AUG-3387 / TFF Pharma, Augmenta Bioworks - LARVOL DELTA

Drum Filling of Thin-Film Freeze-Dried Monoclonal Antibody Powder in UniDose Powder Nasal Spray System. (PubMed, Pharm Res) - "It is feasible to drum fill TFFD mAb powder at low fill weights."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Inhalable dry powders of a monoclonal antibody against SARS-CoV-2 virus made by thin-film freeze-drying. (PubMed, Int J Pharm) - "Finally, we showed that one of the AUG-3387 mAb dry powders have desirable aerosol properties for pulmonary delivery into the lung. We concluded that thin-film freeze-drying represents a viable method to prepare inhalable powders of virus-neutralizing mAbs for pulmonary delivery into the lung."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Intranasal delivery of thin-film freeze-dried monoclonal antibodies using a powder nasal spray system. (PubMed, Int J Pharm) - "AUG-3387, a human-derived mAb that neutralizes the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was used in the present study...Finally, the deposition patterns of the TFF AUG-3387C powder sprayed using the UDS Powder delivery system were studied using 3D-printed nasal replica casts based on the CT scans of an adult and a child. It is concluded that it is feasible to intranasally deliver mAbs as dry powders by transforming the mAbs into dry powders using thin-film freeze-drying and then spray the powder using the powder nasal spray system."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Augmenta Bioworks and TFF Pharmaceuticals Announce Selection of Lead Monoclonal Antibody Candidate AUG-3387 for Clinical Development Against COVID-19 (GlobeNewswire) - "Augmenta Bioworks...and TFF Pharmaceuticals, Inc....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....In in vitro preclinical testing, AUG-3387 effectively neutralizes SARS-CoV2 and has demonstrated activity against all variant strains tested to date, including the major COVID variants of concern, including 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) variants. TFF and Augmenta...will be completing in vivo preclinical efficacy studies in the coming weeks."

New molecule • Preclinical • Infectious Disease • Novel Coronavirus Disease