Research Roundup on Vaccine, Treatment Trials

The pace of research is ramping up as drugmakers and organizations accelerate efforts on COVID-19 treatment candidates, with a number of accomplishments recently, especially for vaccines:

COVID-19 Vaccines:

• The first patient in a coronavirus vaccine clinical trial was dosed last Monday, Moderna Therapeutics announced. The Cambridge, Mass.-biotech firm’s NIH-led phase 1 study is the first trial for a COVID-19 vaccine and was approved in record time, according to Anthony Fauci, director of NIH’s National Institute of Allergy and Infectious Diseases.
• The Chinese government Wednesday approved CanSino Biologics’ phase 1 trial of its vaccine hopeful, Ad5-nCoV, for human testing. The vaccine was developed in conjunction with the Institute of Biotechnology’s Academy of Military Medical Sciences. It uses the replication-defective adenovirus type 5 (Ad5) as its vector, an organism often used in vaccines and gene therapies.
• German biotech company BioNTech announced that its mRNA vaccine candidate, BNT162, will likely be ready for trial soon, with testing slated to begin in late April.
• J&J has teamed up with Beth Israel Deaconess Medical Center in the hopes of developing a candidate vaccine. The drugmaker said its goal is to identify a potential vaccine by the end of the month and have a phase 1 trial in motion by year’s end.

COVID-19 Treatments:

• Mylan, