TFF Pharmaceuticals, Cleveland Clinic to Move Their Influenza Vaccine Candidates into Preclinical Testing


The decision comes after success during formulation testing with convincing stability data.

Image Credit: Adobe Stock Images/

Image Credit: Adobe Stock Images/

Alongside Cleveland Clinic, TFF Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, will be advancing numerous multivalent universal influenza vaccines into preclinical testing.1

These vaccines reportedly protect against seasonal and pandemic viruses; the choice to send these candidates through into preclinical testing was based on the completion of formulation testing with stability data using a combination of hemagglutinin (HA) antigens with four different adjuvants. With the help of these data, three HA antigen/adjuvant candidate vaccines have been selected for testing in a pre-clinical model at Cleveland Clinic Florida.

The goal of the partnership is to design a vaccine that would be able to successfully navigate past failures that have come from mismatches between predicted and actual seasonal flu strains, and mishandling, along with evolutionary changes in the influenza viruses during the course of 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; the collaboration has been funded through the National Institute of Allergy and Infectious Diseases.

“A recent survey2 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,” noted 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.”

As previously alluded to, positive data were one of the major reasons for moving forward with the vaccines.

“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. “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.”


1. TFF Pharmaceuticals and Cleveland Clinic to Advance Multivalent Universal Influenza Vaccine Candidates into Preclinical Testing. TFF Pharmaceuticals. May 20, 2024. Accessed May 22, 2024.

2. European Society of Clinical Microbiology and Infectious Diseases. Study shows experts rate influenza as the number one pathogen of concern of pandemic potential. Medical Xpress. April 20, 2024. Accessed May 22, 2024.

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