TFF Pharma and Augmenta Bioworks Enter Into a Worldwide Joint Development Agreement for COVID-19 Monoclonal Antibody Therapies

TFF Pharmaceuticals, Inc. a clinical-stage biopharmaceutical company, and Augmenta Bioworks, Inc., a biotechnology company enabling breakthroughs in medicine through immune profiling, jointly announce that both companies have entered into a worldwide Joint Development and Collaboration Agreement to develop novel commercial products incorporating Augmenta’s human-derived monoclonal antibodies (mAbs) for potential COVID-19 therapeutics.

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.

“This important agreement represents the culmination of many months of work by our scientific team, as we work towards the development of a never-before-achieved formulation of monoclonal antibodies into a dry powder therapeutic,” said Glenn Mattes, CEO, of TFF Pharmaceuticals, Inc. “It is a testament to the remarkable flexibility and capability of our Thin Film Freezing platform and we are eager to develop these potentially breakthrough mAb therapies internally, along with our other programs in Invasive Pulmonary Aspergillosis, solid organ transplant anti-rejection, and botanicals.”

“Confirmed discovery of novel anti-SARS-Cov-2 antibodies in 8 days was an achievement made possible by years of technology development, and a clear indication of the power and potential of our platform,” said Christopher Emig, Ph.D., CEO and Co-Founder of Augmenta Bioworks, Inc. “We are excited to enter this partnership to bring our COVID-19 treatment into clinical development, and are looking forward to the world’s first effective, affordable and scalable antibody therapeutic to mitigate the devastating effects of this disease.”

“We believe the interest in monoclonal-antibody therapeutics for the treatment of COVID-19 is extremely high, with the promise that they will harness the immune system’s natural response to viral invaders,” said Robert O. Williams III, Ph.D., Division Head of the University of Texas at Austin’s Division of Molecular Pharmaceutics and Drug Delivery and inventor of TFF Pharmaceuticals’ Thin Film Freezing technology.

“The challenge becomes in the delivery of these very large, complex molecules via injection, which does not reach directly to the initial site of infection – the deep lung area. Liquid injections are also subject to all the attendant difficulties of cold chain handling and storage, potentially limiting their use to only areas in the developed world,” continued Williams. “In this collaboration with Augmenta, the first-of-its-kind use of Thin Film Freezing technology applied to monoclonal antibodies has the potential to mitigate both of these challenges and lead to a therapy that is more effective and easier to deliver to a global community.”

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.