Inhalon Biopharma, Inc.

DURHAM, N.C.--(BUSINESS WIRE)-- Inhalon Biopharma (Inhalon), a clinical-stage company advancing a proprietary inhaled antibody platform for treating acute respiratory infections (ARI), today announced initial results from a landmark Phase 1b study that directly compares the distribution and retention of antibodies throughout the human respiratory tract following both inhaled and intravenous (IV) delivery. The study upends prevailing thinking about inhaled antibody delivery by demonstrating that antibodies maintain their activity following nebulization and can be dosed uniformly to all parts of the respiratory tract, including the deep lung. It also shows that inhaled antibodies can achieve concentrations throughout the respiratory tract greatly exceeding the levels required to neutralize most acute respiratory viruses. In the study, 20-fold higher concentrations of antiviral antibodies were observed in the respiratory tracts of subjects who received inhaled antibodies compared with subjects who received antibodies intravenously, despite subjects with inhaled dosing receiving up to 90% less antibodies. The study compared lung function in cohorts of normal healthy volunteers following treatment with either nebulization of Inhalon’s inhaled formulation or the same antibodies delivered intravenously. None of the study subjects in the inhaled treatment cohort experienced drug-related adverse events, and visual inspection of the subject’s lungs via bronchoscopy following five days of daily inhaled treatment did not show any signs of inflammation or medication-related lung damage. Further, there were no antidrug antibodies detected in the serum of subjects who received the inhaled treatments. There were less adverse events detected in subjects in the inhalation arms than in the IV arm. “The results of this study demonstrate the promise of inhaled antibodies as a potential at-home treatment for a broad range of ARIs including respiratory syncytial virus (RSV), human metapneumovirus (hMPV), influenza, and SARS variants,” said John Whelan, president and chief executive officer, Inhalon Biopharma. “With this new evidence showing far superior exposure from inhaled antibodies, we will be advancing our pipeline into additional clinical studies.” Inhalon’s antibodies are designed to be self-administered by patients using a handheld portable nebulizer, making them easier to administer, store, and distribute compared to antibodies currently administered intravenously or by intramuscular injections. The greater convenience, dose savings and reduced burden on healthcare infrastructure supports initiating inhaled antibody treatment at the earliest time possible. The much greater antibody concentrations achieved in the respiratory tract with inhalation suggests the potential for even greater therapeutic effect. About Inhalon Biopharma Inhalon Biopharma is a private, clinical-stage company advancing a proprietary inhaled antibody platform for treating a variety of acute respiratory infections. Inhalon Biopharma’s intellectual property includes approved U.S. and EU patents covering the composition and use of aerosolized muco-trapping antibodies. Inhalon Biopharma is supported by the Thiel Foundation’s Breakout Labs, Cambrian Growth Partners, Berkeley Catalyst Fund, JSR Life Sciences and Life Science Angels, as well as several federal grants from the NIH and USAMRDC.

