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Proof of Concept

Inhalon has gathered a robust set of large animal in vivo efficacy data. Notably, Inhalon's antibodies produced a ≥ 4-log reduction in viral load in an RSV neonatal lamb model—the “gold-standard” large-animal model, since lamb lung physiology closely matches that of a human infant.

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The platform has been validated in the clinic with a Phase 1A study that showed that Inhalon’s antibodies are present in the nose at levels well above typically required for anti-viral activity.  Additionally, serum measurements indicated that large amounts of mAb is delivered to the lung.  This delivery creates a reservoir of mAb in the lung to treat infection for an extended period. 

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In Q3 2023, Inhalon will conduct a Phase 1B study that will study levels of antibody in the lung directly via sampling of Bronchoalveolar lavage fluid (BALF).

Technology

Muco-Trapping Antibodies - A Breakthrough Approach

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Inhalon Biopharma’s breakthrough platform for treating ARIs enables inhaled antibodies to trap viruses and other pathogens in mucus lining the airways, block the infection from spreading within the lung, and rapidly eliminate the germs through natural mucus clearance. This new "muco-trapping" immune function was made possible by key molecular and biophysical insights into antibody-mucin interactions, which allow antibodies to bind to pathogens and trap them in mucus by crosslinking to mucins, the mesh network that makes up mucus. Trapped viruses are carried out of the lung by natural ciliary beating or cough driven expulsion. This unique antibody function is broadly applicable to viruses, bacteria and fungi. Inhalon's muco-trapping technology is protected by four issued patents in the US and Europe and multiple patent applications throughout the world.

 

Our inhaled immunotherapy platform is especially suited for treating ARIs, such as respiratory syncytial virus (RSV), influenza, metapneumovirus (MPV), parainfluenza virus (PIV), adenovirus, coronaviruses, including severe acute respiratory syndrome coronavirus (e.g., SARS-CoV-2) and Middle East respiratory syndrome (MERS).

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Why Muco-Trapping is Different

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Inhalon’s platform halts the infection immediately, directly clears viruses and other pathogens from infected airways, blocks transmission, requires much less antibody compared to systemic dosing, and allows treatment at the comfort of a patient’s home.

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How Muco-Trapping Works

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Our breakthrough discovery enables inhaled antibodies to trap pathogens (i.e., viruses, bacteria, fungi) in the lung mucus, which in turn blocks the infections from further spreading locally and facilitates the rapid elimination of the pathogens from the lung through normal mucus clearance.  Although mucus in the lung airways is designed to protect the body from infections, pathogens have evolved to move easily through mucus to infect cells in the airways.  Inhalon was launched based on the discovery of a new immune function – antibodies trapping pathogens in mucus – and molecular and biophysical insights into how to tune the antibody-mucin affinity.  These “muco-trapping” antibodies bind to pathogens and crosslink them to mucins.  Trapped pathogens are unable to infect cells and are rapidly eliminated by normal mucus clearance every 30 to 60 minutes – swept into the digestive tract and become sterilized by gastric acid.  This muco-trapping function is mediated by glycans in the antibody’s Fc region and enhanced through the normal glycosylation process using Inhalon-engineered production cell lines.  This muco-trapping phenomenon has been confirmed with over a half dozen pathogens to date. 

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Inhalon's Platform Treats ARIs More Effectively

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The videos below show how muco-trapping antibodies added to human mucus can trap bacteria and viruses so they can be swept out of the airways.

Bacteria:

Untreated

Virus:

Untreated

Bacteria:

Muco-Trapping Antibody Added

Virus:

Muco-Trapping Antibody Added

Technology
Product

Product

Patients are treated by inhaling an antibody mist that is generated by a handheld nebulizer. Inhalon uses vibrating nebulizers from third-parties to aerosolize the antibody drug without changing the antibody's properties.  Other types of nebulizers can damage antibodies making them ineffective.

 

Inhalon's muco-trapping antibodies are designed to come in single-use containers that can easily be poured into the nebulizer. Patients inhale the antibody drug for 3 to 5 minutes using the nebulizer mouthpiece or mask. This process is repeated for 3 to 7 days depending on the indication.

