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.
BioNTech starting trial, enters deal with Fosun
BioNTech SE (NASDAQ:BNTX) expects to start a clinical trial of COVID-19 vaccine candidate BNT162 by late April. The biotech also announced a deal with Shanghai Fosun Pharmaceutical Group Co. Ltd. (Shanghai:600196; HKEX:2196) to jointly develop BNT162 in China. Last week, Pfizer Inc. (NYSE:PFE) and BioNTech announced they were working together under a 2018 deal to develop a COVID-19 vaccine candidate (see “Pfizer Developing COVID-19 Vaccine with BioNTech”). BioNTech rose $9.07 (29%) to $40 on Monday.
EUA for Thermo Fisher’s diagnostic
FDA issued an Emergency Use Authorization for a diagnostic from Thermo Fisher Scientific Inc. (NYSE:TMO) to detect nucleic acids from SARS-CoV-2. The test is designed to run on the Applied Biosystems 7500 Fast Dx Real-time PCR instrument, and deliver a result within four hours. The decision follows FDA’s authorization on Friday of a diagnostic from Roche (SIX:ROG; OTCQX:RHHBY) (see “Unlocking Test Capacity”).
Roche ships 400,000 COVID-19 tests
Roche said it began shipping 400,000 SARS-CoV-2 test kits on March 13 and expects to ship an additional 400,000 tests per week to more than 30 hospitals and reference laboratories in the U.S. that are set up to run the test immediately. The tests run on the company’s automated cobas 6800 and cobas 8800 systems.
VIB reveals progress with new anti-COVID-19 mechanism
Flanders Institute of Biotechnology (VIB) said researchers have shown that their single domain heavy chain antibody (VHH) candidate targeting the SARS-CoV2 spike protein neutralized a lab variant of the virus in early preclinical work. VIB said the group, led by Xavier Saelens at VIB and Ghent University, is preparing for more preclinical work (see “mAb Menagerie”).
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