Buffalo, NY – October 2, 2018 – CUBRC, Inc.’s President and CEO, Tom McMahon, announced today that CUBRC, in collaboration with EpiVax, Inc., was awarded a two-year contract worth $1.0 million from the Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS). The new program is relevant to the new draft guidance issued by the Office on Generic Drugs (OGD) highlighting the use of in silico analysis in accelerated new drug applications for generic peptide drugs [for additional info see link to FDA guidance here: FDA].
CUBRC and EpiVax will demonstrate and validate risk assessment methods for generic peptides. OGD scientists will also have access to the EpiVax ISPRI Toolkit for selected peptide drugs and their impurities. 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 further develop these in silico tools to investigate risk for generic peptides. Our commitment to excellence and our outstanding performance history allows us to collaborate with great partners like EpiVax.”
CUBRC will leverage its technical expertise in biomedical R&D and its experience leading large federally-funded contracts and grants to execute the research with EpiVax. “CUBRC plans to leverage our 3+ year partnership with EpiVax to provide systems integration and program management expertise to advance EpiVax’s highly specialized immunoinformatic tools, which will help the FDA with the evaluation of new generic peptide drugs,” according to Katie Edwards, Ph.D., CUBRC’s Co-Principal Investigator and program lead.
The goal of this research program will be to identify best practices and procedures for assessing generic peptides and related impurities for immunogenic potential. “EpiVax has worked hard to be at the forefront of immunogenicity assessment using our proprietary immunoinformatics tools. These tools make it possible perform risk assessments accurately and expeditiously. We look forward to working with FDA scientists to set new standards for immunogenicity risk assessment for generic peptide drug products,” stated Annie De Groot, MD, EpiVax’s CEO/CSO.
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.
EpiVax is a 20-year old privately-held biotechnology company located in Providence RI, with a broad portfolio of projects including vaccines and immunotherapies for infectious diseases, autoimmunity and cancer. Scientists at EpiVax, led by co-founders Annie De Groot and Bill Martin, lead the field in immunogenicity risk assessment. The ISPRI and iVAX toolkits for therapeutics and vaccines are used by a global roster of companies. Visit www.epivax.com for more information.
EpiVax’s spin-out company, EpiVax Oncology, is leveraging a peptide-driven personalized cancer immunotherapy program. Visit www.epivaxonco.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 (~$1.0M) will be financed with federal money.