Our Solution: Inhaled "Muco-Trapping" Antibodies

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Muco-Trapping Antibodies

Third-Party Handheld,

Battery Operated Nebulizer

Inhale Mist

(3-5 min.)

publications

Publications

  • Moench T, Botta L, Farrer B, Lickliter JD, Kang H, Park Y, Kim C, Hoke M, Brennan M, McSweeney M, Richardson Z, Whelan J, Cho JM, Lee SY, Faurot F, Hutchins J, Lai SK. (2022) A randomized, double-blind, Phase 1 study of IN-006, an inhaled antibody treatment for COVID-19. medRxiv. View page

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  • Moench T, Hutchins J, Lai SK, Farrer B, Faurot F, Botta L, Autio E, McSweeney M. IN-006: An Inhalable SARS-CoV-2-Directed mAb. Poster presented at: Medical Technology Enterprise Consortium (MTEC) 7th Annual Membership Meeting; May 24, 2022; Baltimore, MD. Download PDF

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  • McSweeney M, Stewart I, Richardson Z, Kang H, Park Y, Kim C, Tiruthani K, Wolf W, Schaefer A, Kumar P, Aurora H, Hutchins J, Cho J, Hickey A, Lee S, Lai SK. (2022) Stable nebulization and muco-trapping properties of Regdanvimab/IN-006 support its development as a potent, dose-saving inhaled therapy for COVID-19 Pubmed. View page

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  • Cruz-Teran C, Tiruthani K, McSweeney M, Ma A, Pickles R, Lai SK. (2020) Challenges and opportunities for antiviral monoclonal antibodies as COVID-19 therapy. Advanced Drug Delivery Reviews.​​

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  • Lai SK, McSweeney M, Pickles R. (2020) Learning from past failures: challenges with monoclonal antibody therapies for COVID-19. J Controlled Release.​

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  • Schroeder HA, Newby J, Schaefer A, Subramani B, Tubbs A, Forest MG, Miao E, Lai SK. (2020)  LPS-binding IgG arrests actively motile Salmonella Typhimurium in gastrointestinal mucus. Mucosal Immunology. https://doi.org/10.1038/s41385-020-0267-9.

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  • Zhu F, Jay M, Schiller JL, Schroeder HA, Wessler T, Chen A, Forest MG, Lai SK. (2019)  Modeling barrier properties of intestinal mucus reinforced with IgG and secretory IgA against motile bacteria. ACS Infectious Disease. 5(9):1570-1580.

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  • Yang B, Schaefer A, Wang YY, McCallen JD, Lee P, Newby J, Arora H, Kumar PA, Zeitlin L, Whaley KJ, McKinley SA, Fischer W, Harit D, Lai SK. (2018) ZMapp Reinforces the Airway Mucosal Barrier Against Ebola Virus. Journal of Infectious Disease. 218(6):901-910.​

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  • Newby J, Schiller J, Wessler T, Edelstein J, Forest MG, Lai SK. (2017) A blueprint for robust crosslinking of mobile species in biogels using third-party molecular anchors with short-lived anchor-matrix bonds. Nature Communications. 8(1):833.​

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  • Wang YY, Harit D, Subramani DB, Arora H, Kumar P, Lai SK. (2017) Influenza-binding antibodies immobilise influenza viruses in fresh human airway mucus. European Respiratory Journal 49:1601709.​

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  • Wessler T, Chen A, McKinley SA, Cone R, Forest MG, Lai SK. (2015) Using computational modeling to optimize the design of antibodies that trap viruses in mucus. ACS Infectious Disease. 2(1):82-92.​

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  • Chen, A., S.A. McKinley, S. Wang, F. Shi, P.J. Mucha, M.G. Forest, and S.K. Lai, Transient antibodymucin interactions produce a dynamic molecular shield against viral invasion. Biophys J, 2014. 106(9): p. 2028-36.

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  • Wang YY, Kannan A, Nunn KL, Murphy M, Subramani DB, Moench TM, Cone RA, Lai SK. (2014) IgG in cervicovaginal mucus traps HSV and prevents vaginal Herpes infections. Mucosal Immunology. 7(5):1036-44.

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