TFF Pharmaceuticals Reports Positive Preclinical Results for Universal Influenza Vaccine Candidates After Intranasal Immunization

TFF Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company listed on Nasdaq as TFFP, has announced promising preclinical results from their research on a multivalent universal influenza vaccine. The vaccine, developed using the company's patented Thin Film Freezing (TFF) technology, aims to protect against both seasonal and pandemic influenza viruses. The data were produced in collaboration with Dr. Ted Ross, the Global Director of Vaccine Development at Cleveland Clinic.

Dr. Harlan Weisman, the CEO of TFF Pharmaceuticals, noted that the preliminary data indicates that the intranasal administration of the TFF-dry powder hemagglutinin (HA) antigen vaccine candidates is highly immunogenic. This means that it produces protective antibody titers in ferrets, which is significant because the ferret model is considered the gold standard for studying host immune responses and evaluating influenza vaccines. According to Dr. Weisman, these findings support the continued development of a shelf-stable, mucosal universal influenza vaccine that could be effective regardless of the influenza strain that emerges each year and could be self-administered.

The experiments conducted by Dr. Ross demonstrated that the TFF-dry powder HA antigen vaccine candidates were able to induce neutralizing antibody titers in ferrets against both H1 and H3 influenza strains. No similar response was observed in ferrets that received a mock vaccine. These findings are crucial as they underline the immunogenic potential of the vaccine in relevant animal models.

Pre-immune female ferrets were administered the TFF-dry powder HA antigen vaccine intranasally, accompanied by various mucosal adjuvants designed to elicit both cellular and antibody immune responses. Serum samples were collected to evaluate the neutralizing antibody titers against H1N1 and H3N2 subtypes of the influenza A virus. In ongoing studies, researchers will assess neutralizing antibody titers against a panel of 13 influenza A viruses isolated between 2006 and 2018 for the H1N1 subtype, and between 2012 and 2019 for the H3N2 subtype. Following viral challenge, the ferrets will be monitored daily for clinical signs, symptoms, and antibody titers.

These positive results will aid in the selection of an adjuvant for the advanced development of a universal influenza vaccine candidate. This candidate will be delivered as a dry powder designed to offer protection against more than 75% of circulating influenza strains. This research is funded by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health. The funding is provided under a previously awarded Direct to Phase II Small Business Innovation Research (SBIR) grant of approximately $2.97 million to continue the development of this novel pan-flu multivariant mucosal vaccine using TFF Pharmaceuticals' Thin Film Freezing technology.

The ultimate goal is to advance the vaccine candidate to an Investigational New Drug (IND) application and early clinical trials. If successful, the TFF-formulated universal flu vaccine has the potential to generate several billion dollars in annual sales, making it an attractive out-licensing opportunity for the company.

TFF Pharmaceuticals' proprietary Thin Film Freezing technology enables the transformation of both existing compounds and new chemical entities into dry powder formulations with unique characteristics and benefits. The TFF process engineers dry powder particles optimal for inhalation and other routes of administration, enhancing bioavailability and reducing toxicities and side effects. This process does not introduce forces that could damage complex therapeutic components, thereby enabling the reformulation of fragile biologics into stable dry powders that are easy to store and distribute globally.

TFF Pharmaceuticals continues to leverage its TFF technology platform to develop innovative drug products aimed at improving therapeutic outcomes and expanding the accessibility of medicines worldwide.

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