Development of a novel interferon-based therapy to treat and prevent bacterial and viral infections

Important results from the project

Overall, our concept of developing universal immunotherapies against various bovine pathogens is valid but requires further confirmation through in vivo proof-of-concept. As a result of the project, we have 1. In vitro data demonstrating the efficacy of InterferOx against M. bovis and various bovine viruses; 2. An established model of respiratory tract infection in cattle for in vivo proof-of-concept study; 3. An established GMP manufacturing infrastructure for InterferOx.

Expected long term effects

Results from the IMMOONITY project will enable the consortium to conduct an in vivo proof-of-concept study in calves infected with M. bovis and then initiate pivotal efficacy and safety studies in cattle under GCP conditions after regulatory approval. Translating study results into a marketable product requires subsequent marketing approval by EMA-CVMP and/or FDA-CVM. To perform these tasks, FarmPharma needs to secure funding.

Approach and implementation

KI laboratory produced bovine interferons that were forwarded to FarmPharma and tested for activity. Based on the results, FarmPharma determined the optimal composition and dose of InterferOx. Forced change of subcontractors for activity determination affected the work schedule and we did not have time to conduct the in vivo proof-of-concept study, although a bovine model for this study has been developed by Cebiphar. However, Jafral developed an industrial manufacturing method for InterferOx.