Abstract
Infections from the SARS-CoV-2 virus have killed over 4.6 million people since it began spreading through human populations in late 2019. In order to develop a therapeutic or prophylactic antibody to help mitigate the effects of the pandemic, a human monoclonal antibody (mAb) that binds to the SARS-CoV-2 spike protein was isolated from a convalescent patient following recovery from COVID-19 disease. This mAb, designated AUG-3387, demonstrates a high affinity for the spike protein of the original viral strains and all variants tested to date. In vitro pseudovirus neutralization and SARS-CoV-2 neutralization activity has been demonstrated in vitro. In addition, a dry powder formulation has been prepared using a Thin-Film Freezing (TFF) process that exhibited a fine particle fraction (FPF) of 50.95 ± 7.69% and a mass median aerodynamic diameter (MMAD) and geometric standard deviation (GSD) of 3.74 ± 0.73 µm and 2.73 ± 0.20, respectively. The dry powder is suitable for delivery directly to the lungs of infected patients using a dry powder inhaler device. Importantly, AUG-3387, administered as a liquid by intraperitoneal injection or the dry powder formulation delivered intratracheally into Syrian hamsters 24 hours after intranasal SARS-CoV-2 infection, demonstrated a dose-dependent reduction in the lung viral load of the virus. These data suggest that AUG-3387 formulated as a dry powder demonstrates potential to treat COVID-19.
Competing Interest Statement
Cui reports financial support was provided by TFF Pharmaceuticals. Cui reports a relationship with TFF Pharmaceuticals, Inc. that includes: equity or stocks and funding grants. Williams reports a relationship with TFF Pharmaceuticals, Inc. that includes: consulting or advisory, equity or stocks, and funding grants. Xu, Moon and Sahakijpijarn report a relationship with TFF Pharmaceuticals, Inc. that includes: consulting or advisory. Christensen is a consultant for TFF Pharmaceuticals. Emig, Mena, Vitug, Henry, and Ventura are or were employees of Augmenta Bioworks, Inc. Emig, Mena, Vitug, Henry, Cui, Xu, Williams, and Christensen are inventors on IP related to this work.