Inhalon Collaborates with Celltrion, Inc. to Develop Nebulized Form of Regdanvimab to Treat COVID-19 Patients at Home

Inhalon Biopharma, Inc., a clinical-stage immunotherapy company developing an inhaled "muco-trapping" antibody platform for treating a variety of acute respiratory infections, today announced it is partnering with Celltrion, Inc. to develop IN-006, an inhaled form of regdanvimab, for treating patients with COVID-19.

"Working with Inhalon to develop an inhaled form of regdanvimab will allow us to more directly reach the virus in the airways where the infection begins," said SungHyun Kim, Head of Medical Science Division at Celltrion. "Regdanvimab will be the first antibody to be nebulized and inhaled against COVID-19 that has already demonstrated efficacy in a previous phase 3 study. This route of administration will diversify our delivery options and allow patients to self-administer treatment in the convenience of their own home."  

Inhalon's muco-trapping antibody platform directly traps the virus in airway mucus, preventing the local spread of the infection, and quickly eliminating the virus from the lungs through the body's natural ability to clear mucus. Inhaled therapy can be readily self-administered by patients, extend critical drug supplies to more patients by reducing the dosage needed, and does not place excessive demands on healthcare staff and infusion clinic space that intravenous (IV) drugs do.

"As outbreaks and spikes in coronavirus cases continue to emerge, Inhalon's partnership with Celltrion is a significant milestone for our inhaled muco-trapping platform, suggesting it has the potential to provide an easier and possibly more efficacious use of regdanvimab for COVID-19 patients," said John B. Whelan, Inhalon's president and chief executive officer. "Celltrion's regdanvimab has demonstrated efficacy against COVID-19 when delivered by IV administration and is under review by regulatory authorities in the US and Europe. With the financial support of the U.S. Army Medical Research and Development Command, we will start the Phase 1 study of a nebulized formulation of regdanvimab in the next few months."

Inhalon has announced plans to complete a Phase 1 safety and tolerability study of nebulized regdanvimab in healthy volunteers by the end of the year. The study is funded by a $7 million contract from the U.S. Army Medical Research & Development Command. Celltrion recently completed a phase 3 study demonstrating regdanvimab significantly reduced the risk of COVID-19 related hospitalization or death by 72% for patients at high-risk of progressing to severe COVID-19 and 70% for all patients. Regdanvimab has demonstrated in vivo efficacy against the most common variants, including the Alpha, Beta, Gamma and Delta variants.

About Regdanvimab (CT-P59)

T-P59 was identified as a potential treatment for COVID-19 through screening of antibody candidates and selecting those that showed the highest potency in neutralizing the SARS-CoV-2 virus. In vitro and in vivo pre-clinical studies showed that CT-P59 strongly binds to SARS-CoV-2 RBD and significantly neutralizes the wild type and mutant variants of concern including the Alpha variant (B.1.1.7, first identified in the UK). In in vivo models, CT-P59 effectively reduced the viral load of SARS-CoV-2 and inflammation in lung. Results from the global Phase I and II clinical trials of CT-P59 demonstrated a promising safety, tolerability, antiviral effect and efficacy profile in patients with mild- to- moderate symptoms of COVID-19. Celltrion also has recently commenced the development of a neutralizing antibody cocktail with CT-P59 against new emerging variants of SARS-CoV-2.

About Inhalon's "Muco-trapping" Immunotherapy Platform 

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's breakthrough discovery enables inhaled antibodies to trap pathogens in mucus. These trapped pathogens are unable to spread or infect cells and are rapidly eliminated by normal mucus clearance in minutes – swept into the digestive tract where they are killed by stomach acid and can do no further damage. The muco-trapping technology was pioneered by Professor Sam Lai at the University of North Carolina (UNC) at Chapel Hill, and licensed exclusively from UNC and Johns Hopkins University.

About Inhalon

Inhalon Biopharma is a clinical-stage immunotherapy company advancing an inhaled antibody platform for treating a variety of acute respiratory infections. Inhalon's intellectual property includes approved US and EU patents covering the composition and use of aerosolized muco-trapping antibodies. Inhalon is supported by Breakout Labs and angel investor syndicates led by Life Science Angels and others, including, Band of Angels, Sand Hill Angels, Berkeley Catalyst Fund, as well as several federal contracts.

About Celltrion

Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in research, development and manufacturing of biosimilar and innovative drugs. Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. Celltrion received FDA and EC's approval for Inflectra® and Remsima®, respectively, which is the world's first mAb biosimilar to receive approval from a regulatory agency in a developed country. Also Celltrion received FDA and EC's approval for Truxima® and Herzuma®. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines.