This federal Project Grant award from the National Institute of Allergy and Infectious Diseases (NIAID), under the Allergy and Infectious Diseases Research program (CFDA 93.855), provides $390,942 to the Georgia TECH Research Corp to develop a universal influenza vaccine using self-assembled peptide nanoparticles (SAPNs). The goal is to present conserved influenza antigens, including the hemagglutinin stalk (HRHA) and matrix protein 2 ectodomain (4M2E), in a highly repetitive array on the SAPN...
The National Institute of Allergy and Infectious Diseases (NIAID) awarded Orlance, Inc., a woman-owned small business, a $300,000 Project Grant under the Allergy and Infectious Diseases Research program (CFDA 93.855) to develop an enhanced seasonal influenza DNA vaccine. The project aims to combine the advantages of a closely matched seasonal influenza vaccine with a universal influenza vaccine to provide more robust and durable protection, especially for the elderly and immunocompromised...
This Project Grant award of $709,236 from the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research program (CFDA 93.855) aims to develop a nanoparticle-based adjuvant formulation containing a TLR7 agonist to overcome immunodominance and induce broad antibody responses against the influenza virus. The primary research goals are to: 1) Determine how the TLR7 nanoparticle adjuvant impacts immunodominance, breadth, and tolerance across...
The Defense Health Agency awarded Flugen Inc. a $6,237,445 Project Grant under the Military Medical Research and Development program (CFDA 12.420) to optimize downstream recovery and stabilization of the drug substance for their intranasal influenza vaccine. The three-year grant also supports research on concurrent administration of Flugen's H3N2 M2SR monovalent influenza vaccine with inactivated flu vaccines in older adult populations. This award builds on Flugen's previous federal grants...
The University of Missouri System, under a $650,000 project grant from the USDA National Institute of Food and Agriculture (NIFA) Agriculture and Food Research Initiative (AFRI) program, is developing safe and effective live attenuated swine influenza vaccines using Newcastle disease virus (NDV) as the vector. The project aims to address the challenges with current swine influenza vaccines, which often fail to provide cross-protection against diverse virus strains. The key products and...
This Project Grant award of $811,009 from the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research program (CFDA 93.855) aims to develop a new technology called the Shear-Force Avidity-based Cell Selector (SACS) to assess functional immunity to influenza infection. The primary objectives are to: 1) enhance and optimize a microfluidic device to capture and separate B cells based on their B cell receptor (BCR) binding avidity to influenza...
This federal Cooperative Agreement award, valued at $1,225,986.00, was granted by the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research program (CFDA 93.855). The purpose of the award is to study the factors that determine a strong, durable, and broadly protective adaptive immune response to influenza vaccination, particularly in individuals with prior exposure to the virus. The University of Chicago, the awardee, will conduct a...
This federal Project Grant award from the National Institute of Allergy and Infectious Diseases (NIAID), under the Allergy and Infectious Diseases Research program (CFDA 93.855), provides $668,569.00 to characterize and optimize a novel genetic vaccine platform called PARVAX. The key objectives are to: Investigate the mechanism behind the potency and durability of the PARVAX platform, hypothesized to be correlated with antigen expression kinetics. Use rational engineering approaches to enhance...
This Project Grant from the National Science Foundation's Technology, Innovation, and Partnerships program totaling $256,000 will develop Recombinant BCG as a novel immunoadjuvant for viral infections. The awardee, Oncosting LLC located in Baltimore, Maryland, will optimize media and lyophilization manufacturing of BCG-STING, evaluate its immunological effects as an adjuvant for H1N1 influenza vaccination, and assess its protective effects as an H1N1 vaccine adjuvant. By adding stimulator of...
This Project Grant award of $755,225.00, provided by the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research program (CFDA 93.855), supports the development of a unique vaccine to prevent future pandemics caused by emerging coronavirus (CoV) strains. The goal is to design a mucosal CoV vaccine that targets conserved CoV antigens (S2, M, N) to induce protective T-cell responses, particularly tissue-resident memory T cells in the upper...
