Spotlight Q&A: TFF Pharmaceuticals – Innovative Drug Formulation May Expand Geographic Reach of COVID-19 Vaccines and Treatments

LaVoieHealthScience Client Spotlight

Glenn Mattes

Following is a Q&A with Glenn Mattes, President, CEO and Director of TFF Pharmaceuticals (Nasdaq: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform.

Welcome to Big4Bio, Mr. Mattes. Can you share with our readers what is important about your Thin Film Freezing platform as a way to improve the performance of existing drugs?

Thank you, our Thin Film Freezing platform is an extremely versatile drug formulation platform that can improve the delivery, efficacy and safety of many existing drugs. Our technology can convert small and large molecules that normally must be given orally or via infusion or injection into a stable dry powder matrix that can be inhaled directly into the lungs. Our process can significantly improve the solubility and absorption – the pharmacokinetics – of poorly water-soluble drugs, which comprise approximately one-third of the major pharmaceuticals worldwide.

Lack of robust water solubility is a significant impediment to effective dosing, since it means that only a small percentage of many medications’ active ingredients actually reach the target site in the patient’s body. For example, while only 10% of poorly water-soluble oral, injected or infused medications may reach their target site, drugs that have been reformulated with our TFF process can deliver closer to 75% of the active ingredients to the deep lung. This means that patients can receive the full therapeutic effect using lower doses of the drug, while potentially avoiding many of the adverse events and side effects that often accompany systemic administration.

That sounds very promising. Do you have data that demonstrate that this approach works in patients?

Yes, we have strong proof-of-concept data for our dry powder reformulation process. Right now, we have two candidates that are advancing through the clinic towards filings with the FDA. These two drug candidates are a reformulated dry powder version of voriconazole, a widely used lung anti-fungal that is now entering Phase 2 trials, and tacrolimus, an important immunosuppressive agent to help prevent lung transplant rejection that has just reported positive Phase 1 data. To date, the TFF platform’s ability to convert poorly soluble drugs into stable dry powder matrices has demonstrated all the clinical advantages we had hoped for.

Where else do you see applications for your TFF platform?

That is what is so exciting right now. We see tremendous potential for our TFF platform to help address one of the greatest difficulties in distributing vaccines and therapeutics for COVID-19 at global scale.

As virtually every person on the planet probably knows by now, a number of vaccines have been shown in clinical trials to be highly effective against COVID-19. Equally as important is the growing number of therapeutics to treat the disease that are beginning to approach registration review with global regulatory authorities. None of these accomplishments have been easy, and taken together they will hopefully provide a pathway to control and then shut down the global devastation of the SARS-CoV-2 pathogen.

However, there are serious barriers that threaten to derail the distribution of these first generation COVID-19 vaccines within the United States and around the world. Not only are the sheer logistics of shipment, clinician training and patient outreach enormous, but the two front-runner mRNA vaccines will require very stringent temperature controls to be maintained from the manufacturer to patients.

Moderna’s vaccine candidate requires temperatures comparable to those of a home freezer, while Pfizer/BioNTech’s requires shipment and storage at negative 70 Celsius. Such “cold chain” requirements do not exist in many parts of the world. It is estimated that poor temperature control spoils or degrades 25% of conventional vaccines en route to patients; imagine the extent of loss due to inadequate temperature control with these precious mRNA vaccines that are now so urgently needed across the globe to fight the pandemic.

We think the TFF platform can help overcome these barriers. In pre-clinical work, we have already successfully reformulated other vaccines into our shelf stable dry powder matrices. If a second generation of the current vaccine candidates were reformulated into a dry powder form, there would be no need for cold chain distribution or storage. We believe that, if reformulated through our TFF platform, vaccines against the SARS-CoV-2 virus could be stable for as long as needed and would demand no special transportation or storage requirements.

Our technology also has the potential to enhance the delivery of therapeutics and vaccines directly to the part of the body most immediately affected by the COVID-19 virus – the lungs – using needle-free intranasal or oral inhalation administration.

You mentioned both vaccines and therapeutics for COVID-19. Do you see a potential role for the TFF platform for disease treatments as well as preventive vaccines?

Yes, we are already involved in studies for remdesivir, niclosamide and various monoclonal antibodies, all potentially promising treatments for COVID-19. We have reformulated remdesivir into a dry powder that can be directly administered to the site of infection using a conventional, commercially available dry powder inhaler. We believe this inhalation method of delivery has the potential to maximize the drug’s effectiveness in the lungs, where the coronavirus first takes hold. Injectable remdesivir has already gained an emergency use authorization from the FDA to treat COVID-19. Our reformulation could result in a more accessible and effective outpatient treatment option that could be provided early in the course of infection.

We are in the pre-clinical stages of developing a dry powder form of niclosamide, an existing antiviral drug that in an oral form is in Phase 2/3 clinical trials to evaluate its safety and efficacy against COVID-19, as well as a dry powder delivery method for monoclonal antibodies for COVID-19 therapeutics, which hold the promise of enhancing the immune system’s natural response to fighting viruses.

Is there anything else about TFF Pharmaceuticals that our readers should know?

Based on our success in creating successful dry powder formulations of both small and large molecule drugs, we are confident that our novel drug development approach can make a vital contribution to the global response to the SARS-CoV-2 pandemic. No one company or approach will be able to restore the world to “normal” in the face of today’s unprecedented challenges. However, by overcoming these serious challenges to the safe storage and distribution of vaccines and therapeutics to combat this pathogen, Thin Film Freezing technology offers a way to bring first-world medicines to the global community.

That in itself could be something to celebrate.