TFF Pharmaceuticals announces preclinical data from influenza vaccine candidates

TFF Pharmaceuticals announces preclinical data advancing a multivalent universal influenza vaccine manufactured by TFF to protect against seasonal and pandemic viruses. The data were produced in collaboration with Dr. Ted Ross, Global Director of Vaccine Development at Cleveland Clinic. The experiments conducted by Dr. Ross demonstrated that TFF-dry powder HA antigen vaccine candidates induce neutralizing antibody titers in ferrets against H1 and H3 influenza strains. No response was observed in animals vaccinated with mock vaccine. The ferret model is the gold standard to study host immune responses and evaluate influenza vaccine and antiviral therapies due to similarities with humans. Pre-immune female ferrets received TFF-dry powder HA antigen vaccine for intranasal delivery with various mucosal adjuvants that can elicit both cellular and antibody immune responses. Mock vaccine was used as a control. Serum was collected to assess neutralizing antibody titers against influenza A viruses for H1N1 and H3N2 subtypes. Ongoing studies will assess neutralizing antibody titers against a panel of 13 influenza A viruses isolated between 2006-2018 for H1N1 and 2012-2019 for H3N2 subtypes. After viral challenge, ferrets will be monitored daily for clinical signs and symptoms and antibody titers. These positive results will allow TFF to select an adjuvant for advanced development of a universal influenza vaccine candidate that will be delivered as a dry powder designed to protect against greater than 75% of the circulating influenza strains. This work is funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, under a previously awarded Direct to Phase II Small Business Innovation Research grant of approximately $2.97 million to continue development of a novel, pan-flu multivariant mucosal vaccine using the Company’s Thin Film Freezing technology. The goal of this program is to advance a vaccine candidate to IND and early clinical trials. If successful, a TFF-formulated universal flu vaccine has the potential to generate several billion dollars in annual sales, presenting a highly attractive out-licensing opportunity for the company.