TFF Pharmaceuticals and Leidos to Advance Biodefense Countermeasures into Preclinical Testing under DARPA PPB Program

TFF Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, has made significant strides in the development of next-generation medical countermeasures (MCMs) using its proprietary Thin Film Freezing (TFF) technology. The advancements are made in collaboration with Leidos, a prominent Fortune 500 company specializing in information technology, engineering, and science solutions. These efforts are funded by the Defense Advanced Research Projects Agency (DARPA) as part of its Personalized Protective Biosystems (PPB) program.

Progress in MCM Development

Recently, several MCM candidates, developed by Leidos and formulated using TFF Pharmaceuticals' technology, have shown promising results in vitro models. These candidates demonstrated chemical and biological neutralizing capabilities. The next phase for these countermeasures involves advanced preclinical testing, which will take place in DARPA-contracted laboratories.

Dr. Harlan Weisman, CEO of TFF Pharmaceuticals, expressed optimism about the collaboration, emphasizing the goal of protecting military and healthcare personnel from future chemical and biological threats. "Our Thin Film Freezing technology continues to prove its adaptability in addressing unique challenges in biodefense drug development," said Dr. Weisman. He also highlighted the potential for these MCMs to be developed as needle-free and temperature-independent solutions, which would greatly enhance their storage and deployment flexibility in emergency scenarios.

TFF Technology Overview

TFF Pharmaceuticals' Thin Film Freezing technology is a particle engineering process that converts both existing compounds and new chemical entities into dry powder formulations. These powders possess advantageous properties for various administration routes, including inhalation, nasal, oral, topical, and ocular. The process can generate powders tailored for direct delivery to specific sites, thereby improving bioavailability, action onset, safety, and efficacy.

One of the notable benefits of TFF technology is its ability to deliver therapeutic agents directly to the target organ, such as the lungs, at lower doses compared to traditional oral drugs. This targeted delivery reduces the potential for toxicities and side effects. Laboratory data suggests that TFF-created powders can deliver up to 75% of the dose to the deep lung. Moreover, the TFF process does not involve heat or mechanical stress, which can degrade complex therapeutic components like fragile biologics. This makes the technology well-suited for creating stable, easily stored dry powders that can improve the accessibility of therapeutics and vaccines globally.

Future Outlook

Looking ahead, TFF Pharmaceuticals plans to demonstrate the efficacy of their countermeasures in neutralizing biochemical threats directly at the site of entry in vivo. The company is also hopeful that the flexibility and robustness of their TFF technology will enable the development of new pharmaceutical products that are both effective and easy to deploy.

Company Background

TFF Pharmaceuticals is at the forefront of developing innovative drug products through its rapid freezing technology, dedicated to enhancing the efficacy, safety, and stability of medicines. The company's TFF technology platform is versatile enough to convert a wide array of drugs, including vaccines, small and large molecules, and biologics, into efficient dry powder formulations suitable for inhalation or topical applications.

In summary, TFF Pharmaceuticals' collaboration with Leidos represents a significant advancement in the development of next-generation medical countermeasures. With the backing of DARPA, the company's proprietary Thin Film Freezing technology holds promise for creating more effective, stable, and easily deployable solutions to combat chemical and biological threats.

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