Paullee
6月前
TFF Pharmaceuticals and Cleveland Clinic to Advance Multivalent Universal Influenza Vaccine Candidates into Preclinical Testing
May 20, 2024 07:00 ET
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.
Paullee
2年前
FORT WORTH, Texas, May 01, 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 Leidos, a leading Fortune 500 information technology, engineering and science solutions and services leader, has awarded the Company additional funding under the DARPA Personalized Protective Biosystems (PPB) program to develop next-generation countermeasures for military and healthcare personnel.
The PPB research program, managed by the Defense Advanced Research Projects Agency (DARPA), is developing an integrated system that simultaneously reduces protective equipment needs while increasing protection for the individual against existing and future chemical and biological (CB) threats. This will be achieved through lightweight materials that protect the military or healthcare personnel from exposure to CB threats, while simultaneously providing a second layer of protection, at the tissue barrier, with bio-molecular, commensal organisms, or other technologies that protect the skin, eyes, and airway from CB threats. Successful PPB technologies could change how the military and public health communities perform in unpredictable threat environments.
In April 2021, the Company entered into a 60-month, three-phase subcontract with Leidos to utilize its Thin Film Freezing platform to formulate a series of countermeasures designed to neutralize chemical and biological agents at the site of vulnerable tissue barriers, including the skin, the eyes and the respiratory system.
“We are pleased with the continued advancement of this program and our relationship with Leidos,” said Harlan Weisman, M.D., Chief Executive Officer of TFF Pharmaceuticals. “There is an unmet need to develop next-generation countermeasures to adequately protect our military and civilian populations. Our technology not only allows for delivery of various countermeasures to neutralize biochemical threats directly at the site of entry, but is also needle-free and temperature independent, making these countermeasures easily deployed and administered with ease for future biochemical threat preparedness and biodefense. We believe our Thin Film Freezing platform has extraordinary potential to improve upon numerous applications, including the development of the next generation of chemical and biological protective technologies that can significantly improve the level of protection for our military and front-line personnel.”
ABOUT LEIDOS
Leidos is a Fortune 500® information technology, engineering, and science solutions and services leader working to solve the world’s toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company’s 37,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Va., Leidos reported annual revenues of approximately $11.09 billion for the fiscal year ended January 3, 2020. For more information, visit www.leidos.com.
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.
Paullee
2年前
TFF Pharmaceuticals Announces Collaboration with Aptar Pharma to Explore and Develop Intranasal Delivery of Dry Powder Vaccines and Dry Powder Therapeutics
Administration of dry powders will utilize Aptar Pharma’s Unidose (UDS) Powder Nasal Spray System The TFF dry powder vaccines maintain the antigen’s integrity, can be delivered to the targeted region of the nasal cavity, and have desirable particle size distribution, spray pattern and plume geometry A shelf-stable dry powder vaccine formulation delivered intranasally could dramatically change the existing vaccine landscape
By
Daniel Carlson
-
November 3, 2022
TW’s Take: another early stage partnership that positions TFF well for next-gen vaccines but does little to overcome the concerns around the company’s finances. TFF is as exciting as ever, long-term, but needs to show a clear path to revenue to get investors excited again.
FORT WORTH, Texas, Nov. 03, 2022 — TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing technology platform, today announced a collaboration with Aptar Pharma, a global leader in drug delivery and active material science solutions and services, aimed at developing and testing the administration of dry powder vaccines utilizing TFF Pharmaceutical’s Thin Film Freezing technology and Aptar Pharma’s proprietary intranasal Unidose (UDS) Powder Nasal Spray System.
A need for alternative routes of vaccination, such as intranasal, were highlighted at the White House Summit on the Future of COVID-19 Vaccines, which took place in July 2022. The development of an effective intranasal vaccine has numerous potential advantages over conventional, subcutaneous or intramuscular-based delivery. First, the nasal passageway is very often the first point of entry for respiratory pathogens, and if the pathogen can be halted in the nasal passages, the spread of infection is likely to be significantly curtailed, leading to an improved prognosis.
In addition, the direct immunization of nasal mucosa may promote both systemic and mucosal immunity. Mucosal immunity may be a key to preventing viral shedding and disease transmission.
Furthermore, self-administration of a “needle-free” vaccine provides for pain-free administration to the patient, results in less medical waste by avoiding syringe disposal, eliminates extreme cold storage requirement from the supply chain and simplifies global distribution. These aspects of nasal delivery could expand vaccine availability to larger populations in regions and countries with limited refrigeration infrastructure.
During the Vaccines Summit-2022, which took place from October 11 to 13, 2022 in Washington DC, U.S., Aptar Pharma presented research findings from their collaboration with TFF Pharmaceuticals. The presentation highlighted data related to nasal deposition of a dry powder vaccine, physical characteristics of the administered formulation, the integrity and activity testing of the dry powder vaccine after administration, and the emitted particle size. The amount of dry powder delivered to the targeted region of the nasal cavity was also presented. Aptar Pharma will present additional data on these efforts at the World Vaccine & Immunotherapy Congress, which will be held in San Diego, CA from November 28 to December 1, 2022.
“We are very excited to partner with Aptar Pharma to test our Thin Film Freezing formulation with their unique intranasal device,” said Glenn Mattes, President & CEO of TFF Pharmaceuticals. “By combining our collective and proprietary expertise in drug development, device engineering and formulation technologies, we believe this collaboration has the potential to create ground-breaking advancements in the field of drug delivery. Intranasal dry powder vaccines could be a true game changer for people around the world.”
“The nasal vaccine formulation developed using TFF Pharmaceutical’s technology combines the antigen and adjuvant into one ready to use device,” commented Dr. Julie D. Suman, Vice President, Scientific Affairs at Aptar Pharma. “This eliminates the need for combining separate vials, saves time, reduces human error and medical waste.”
The results of the feasibility testing will be published by Aptar Pharma, The University of Texas at Austin (UT) and TFF Pharmaceuticals in the coming months. Aptar, UT and TFF are preparing to summarize the results of the initial intranasal vaccine feasibility testing in a pre-print publication to be followed by a peer-reviewed publication in the coming months.
About Aptar Pharma
Aptar Pharma is part of AptarGroup, Inc., a global leader in the design and manufacturing of a broad range of drug delivery, consumer product dispensing and active material science solutions and services. Aptar’s innovative solutions and services serve a variety of end markets including pharmaceutical, beauty, personal care, home care, food and beverage. Using insights, proprietary design, engineering and science to create dispensing, dosing and protective technologies for many of the world’s leading brands, Aptar in turn makes a meaningful difference in the lives, looks, health and homes of millions of patients and consumers around the world. Aptar is headquartered in Crystal Lake, Illinois and has 13,000 dedicated employees in 20 countries. For more information, visit www.aptar.com.
About TFF Pharmaceuticals’ Thin Film Freezing technology platform
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: Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder and continues to expand its pipeline by collaborating 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.
https://twresearchgroup.com/2022/11/tff-pharmaceuticals-announces-collaboration-with-aptar-pharma-to-explore-and-develop-intranasal-delivery-of-dry-powder-vaccines-and-dry-powder-therapeutics/
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