ADVANCED TESTING OF A HEXAVALENT ADJUVANTED INFLUENZA VACCINE PLATFORM FOR DOSE SPARING, MULTIPLEXING, AND RAPID DEPLOYMENT - ABSTRACT INFLUENZA IS THE CAUSE OF CONSIDERABLE MORBIDITY AND MORTALITY GLOBALLY. DESPITE IMMUNIZATION BEING THE MOST EFFECTIVE AND ECONOMICAL PROPHYLACTIC APPROACH, VACCINES OFTEN PROVIDE LESS THAN OPTIMAL DEFENSE AGAINST AN INFLUENZA VIRUS INFECTION AND ILLNESS. WHILE HEMAGGLUTININ (HA) IS THE PRIMARY TARGET OF INFLUENZA VACCINES, IT IS ALSO KNOWN THAT THE OTHER MAJOR SURFACE PROTEIN, NEURAMINIDASES (NA) INDUCES PROTECTIVE ANTIBODIES. THIS DIRECT TO PHASE 2 SBIR PROPOSAL CONTINUES OUR DEVELOPMENT AND CHARACTERIZATION OF A UNIQUE VACCINE PLATFORM THAT HAS BEEN FORMULATED BY POP BIO. THIS PLATFORM CONSISTS OF FABRICATING LIPID BILAYER NANOLIPOSOMES WITH A COBALT- PORPHYRIN MOIETY INTERCALATED INTO THE BILAYER (COPOP) ALONG WITH A MONOPHOSPHORYL LIPID A, A TLR4-BASED VACCINE ADJUVANT, AND A SAPONIN QS-21. COPOP ENABLES SPONTANEOUS NANOLIPOSOME ADJUVANT PARTICLE FORMATION (SNAP). WHEN SNAP LIPOSOMES ARE COMBINED WITH HIS-TAGGED RECOMBINANT TRIMERIC HAS AND TETRAMERIC NAS, A MOSAIC NANOPARTICLE VACCINE CANDIDATE, SNAP-FLU IS FORMED. THE HIS-TAG STABLY INSERTS INTO THE BILAYER BY ASSOCIATION WITH THE COBALT PRODUCING NANOLIPOSOMES DECORATED WITH THE IMMUNOGENIC INFLUENZA ANTIGENS. IN PRELIMINARY DATA, WE HAVE ESTABLISHED THAT HA AND NA PROTECT MICE FROM LETHAL H1N1, H3N2 AND B STRAIN INFLENZA VIRUS CHALLENGE, WHILE EVEN BETTER PROTECTION IS OBSERVED WITH THE MULTIVALENT SNAP-FLU NANOPARTICLE VACCINE. IT HAS ALSO BEEN SHOWN THAT THIS PLATFORM ALLOWS FOR THE USE OF MUCH LESS ANTIGEN IN THE VACCINE (ANTIGEN SPARING) IN ADDITION TO THE CAPACITY FOR MULTIPLEXING WITH NUMEROUS ANTIGENS FROM DIFFERENT INFLUENZA STRAINS. THIS STUDY WILL INVOLVE POP BIO PRODUCING AND CHARACTERIZING THE PHYSICAL AND CHEMICAL PROPERTIES OF SNAP-FLU. POP BIO WILL INTERACT WITH THE UNIVERSITY AT BUFFALO, BIOQUAL, AND TEXAS BIOMEDICAL RESEARCH INSTITUTE TO ASSESS THE LEVEL OF PROTECTION OF SNAP-FLU AGAINST CHALLENGE WITH MOUSE-ADAPTED STRAINS OF INFLUENZA IN MICE, HUMAN INFLUENZA STRAINS IN FERRETS, AND HUMAN INFLUENZA STRAINS IN NON-HUMAN PRIMATES. THE AMOUNT OF ANTIGEN-SPARING WILL BE DETERMINED AS WILL HEAD-TO-HEAD COMPARISON WITH OTHER COMMERCIALLY AVAILABLE INFLUENZA VACCINE FORMULATIONS. THIS DIRECT TO PHASE 2 SBIR PROPOSAL WILL EXPAND DEVELOPMENT OF THIS PLATFORM TO NOVEL INFLUENZA ANTIGEN DESIGNS IN PREPARATION FOR CLINICAL TRANSLATION.