TFF Pharmaceuticals and Cleveland Clinic to Advance Multivalent Universal Influenza Vaccine Candidates into Preclinical Testing

Rhea-AI Summary

TFF Pharmaceuticals, in collaboration with Cleveland Clinic, announced the advancement of multiple multivalent universal influenza vaccines into preclinical testing. Utilizing TFF's Thin Film Freezing technology, these vaccines aim to protect against seasonal and pandemic flu viruses. The preclinical testing decision follows successful formulation testing and stability data on hemagglutinin (HA) antigens with four adjuvants. Funded by NIAID, this work aims to create a universal, shelf-stable, and easy-to-transport vaccine, potentially advancing to human clinical trials. The research targets a vaccine that circumvents cold chain storage needs and improves distribution. TFF received a $2.97M SBIR grant in June 2023 for this project, highlighting its potential efficacy and protection against influenza A viruses.

Positive

• TFF Pharmaceuticals is advancing preclinical testing for universal influenza vaccines, indicating progress in product development.
• The collaboration with Cleveland Clinic adds credibility and expertise to the project.
• Funding from NIAID and a $2.97 million SBIR grant supports the financial stability of this research.
• Successful formulation and stability testing of HA antigens with four adjuvants.
• Potential to develop a shelf-stable vaccine, eliminating the need for cold chain storage.
• The vaccine aims to protect against both seasonal and pandemic influenza viruses.
• The project aligns with global health priorities, potentially increasing future demand and relevance.

Negative

• The project is still in the preclinical stage, meaning it is far from generating revenue.
• There is inherent risk and uncertainty in transitioning from preclinical to human clinical trials.
• The long timeline for vaccine development may delay potential market entry and financial returns.
• Dependency on SBIR and NIAID funding could be a risk if future grants are not secured.
• No guarantee that the vaccine will meet the efficacy targets set by preclinical studies.

Insights

Medical Research Analyst

The collaboration between TFF Pharmaceuticals and Cleveland Clinic to advance multivalent universal influenza vaccines is significant in the landscape of infectious disease prevention. Currently, one of the major hurdles in vaccine effectiveness is the unpredictability of flu strains, which can lead to mismatches and reduced efficacy. A universal flu vaccine that can overcome these limitations would be a game-changer. The use of the Thin Film Freezing technology to create a shelf-stable and easy-to-transport vaccine addresses critical logistical challenges, particularly in low-resource settings. This innovation could drastically improve vaccine distribution and accessibility globally.

The fact that the vaccine candidates have shown positive in vitro and in vivo data is promising and sets a strong foundation for preclinical testing. However, it's important to note that preclinical success does not always translate to clinical success in humans. Investors should be cautiously optimistic but aware of the significant developmental hurdles still ahead.

Market Research Analyst

The announcement from TFF Pharmaceuticals also has substantial market implications. Influenza vaccines represent a multi-billion-dollar market and the development of a universal flu vaccine could disrupt the market significantly. The funding from NIAID and the Phase II SBIR grant of $2.97 million provide not only financial backing but also validation from reputable institutions, which can enhance investor confidence.

Moreover, the collaboration with Cleveland Clinic, a highly regarded institution, adds significant credibility to the project. From a market perspective, such collaborations often lead to increased investor interest and potential for higher stock valuations. However, there are risks associated with the lengthy development timelines and regulatory hurdles that could affect the project's future marketability and profitability.

Financial Analyst

From a financial standpoint, TFF Pharmaceuticals' progress on a universal influenza vaccine represents a potential revenue driver. The current annual influenza vaccine market is valued in billions of dollars and capturing even a fraction of this market with a universal vaccine could significantly impact the company's financials. The Direct to Phase II SBIR grant of $2.97 million mitigates some financial risks by offsetting research and development costs.

However, investors need to be aware of the long and uncertain path from preclinical to market approval. It involves substantial investment, not only in clinical trials but also in regulatory submissions and manufacturing scale-up. The stock could experience volatility based on clinical results and regulatory feedback. Short-term investors may see this as a speculative investment, while long-term investors might view it as a high-risk, high-reward opportunity.

FORT WORTH, Texas, May 20, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc (Nasdaq: TFFP) (the “Company” or “TFF Pharmaceuticals”), 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, in collaboration with Cleveland Clinic, the Company is advancing multiple multivalent universal influenza vaccines to protect against seasonal and pandemic viruses into preclinical testing. The decision to advance the vaccine candidates into preclinical testing was based upon the successful completion of formulation testing with stability data on the combination of hemagglutinin (HA) antigens with four different adjuvants. Based on these data, three HA antigen/adjuvant candidate vaccines have been selected for testing in a pre-clinical model at Cleveland Clinic Florida.

Funded through the National Institute of Allergy and Infectious Diseases (NIAID), the purpose of the research collaboration between TFF Pharmaceuticals and Cleveland Clinic is to develop a first-in-class, stable, universal, 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 the work funded by the Direct to Phase II SBIR grant will fulfill the IND-enabling requirements to potentially advance to human clinical testing.

“A recent survey¹ 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,” said Dr. Harlan Weisman, Chief Executive Officer 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.”

“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 (CIVR-HRP). “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.”

In June 2023, the Company was awarded a Direct to Phase II Small Business Innovation Research (SBIR) grant of $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. Ross, 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.

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 has resulted 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.

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 TFF 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 TFF can deliver as much as 75% of the dose to the deep lung. TFF 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 TFF 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 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, or for topical delivery to the eyes, nose and the skin.

SAFE HARBOR

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements in this press release include, but are not limited to, statements by the Company relating to the expectation that the preclinical testing of the Company’s multiple multivalent universal influenza vaccine candidates will favorably consistent with formulation testing conducted to date, the expectation that the Company will be able to move its vaccine candidates into the Phase II clinical trial and the benefits of the Company’s TFF platform. Forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially, including (i) the risk the preclinical testing of the Company’s influenza vaccine candidates will not be favorably consistent with the formulation testing to date, (ii) the risk that the Company may not be able to advance its influenza vaccine candidates to Phase II clinical trials, (iii) success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (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, and (vii) 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 14, 2024. The Company cautions readers not to place undue reliance on any forward-looking statements. The Company 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.

Investor Relations Contact:
Corey Davis, Ph.D.
LifeSci Advisors
(212) 915-2577
cdavis@lifesciadvisors.com

¹ Source: https://medicalxpress.com/news/2024-04-experts-influenza-pathogen-pandemic-potential.html

FAQ

What is the recent development with TFF Pharmaceuticals' influenza vaccine?

TFF Pharmaceuticals, in collaboration with Cleveland Clinic, is advancing multiple universal influenza vaccines into preclinical testing.

When did TFF Pharmaceuticals announce the preclinical testing of their influenza vaccine?

The announcement was made on May 20, 2024.

What technology is TFF Pharmaceuticals using for their influenza vaccine?

TFF Pharmaceuticals is using its patented Thin Film Freezing technology for the influenza vaccine.

Who is funding TFF Pharmaceuticals' influenza vaccine research?

The research is funded by the National Institute of Allergy and Infectious Diseases (NIAID) and supported by a $2.97 million SBIR grant.

What are the key features of the TFF Pharmaceuticals influenza vaccine?

The key features include being universal, shelf-stable, easy-to-transport, and effective against groups I and II influenza A viruses.

What stage is TFF Pharmaceuticals' influenza vaccine currently in?

The influenza vaccine is currently in the preclinical testing stage.

What are the potential benefits of TFF Pharmaceuticals' influenza vaccine?

The vaccine aims to protect against seasonal and pandemic influenza viruses, eliminate cold chain storage needs, and improve distribution.