AUSTIN, Texas--(BUSINESS WIRE)--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 (TFF) technology platform, today provided a year-end 2019 corporate update and anticipated clinical milestones for 2020.
“Since our Initial Public Offering at the end of October 2019, the company has been proceeding as expected in its clinical development programs, as well as in leveraging its platform technology in collaboration with leading pharmaceutical and biopharmaceutical companies,” said Glenn Mattes, President and CEO of TFF Pharmaceuticals. “The meaningful progress we’ve have made to date is a further validation of the potential of our Thin Film Freezing technology platform.”
Recent Clinical and Corporate Highlights:
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Voriconazole Inhalation Powder: At the end of 2019, TFF’s lead clinical program, Voriconazole Inhalation Powder, to treat the severe and life-threatening disease of Invasive Pulmonary Aspergillosis, or IPA, began dosing subjects in its Phase 1 clinical trial. To date, the Single Ascending Dose (SAD) stage of the trial has successfully completed the second of four dosing cohorts. The Company anticipates SAD dosing will be completed by the end of March. The Multiple Ascending Dose (MAD) stage of the study will begin by the end of February. The Company anticipates a Phase I study database lock by the end of Q2-2020, with 6-month toxicology studies complete by the end of Q4-2020.
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Tacrolimus Inhalation Powder: TFF’s second clinical program, Tacrolimus Inhalation Powder, an inhaled dry powder version of tacrolimus, one of the most commonly administered immunosuppressive drug used in solid organ transplants, is also making solid progress. The Company expects to file an Investigational New Drug Application, or IND, for Tacrolimus Inhalation Powder in Q1-2020 and, subject to the FDA’s clearance of the IND, intends to begin Single Ascending Dose Phase I studies by the end of Q1-2020, with Multiple Ascending Dose studies beginning in Q2-2020. The Company anticipates the completion of 6-month toxicology studies by the end of 2020.
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Strategic Business Development and Partnership Activities – Commercial pharma- and biopharmaceutical companies: In December TFF Pharmaceuticals entered into a feasibility agreement with the University of Texas at Austin (UT-Austin) and an undisclosed leading worldwide biopharmaceutical company (“Partner No. 1”), to explore using the Company’s Thin Film Freezing technology platform to formulate, perform testing on and collaborate on optimization work for two proprietary compounds of Partner No.1. This work is ongoing.
TFF is collaborating with a large multi-national pharma company (“Partner No. 2”) and UT-Austin to explore using the Company’s Thin Film Freezing technology platform to formulate a liquid vaccine product candidate of Partner No. 2 into a dry powder formulation for reconstitution. The Company, with the assistance of UT-Austin, has successfully taken the partner’s vaccine, which contains an aluminum adjuvant, and formulated it using the Company’s Thin Film Freezing technology. The Company has performed internal testing and the TFF reconstituted dry powder has the same properties as the initial liquid vaccine. The TFF dry powder vaccine has been delivered to Partner No. 2 for internal testing, which includes animal testing, and such testing has confirmed that the TFF dry powder formulation meets the same specifications as the liquid vaccine currently in development. Ongoing formulation optimization and additional testing is underway.
TFF continues to engage with several leading multi-national pharma companies in an effort to enter into feasibility projects taking the partner’s product candidates, whether small molecule, large molecule, biologics, enzymes, antibodies, gene therapy, DNA derived therapy and/or vaccines, to utilize the Company’s Thin Film Freezing technology platform to deliver new and innovative products directly to the lung.
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Strategic Business Development and Partnership Activities – Governmental and defense contracting agencies: TFF continues to engage with a number of government and defense contracting agencies in an effort to utilize the Company’s Thin Film Freezing technology platform to formulate dry powder vaccines for delivery via reconstitution or lung inhalation or nasal inhalation. The Company’s testing confirms that Thin Film Freezing maintains the vaccine’s particle size distribution and immunogenicity, is robust for extended periods at room temperature, withstands unintentional freezing, and can be stored and shipped free of cold-chain handling, displays extended stability for stockpiling – dry powder storage over liquid, and provides for needle-free vaccination (nasal or inhalation administration).
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CBD Development Studies – The Company is also engaged in the development of a dry powder formulation of cannabidiol, or CBD, which has been reported to be used by some for the treatment of various epilepsy syndromes as well as anxiety, insomnia, and different types of pain. We are in the early stages of developing an inhaled dry powder form of CBD that could be used to support or to treat a variety of health issues that may benefit from CBD administration. We are also actively engaged in discussions with several third parties concerning our grant of a license to our TFF technology platform in the field of use of CBD.
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Ongoing Investor Relations Activities – In January, TFF met with numerous investors, analysts and potential commercial partners in San Francisco during the annual JP Morgan Healthcare Conference. On February 10-11, Company management will be meeting with investors and commercial partners in New York at the 22nd annual BIO CEO & Investor Conference. And the Company has been invited to participate in the 32nd annual ROTH Conference, scheduled for March 15-17 in Orange County, CA.
About TFF Pharmaceuticals’ Thin Film Freezing technology platform
TFF Pharmaceuticals’ Thin Film Freezing (TFF) platform was designed to improve the solubility and absorption of poorly water-soluble drugs and is particularly suited to generate dry powder particles with properties targeted for inhalation delivery, especially to the deep lung, an area of extreme interest in respiratory medicine. The TFF process results in a “Brittle Matrix Particle,” which possesses low bulk density, high surface area, and typically an amorphous morphology, allowing the particles to supersaturate when contacting the target site, such as lung tissue. Based upon laboratory experiments, the aerodynamic properties of the particles are such that the portion of a drug deposited to the deep lung has the potential to reach as high as 75 percent.
About TFF Pharmaceuticals
TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing, or TFF, technology platform. Early testing confirms that the TFF platform can significantly improve the solubility and absorption of poorly water-soluble drugs, a class of drugs that comprises approximately one-third of the major pharmaceuticals worldwide, thereby improving their pharmacokinetics. TFF Pharmaceuticals has two lead drug candidates: Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder. The Company plans to add to this pipeline by collaborating with large pharmaceutical partners. The TFF Platform is protected by 39 patents issued or pending in the US 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 the benefits of the Company’s TFF platform and its dry powder version of Voriconazole and Tacrolimus, 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) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (ii) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (iii) there can be no assurance that any feasibility studies we enter into with a pharma company will lead to a commercial agreement and (iv) those other risks disclosed in the section “Risk Factors” included in the Company’s Quarterly Report on Form 10-Q filed with the on December 9, 2019. 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.
