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Inhaled Dry-Powder Covid-19 Antibodies in the Works

Human lungs illustration

(NIH.gov)

2 Nov. 2020. Two biotechnology companies are developing synthetic antibodies to treat Covid-19 infections formulated as an inhaled dry powder rather than an infusion. While dollar amounts were not disclosed, TFF Pharmaceuticals Inc. in Austin, Texas and Augmenta Bioworks Inc. in Menlo Park, California are equally sharing expenses, revenues, and access to intellectual property rights in the deal.

Augmenta Bioworks discovers therapeutics resembling human antibodies with superior protective immunity to disease. The company says its technology identifies individuals with immune system cells creating antibodies having those desirable properties. Augmenta says those cells from the immune system can be rare, but when identified, the company looks particularly for receptor proteins with protective immunity. Once those B- or T-cells in the immune system are found, Augmenta says it uses a variety of computational and analytical tools to identify the protective receptors for specific disease antigens for infectious diseases, and cell therapies for cancer.

TFF Pharmaceuticals develops drugs formulated as dry powders for inhalation into the lungs. The two year-old company says oral drugs may not be adequately absorbed by the body, thus are often not feasible for treating lung disorders. TFF says its technology — TFF stands for thin film freezing — takes drugs in liquid form, combines them with solvents, freezes the solution quickly on a drum, dries the frozen solution to remove the solvents, and captures the fine powder in capsules. Those capsules can then be inserted into inhalers for the patient.

TFF Pharma has two products in early-stage clinical trials for treating invasive pulmonary aspergillosis, a severe fungal disease, and an immunosuppressive drug to prevent lung transplant rejections. TFF Pharma says its collaborators at University of Texas in Austin tested the technology with biologic therapies in lab animals and combinations of two or more drugs in lab cultures. The company licenses its technology from the lab of UT-Austin pharmacy professor Robert Williams that specializes in drug delivery processes.

In June, Augmenta and TFF Pharma began investigating the feasibility of creating a dry-powder form of synthetic monoclonal antibodies to treat Covid-19 infections. The companies say they succeeded in preparing a dry powder from Augmenta antibodies for delivery into the lungs. Augmenta and TFF Pharma now are focusing this work on Covid-19 treatments in preclinical and toxicology testing, for eventual human clinical trials.

“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,” says Williams in a TFF Pharma statement. “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. 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.”

The new agreement calls for continued joint development of inhaled dry-powder Covid-19 treatments, where the dry powder can be administered to patients without the need for refrigerated shipping or storage. The companies agree to equally divide costs and expenses, as well as revenues and payments, including any future licensing and product sales revenues. And the companies provide equal access to each other’s patent rights in order to jointly develop the Covid-19 therapy. TFF Pharma also has the option to formulate two more Augmenta antibodies for diseases other than Covid-19.

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