TFF Pharmaceuticals and Augmenta Bioworks Publish Positive In Vivo Data Showing Dry Powder Formulation of COVID-19 Antibody, AUG-3387, Neutralizes SARS-CoV-2 Infection and Reduces Viral Load
Results published in bioRxiv Show That Delivery of Dry Powder AUG-3387 Following Viral Inoculation Led to Dose-Dependent Reduction in Lung Viral Load in Hamsters
Dry Powder Formulations Show Equivalent Binding as Original Antibody with No Loss of Biologic Activity
Study Indicates AUG-3387 Binds to Both Lambda and Mu Variants of SARS-CoV-2
AUSTIN, Texas and MENLO PARK, Calif., Oct. 14, 2021 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, and Augmenta Bioworks, a biotechnology company leveraging immune profiling technologies to enable breakthroughs in medicine, today announced the publication of a research paper highlighting positive preclinical study results of AUG-3387, a monoclonal antibody (mAb) therapy being developed in collaboration between the two companies for the treatment of SARS-CoV-2 infection. The findings have been published online through the bioRxiv preprint server, under the title “AUG-3387, a Human-Derived Monoclonal Antibody Neutralizes SARS-CoV-2 Variants and Reduces Viral Load from Therapeutic Treatment of Hamsters In Vivo.”
The AUG-3387 mAb was formulated as a dry powder using TFF Pharmaceuticals’ proprietary Thin Film Freezing process to enable direct delivery to the lungs and remove the need for intravenous infusion that is required for delivery of current COVID-19 antibody therapies. AUG-3387 was isolated using the SingleCyte® platform developed at Augmenta Bioworks. SingleCyte® rapidly profiles human immunity to discover antigen-specific antibodies using AI driven single cell imaging and retrieval technology.
Delivery of the dry powder formulation of AUG-3387 to infected hamsters resulted in a dose-dependent reduction of viral load when administration of the mAb was initiated 24 hours after infection with SARS-CoV-2. Previous mAbs that have received Emergency Use Authorization from the FDA for treatment of COVID-19 have only reported efficacy in the hamster model when the mAbs were delivered prophylactically 24 hours before infection with SARS-CoV-2. This study also represents the first report of successful reduction of viral load using inhaled delivery of a dry powder monoclonal antibody therapeutic for COVID-19 disease. The results suggest that AUG-3387 represents a viable opportunity to improve on current approved COVID-19 antibody treatments through convenient at-home administration, direct delivery to the lungs and distribution worldwide without requiring cold-chain storage.
In addition to the in vivo efficacy, AUG-3387 also showed binding activity against the Alpha, Beta, Delta, Gamma, Kappa, Lambda and Mu variants of SARS-CoV-2. Robust binding to all tested strains of SARS-CoV-2 suggests AUG-3387 targets a highly conserved region of the virus, making AUG-3387 likely to remain effective despite the frequent emergence of new variant strains.
“We are very excited to publish these additional results from our monoclonal antibody program in development with Augmenta, which demonstrate how we can apply our Thin Film Freezing technology to formulate monoclonal antibodies into an inhaled dry powder without changing the underlying biologic properties of the molecule itself,” said Glenn Mattes, Chief Executive Officer of TFF Pharmaceuticals. “We completed this study as quickly and efficiently as possible knowing the urgent need for new COVID-19 treatments, but adhered to a rigorous model to ensure accurate assessment of our dry powder formulation of AUG-3387. Unlike prior in vivo studies of currently approved COVID-19 antibody therapies that failed to show viral load reduction in animals when delivered after inoculation with the SARS-CoV-2 virus, AUG-3387 demonstrated the ability to reduce viral load in a dose-dependent manner after the animals had been fully inoculated. In our view, AUG-3387 is fast emerging as one of the most promising new therapeutics for the treatment of COVID-19.”
Augmenta and TFF Pharmaceuticals plan to develop AUG-3387 as an inhaled therapy for the treatment of COVID-19 disease in two types of individuals: (1) those already infected with SARS-CoV-2 who are at a high risk for severe disease but who have not yet been hospitalized, and (2) for the prevention of SARS-CoV-2 infection for individuals who are at a high risk for sevee disease. With the completion of in vivo preclinical efficacy studies, Augmenta and TFF now plan to enter toxicology studies in early 2022 and human clinical trials shortly thereafter. Ongoing formulation development studies are expected to demonstrate that a sufficient dose of AUG-3387 to achieve a neutralizing concentration in the lungs can be delivered via already approved commercial dry powder inhaler devices. TFF and Augmenta are working with Catalent Biologics to conduct cell line development, drug substance manufacturing and scale-up efforts for AUG-3387 as the program advances through clinical development.
“This study confirms the power of Augmenta’s SingleCyte® platform to isolate therapeutic antibody candidates with unique functional properties, such as AUG-3387, which broadly neutralizes SARS-CoV-2,” added Dr. Christopher Emig, Chief Executive Officer of Augmenta Bioworks. “We continue to be impressed with TFF’s Thin Film Freezing platform and the stability of AUG-3387 formulated as a dry powder without any loss of potency. The successful validation of both of our technology platforms in this rigorously designed in vivo study suggests that AUG-3387 could play a key role in the ongoing global need for distribution of shelf-stable, highly effective COVID-19 antibody treatments.”
In prior in vitro preclinical testing, AUG-3387 effectively neutralized SARS-CoV-2 and demonstrated activity against other major COVID variants of concern, including the previously identified Delta variant (B.1.617.2) Alpha variant (B.1.1.7), Beta variant (B.1.351), Gamma variant (P.1) and Kappa variant (B.1.617.1). The additional positive data demonstrating activity against Lambda and Mu variants validates Augmenta’s discovery approach and reflects TFF and Augmenta’s ongoing commitment to develop a therapy that is effective against emerging variant strains of SARS-CoV-2.
About the Development Agreement Between Augmenta Bioworks and TFF Pharmaceuticals
About Augmenta Bioworks
About TFF Pharmaceuticals’ Thin Film Freezing Technology Platform
About TFF Pharmaceuticals
Christopher Emig, Ph.D.
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Source: TFF Pharmaceuticals, Inc.
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