March 9 Quick Takes: A first for Boehringer’s Ofev; plus Cel-Sci’s COVID-19 therapy, Sinopharm, AZ, Urovant, Hengrui, Trevena, and Tetra-Shionogi

Boehringer’s Ofev approved as first therapy for lung scarring disease
FDA approved Ofev nintedanib from Boehringer Ingelheim GmbH as the first therapy for chronic fibrosing interstitial lung diseases; the NDA had received Priority Review. The small molecule inhibitor of VEGF, PDGFR and FGFR is already approved to treat idiopathic pulmonary fibrosis and systemic sclerosis interstitial lung disease.

Cel-Sci developing peptide-based COVID-19 therapy
Cel-Sci Corp. (NYSE-A:CVM) is developing a COVID-19 therapy using its LEAPS (Ligand Epitope Antigen Presentation System) peptide platform that aims to induce cell-mediated, rather than antibody-mediated, immunity. The therapy, which comprises conserved regions of coronavirus proteins, is intended to reduce viral load and stimulate T cell response while also avoiding unwanted inflammatory responses and lung tissue damage. While many COVID-19 products in development target the virus’ spike protein, Cel-Sci is targeting antigens within the nucleoprotein that elicit cytolytic T cell responses, which the company thinks are less variable between viral strains and less likely to change in response to antibodies elicited by prior infection or other vaccines (see “COVID-19: A Growing List of New Vaccines and Therapeutics”)...