TFF Pharmaceuticals Announces Publication of Data Demonstrating Feasibility of Intranasal Delivery of Monoclonal Antibodies with Thin Film Freezing

FORT WORTH, Texas, Nov. 08, 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 the publication of research demonstrating the feasibility of intranasal delivery of monoclonal antibodies (mAbs) using the Company’s proprietary Thin Film Freezing technology. The paper, entitled “Feasibility of Intranasal Delivery of Thin-film Freeze-dried Monoclonal Antibodies”, was first published on October 24, 2023, by bioRxiv and can be found .

More specifically, the research assessed the feasibility of applying the Company’s Thin Film Freezing technology to convert mAbs into aerosolizable dry powders that can be delivered into the posterior nasal cavity using Aptar Pharma’s Unidose (UDS) Powder Nasal Spray System. Based on the results of these studies, researchers concluded that, with proper formulation compositions, subjecting mAbs to Thin Film Freezing did not cause an increase in high molecular weight species and the mass percentage of proteinaceous particles remained below 2% weight concentration (w/w). Maintaining low molecular weight for droplet/particle size distribution is considered to be a critical attribute for effective delivery of intranasal liquid products.

“We are pleased with the results of this research, which provide further evidence that Thin Film Freezing can be applied across a board range of antibody-based drug candidates for intranasal delivery,” said Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals. “While TFF Pharmaceuticals continues to focus on advancing its two lead clinical programs, TFF VORI and TFF TAC, there remains strong interest across a diverse group of academic, industry and government entities to assess intranasal drug delivery given its potential advantages of providing a less invasive, more targeted approach of delivering drugs.”

“As a non-invasive delivery system, intranasal drug formulations hold many potential advantages over traditional, systemic-based delivery, including the potential for fast onset of action and reduced drug-related toxicities based on a more targeted approach,” said Dr. Julie D. Suman, Vice President, Scientific Affairs at Aptar Pharma. “The publication of this research demonstrates the broad utility of our Unidose technology to effectively deliver biologic-based therapeutics to the posterior of the nasal cavity.”

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 suggests the aerodynamic properties of the powders created by TFF can deliver as much as 75% of the dose to the deep lung. TFF 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 TFF 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 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 topically to the skin. TFF Pharmaceuticals 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 over 170 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 .

SAFE HARBOR This press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including, plans for releasing initial clinical data by the end of 2023, the adequacy of the Company’s cash runway to meet its near-term funding needs, and the benefits of the Company’s TFF platform. 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 be able to release initial clinical data for TFF VORI and TFF TAC by the end of 2023 or, if it is able to do so, that such clinical data will be positive, (ii) the risk that the Company’s working capital after giving effect to the recently announced public offering will not be sufficient to fund the Company’s working capital requirements through Q1 2024, (iii) the risk that the Company’s preclinical and IND enabling studies of the dry powder formulation of the universal influenza vaccine may not be successful, (iv) the risk that the Company may not be able to successfully conclude clinical testing of its TFF VORI or TFF TAC or obtain pre-market approval of any of its dry powder product candidates, (v) success in early phases of pre-clinical and clinical trials does not ensure that later clinical trials will be successful, and interim results of a clinical trial do not necessarily predict final results, (vi) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (vii) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (viii) the risk that the Company will not be able to conclude a long-term commercial agreement with any third-party, and (ix) 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, 2023. 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.

Investor Relations Contact:

Corey Davis, Ph.D.

LifeSci Advisors

(212) 915-2577