Administration of LMN-301 pre- and post-viral challenge associated with improved clinical outcomes
Seattle, WA, December 20, 2022 – Lumen Bioscience — a clinical stage biopharmaceutical company developing biologic drugs for highly prevalent diseases — announced today preliminary results from a Biomedical Advanced Research and Development Authority (BARDA)-supported effort to develop an intranasal formulation of its drug candidate, LMN-301. This drug, produced in spirulina, contains an antibody cocktail for SARS-CoV-2, the virus that causes COVID-19.
Funding from the BARDA Division of Research, Innovation, and Ventures (DRIVe) enabled the company to reformulate LMN-301, previously developed for oral delivery, and to evaluate its potential as an anti-viral therapeutic delivered to the respiratory tract, the primary site of SARS-CoV-2 infection. The efficacy of the intranasal formulation was evaluated by collaborators at the U.K. Health Security Agency (UKHSA) in hamsters.
Three LMN-301 dosing regimens were tested: pre-exposure prophylaxis (dosed a day before viral challenge), post-exposure prophylaxis (dosed a day after viral challenge), and pre- plus post-exposure prophylaxis.
See Figure 1 here.
Figure 1. Evaluation of intranasal LMN-301 efficacy in a hamster SARS-CoV-2 challenge model. Body weight (left panel) and clinical scores (right panel) were the primary outcomes of interest. Animals were treated with LMN-301 or saline solution and monitored for 7 days. Placebo group in red. Group 4 (pre/post treatment group) in blue.
In this model, animals experience serious weight loss resulting from COVID infection. Animals in all treatment groups experienced significantly less weight loss compared with the placebo group at day 6 (p<0.0001 to p=0.048). Likewise, clinical signs of infection were significantly reduced compared to the placebo group at day 6(p<0.0001 to p=0.0056).
“Given the simplicity of this therapeutic modality and prior research with similar antibodies we were expecting to see positive results here, but we were happily surprised to observe such robust protection right off the bat,” said Craig Behnke, EVP Production and Development. “The data announced today will support further development of LMN-301, including a phase I clinical trial to evaluate the tolerability and pharmacokinetics of the intranasal formulation.”
The work was supported through BARDA’s Beyond the Needle program, managed by BARDA DRIVe. This initiative seeks to make vaccines and therapeutics more usable and available by minimizing the reliance on needles, syringes, vials, and cold-chain distribution for the delivery of medical countermeasures. This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50122C00025.
Lumen’s unique GMP biomanufacturing platform offers drug developments a way to manufacture intranasal and orally delivered biologic drugs in vast quantities at low cost and distribute them without cumbersome refrigerated cold-chain logistics. These features, and the speed at which Lumen can advance from product concept to GMP-manufactured drug product, offers society a new rapid-response tool for countering future pandemics. The approach is directly translatable to other respiratory viral pathogens with pandemic potential, where interruption of disease transmission will aid in efforts to prevent disease, particularly in populations at high risk for severe clinical outcomes.
The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies such as chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases. Together with our industry partners, BARDA promotes the advanced development of medical countermeasures to protect Americans and respond to 21st century health security threats.