National Institute of Health/National Institute of Allergy and Infectious Disease Direct to Phase II SBIR Grant Will Fund Preclinical and IND Enabling Studies on a Shelf-Stable Mucosal Delivered Universal Flu Vaccine Using Thin Film Freezing
Significant Funding a Result of a Multi-Year Collaboration with Dr. Ted Ross of the Cleveland Clinic
FORT WORTH, Texas, June 26, 2023 (GLOBE NEWSWIRE) — TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has awarded the Company a Direct to Phase II Small Business Innovation Research (SBIR) 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 purpose of the SBIR is to provide funding to support preclinical and IND enabling studies to advance the development of a shelf-stable dry powder formulation of a novel universal influenza virus vaccine, developed in the laboratory of Dr. Ted Ross at the Cleveland Clinic (previously of University of Georgia), that is more than 75% effective against symptomatic influenza virus infection and protects against groups I and II influenza A viruses, the form of virus that has historically given rise to all known influenza pandemics and that contributes to seasonal flu each year. If successful, this work could provide a first-in-class stable, 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 this Direct to Phase II SBIR grant will fulfill the IND-enabling requirements to potentially advance to human clinical testing.
“The advancement of this program is a result of a highly productive, multi-year collaboration between TFF Pharmaceuticals and world-renowned vaccine researcher Dr. Ted Ross, Global Director of Vaccine Development at Cleveland Clinic,” said Dr. Dale Christensen, VP of Preclinical Development at TFF Pharmaceuticals. “Traditional liquid vaccines require cold-chain handling which increases cost and present substantial barriers to establishing a stockpile or accessibility to underdeveloped areas. By developing dry powder vaccines that circumvent the need for cold chain storage, we can reduce those barriers. The funding for this project recognizes the potential of our technology to improve vaccine formulation of a universal flu vaccine in collaboration with Dr. Ross’ groundbreaking work.”
More specifically, the research from this grant will evaluate different adjuvants for intranasal and pulmonary inhalation delivery and confirm the stability, immunogenicity, and efficacy of the TFF-formulated HA vaccine in ferrets, the gold standard for influenza virus vaccine testing. Additional research includes tests to evaluate scale up manufacturing of the vaccine, complete GLP toxicology studies, and upon successful completion, advancement of the vaccine candidate to IND and human studies. Funding from the SBIR grant is expected to take place over three years.
“We would like to thank the NIAID for this grant, which provides significant funding to help us apply our Thin Film Freezing technology to develop a novel influenza vaccine that is potentially both highly effective and more accessible globally compared to current options,” said Harlan Weisman, M.D., Chief Executive Officer of TFF Pharmaceuticals. “A shelf-stable mucosal formulation will revolutionize the public health approach, providing an influenza vaccine that is effective regardless of which strain emerges in any given year. We look forward to advancing this program alongside Dr. Ross and his colleagues and appreciate the opportunity to further demonstrate the versatility of our Thin Film Freezing technology, while also advancing a potentially important new vaccine to help millions of people combat influenza.”
Influenza is a contagious viral infection that attacks the respiratory system infecting the nose, throat and sometimes the lungs. According to the U.S. Centers for Disease Control and Prevention (CDC), influenza results in tens of thousands of deaths annually in the US since 2010 and hundreds of thousands of deaths globally. There is a significant need to improve flu prevention and management programs, and major efforts are under way to develop better and more broadly protective influenza vaccines.
“Most healthy adults infected with the flu experience minor symptoms; however, the virus can cause serious complications to young children, the elderly, and people with weakened immune system and chronic conditions, including asthma, diabetes, and heart disease,” 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). “Based on positive data generated in collaboration with TFF Pharmaceuticals, we are moving closer to achieving our goal of developing a universal influenza vaccine to protect all patient populations in the US and globally.”
ABOUT TFF PHARMACEUTICALS’ THIN FILM FREEZING (TFF) TECHNOLOGY
TFF Pharmaceuticals’ proprietary Thin Film Freezing (TFF) technology allows for the transformation of both existing compounds and new chemical entities into dry powder formulations exhibiting unique characteristics and benefits. The Thin Film Freezing process is a particle engineering process designed to generate dry powder particles with advantageous properties for inhalation, as well as parenteral, nasal, oral, topical and ocular routes of administration. The process can be used to engineer powders for direct delivery to the site of need, circumventing challenges of systemic administration and leading to improved bioavailability, faster onset of action, and improved safety and efficacy. The ability to deliver therapies directly to the target organ, such as the lung, allows TFF powders to be administered at lower doses compared to oral drugs, reducing unwanted toxicities and side effects. Laboratory data suggests the aerodynamic properties of the powders created by Thin Film Freezing can deliver as much as 75% of the dose to the deep lung. Thin Film Freezing does not introduce heat, shear stress, or other forces that can damage more complex therapeutic components, such as fragile biologics, and instead enables the reformulation of these materials into easily stored and temperature-stable dry powders, making therapeutics and vaccines more accessible for distribution worldwide. The advantages of Thin Film Freezing can be used to enhance traditional delivery or combined to enable next-generation pharmaceutical products.
ABOUT TFF PHARMACEUTICALS
TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company engaging patented rapid freezing technology to develop and transform medicines into potent dry powder formulations for better efficacy, safety, and stability. The company’s versatile Thin Film Freezing (TFF) technology platform has broad applicability to convert most any drug, including vaccines, small and large molecules, and biologics, into an elegant dry powder highly advantageous for inhalation, with improved absorption so drugs can also be delivered to the eyes, nose and topically to the skin. TFF has two lead drug candidates in the clinic: TFF VORI (Voriconazole Inhalation Powder) and TFF TAC (Tacrolimus Inhalation Powder). The Company continues collaborations with a broad array of pharmaceutical companies, academic institutions, and government partners to revolutionize healthcare around the globe. The TFF Platform is protected by 120+ patents issued or pending in the U.S. and internationally. To learn more about TFF Pharmaceuticals and its product candidates, visit the Company’s website at https://tffpharma.com.
This press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including, the benefits of the Company’s TFF platform and the Company’s plans to add to its existing pipeline of product candidates. Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among those factors are: (i) the risk that the Company’s preclinical and IND enabling studies of the dry powder formulation of the universal influenza vaccine may not be successful, (ii) the risk that the Company may not be able to successfully conclude clinical testing or obtain pre-market approval of any of its other dry powder product candidates, (iii) success in early phases of pre-clinical and clinical trials does not ensure that later clinical trials will be successful, and interim results of a clinical trial do not necessarily predict final results, (iv) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (v) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (vi) the risk that the Company will not be able to conclude a long-term commercial agreement with any third-party, and (vi) those other risks disclosed in the section “Risk Factors” included in the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 11, 2023. TFF Pharmaceuticals cautions readers not to place undue reliance on any forward-looking statements. TFF Pharmaceuticals does not undertake, and specifically disclaims, any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law.
TFF Pharmaceuticals, Inc.
Investor Relations Contact:
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