Phase II year
2015
(last award dollars: 2022)
Phase II Amount
$5,908,638
Trellis Bioscience's CellSpot" technology for identification of rare human antibodies with high specificity and affinity against multiple antigen has enabled discovery of highly efficacious strain- independent antibodies to Respiratory Syncytial Virus and to Cytomegalovirus. We have now applied CellSpot to isolate two native human antibodies with broad reactivity to Group 1 and Group 2 influenza A strains respectively. Both of these antibodies have now been shown to have in vivo efficacy. In addition, we have isolated a human antibody with in vitro activity against Influenza B. We propose to advance these therapeutic candidates to IND stage, including additional neutralization studies in vitro and in vivo, manufacturing, toxicity, and PK studies. The resulting clinical candidates are expected to provide potent post-infection antiviral activity against all currently circulating strains, and effective prophylaxis against any emerging pandemic strain.
Public Health Relevance Statement: Public Health Relevance: This project will advance the development of broad spectrum therapeutic antibodies to the influenza virus HA protein. The antibodies will have the ability to protect animals and, ultimately humans, during influenza infection and will be developed as a new therapeutic agent for this disease, with the end result of this work being a fully characterized IND candidate.
NIH Spending Category: Biodefense; Biotechnology; Emerging Infectious Diseases; Immunization; Infectious Diseases; Influenza; Pneumonia & Influenza
Project Terms: Acute; Advanced Development; Affect; Affinity; Animals; Antibodies; Antigens; Antiviral Agents; Arts; base; Binding (Molecular Function); Biodistribution; Biological; biosafety level 3 facility; Birds; cell bank; Cell Line; Cells; Clinical; Clinical Trials; Communicable Diseases; cost; Cytomegalovirus; design; Disease; Dose; Drug Formulations; Epitopes; Event; Family suidae; Ferrets; Genetic Recombination; Half-Life; Health; Hemagglutinin; Human; human disease; human monoclonal antibodies; human tissue; Immunity; immunogenic; Immunohistochemistry; improved; In Vitro; in vitro activity; in vivo; Infection; Influenza; Influenza A virus; Influenza A Virus, H1N1 Subtype; Influenza B Virus; influenzavirus; innovation; Lung; Marketing; Mediating; method development; Modeling; Monoclonal Antibodies; monoclonal antibody production; mouse model; Mus; novel therapeutics; pandemic disease; pathogen; Pathology; Phase; Population; Pre-Clinical Model; Production; programs; Prophylactic treatment; Proteins; Publishing; Respiratory syncytial virus; Route; screening; seasonal influenza; Sentinel; Serum; Site; Specificity; Staging; T-Lymphocyte; Technology; Testing; Therapeutic; Therapeutic Agents; Therapeutic antibodies; Toxic effect; Toxicity Tests; Toxicology; Transfection; Virus; Work
