Salute e Benessere
EpiVax and CUBRC Awarded FDA Contract Worth $2M for Development of Control Peptides for Immunogenicity Risk Assessment Assays Supporting Regulatory Filings of Generic Peptide Drugs
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.
For the latest research program, EpiVax will identify and qualify 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 by leading in the development of new industry standards for generic peptide drug immunogenicity assessment.
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 www.epivax.com for more information.
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 www.cubrc.org for more information.
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.
Sarah Moniz
Director, Business Development
EpiVax
smoniz@epivax.com