Data published in Advanced Science and Bioengineering and Translational Medicine evaluates the efficacy of intranasal delivery of antibodies to RSV-infected neonatal lambs and SARS-CoV-2 infected hamsters DURHAM, N.C.--(BUSINESS WIRE)-- Inhalon Biopharma (Inhalon), a clinical-stage company advancing a proprietary inhaled antibody platform for treating acute respiratory infections, today announced the publication of preclinical data showcasing the advantages and efficacy of its “muco-trapping” technology in animal models of respiratory syncytial virus (RSV) and SARS-CoV-2 infections. The data, published in Advanced Science and in Bioengineering and Translational Medicine, underscore the potential therapeutic benefits from leveraging inhaled delivery of antibodies to treat a range of acute respiratory infections, including not only RSV and SARS-CoV-2 variants, but also influenza, human metapneumovirus (hMPV), and parainfluenza (PIV). “Inhalon’s approach rethinks the use of antibodies for the treatment of acute respiratory infections by delivering antibodies directly to the site of the infection,” said John Whelan, president and chief executive officer, Inhalon Biopharma. “Our studies in Advanced Science and in Bioengineering and Translational Medicine demonstrate the exceptional effectiveness of our inhaled antibody platform, which offers the potential to treat a wide array of acute respiratory infections. With the results from these studies, we are advancing candidates against RSV and all variants of SARS-CoV-2 into the clinic.” There remains a high unmet need for new outpatient treatments for acute respiratory infections despite the availability of vaccines for influenza, RSV, and COVID-19. The U.S. Centers for Disease Control and Prevention estimates that 360,000 people were hospitalized with influenza during the 2022-2023 season.1 RSV is responsible for 58,000-80,000 hospitalizations in children ages five and under, as well as 60,000-160,000 hospitalizations in older adults every year.2 While COVID-19 is harder to estimate on an annual basis, there are currently more than 15,000 hospitalizations per week in the U.S.3 The preclinical data published in Advanced Science evaluates the efficacy of treating an established RSV infection with inhaled antibodies. In the study, RSV-infected neonatal lambs received daily nebulized delivery of Mota-MT, Inhalon’s muco-trapping antibody against RSV. Treatment was delayed until three days post infection when the virus was at peak levels in the lung. Following three days of once-per-day nebulized treatment, Mota-MT reduced viral load by 10,000-fold to 100,000-fold compared to the placebo group, with most animals exhibiting no detectable virus in the respiratory tract. This directly correlated with reduced inflammation, bronchiolitis, neutrophil infiltration, and airway remodeling; the lungs of many animals treated with Mota-MT appeared no different than uninfected animals, despite the very late initiation and short duration of treatment. Inhalon has completed IND-enabling studies with a derivative of Mota-MT and is planning to start a Phase 1 study later this year. The study published in Bioengineering and Translational Medicine assesses the efficacy of a muco-trapping ACE2-(G4S)6-FC decoy that binds and neutralizes SARS-CoV-2, without risk of viral escape. The molecule has shown picomolar potencies against all strains of SARS-CoV-2 tested, including Omicron variants. In the study, hamsters that received intranasal dosing as late as two days post infection saw at least a ten-fold viral load decrease by day four. With the support of the USAMRDC, Inhalon has begun preclinical activities and manufacturing to advance this candidate into the clinic in 2025. About Inhalon Biopharma Inhalon Biopharma is a private, clinical-stage company advancing a proprietary inhaled antibody platform for treating a variety of acute respiratory infections. Inhalon Biopharma’s intellectual property includes approved U.S. and EU patents covering the composition and use of aerosolized muco-trapping antibodies. Inhalon Biopharma is supported by the Thiel Foundation’s Breakout Labs, Cambrian Growth Partners, Berkeley Catalyst Fund, JSR Life Sciences and Life Science Angels, as well as several federal grants from the NIH and USAMRDC. The muco-trapping mAb technology, Mota-MT and the ACE2-(G4S)6-FC decoy were originally developed by Prof. Sam Lai at the University of North Carolina (UNC) - Chapel Hill, and licensed exclusively by Inhalon. Centers for Disease Control and Prevention, “Burden of Flu.” Available: . Centers for Disease Control and Prevention, “Respiratory Syncytial Virtus Infection (RSV).” Available: . Centers for Disease Control and Prevention, “COVID Data Tracker.” Available: .

DURHAM, N.C.--(BUSINESS WIRE)-- Inhalon Biopharma, a clinical-stage company advancing a proprietary inhaled antibody platform for treating acute respiratory infections (ARI), today announced a new agreement with the University of Georgia to license a panel of Human Metapneumovirus (hMPV) antibodies. With this license, Inhalon Biopharma plans to select antibody candidates to advance into clinical development for the treatment of hMPV. “This agreement allows us to continue building a robust pipeline of potential treatments for acute respiratory infections on our innovative platform,” said John Whelan, president and chief executive officer, Inhalon Biopharma. “Our team is committed to building upon our initial clinical successes with COVID-19 and advancing antibody treatments for a range of respiratory infections including RSV, influenza, and hMPV.” Human metapneumovirus is an acute respiratory infection characterized by cough, fever, nasal congestion, and shortness of breath, which is responsible for more than 1 million clinical visits, 260,000 pediatric emergency department visits, and 20,000 hospitalizations annually in the U.S.1,2 Most prevalent in the winter and spring, it is transmitted through coughing, sneezing, contact with affected individuals, and contaminated surfaces. Similar to respiratory syncytial virus (RSV), hMPV is in the Pneumoviridae family and is most dangerous to young children, older adults, and people with weakened immune systems as clinical symptoms of hMPV infection may progress to bronchitis or pneumonia like other viruses that cause upper and lower respiratory infections.3 "It's truly gratifying to see Inhalon working to advance treatment for patients with hMPV. I am hopeful that our work can one day ease the burden of disease for individuals affected by hMPV," said Jarrod Mousa, Ph.D., Associate Professor at the Center for Vaccines and Immunology, Department of Infectious Diseases at the University of Georgia whose lab developed the antibodies. About Inhalon Biopharma Inhalon Biopharma is a clinical-stage company advancing a proprietary inhaled antibody platform for treating a variety of acute respiratory infections. Inhalon Biopharma’s intellectual property includes approved U.S. and EU patents covering the composition and use of aerosolized muco-trapping antibodies. Inhalon Biopharma is supported by the Thiel Foundation’s Breakout Labs, Life Science Angels, and JSR Life Sciences as well as several federal grants from the NIH and USAMRDC. ____________________ 1 Gálvez, Nicolás M S et al. “Host Components That Modulate the Disease Caused by hMPV.” Viruses vol. 13,3 519. 22 Mar. 2021, doi:10.3390/v13030519 2 Edwards, Kathryn M et al. “Burden of Human Metapneumovirus Infection in Young Children.” The New England Journal of Medicine vol. 368,7 (2013): 633-43. doi:10.1056/NEJMoa1204630 3 Human Metapneumovirus (HMPV), Centers for Disease Control and Prevention. Available: .