FDA awards EpiVax $1.1 million research contract

PROVIDENCE – Biotechnology company EpiVax Inc. received $1.1 million in funding Wednesday from the U.S. Food and Drug Administration to further research efforts in the field of informatics and immunology.

The company has been pursuing development of a COVID-19 vaccine and personalized cancer vaccines.

The FDA’s Office of Generic Drugs in the Center of Drug Evaluation and Research awarded the two-year $1.1 million contract to EpiVax and CUBRIC Inc., a Buffalo, N.Y.-based research company.

The funding allows the continuation of a previous two-year collaboration between the two companies in which EpiVax demonstrated the value of in silico tools and in vitro validation methods for the evaluation of generic peptide drugs and their impurities, the company said.

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EpiVax said it analyzed the immunogenic risk of two generic peptide drugs, applying the concepts outlined in FDA draft guidance, ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin, published in 2017.

Since initiating the program, EpiVax produced the “What-If Machine,” an advanced immunoinformatics tool that performs iterative modifications to synthetic peptide drugs entirely in silico, generating a comprehensive list of all potential impurities that might occur due to deletions, insertions, duplications or side-chain modifications at any residue of the active pharmaceutical ingredient. EpiVax said it uses existing algorithms to rank the impurities produced by the What-If Machine – WhIM – for their immunogenic potential in global patient populations. This output enables identification of high-, moderate-, and low-risk impurities prospectively.

The new contract will provide proof of concept for the WhIM, using two case studies as validation. EpiVax will continue to work with Katie Edwards, CUBRC prime technical program lead, to achieve the goals set out in the contract.

“The WhIM has significant potential to contribute to prospective identification of high-risk impurities, allowing for generic peptide drug products to be de-risked early in the development process,” said Dr. Annie De Groot, CEO and chief security officer of EpiVax.

In 2017, EpiVax received funding from the R.I. Commerce Corp. to accelerate development of cancer vaccines using in silico methods. That funding was used in collaboration with Rhode Island Hospital to identify toxins that are capable of directing immune responses, as part of EpiVax’s research of personalized cancer vaccine therapy.

EpiVax is also involved with developing a COVID-19 vaccine, working on several iterations, with partners that include the University of Georgia, Belgian vaccine developer eTheRNA Immunotherapies, and Miramar, Florida biotech outfit Generex and Maryland biotech firm Immunomic Therapeutics.

Cassius Shuman is a staff writer and researcher at the PBN. You may reach him at Shuman@PBN.com.