Wisconsin Alumni Research Foundation

Drug Discovery & Development
Drug Discovery Development
Recombinant Rhinovirus A16 for Human Inoculation Studies
WARF: P170018US01

Inventors: James Gern, Wai-Ming Lee

The Wisconsin Alumni Research Foundation (WARF) is seeking commercial partners interested in an inoculum of ‘common cold’ rhinovirus A16, produced through reverse genetics techniques, for use in research and clinical trials.
Human inoculum strains of rhinoviruses have been used for more than 50 years to induce experimental colds to study disease mechanisms and to test the efficacy of antiviral drugs. Traditional inocula are obtained from the nasal secretions of patients with common cold symptoms, and require extensive safety testing of both the virus and the volunteer to exclude extraneous pathogens.

This process can be challenging given the many potential contaminants, and because new viruses and infectious agents continue to be discovered.
The Invention
To improve safety and shorten the production time of viral inocula, UW–Madison researchers have developed the first recombinant viral inoculum using reverse genetics techniques. Reverse genetics manufacturing eliminates the need to start the inoculum from infected nasal secretions.

Moreover, new inocula can be manufactured quickly from plasmids using this established protocol, and the manufacturing method and extensive testing provide safety assurances for clinical trials. The inoculum was produced under GMP (good manufacturing practice) conditions.
  • Research and clinical trials
  • Available as a biomaterial
Key Benefits
  • Reverse genetics protocol avoids contamination issues associated with traditional preparation methods.
  • Shortens production time
Stage of Development
The plasmid containing the cloned Rhinovirus A16 sequence was provided to the Waisman Biomanufacturing facility. There, approximately 1,300 vials were manufactured under GMP conditions. The cell line that was used to manufacture the virus plasmid and viral suspension have undergone extensive safety testing and are free from extraneous pathogens and contaminants.

The inoculum is now being tested under FDA Investigational New Drug (IND) status to determine the dose of virus that causes moderate colds in most individuals. Dosing levels to date have included 100, 500 and 1000 TCID50, and interim results indicate nearly all volunteers have become infected, most developing either mild or moderate upper respiratory illness.
Additional Information
For More Information About the Inventors
For current licensing status, please contact Jennifer Gottwald at [javascript protected email address] or 608-960-9854