2 November 2020 - - US-based biopharmaceutical company TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) and US-based biotechnology company Augmenta Bioworks, Inc have entered into a worldwide joint development and collaboration agreement to develop novel commercial products incorporating Augmenta's human-derived monoclonal antibodies for potential COVID-19 therapeutics, the company said.

Under the terms of the agreement, both companies will collaborate in a joint development project to develop one or more commercial therapeutics based on, derived from, and/or incorporating Augmenta's human monoclonal antibodies to potentially treat patients with COVID-19.

These products will be developed utilizing TFF Pharmaceuticals' Thin-Film Freezing technology to manufacture dry powder formulations of these specific mAbs for inhalation delivery directly to the lungs of patients.

The agreement also includes the development of formulations suitable for parenteral administration, where the Thin Film Freezing dry powder formulations can be reconstituted, potentially mitigating the impacts of cold-chain storage and handling.

TFF Pharmaceuticals will also have the option to develop two additional Augmenta mAbs for indications other than COVID-19.

Augmenta Bioworks and TFF Pharmaceuticals will allocate patent license rights to their respective technologies to allow each company to jointly commercialize the products developed under the Joint Development Project.

The companies have agreed to a 50-50 split of all costs and expenses to further the Joint Development Project and both companies have agreed to the same 50-50 split of all revenues, cash payments and/or future cash payments related to the sale and/or license of the products resulting from the Joint Development Project to a third party.

In June 2020, the companies entered into a Feasibility and Material Transfer Agreement under which Augmenta Bioworks supplied various mAb product materials to TFF Pharmaceuticals for compatibility and feasibility testing.

TFF Pharmaceuticals was successful in formulating dry powder formulations of the Augmenta mAbs, which exhibited superior aerosol properties for lung delivery.

Based on this successful formulation work and confirmatory in-vitro testing, which included viability testing, binding testing and neutralization testing, both parties agreed to pool their efforts and resources through a joint development project, and collectively move the dry powder mAb products into pre-clinical and toxicology studies with the goal of further advancement of these dry powder mAbs into human testing in the clinic.

Augmenta Bioworks is a venture-backed biotechnology company leveraging immune profiling technologies to enable breakthroughs in medicine.

Through its DeepGrid and SingleCyte Technologies, Augmenta profiles human immunity at unprecedented scale and speed, shrinking new drug discovery timelines from years to days.

The company's platform utilizes the latest software, automation, microfluidics, high throughput DNA sequencing, and scalable computational analysis to identify immune receptors and their antigen specificity.

The results are therapeutics derived from natural human immunity. The company works through partnerships in antibody discovery (infectious disease), cell therapy development (oncology), and other advanced research (auto-immunity).

TFF Pharmaceuticals' Thin Film Freezing 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%.