TFF Pharmaceuticals Inc., a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, has joined forces with Cleveland Clinic to advance multiple multivalent universal influenza vaccines to protect against seasonal and pandemic viruses into preclinical testing.
 
The decision to advance the vaccine candidates into preclinical testing was based upon the successful completion of formulation testing with stability data on the combination of hemagglutinin (HA) antigens with four different adjuvants. Based on these data, three HA antigen/adjuvant candidate vaccines have been selected for testing in a pre-clinical model at Cleveland Clinic Florida.
 
Funded through the National Institute of Allergy and Infectious Diseases (NIAID), the purpose of the research collaboration between TFF Pharmaceuticals and Cleveland Clinic is to develop a first-in-class, stable, universal, easy-to-transport and easy-to-stockpile vaccine that would overcome the vaccine failures that result from mishandling, mismatches between predicted and actual seasonal flu strains, and evolutionary changes in influenza viruses across the season.
 
Successful completion of the work funded by the Direct to Phase II SBIR grant will fulfill the IND-enabling requirements to potentially advance to human clinical testing.
 
“A recent survey of infectious disease specialists presented at this year’s ESCMID Global Congress indicates that influenza could represent the next pandemic threat to the global population,” said Dr. Harlan Weisman, CEO of TFF Pharmaceuticals. “Working in collaboration with Dr. Ted M. Ross and his colleagues, our goal is to develop a shelf-stable mucosal vaccine with unique characteristics for inhalational delivery and would circumvent the need for cold chain storage which could significantly improve the availability and distribution of potentially life-saving medicine. We look forward to advancing these vaccine candidates into preclinical studies formulated with our Thin Film Freezing technology.”
 
“Over the last year, we have generated an impressive body of positive in vitro and in vivo data from these experimental influenza vaccines, enabling us to further advance these promising candidates into additional in vivo preclinical efficacy studies,” said Ted M. Ross, Global Director of Vaccine Development at Cleveland Clinic and PI of the Center for Influenza Vaccine Research for High-Risk Populations (CIVR-HRP). “Our team at Cleveland Clinic looks forward to advancing this important research, which brings us one step closer toward developing a universal influenza vaccine with the potential to protect patients worldwide.”