TFF Pharmaceuticals and Cleveland Clinic to Begin Preclinical Testing of Universal Flu Vaccine Candidates

TFF Pharmaceuticals, Inc. (Nasdaq: TFFP), a clinical-stage biopharmaceutical company, has announced a significant advancement in its efforts to develop universal influenza vaccines. In collaboration with Cleveland Clinic, the company is moving multiple multivalent universal influenza vaccines into preclinical testing.

This decision follows the successful completion of formulation testing, which demonstrated stable data for hemagglutinin (HA) antigens combined with four different adjuvants. Subsequently, three candidate vaccines have been selected for further testing in a pre-clinical model at Cleveland Clinic Florida.

This research collaboration is funded by the National Institute of Allergy and Infectious Diseases (NIAID). The primary objective is to develop a stable, universal, easy-to-transport, and easy-to-stockpile influenza vaccine. Such a vaccine aims to overcome common challenges, such as vaccine mismatches with seasonal flu strains, mishandling, and the influenza virus's evolutionary changes.

The progress made by TFF Pharmaceuticals and Cleveland Clinic aligns with the goal to develop a first-in-class mucosal vaccine. This vaccine would be shelf-stable and suitable for inhalational delivery, eliminating the need for cold chain storage. Dr. Harlan Weisman, CEO of TFF Pharmaceuticals, emphasized the importance of this development, citing a recent survey indicating that influenza could be the next global pandemic threat.

Over the past year, significant positive data have been generated from these experimental influenza vaccines. These promising results enable the advancement of these candidates into additional preclinical efficacy studies. Dr. Ted M. Ross, Global Director of Vaccine Development at Cleveland Clinic, expressed optimism about the progress, highlighting the potential of developing a universal influenza vaccine that could protect patients globally.

In June 2023, TFF Pharmaceuticals received a $2.97 million grant from the Direct to Phase II Small Business Innovation Research (SBIR) program. This grant supports the development of a novel, pan-flu multivariant mucosal vaccine using the company's Thin Film Freezing (TFF) technology. The goal is to create a shelf-stable dry powder formulation of a universal influenza vaccine that is over 75% effective against symptomatic influenza and offers protection against groups I and II influenza A viruses. These viruses have historically caused all known influenza pandemics and contribute significantly to seasonal flu.

Influenza is a highly contagious viral infection that impacts the respiratory system, including the nose, throat, and lungs. According to the U.S. Centers for Disease Control and Prevention (CDC), influenza has caused tens of thousands of deaths annually in the U.S. since 2010, with hundreds of thousands of deaths globally. There is a pressing need to enhance flu prevention and management programs, and major efforts are underway to develop more effective and broadly protective influenza vaccines.

TFF Pharmaceuticals' Thin Film Freezing (TFF) technology is a proprietary process that transforms both existing compounds and new chemical entities into dry powder formulations. This technology offers unique benefits and characteristics, such as improved bioavailability, faster onset of action, and reduced toxicities by enabling direct delivery to the target organ. TFF technology can create powders suitable for various administration routes, including inhalation, parenteral, nasal, oral, topical, and ocular.

The TFF process does not introduce heat or stress that could damage complex therapeutic components, allowing fragile biologics to be reformulated into stable, easily stored dry powders. This makes therapeutics and vaccines more accessible for global distribution. The advantages of TFF technology enhance traditional delivery methods and enable the development of next-generation pharmaceutical products.

TFF Pharmaceuticals, Inc. is dedicated to transforming medicines using its patented rapid freezing technology. This technology platform is versatile and can convert most drugs into potent dry powder formulations suitable for inhalation or topical delivery, offering improved efficacy, safety, and stability.