Buffalo, NY – October 24, 2024– CUBRC, Inc.’s President and CEO, Tom McMahon, announced today that CUBRC, in collaboration with EpiVax, Inc., was awarded a two-year contract worth $2 million from the Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS). The goal of this research program is to provide information that 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.
The new FDA-funded collaboration builds on research performed by CUBRC and EpiVax during two previous FDA contracts that evaluated the immunogenicity risk of generic drug impurities. Under this newly awarded program (contract No. 75F40124C00094), CUBRC and EpiVax will 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 for generic drugs, such as such as teriparatide, exenatide, liraglutide and tirzepatide. Mr. David Mangino, Vice President of CUBRC’s Chemical, Biological and Medical Sciences Sector, stated, “CUBRC is thrilled to be selected by the FDA to develop these important new standards for the FDA. Our technical excellence and outstanding performance history allow us to collaborate with great partners like EpiVax.”
CUBRC will leverage its technical expertise in biological and medical R&D and its experience leading large federally-funded contracts to execute the program with EpiVax. “CUBRC is very much looking forward to continuing our long partnership with EpiVax and providing systems integration and program management expertise to identify and qualify controls to support generic peptide drug applications for FDA.,” said Katie Edwards, Ph.D., CUBRC’s Co-Principal Investigator and Program Manager.
CUBRC looks forward to executing this latest FDA-funded research in collaboration with EpiVax 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 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 www.cubrc.org for more information.
About EpiVax
EpiVax is a global 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.
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.
For further information regarding this press release, please contact Dr. Katie Edwards of CUBRC at 716-204-5131 or by email at edwards@cubrc.org
