COVID-19 Roundup: Trial starts for Moderna, Sanofi-Regeneron and BioNTech; plus Thermo Fisher, Roche and VIB
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First patients receive Moderna’s coronavirus vaccine
Moderna Inc. (NASDAQ:MRNA) said NIH has begun dosing patients in a Phase I study of mRNA-1273, the company’s vaccine against SARS-CoV-2. The trial is enrolling 45 healthy adults at a site in Seattle, Wash., to receive two doses 28 days apart; endpoints will measure safety, reactogenicity and immunogenicity to the virus’ spike protein. Data are due on or about June 1, according to ClinicalTrials.gov. The new study is conducted under NIH’s IND, and the Coalition for Epidemic Preparedness Innovations (CEPI) funded its manufacture. Moderna is preparing for a Phase II trial under its own IND. Moderna shares rose $5.19 (24%) to $26.49 on Tuesday, adding $1.9 billion to the company’s market cap.
Sanofi, Regeneron start trial of mAb for severe COVID-19
Sanofi (Euronext:SAN; NASDAQ:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) began a Phase II/III trial of IL-6 inhibitor Kevzara sarilumab to treat hospitalized patients with severe COVID-19 infections. The companies believe Kevzara’s mechanism can address the immune response that causes acute respiratory distress syndrome (ARDS) in infected patients. Sanofi and Regeneron are developing the therapy in concert with HHS’s Biomedical Advanced Research and Development Authority (BARDA). The trial is to enroll up to 400 patients. Kevzara is approved to treat rheumatoid arthritis...