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Partnership could help diminish cold-chain challenges surrounding storage and handling
TFF Pharmaceuticals, Inc., a clinical-stage biopharma that recently increased its cGMP capabilities, and Augmenta Bioworks, Inc., a biotech that uses immune profiling technologies for medicinal purposes, have entered into a joint development and collaboration agreement to develop products incorporating Augmenta’s human-derived monoclonal antibodies (mAbs) for potential Covid-19 therapeutics. Previously, in June, the companies struck a feasibility and material transfer agreement under which Augmenta supplied various mAb product materials to TFF for compatibility and feasibility testing.
Per the most recent agreement, both companies will collaborate to develop one or more commercial therapeutics based on, derived from and/or incorporating Augmenta’s human mAbs to potentially treat patients with Covid-19. These products will be developed using TFF's thin-film freezing technology to manufacture dry powder formulations of these specific mAbs for inhalation delivery directly to patients' lungs.
Further, the agreement 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 will also have the option to develop two additional Augmenta mAbs for indications other than Covid-19.
Robert O. Williams III, PhD, division head of the University of Texas at Austin’s Division of Molecular Pharmaceutics and Drug Delivery and inventor of TFF’s thin-film freezing technology, said a challenge of mAbs is in their delivery 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,” noted Williams.