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TFF Pharmaceuticals Announces Collaboration with Aptar Pharma to Explore and Develop Intranasal Delivery of Dry Powder Vaccines and Dry Powder Therapeutics

TFF Pharmaceuticals, Inc.
TFF Pharmaceuticals, Inc.

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

FORT WORTH, Texas, Nov. 03, 2022 (GLOBE NEWSWIRE) -- 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.

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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.

Safe Harbor
This press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including expectations for its collaboration arrangement with Aptar, the benefits of the Company’s TFF platform and the Company’s plans to add to its existing pipeline of product candidates. Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among those factors are: (i) the risk that the Company may not achieve the favorable results expected from its collaboration and feasibility studies with Aptar, (ii) the risk that the Company may not be able to conclude a commercial agreement with Aptar on terms favorable to TFF, or at all, regardless of the success of the feasibility study, (iii) the risk that the Company may not be able to successfully conclude clinical testing or obtain pre-market approval of any of its dry powder product candidates, (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, (vi) the risk that the Company will not be able to conclude a long-term commercial agreement with any third-party, and (vi) those other risks disclosed in the section “Risk Factors” included in the Company’s 2021 Annual Report on Form 10-K filed with the SEC on March 24, 2022. TFF Pharmaceuticals cautions readers not to place undue reliance on any forward-looking statements. TFF Pharmaceuticals 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.

TFF Contacts:

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

Media Contact:
Raena Mina, Ph.D.
LifeSci Communications
rmina@lifescicomms.com