2021 Biopharma Update on the Novel Coronavirus: March 23

2021-03-23

疫苗抗体紧急使用授权合作

News information is not all-inclusive and updates are published once a week on Tuesdays. Here's a look at some of the top COVID-19 news over the past week. A year ago, the collaboration between AstraZeneca and the University of Oxford on a COVID-19 vaccine COVID-19 vaccine was the leading effort. Through a series of hiccups and complications, only now is the vaccine data being announced in the U.S., although the vaccine itself is being deployed in other parts of the world. AstraZeneca reported that the U.S. Phase III trial of the vaccine, AZD1222, demonstrated an efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalization. Then, late Monday, the National Institutes of Health issued a statement concerning the Data and Safety Monitoring Board (DSMB) that is supervising the clinical trial, which had informed the National Institute of Allergy and Infectious Diseases Infectious Diseases (NIAID), the Biomedical Advanced Research and Development Authority (BARDA) and AstraZeneca “that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.” The question over the data is related to the information AstraZeneca included in its press release, not data that was sent to the agency or submitted to a peer-reviewed technical journal. Medical professionals in the U.S. are pushing back, working to minimize the public’s fears that COVID-19 vaccines may be unsafe. The European Medicines Agency (EMA), the European equivalent of the U.S. Food and Drug Administration (FDA), has argued that the benefits of the vaccine “outweigh the risks of side effects.” It is holding a meeting today to review the findings. The World Health Organization (WHO) has also urged countries to continue using the AstraZeneca AstraZeneca vaccines. A COVID-19 nasal spray vaccine developed by Rokote Laboratories Finland Ltd., is preparing for Phase I trials in Finland…if it can win funding. The vaccine has the potential to help ensure vaccine self-sufficiency for Finland and Europe, as well as an alternative to jabs. Rokote’s nasal spray vaccine uses an adenovirus to carry a cloned DNA strand to nasopharyngeal cells, causing them to produce a protein that launches an immune response. Investigators from Brigham and Women's Hospital, Massachusetts General Hospital (MGH) and the Broad Institute identified two metabolic pathways that SARS-CoV-2, the virus that causes COVID-19, hijacks for self-replication. They found that the infected cells quickly depleted stores of glucose and folate. The virus diverts building blocks from glucose production to assemble purine bases that it needs to create huge amounts of viral RNA. With the increase of multiple variants of COVID-19 across the United States, the U.S. Department of Health and Human Services will limit the use of monoclonal antibody treatments developed by Regeneron and Eli Lilly due to concerns the medications are not effective against these new strains. Top research scientists said better vaccines for coronavirus disease 2019 (COVID-19) may soon be on the way by the end of 2021. Between six and eight new COVID-19 vaccines may enter regulatory review by the end of this year, the scientists said, and some of these vaccines don’t require needles and can also be stored at room temperature. Last April, researchers from the Vlaams Institute for Biotechnology in Ghent (VIB) found antibodies in llama blood they believed could help neutralize the global pandemic bringing our world to its knees. Belgium-based ExeVir is now well on its way to turning VIB's research into effective therapeutics against COVID-19 and its variants. The 9-month-old-startup announced a $50 million Series A to take its lead antibody compound XVR011 into a global Phase Ib/II clinical trial soon. This will be the first in-human trials using this unique, llama-derived antibody. Last week, the FDA granted the first full approval for a COVID-19 test developed by BioFire, out of Utah. The U.S. Food and Drug Administration (FDA) no longer requires Pfizer to transport their vaccine at ultra-cold temperatures. The company submitted data to the FDA to support the alternative temperatures, which were originally between -80 and -60 degrees C (-112 and -76 degrees F). Regeneron reported that its REGEN-COV antibody cocktail (casirivimab with imdevimab) decreased the risk of hospitalization or death by 70% in non-hospitalized COVID-19 patients. This cut the duration of symptoms by four days. They found that all doses, 8,000 mg, 2,400 mg and 1,200 mg, had similar efficacy. The FDA updated its Emergency Use Authorization fact sheets for all authorized monoclonal antibody therapies and indicated that REGEN-COV was the only one to retain its efficacy against key emerging variants. Thermo Fisher Scientific partnered with Artificial, developers of flexible automation software, to develop an integrated and comprehensive software automation platform for Thermo Fisher's standardized COVID-19 Testing Platform. The integration will result in increased testing throughput and support global healthcare initiatives. As part of the collaboration, Artificial will provide access to its aLab Suite software, designed to seamlessly integrate with Thermo Scientific Momentum Workflow software and robotics hardware. This will form part of the COVID-19 Testing Platform that will enable laboratories to quickly upscale COVID-19 testing volumes to help reduce the spread of the disease and restore economies and communities. U.K.-based IONTAS Limited and Portugal’s FairJourney Biologics announced the identification of neutralizing antibodies, which bind to multiple emerging SARS-CoV-2 variants. The results, generated from a combination of phage display technology and B-cell receptor repertoire sequencing of hospitalized COVID-19 patients, have identified potent neutralizing antibodies with distinct mechanisms of action. IONTAS is developing a panel of therapeutics based on this discovery. Hoth Therapeutics announced its lead peptide candidate, HT-002, a novel therapeutic target for COVID-19, presented new in vitro data demonstrating SARS-CoV-2 antiviral activity.

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