TFF Pharmaceuticals Partners with Emory University and BARDA to Develop a Dry Powder Inhaled mRNA-based Treatment for Influenza and COVID
TFF Pharmaceuticals (Nasdaq: TFFP) has partnered with Emory University and BARDA to develop a dry powder inhaled mRNA-based treatment for Influenza and COVID. This collaboration, funded by BARDA and other US government agencies, aims to test the feasibility of converting Emory's mRNA-based Cas13a antiviral into a dry powder formulation using TFF's Thin Film Freezing technology. The project's goals include more precise inhalational delivery, improved stability, and widespread distribution without cold-chain storage.
The partnership is part of BARDA's Flexible and Strategic Therapeutics (FASTx) program, designed to develop rapidly adaptable platforms to combat viral threats. TFF's technology could potentially enhance the efficacy of antiviral therapies by delivering the drug directly to where respiratory viruses replicate, while also improving practicality for distribution.
TFF Pharmaceuticals (Nasdaq: TFFP) ha stretto una collaborazione con l'Università di Emory e BARDA per sviluppare un trattamento a base di mRNA inalato in polvere secca per l'influenza e il COVID. Questa collaborazione, finanziata da BARDA e altre agenzie governative statunitensi, si propone di testare la fattibilità della conversione dell'antivirale Cas13a basato su mRNA dell'Emory in una formulazione in polvere secca utilizzando la tecnologia di congelamento a film sottile di TFF. Gli obiettivi del progetto includono una somministrazione inalatoria più precisa, una stabilità migliorata e una distribuzione più ampia senza necessità di una catena del freddo.
Il partenariato fa parte del programma di BARDA per le Terapeutiche Flessibili e Strategiche (FASTx), progettato per sviluppare piattaforme rapidamente adattabili per combattere le minacce virali. La tecnologia di TFF potrebbe potenzialmente migliorare l'efficacia delle terapie antivirali somministrando il farmaco direttamente nel luogo in cui i virus respiratori si replicano, migliorando al contempo la praticità per la distribuzione.
TFF Pharmaceuticals (Nasdaq: TFFP) se ha asociado con la Universidad de Emory y BARDA para desarrollar un tratamiento inhalado a base de mRNA en polvo seco para la Influenza y el COVID. Esta colaboración, financiada por BARDA y otras agencias del gobierno de EE. UU., tiene como objetivo probar la viabilidad de convertir el antiviral Cas13a basado en mRNA de Emory en una formulación en polvo seco utilizando la tecnología de congelación de película delgada de TFF. Los objetivos del proyecto incluyen una administración inhalatoria más precisa, una estabilidad mejorada y una distribución amplia sin necesidad de almacenamiento en cadena de frío.
La asociación es parte del programa Flexible y Estratégico de Terapéuticas de BARDA (FASTx), diseñado para desarrollar plataformas rápidamente adaptables para combatir amenazas virales. La tecnología de TFF podría mejorar potencialmente la eficacia de las terapias antivirales al administrar el medicamento directamente donde los virus respiratorios se replican, al mismo tiempo que mejora la practicidad para la distribución.
TFF 제약 (Nasdaq: TFFP)는 에모리 대학교 및 BARDA와 협력하여 인플루엔자 및 COVID를 위한 건조 분말 흡입 mRNA 기반 치료제를 개발하고 있습니다. BARDA와 기타 미국 정부 기관이 자금을 지원하는 이번 협력은 TFF의 얇은 필름 냉각 기술을 사용하여 에모리의 mRNA 기반 Cas13a 항바이러스를 건조 분말 제형으로 전환하는 가능성을 시험하는 것을 목표로 합니다. 이 프로젝트의 목표에는 보다 정확한 흡입 전달, 향상된 안정성 및 냉장 보관 없이 광범위한 분배가 포함됩니다.
이 파트너십은 바이러스 위협에 맞서기 위해 신속하게 적응 가능한 플랫폼을 개발하기 위해 설계된 BARDA의 유연하고 전략적인 치료법(FASTx) 프로그램의 일환입니다. TFF의 기술은 호흡기 바이러스가 복제되는 곳에 약물을 직접 전달함으로써 항바이러스 치료의 효과를 향상시킬 수 있으며, 배급의 실용성을 개선할 수 있습니다.
TFF Pharmaceuticals (Nasdaq: TFFP) a associé ses efforts à ceux de l'Université d'Emory et de BARDA pour développer un traitement à base de mRNA inhalé sous forme de poudre sèche pour la grippe et le COVID. Cette collaboration, financée par BARDA et d'autres agences gouvernementales américaines, vise à tester la faisabilité de la conversion de l'antiviral Cas13a basé sur l'mRNA d'Emory en une formulation en poudre sèche utilisant la technologie de congélation à film mince de TFF. Les objectifs du projet incluent une administration par inhalation plus précise, une stabilité améliorée et une distribution étendue sans nécessité de stockage en chaîne du froid.
Ce partenariat s'inscrit dans le programme de BARDA pour des thérapeutiques flexibles et stratégiques (FASTx), conçu pour développer des plateformes rapidement adaptables pour lutter contre les menaces virales. La technologie de TFF pourrait potentiellement améliorer l'efficacité des thérapies antivirales en administrant le médicament directement là où les virus respiratoires se répliquent, tout en améliorant la praticité de la distribution.
TFF Pharmaceuticals (Nasdaq: TFFP) hat eine Partnerschaft mit der Emory University und BARDA geschlossen, um eine inhaliertes mRNA-basiertes Trockenpulverbehandlung für Influenza und COVID zu entwickeln. Diese Kooperation, die von BARDA und anderen US-Regierungsbehörden finanziert wird, hat zum Ziel, die Machbarkeit der Umwandlung des mRNA-basierten Cas13a-Antiviral von Emory in eine Trockenpulverformulierung unter Verwendung der Dünnfilmgefrieren-Technologie von TFF zu testen. Zu den Zielen des Projekts gehören genauere inhalative Abgabe, verbesserte Stabilität und breitere Verteilung ohne Kühlkettenlagerung.
Die Partnerschaft ist Teil des FLEXIBLE und STRATEGISCHE Therapeutika-Programms (FASTx) von BARDA, das darauf abzielt, schnell anpassbare Plattformen zur Bekämpfung viraler Bedrohungen zu entwickeln. Die Technologie von TFF könnte potenziell die Wirksamkeit von antiviralen Therapien verbessern, indem das Medikament direkt dorthin geliefert wird, wo Atemwegsviren sich replizieren, und gleichzeitig die Praktikabilität für die Verteilung verbessert wird.
- Partnership with Emory University and BARDA for developing innovative antiviral treatment
- Funding support from BARDA and other US government agencies
- Potential for improved drug delivery, stability, and distribution without cold-chain storage
- Alignment with BARDA's strategic program for combating viral threats
- None.
Insights
This partnership marks a significant advancement in antiviral therapy development. The combination of TFF's dry powder technology with Emory's mRNA-based Cas13a antiviral could revolutionize the treatment of respiratory viruses. The potential for room-temperature storage and inhalational delivery addresses major challenges in vaccine distribution and efficacy. However, it's important to note that this is an early-stage development and success in feasibility testing doesn't guarantee clinical efficacy or regulatory approval. The
This partnership positions TFF Pharmaceuticals at the forefront of a potentially lucrative market. The global influenza therapeutics market is projected to reach
The application of CRISPR-Cas technology in antiviral therapy is a cutting-edge approach. Cas13a, specifically targeting RNA, is well-suited for combating RNA viruses like influenza and SARS-CoV-2. TFF's Thin Film Freezing technology could solve the stability issues often associated with RNA-based therapeutics. If successful, this could lead to a paradigm shift in rapid response to viral threats. However, challenges remain in ensuring precise delivery to infected cells and managing potential off-target effects. The success of this project could have far-reaching implications beyond just influenza and COVID-19, potentially opening doors to treating a wide range of viral infections.
Partnership funded by BARDA and other US government agencies
TFF formulation may provide flexibility of delivery and improve storage and distribution conditions
FORT WORTH, Texas, Sept. 11, 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 announces its new partnership with Emory University and the Biomedical Advanced Research and Development Authority (BARDA). Under the partnership, TFF Pharmaceuticals will test the feasibility of converting Emory’s mRNA-based Cas13a antiviral against influenza A and B and SARS-CoV-2 into a dry powder formulation for more precise inhalational delivery, improved stability and widespread distribution without the need for cold-chain storage.
The competitively awarded Easy Broad Agency Announcement (EZ-BAA) contract supports early-stage therapeutic platform development under BARDA’s Flexible and Strategic Therapeutics (FASTx) program. The FASTx program is designed to transform antiviral therapy by developing rapidly adaptable platforms to combat viral threats through the use of next generation technology such as clustered regular interspaced short palindromic repeat-associated proteins (CRISPR-Cas), which can be rapidly manufactured in response to emerging viral threats.
“Viruses pose a significant public health challenge through their ability to evolve rapidly, which renders traditional antiviral therapies ineffective and risks widespread outbreaks in case of emerging strains. Our partnership with Emory University and BARDA is an important opportunity to deploy our TFF technology to combat rapidly changing respiratory viruses, including influenza and COVID,” said Dr. Harlan Weisman, TFF Pharmaceuticals’ Chief Executive Officer. “Inhalational delivery of antiviral therapy against respiratory viruses is poised to drive efficacy by providing the drug where the virus replicates while improved stability and room temperature storage enhance practicality for widespread distribution.”
“TFFs novel dry powder formulation provides an important new approach to address the unmet need for precise delivery of novel therapeutics against potentially deadly respiratory viral infections. With ever-changing influenza and COVID strains emerging, flexibility of delivery without the need for cold chain storage and distribution is all the more important. We look forward to working closely with the TFF team to develop new approaches to treat these conditions faster and more efficiently,” said Philip J. Santangelo, Professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech School of Engineering and Emory University School of Medicine.
This work is supported with federal funds from BARDA, part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS).
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 suggest the aerodynamic properties of the powders created by TFF can deliver as much as
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 potential development of a novel, innovative approach for treating respiratory viruses, including influenza and COVID, using its TFF technology. Forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially, including (i) the risk that the Company’s partnership with Emory University and BARDA may not lead to a successful treatment of respiratory viruses, such as influenza and COVID, (ii) the risk that the Company may not be able to obtain additional working capital with which to continue its current operations and clinical trials as and when needed, (iii) success in early phases of pre-clinical and clinical 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 (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 August 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:
Core IR
Jason Nelson
investorinfo@tffpharma.com
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