September 6, 2016 (Providence, RI) – EpiVax, Inc., “immune engineering” pioneer, has won a new $600,000 National Institutes of Health grant under the Small Business Innovation Research (SBIR) program to improve a vaccine for the problematic H7N9 avian influenza virus. The vaccine development program will be directed by Annie De Groot, M.D., EpiVax CEO/CSO, and Lenny Moise, Ph.D., EpiVax Director of Vaccine Research, and carried out in collaboration with Ted Ross, Ph.D., Professor, Department of Infectious Diseases, and Director, Center for Vaccines and Immunology, University of Georgia.

H7N9 influenza has earned the moniker “stealth virus” for the ability to evade the human immune response, both in natural infection[1] and in vaccine formulations[2]. H7N9 vaccines developed using conventional methods have significantly underperformed in the clinic[3][4][5]. EpiVax’s SBIR-funded avian influenza research program aims to re-engineer H7N9 viral proteins to be more easily detected by the immune system, resulting in a more potent vaccine product. The first version of the optimized influenza vaccine designed by EpiVax will soon enter a Phase I trial in Australia, in collaboration with Vaxine (Australia) and Protein Sciences Corporation (Connecticut).

Dr. Manon Cox (Protein Sciences CEO) said “We are pleased to work with EpiVax in exploring the potential of immune engineering”. Protein Sciences is the manufacturer of Flublok® – the only FDA-approved recombinant influenza vaccine – a production platform  that can be used to make better influenza vaccines faster.

The goal of the SBIR-funded avian influenza program is to explore additional ‘camouflage’ sequences in the influenza virus, and to further validate the discovery of regulatory T cell epitopes (Tregitopes) in human pathogens, a novel means of immune escape now known as “immune camouflage”[6].

H7N9 influenza emerged in China in 2013, and has one of the highest mortality rates among all avian influenza viruses for humans (30%). Although sustained human-to-human spread of this virus has yet to occur, the high lethality of this virus is of great concern, should it develop pandemic potential. Re-engineering the viral proteins to be more immunogenic without modifying its ability to generate protective antibodies to the original, ‘wild-type’ version is the primary focus of the work to be carried out under this SBIR Program.

EpiVax is one of the founding members of Rhode Island’s expanding biotechnology community. “We are fortunate to have Dr. Annie De Groot and her team conducting innovative biotech research here in Rhode Island,” said Senator Sheldon Whitehouse.  “This federal funding is a boost for EpiVax’s work to engineer new vaccines and an investment in Providence’s life sciences industry.”

“This grant is evidence of the world-class life science innovations taking place in Rhode Island every day,” said Rhode Island Secretary of Commerce Stefan Pryor. “A fine example of our state’s high-performing companies, EpiVax continues to be a cornerstone of our local biotech industry. The NIH’s funding for this important research is in extremely capable hands.”

About EpiVax
EpiVax, Inc. is a privately-held biotechnology company that is focused on the development of vaccines and immunotherapies for infectious diseases, autoimmunity and cancer. Led by Dr. Anne S. De Groot, M.D., an internationally recognized vaccine design thought leader, the company has enjoyed significant success in the fields of immunology and bioinformatics. The immunoinformatics team at EpiVax have also developed the cloud-based ISPRI and iVAX toolkits, used by a global roster of companies to design and optimize therapeutic proteins and vaccines.

Side-stepping Immune Camouflage and Stealth Pathogens to make Better Vaccines
Scientific studies validating the “stealth” virus and immune camouflage concepts are described in greater detail in publications by De Groot and Moise that are freely accessible on PubMed.

About previous commercial Avian Influenza H7N9 vaccines:
The Novartis vaccine company reported that H7N9 cell culture-produced vaccine without adjuvant produced seroconversion rates of 6%. In contrast, the rate of seroconversion to unadjuvanted monovalent pandemic H1N1 was 89% in one study. Rates of seroconversion to trivalent seasonal vaccine are 84% on average to the three strains of virus in the vaccine.

NIH funding statement
Research reported in this release is to be supported by the National Institute of Allergy And Infectious Diseases of the National Institutes of Health under grant number R43AI118189. The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

[1] doi:10.4161/hv.36134
[3] doi:10.4161/hv.24939
[4] doi:10.4161/hv.28135
[5] doi:10.1056/nejmc1313186
[6] doi:10.1586/14760584.2016.1123098

Media Contact:
Steven Vessella

Dr. Annie De Groot