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Principal Investigator: JEFF T HUTCHINS
Organization: INHALON BIOPHARMA, INC.
Fiscal Year: 2024
Award: $1,024,926
Funding agency: National Institute of Allergy and Infectious Diseases
Project Summary
Respiratory Syncytial Virus (RSV) is the leading cause of viral hospitalization and death in infants and young
children, and also a major cause of respiratory illness in immunocompromised and elderly. Unfortunately, for
the millions infected with RSV each year, there is no currently no treatment option available.
Like many respiratory pathogens, RSV spreads in the lungs by shedding daughter virions from infected
cells exclusively back into the airways. From there, RSV must traverse the airway mucus (AM) before
infecting other neighboring cells, remaining restricted to the airways with little-to-no systemic viremia. This
important mechanism of spread makes RSV difficult to target by systemically dosed therapies; the antiviral
drugs need to make their way to the airway mucus in order to inactivate virions and halt infection. We believe
an RSV-specific, safe, and effective antiviral therapy that can be inhaled directly into the respiratory tract using
a hand-held device at home would provide a powerful treatment option.
To meet this goal, Inhalon has been advancing IN-002, a mAb that binds and neutralizes RSV F protein
with picomolar affinity, and has minimal risks of viral escape. Importantly, in addition to the well-established
IgG Fc effector functions, IN-002 is also engineered to possess Fc N-glycans optimized to trap RSV in AM.
Once trapped, RSV virions are quickly purged from the airways via natural mucociliary clearance mechanisms.
We have further formulated IN-002 to be stably nebulized using a portable vibrating mesh nebulizer. In a
neonatal lamb model of RSV infection, nebulized IN-002 reduced RSV viral load in the lungs and BALF to
almost non-detectible levels within just 3 days. Inhalon has already manufactured clinical trial materials, and
completed the full range of IND-enabling studies including GLP inhalation tox, tissue cross-reactivity and
nebulization characterization studies. Inhalon is thus in position to execute a Phase 1 study for IN-002 in 2024.
Inhalon has strong experience carrying out clinical studies with its inhaled mAb pipeline, being the first
company to successfully complete a Phase 1 study for an inhaled mAb therapy for COVID (IN-006), and more
recently executed a Phase 1b study to directly compare pulmonary distribution of the same mAb given by IV
vs. by inhalation. This makes Inhalon exceptionally well positioned to execute a Phase 1 study for IN-002.
In this proposal, we seek to obtain support to complete the non-clinical activities associated with the
Phase 1 study, including processing of collected clinical trial biospecimens to determine drug levels in nasal
swabs and serum, perform biostatistics calculations and PK modeling, and perform the medical writing to
complete the clinical study report. These activities would in turn put Inhalon in a position to initiate a Phase 2
study to determine the efficacy of IN-002 in RSV-infected individuals. The work will further aid the development
of future generations of inhaled, mAb-based therapies for a variety of pulmonary indications.
