National Institutes of Health
BlueWillow has maintained a strategic relationship with NIH, which has continued to support the development of several key intranasal NanoVax vaccines:
Peanut Allergy – in 2019, BlueWillow received an SBIR Fast-Track award from NIH for up to $3.2 million to advance the development of the company’s intranasal immunotherapy for patients suffering from peanut allergy. In animals, 3 doses of the company’s intranasal peanut immunotherapy has been shown to (i) induce mucosal immune responses in the gastrointestinal tract where the allergen enters the body, (ii) induce Th1 immunity while suppressing pre-existing Th2 allergic immunity and IgE antibody production, and (iii) provide long-term protection against inflammatory and anaphylactic responses upon subsequent exposure to peanut allergen.
Pandemic Influenza – BlueWillow and the University of Michigan have received two consecutive $10 million contracts from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the NIH, to develop BlueWillow’s intranasal NanoVax platform and to study the platform’s application to pandemic influenza vaccines. The company’s intranasal NanoVax rH5 vaccine has demonstrated safety, immunogenicity and efficacy in mice, ferrets and rabbits and is expected to enter Phase 1 human testing in 2020.
Anthrax – the company has an ongoing partnership with Porton Biopharma Limited and Public Health England (PHE) to develop an intranasal NanoVax rPA vaccine through Phase 1 human testing, under a $24 million contract award from NIAID. The intranasal NanoVax anthrax vaccine has demonstrated safety, immunogenicity and efficacy in the primary rabbit model, and is currently in Phase 1 human testing.
Respiratory Syncytial Virus (RSV) – pursuant to BlueWillow’s agreement with the Division of Microbiology and Infectious Diseases (DMID), a division of NIAID, DMID has agreed to fund certain studies in support of developing an intranasal NanoVax vaccine for RSV. This has included the completion of studies demonstrating the efficacy of an intranasal NanoVax pre-F vaccine in a cotton rat challenge model.
Pertussis – DMID has also provided recent support to study application of the NanoVax platform in vaccines for pertussis. Research has included completion of studies demonstrating (i) the efficacy of an intranasal NanoVax aP vaccine in a baboon challenge model, and (ii) the ability of an intranasal NanoVax aP vaccine to effectively boost rats that were previously vaccinated with intramuscular alum aP.
STI infections – BlueWillow’s intranasal vaccine programs for chlamydia and HSV-2 have been the recipient of recent NIH SBIR Phase I and Phase II grants. In addition, the company has received directed funding from DMID which allowed for the completion of studies demonstrating the efficacy of an intranasal NanoVax gD2/gB2 vaccine in both the prophylactic and therapeutic guinea pig HSV-2 challenge models.
Porton Biopharma Limited & Public Health England
Development of an intranasal NanoVax anthrax vaccine is ongoing through BlueWillow’s partnership with Porton Biopharma Limited (PBL), a company formed by Public Health England. The research is being conducted under a contract from NIAID for the development of a next-generation NanoVax anthrax vaccine. The contract could be worth up to $24 million over its eight-year term if all options are exercised. The vaccine combines BlueWillow’s novel intranasal NanoVax system with recombinant protective antigen (rPA) for anthrax from PBL.
University of Maryland School of Medicine
Development of an intranasal NanoVax pandemic influenza vaccine is ongoing through BlueWillow’s partnership with the University of Maryland. The research is being advanced through a U01 contract awarded by NIH to Maryland for conducting a Phase 1 human clinical study of an intranasal NanoVax rH5 vaccine. The vaccine combines BlueWillow’s novel intranasal NanoVax system with plant-based recombinant H5 antigen from Fraunhofer USA’s Center for Molecular Biotechnology.
The Gates Foundation
BlueWillow and the University of Michigan previously received two $6 million grants from The Gates Foundation to advance preclinical research of BlueWillow’s intranasal NanoVax platform for use in vaccines for Hepatitis B and RSV. The grants funded critical research studies demonstrating the safety, immunogenicity and efficacy of intranasal NanoVax vaccines in several animal models, and the long-term stability of the vaccines at room temperature.
Leading Research Institutions
BlueWillow has ongoing collaborations with several leading research institutions who are studying application of the company’s intranasal NanoVax platform for challenging diseases, including:
- Chlamydia – Dr. Toni Darville, the University of North Carolina School of Medicine, and Dr. Ken Beagley, Queensland University of Technology
- HSV-2 – Dr. David I. Bernstein, Cincinnati Children’s Hospital Medical Center
- Peanut and Other Food Allergies – Dr. James R. Baker and Dr. Jessica J. O’Konek, the Mary H. Weiser Food Allergy Center at the University of Michigan
- Tuberculosis – Dr. Shabaana Khader, Washington University in St. Louis School of Medicine
- Universal Influenza – Dr. Ted M. Ross, the University of Georgia Center for Vaccines and Immunology
BlueWillow has ongoing collaborations with several leading pharmaceutical companies who are studying the company’s novel NanoVax adjuvant platform for selected disease targets using intramuscular, intranasal or dermal application. The companies and the disease targets are not disclosed here given confidentiality restrictions.