EpiVax, Inc.

PROVIDENCE, R.I., Dec. 7, 2024 /PRNewswire/ -- EpiVax, Inc., a leader in preclinical immunogenicity risk assessment for biologic and peptide therapeutics, celebrates a productive 2024 marked by scientific innovation, service diversification, and corporate growth. This year, EpiVax expanded the breadth of its immunogenicity risk assessment services with the launch of many new capabilities in the ISPRI™ ( Immunogenicity Screening and Protein Re-engineering Interface) Toolkit and many new assessment offerings. Notably, EpiVax released the ISPRI Downselect™, Quantify™, Analyze™, Evaluate™, Complete™, Optimize™, and Design™ fee-for-service analyses – options that assess biologic modalities at different stages of preclinical development, enabling the ranking of individual candidates, modality-specific benchmarking, sequence optimization and in-depth risk analyses with enhanced accuracy, and more. Class I analysis was also added to the ISPRI toolkit this year for selected gene therapy and CAR-T clients. Further, EpiVax advanced its PANDA® Screening program to support sponsors entering the FDA's Abbreviated New Drug Application (ANDA) pathway for generic peptides and their impurities. Key updates included the release of enhanced adaptive in vitro assay offerings and the Innate Immune Response Assay, establishing EpiVax as a "one stop shop" (featuring in silico, in vitro and innate assessment) for generic drug developers. Additionally, EpiVax and FDA-initiated a new contract to develop standardized controls for T cell assays which will help to improve the specificity and sensitivity of such assays industry-wide. This work was accompanied by notable contributions to the field with the publication of several highly cited articles by the EpiVax team in 2024. As a result of the expanded offerings, EpiVax immunogenicity risk assessment bookings surged nearly 60% over 2023, driven by a doubling of new clientele across the ISPRI™ Access, ISPRI™ Fee-for-Service, and PANDA® service verticals. This success supported an 18% headcount expansion, including strategic leadership additions to continue driving the company's new offerings. Looking to 2025, guided by nearly three decades of "fearless science", EpiVax is prepared to build on this year's achievements by further integrating artificial intelligence and machine learning enhancements to existing platforms, expanding laboratory capability, and adding scientific expertise that will be announced later in the new year. About EpiVax EpiVax is a leader in preclinical immunogenicity assessment and sequence optimization for peptide therapeutics, biologic therapeutics, and vaccines. EpiVax partners with a global roster of companies, agencies, and academics to accelerate immunogenicity risk assessment, immune modulation and rapid vaccine design. Press Contact Sarah Moniz Director, Business Development EpiVax [email protected] Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

PROVIDENCE, R.I., Dec. 6, 2024 /PRNewswire/ -- EpiVax, a leader in biotechnology known for its advanced immunoinformatics tools, proudly announces its continued support for two nonprofits, Clínica Esperanza/Hope Clinic and GAIA Vaccine Foundation. EpiVax supports these organizations through donations, office initiatives, and volunteerism. Clínica Esperanza: Bridging Gaps in Local Healthcare Located two blocks from EpiVax headquarters in Providence, Clínica Esperanza provides free, linguistically appropriate healthcare to Rhode Island's uninsured population, serving over 30,000 patients since 2010. Eighty percent of its patients are Spanish speaking, with care delivered by a multilingual team of staff and volunteers. The clinic's efforts to combat health disparities were highlighted in a recent project, Bridging the Gap (BTG), developed by volunteers. Their report, Continuity of Care and Lifestyle Intervention Programs for Spanish-Speaking Immigrants Without Health Insurance at a Free Clinic in Rhode Island, was published in CDC's Preventing Chronic Disease journal and is being considered for a CDC student research award. Participants saw significant improvements in diabetes and heart disease markers, demonstrating the program's impact. GAIA Vaccine Foundation: Global Impact on Infectious Disease Prevention The GAIA Vaccine Foundation addresses infectious diseases disproportionately affecting underserved populations in West Africa, improving access to preventive interventions like vaccines and therapeutics. GAIA partners with physicians to implement novel educational outreach and vaccination initiatives in Mali, improving the health of women and their families. GAIA's recent publication, Our Daughters—Ourselves: Evaluating the Impact of Paired Cervical Cancer Screening of Mothers with HPV Vaccination for Daughters to Improve HPV Vaccine Coverage in Bamako, Mali, highlights an innovative approach to cervical cancer prevention. The study demonstrated a 10.7% increase in HPV vaccination rates among out-of-school girls by pairing maternal cervical cancer screenings with their daughters' HPV vaccinations. This approach raised awareness and will expand to more communities as a nationwide HPV vaccination campaign begins in Mali. Supporting Shared Missions Annie De Groot, MD, co-founder, former CEO, and current CSO of EpiVax, takes pride in EpiVax employees' willingness to volunteer with Clínica Esperanza and the company's contributions to both organizations. "This engagement exemplifies EpiVax's commitment to improving human health everywhere," said Dr. De Groot. About EpiVax: EpiVax is a leader in immunogenicity assessment and sequence optimization for biologic therapeutics and vaccines. EpiVax partners with a global roster of companies and agencies to accelerate immunogenicity assessment, immune modulation, and rapid vaccine design. Press Contact: Sarah Moniz Director, Business Development [email protected] SOURCE EpiVax, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