Terms: <0-11 years old><21+ years old><7S Gamma Globulin><Address><Adult><Adult Human><Affinity><Age><Animal Model><Animal Models and Related Studies><Anti-viral Agents><Anti-viral Therapy><Antibodies><Antibody Therapy><Assay><Award><Back><Binding><Bioassay><Biological Assay><Biometrics><Biometry><Biostatistics><Blood><Blood Reticuloendothelial System><Blood Serum><Body Tissues><Bronchiolitis><COVID-19><COVID-19 therapy><COVID-19 treatment><CV-19><Cell Body><Cells><Cessation of life><Child><Child Youth><Children (0-21)><Climate><Clinic><Clinical><Clinical Research><Clinical Study><Clinical Treatment Moab><Clinical Trials><Common Rat Strains><Conchae Nasales><Coronavirus Infectious Disease 2019><Daughter><Death><Development><Dorsum><Dose><Drug Kinetics><Drugs><ELISA><Early treatment><Early-Stage Clinical Trials><Elderly><Elements><Engineering><Environment><Enzyme-Linked Immunosorbent Assay><Epithelium><Fc domain><Focal Infection><Funding><Future Generations><Glycans><Goals><Grant><Guidelines><Healthcare><Home><Hospital Admission><Hospitalization><Human><IgG><Immunocompromised><Immunocompromised Host><Immunocompromised Patient><Immunoglobulin G><Immunosuppressed Host><Individual><Infant Mortality><Infant Mortality Total><Infection><Infrastructure><Inhalation><Inhaling><Lung><Lung Parenchyma><Lung Respiratory System><Lung Tissue><Measures><Medical><Medication><Meteorological Climate><Modeling><Modern Man><Molecular Interaction><Monoclonal Antibodies><Monoclonal Antibody Therapy><Morbidity><Morbidity - disease rate><Mucins><Mucociliary Clearance><Mucociliary Transport><Mucous body substance><Mucus><Mucus Glycoprotein><Nasal><Nasal Passages Nose><Nasal turbinate bone structure><Nebulizer><Necrosis><Necrotic><Neonatal><Nose><Palivizumab><Pharmaceutical Preparations><Pharmacokinetics><Phase><Phase 1 Clinical Trials><Phase 2 Clinical Trials><Phase I Clinical Trials><Phase I Study><Phase II Clinical Trials><Pneumonia><Polysaccharides><Population><Position><Positioning Attribute><Premature Infant><Prophylactic treatment><Prophylaxis><Pulmonary Body System><Pulmonary Organ System><RSV infection><Rat><Rats Mammals><Rattus><Reporting><Research Specimen><Respiratory Syncytial Virus Infections><Respiratory System><Respiratory System, Nose, Nasal Passages><Respiratory Tracts><Respiratory syncytial virus><Respiratory syncytial virus F protein><Respiratory syncytial virus RSV F proteins><Respiratory tract structure><SARS-CoV-2 therapy><SARS-CoV-2 treatment><Safety><Schedule><Series><Serum><Sight><Site><Specimen><Structure of parenchyma of lung><Synagis><Therapeutic><Time><Tissues><Turbinates><Vaccines><Validation><Viral><Viral Burden><Viral Load><Viral Load result><Viremia><Virion><Virus><Virus Particle><Vision><Work><Writing><adulthood><advanced age><ages><anti-viral compound><anti-viral drugs><anti-viral medication><anti-viral therapeutic><anti-virals><antibody based therapies><antibody treatment><antibody-based therapeutics><antibody-based treatment><climatic><coronavirus disease 2019><coronavirus disease 2019 therapy><coronavirus disease 2019 treatment><coronavirus disease-19><coronavirus infectious disease-19><cost><cross reactivity><death among infants><death in first year of life><death in infancy><death in infants><determine efficacy><developmental><drug/agent><early therapy><efficacy analysis><efficacy assessment><efficacy determination><efficacy evaluation><efficacy examination><enzyme linked immunoassay><evaluate efficacy><examine efficacy><expectation><experience><first in man><first-in-human><geriatric><handheld device><handheld equipment><health care><homes><human study><immunoprophylaxis><immunosuppressed patient><infant death><infant demise><infantile death><infants born premature><infants born prematurely><infection localized><kids><lamb model><local infection><mAB-based therapy><mAb therapy><mAb-based therapeutics><mAbs><manufacture><minimal risk><model of animal><monoclonal Abs><mortality><mortality in infants><mucous><nasal swab><nebulization><nebulize><neutralizing mAb><neutralizing monoclonal antibodies><phase 1 study><phase 2 study><phase I protocol><phase II protocol><phase II study><portability><premature baby><premature infant human><preterm baby><preterm infant><preterm infant human><prevent><preventing><programs><pulmonary><respiratory><respiratory pathogen><safety and feasibility><senior citizen><severe acute respiratory syndrome coronavirus 2 therapy><severe acute respiratory syndrome coronavirus 2 treatment><treat COVID-19><treat SARS-CoV-2><treat coronavirus disease 2019><treat severe acute respiratory syndrome coronavirus 2><validation studies><validations><vibration><viraemia><viral infectious disease treatment><viral sepsis><virtual><virusemia><visual function><youngster>