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Pharma Tech Outlook | Tuesday, June 29, 2021
AUG-3387, which targets the SARS-Cov2 spike protein, was isolated from an asymptomatic patient and identified in less than two weeks using Augmenta’s platform.
FREMONT, CA: Augmenta Bioworks, a biotechnology firm enabling breakthroughs in medicine through immune profiling, and TFF Pharmaceuticals, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, recently announced that AUG-3387 has been selected as the first lead monoclonal antibody for clinical development against COVID-19 under their Joint Development and Collaboration Agreement. AUG-3387, which targets the SARS-Cov2 spike protein, was isolated from an asymptomatic patient and identified in less than two weeks using Augmenta’s platform.
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“The activity of AUG-3387 against all SARS-CoV2 variants tested to date provides strong justification for the continued development of this unique monoclonal antibody therapy, especially when combined with the potential to break the cold chain requirement of other therapies and the cost-effective delivery of lower doses via inhalation, made possible through the TFF process,” stated Dr. Christopher Emig, Chief Executive Officer, Augmenta Bioworks.
Augmenta and TFF Pharmaceuticals intend to develop AUG-3387 as an inhaled therapy for the treatment of COVID-19 disease in two types of individuals: (1) those who have already been infected with SARS-CoV2 and are at high risk for severe disease but have not yet been hospitalized, and (2) those who are at high risk for severe disease but have not yet been infected with SARS-CoV2.
“By combining the novel pan-variant activity of AUG-3387 with the enhanced stability and ease of delivery provided by the TFF technology, we believe this drug could potentially make significant impact on bringing COVID-19 disease under control where vaccines with extreme cold chain requirements are not feasible,” added Glenn Mattes, Chief Executive Officer, TFF Pharmaceuticals. “We look forward to continued scale up manufacturing, completion of toxicology studies and enablement of human clinical trials in the coming months.”
In vitro preclinical testing has shown that AUG-3387 effectively neutralizes SARS-CoV2 and has activity against all variant strains tested to date, including the major COVID variants of concern, such as the previously identified UK (B.1.1.7 - Alpha), South African (B.1.351 - Beta), Brazil (P.1 - Gamma), and India (B.1.617.1 - Kappa). TFF and Augmenta have committed to continuing to study AUG-3387’s activity against new SARS-CoV2 variants, and in vivo preclinical efficacy investigations will be completed in the following weeks.
The companies announced a worldwide Joint Development and Collaboration Agreement in November 2020 to develop novel commercial products using Augmenta’s human-derived Monoclonal Antibodies (mAbs) for potential COVID-19 treatments. TFF Pharmaceuticals has also been granted the option to develop two more Augmenta mAbs for purposes other than COVID-19. These antibodies will be created using TFF Pharmaceuticals’ Thin-Film Freezing technology to create dry powder formulations for direct inhalation delivery to patients’ lungs. The agreement also calls for developing parenteral formulations that use Thin Film Freezing dry powder formulations that may be reconstituted, potentially reducing the effects of cold-chain storage and handling.
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