimize antigen sequences during vaccine development.
• Class II HLA Binding Assay Cell-free in vitro assessment using recombinantly produced Class II HLA-DR supertype alleles to measure relative binding affinity of putative HLA ligands in a competition-based assay, enabling coverage of prevalent HLA types across the human population.
• Whole Blood Assay In vitro assay evaluating cytokine release from human whole blood following exposure to test articles using multiplexed cytokine analysis (Luminex), providing early insight into immune overstimulation risk and innate activation mechanisms relevant to immunotoxicities and critical quality attributes.
• PBMC Assay Modular in vitro assay evaluating innate and/or adaptive immune responses through cytokine profiling (Luminex or FluoroSpot) and cell activation/proliferation (flow cytometry) readouts using peripheral blood mononuclear cells, customizable for discovery, characterization, or regulatory submissions.
• DC:PBMC Assay Dendritic cell and PBMC co-culture assay assessing adaptive immune responses in a mechanistic context through cell activation/proliferation and cytokine profiling, particularly valuable for immunogenicity risk assessment of immunomodulatory products.
• Tregitopes™ Immune-modulating peptides derived from human immunoglobulin that activate natural regulatory T cells, binding to multiple MHC class II molecules, suppressing effector T-cell responses, and upregulating Treg-associated cytokines. Available for licensing for autoimmune, allergy treatments, and tolerance induction applications.
• Trusted Expert Advice (TEA) Personalized consulting service providing one-on-one partnerships with experienced immunogenicity consultants for preclinical and clinical immunogenicity risk strategy, regulatory requirements navigation, and biologic therapeutic pipeline enhancement.
• IRA & ISI Writing Services Expert consulting for Immunogenicity Risk Assessment (IRA) and Integrated Summaries of Immunogenicity (ISI) writing, supporting development of cohesive regulator-ready submission packages integrating computational and experimental data into defensible narratives.

Quantifiable outcome

• Saves up to 20-fold resources by reducing downstream in vitro and in vivo studies through early in silico screening
• +3 more outcomes

Named customers5 records

Segments5 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

Yes

API docs

API detail

Core technology

AI maturity

App detail

AI capability8 records

Feature9 records

Partnerships

Six partnerships are on record, tiered core, strategic and social impact.

• CUBRC, Inc.coreStrategic or Co-development Partner · 1 December 2025EpiVax collaborated with FDA scientists and CUBRC, Inc. to publish a study on immunogenicity risks of peptide-related impurities in generic teriparatide products. CUBRC provides technical expertise in biomedical research, systems integration, and program management for immunogenicity assessment collaborations with FDA.
• FDA (Food and Drug Administration)coreStrategic or Co-development Partner · 1 September 2022EpiVax received a two-year, $2 million grant from FDA's Office of Center for Drug Evaluation and Research to develop immunogenicity risk assessment methods for biosimilar products. Research starting September 2022 aims to validate in silico tools to improve biosimilar safety and expedite risk assessment for biologics. This builds on previous collaborations with FDA scientists.
• ZoetiscoreTechnology or IntegrationEpiVax and Zoetis collaborated to develop Circo-Match™, an award-winning bioinformatic tool that incorporates EpiCC™ to predict coverage of Porcine Circovirus Type 2 (PCV2) vaccines against field isolates. The tool enables swine veterinarians and producers to make informed vaccination program decisions, improving animal care and farm profitability.
• IntravaccstrategicStrategic or Co-development PartnerEpiVax joined Intravacc and CEPI on a project to develop a universal betacoronavirus vaccine. This collaboration leverages EpiVax's expertise in computational vaccine design and T cell epitope optimization for broad-spectrum coronavirus vaccine development.
• GAIA Vaccine Foundationsocial impactOthersNonprofit partnership supporting global vaccine access and preventive care in underserved communities. GAIA focuses on community-based programs emphasizing education and trust, aligning with EpiVax's mission to improve global health outcomes.
• Clínica Esperanza/Hope Clinic (CEHC)social impactOthersNonprofit partnership serving uninsured and underinsured populations in Rhode Island with culturally responsive, linguistically appropriate preventive care. EpiVax supports CEHC through charitable giving and volunteer efforts as part of its corporate responsibility program.

Scale indicators9 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• ProImmune: ProImmune is a UK-based specialty CRO that provides immunogenicity risk assessment services for biologics using proprietary MHC-peptide binding assays and T cell epitope analysis. It directly competes with EpiVax's ISPRI and in vitro assay services for the same pharmaceutical and biotech customer base.
• Abzena: Abzena is a CRO/CDMO specializing in biologics development with dedicated immunogenicity and bioanalytical services including anti-drug antibody assays and risk assessment. Its integrated discovery-to-manufacturing model overlaps with EpiVax's preclinical immunogenicity focus.
• BioAgilytix: BioAgilytix is a bioanalytical CRO specializing in pharmacokinetics, immunogenicity, and biomarker services for biologics. It directly competes with EpiVax's in vitro assay and ADA assessment services for pharma and biotech clients in regulated studies.
• ImmunXperts (a Lonza company): ImmunXperts, acquired by Lonza, is a specialized immunogenicity CRO offering in vitro T cell and B cell assays for biologics. It directly competes with EpiVax's PBMC, DC:PBMC, and HLA binding assay services.

Broad incumbents

• Lonza Biologics: Lonza is a global CDMO/CRO providing biologics development and manufacturing services including bioanalytical and immunogenicity offerings. As a broad incumbent, it serves many of the same large pharma customers that EpiVax supports.
• WuXi AppTec: WuXi AppTec is a global CRO/CDMO with comprehensive biologics testing services including immunogenicity assessment. As a broad incumbent with strong Asian market presence, it competes for the same multinational pharma clients.
• Charles River Laboratories: Charles River is a large, publicly-traded CRO offering comprehensive preclinical and clinical services including immunogenicity assessment for biologics. As a broad incumbent, it offers overlapping capabilities but is not specialized in EpiVax's niche computational immunology approach.
• Labcorp Drug Development: Labcorp (formerly Covance) is a global CRO with extensive bioanalytical and immunogenicity capabilities serving large pharma. It competes broadly with EpiVax's preclinical services but lacks EpiVax's specialized in silico T cell epitope prediction platform.

Others

• Bio-Rad Laboratories: Bio-Rad is a life science tools provider offering HLA typing products and bioanalytical instruments used by immunogenicity researchers. As an enabling technology supplier, it provides complementary rather than competing services to EpiVax's CRO offerings.

Emerging players

• NeoPhore: NeoPhore is an emerging cancer immunotherapy company using neoantigen identification approaches. Its focus on personalized neoantigen vaccines overlaps with EpiVax's Ancer® platform and represents both a potential customer and competitor in the precision oncology space.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/epivax-inc-
• Xx.com/EpiVax

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Subsidiaries1 record

Funding overview

Funding rounds11 records

Investors3 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about EpiVax