PROVIDENCE, R.I., Oct. 24, 2024 /PRNewswire/ -- EpiVax, Inc. ("EpiVax") and CUBRC, Inc. ("CUBRC") announce today that they have been awarded a two-year, $2 million contract (#75F40124C00094) from the Office of Generic Drugs (OGD) of the Food and Drug Administration (FDA) to develop standardized controls for T cell assays performed to assess the immunogenicity risk of generic drugs in support of ANDA applications as outlined in the relevant FDA guidance. The new contract will establish new "standards" that may be used to enhance specificity and sensitivity across industry assay methods. Generic peptide drugs (including generic versions of well-known brands like Ozempic and Wegovy) play a vital role in improving healthcare access by providing affordable and effective treatment options at a lower cost. FDA has been working to facilitate access to needed medicines at lower costs without sacrificing standards that result in high-quality, safe, and effective medications. See, for example, information provided by the FDA here. The new FDA-funded collaboration builds on research performed by EpiVax during two previous FDA contracts that evaluated the immunogenicity risk of generic drug impurities. Under the first contract, EpiVax demonstrated the value of in silico and in vitro methods for immunogenicity risk assessment of two well-known generic peptide drugs. Under the second contract, EpiVax developed the What-if Machine (WhIM), an algorithm designed to perform iterative modifications to the amino acid sequence of a synthetic peptide drug (in silico), generating a comprehensive list of impurities for that sequence, and prospectively identifying high and low risk impurities to allow for the de-risking of drug products. This information helps to 'frame' the risk for each generic drug and may assist drug developers and FDA reviewers to differentiate impurities that are potentially riskier from those that are lower risk. For the latest research program, EpiVax will identify and qualify standard peptide-sized positive and negative controls to support generic peptide drug ANDA applications for common generic drug peptides such as teriparatide, exenatide, liraglutide and tirzepatide. EpiVax's Peptide Abbreviated New Drug Application (PANDA ®) approach uses the same orthogonal methods utilized to identify and assess potentially immunogenic impurities for the FDA. The approach is described in a review titled "Immunogenicity Risk Assessment of Synthetic Peptide Drugs and Their Impurities." The details of one of the FDA-contracted programs were expanded upon in, "Assessing the Immunogenicity Risk of Salmon Calcitonin Peptide Impurities Using In Silico and In Vitro Methods." EpiVax looks forward to executing this latest FDA-funded research in collaboration with CUBRC and continuing to improve access to safe and effective generic peptide drug products by leading in the development of new industry standards for generic peptide drug immunogenicity assessment. About EpiVax EpiVax is a leader in the industry of immunogenicity assessment and sequence optimization for peptide therapeutics, biologic therapeutics, and vaccines. EpiVax partners with a global roster of companies, agencies, and academics to accelerate immunogenicity risk assessment, immune modulation and rapid vaccine design. Visit for more information. About CUBRC CUBRC is an independent not-for-profit scientific corporation that executes Research, Development, Testing and Systems Integration programs in Medical Sciences, Chemical and Biological Defense, Data Science and Information Fusion, Command and Control, and Hypersonics. Visit for more information. FDA Funding Statement The FDA sponsors the project referenced in this press release. The content of the information does not necessarily reflect the position or the policy of the federal government, and no official endorsement should be inferred. The entire project (~$2M) will be financed with federal money. Press Contact Sarah Moniz Director, Business Development EpiVax [email protected] Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED