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TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative drug products utilizing their patented Thin Film Freezing (TFF) technology. This groundbreaking technology allows for the transformation of both existing compounds and new chemical entities into dry powder formulations. The TFF platform provides numerous advantages, including high absorption and yield, uniform particle size, and a gentle process that preserves the integrity of complex therapeutic components.
Core Business and Products
TFF Pharmaceuticals has two lead drug candidates currently under clinical evaluation: Voriconazole Inhalation Powder (TFF VORI) and Tacrolimus Inhalation Powder (TFF TAC). These inhaled dry powder drugs are designed to treat lung disorders and organ transplant rejection, respectively.
Recent Achievements and Projects
Recently, TFF Pharmaceuticals announced positive data from their ongoing Phase 2 study of TFF TAC, which is being developed to prevent organ rejection in lung transplant recipients. The study indicates that TFF TAC provides sufficient immunosuppression to prevent rejection at significantly reduced doses compared to oral tacrolimus, potentially reducing the risk of kidney toxicity.
Financial Condition and Partnerships
As of the first quarter of 2024, TFF Pharmaceuticals has secured additional financing to continue advancing their TFF TAC program toward registrational testing. The company is actively collaborating with large pharmaceutical companies, academic institutions, and government partners to expand their pipeline and revolutionize healthcare globally.
Technology and Patents
The TFF technology platform is protected by over 170 patents issued or pending in the U.S. and internationally. This versatile platform can convert vaccines, small and large molecules, and biologics into elegant dry powders, making them ideal for inhalation or topical delivery.
The company’s proprietary TFF process allows for the direct delivery of therapies to target organs such as the lungs, which can improve bioavailability, reduce dosages, and minimize side effects. Laboratory data suggest that the aerodynamic properties of TFF powders can deliver as much as 75% of the dose to the deep lung.
Conclusion
TFF Pharmaceuticals is at the forefront of transforming biopharmaceutical delivery methods with its innovative TFF technology. By developing dry powder formulations that offer enhanced efficacy, safety, and stability, the company is poised to make significant impacts in the treatment of lung disorders and beyond.
NeuroRx and TFF Pharmaceuticals (NASDAQ: TFFP) have signed a Feasibility Agreement, enabling the transfer of ZYESAMI™ materials to TFF for formulation work. This aims to develop a stable dry powder version of ZYESAMI™, enhancing aerosol delivery to the lungs. ZYESAMI™ is a synthetic peptide that aids in treating lung conditions linked to COVID-19 by potentially increasing surfactant production. The collaboration seeks to broaden its therapeutic applications, particularly for patients with varying severity of COVID-19 symptoms.
GreenLight Biosciences and TFF Pharmaceuticals have partnered to explore feasibility studies for developing a shelf-stable powder form of a messenger RNA COVID-19 vaccine. This collaboration aims to simplify vaccine distribution by eliminating the need for extreme cold storage, which complicates logistics and increases costs. The partnership could lead to vaccines that can be transported at higher temperatures and reconstituted before administration. If successful, this initiative may significantly enhance global vaccine accessibility and response to the pandemic.
GreenLight Biosciences and TFF Pharmaceuticals have partnered to explore a feasibility study for a shelf-stable dry powder form of a COVID-19 mRNA vaccine. This collaboration aims to address challenges associated with current cold chain requirements for vaccine distribution, which necessitate temperatures as low as -80°C. If successful, the new formulation could simplify vaccine delivery worldwide, especially in regions with limited cold chain infrastructure. TFF Pharmaceuticals will test the reconstitutability and viability of the vaccine candidate, which may lead to innovative, non-needle administration methods.
TFF Pharmaceuticals (NASDAQ: TFFP) will participate in the H.C. Wainwright Global Life Sciences Conference on March 9-10, 2021, and the 33rd Annual ROTH Conference on March 15-17, 2021. Glenn Mattes, President & CEO, will deliver pre-recorded presentations. Dr. Dale Christensen will join a panel discussion at ROTH on March 15th at 12 PM ET, discussing therapeutics against SARS-CoV-2. Recordings will be available for registered attendees on the TFF Pharmaceuticals website. TFF's technology enhances drug solubility for effective inhalation.
TFF Pharmaceuticals (NASDAQ: TFFP) has reported progress in clinical trials for its Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder. The Phase 1 trial for Voriconazole showed no significant adverse events, with blood levels exceeding expectations, marking it as a promising treatment for invasive pulmonary aspergillosis (IPA). TFF has selected an 80 mg dose for an upcoming pivotal trial. The Single Ascending Dose phase for Tacrolimus has also been completed, achieving therapeutic levels without adverse effects, indicating potential applications beyond lung transplants.
TFF Pharmaceuticals (NASDAQ: TFFP) will announce its financial results for Q4 and full-year 2020 on March 10, 2021, after U.S. market close. A conference call is scheduled at 4:30 PM ET to discuss these results and recent developments, followed by a Q&A session. The TFF platform enhances the solubility and absorption of poorly water-soluble drugs, particularly for inhalation therapy, and is supported by 42 patents. The company is advancing its lead candidates, Voriconazole and Tacrolimus Inhalation Powders, in collaboration with pharmaceutical partners.
TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) and the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) announced positive preclinical in vitro efficacy data for TFF formulated biodefense countermeasures. Their collaboration, established in April 2020, focused on developing needle-free, temperature-insensitive inhaled treatments. Results showed preserved efficacy for a monoclonal antibody against Ebolavirus and a vaccine candidate against Venezuelan equine encephalitis. Future steps include in vivo testing. This advancement highlights the potential of TFF's technology to enhance biodefense measures for military personnel.
TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a biopharmaceutical firm specializing in innovative drug products, will participate in the 2021 BIO CEO & Investor Digital Conference from February 16-18, 2021. CEO Glenn Mattes will present a pre-recorded session available on-demand for 30 days to registered attendees. TFF Pharmaceuticals utilizes its patented Thin Film Freezing (TFF) technology to enhance drug solubility and absorption, focusing on inhalation delivery to the deep lung, with potential drug deposition as high as 75%. The company aims to expand its pipeline through collaborations.
TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) has been invited to present at H.C. Wainwright’s BioConnect 2021 Conference, taking place virtually from January 11-14, 2021. CEO Glenn Mattes will deliver a pre-recorded presentation available on-demand for one week starting January 11 at 6:00 AM Eastern time. The company will also engage with investors at the Biotech Showcase and participate in meetings through BIO’s One-on-One Partnering System throughout the event. TFF Pharmaceuticals focuses on its patented Thin Film Freezing technology, aimed at enhancing drug solubility and absorption.
TFF Pharmaceuticals (NASDAQ: TFFP) has initiated dosing in a Phase 1b clinical trial for its Voriconazole Inhalation Powder, targeting patients with asthma. The trial will assess safety and pharmacokinetics, crucial for treatment without bronchospasm induction in hyperreactive airway patients. Previous studies showed the formulation was well tolerated in healthy volunteers. Voriconazole is highly regarded for treating Invasive Pulmonary Aspergillosis (IPA), but its oral form has significant interactions. The inhaled version aims to enhance efficacy and reduce systemic side effects, paving the way for pivotal Phase 2 studies.
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