August 14, 2020 | Vaccine updates—both research and commercial, a new drug combo being tested for treatment, and a spotlight on the racial disparity in COVID-19 trials and impacts. Plus, mAbs on trial.  

Research Updates

An experimental vaccine is effective at preventing pneumonia in mice infected with the COVID-19 virus, according to a study from Washington University School of Medicine in St. Louis. The vaccine, which is made from a mild virus genetically modified to carry a key gene from the COVID-19 virus, is described in the journal Cell Host and Microbe. The COVID-19 virus uses spike to latch onto and infect human cells, and the human body defends itself by generating protective antibodies targeting spike. By adding the gene for spike to a fairly harmless virus, the researchers created a hybrid virus that, when given to people, ideally would elicit antibodies against spike that protect against later infection with the COVID-19 virus. The approach is being tested in mice (which must be genetically modified to become infected with SARS-CoV-2), and the mice are producing neutralizing antibodies. DOI: 10.1016/j.chom.2020.07.018

Novateur Ventures has published a study outlining its new strategy for treating COVID-19 in Frontiers in Pharmacology. The strategy targets leukotrienes as the cause for hyperinflammatory response manifested in severe COVID-19 cases. Novateur's research proposes a simple treatment paradigm using two generic drugs, normally directed to blocking inflammation in airways of patients with asthma, to target the hyper-inflammatory response insevere COVID-19.This will be accomplished by a combination of a leukotriene biosynthesis blocker zileuton (Zyflo controlled release formulation) and an inhibitor of the cysteinyl leukotriene 1 receptor montelukast (Singulair). DOI: 10.3389/fphar.2020.01214

In a Perspective in the New England Journal of Medicine, authors highlighted the racial disparity in COVID-19 trials. “Black Americans accounted for only about 20% of the 1063 patients in the placebo-controlled Adaptive Covid-19 Treatment Trial (ACTT-1) funded by the National Institute of Allergy and Infectious Diseases (NIAID)3 and 11% of the 397 patients randomly assigned to 5 or 10 days of remdesivir in the Gilead-funded study (GS-U.S.-540-5773),” they write. “The proportions of Latinx and Native American patients were provided only for ACTT-1 and were 23% and 0.7%, respectively.” COVID-19 clinical trials must prioritize inclusion of at-risk populations they write, and funding for scientists from underrepresented ethnic groups must be increased. DOI: 10.1056/NEJMp2021971

Industry Updates

Baylor College of Medicine and Biological E. Limited (BE) have announced a licensing agreement for the development of a safe, effective and affordable COVID-19 vaccine. BE, an India-based company, has licensed the recombinant protein COVID-19 vaccine candidate developed at Baylor. The company engaged in license negotiations with the BCM Ventures team, part of Baylor College of Medicine, after initial discussions on Baylor’s technology and how it could possibly inform a vaccine to address the current global pandemic. The company will leverage its past experience for the further development and commercialization of the vaccine candidate, which currently is produced using a proven yeast-based expression technology. Press release.

The Arnhold Institute for Global Health at the Icahn School of Medicine at Mount Sinai and NYC Health + Hospitals have launched the COVID-19 Unit for Research at Elmhurst (CURE-19). The new initiative will translate data, experiences, and lessons from clinicians at NYC Health + Hospitals/Elmhurst and NYC Health + Hospitals/Queens into research that will address both the pandemic and root causes of health disparities in New York City. CURE-19 has identified three areas of urgent need in Queens to address in collaboration with leaders and experts in the borough's communities: reproductive and child healthcare, people living with HIV, and social and environmental determinants. Press release.

A new robotic system being developed and tested at Johns Hopkins University allows medical staff to remotely operate ventilators and other bedside machines from outside intensive care rooms of patients suffering from infectious diseases. Initial trials have demonstrated how it could be deployed to help hospitals preserve protective gear, limit staff exposure to COVID-19 and provide more time for clinical work. Press release.

Baycrest’s Rotman Research Institute (RRI) is launching an investigation of the possible effects of COVID-19 and infection prevention measures on dementia risk in older adults. In this study, the researchers are making bi-weekly phone calls to healthy older adults living in the community and asking them about their mental health, their exercise and socialization levels, and their exposure to COVID-19. They are also testing these older adults’ cognitive functions, like memory. The study is part of a larger research project looking at the factors that may predict which older adults ultimately develop MCI or dementia. Press release.

Two Phase 3 trials to determine whether monoclonal antibodies (mAbs) can prevent SARS-CoV-2, the virus that causes COVID-19. The first trial, CoVPN 3501, will evaluate LY-CoV555, an Eli Lilly and Company mAb to see whether it can prevent SARS-CoV-2 infection among people living or working in skilled nursing and assisted living facilities. Scientists from the National Institute of Allergy and Infectious Diseases Vaccine Research Center and Abcellera Biologics discovered LY-CoV555. The trial will enroll up to 2,400 participants in the U.S. who will be randomized to receive an intravenous infusion of LY-CoV555 or a placebo. The second trial, CoVPN 3502, will evaluate REGN-COV-2, a Regeneron Pharmaceutical double mAb combination, to see if it will prevent infection among household contacts with close exposure to someone recently diagnosed with COVID-19 that has been sustained for at least 48 hours. The study will enroll approximately 2,000 participants in the U.S. Press release.

The first patients in the NIH ACTIV-3 Trial have enrolled in Dallas through Baylor Scott & White Research Institute. The ACTIV-3 Trial is part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program created in a partnership between the National Institute of Allergy and Infectious Diseases (NIAID) and the National Heart, Lung, and Blood Institute (NHLBI). The two institutes within the NIH collaborated to combine their clinical trial networks and create a worldwide network of 400 sites to evaluate promising therapies in an adaptive trial design platform. The ACTIV-3 Trial will test the safety and effectiveness of a potential new treatment option, a neutralizing monoclonal antibody manufactured by Eli Lilly and Company for hospitalized patients with COVID-19. Press release.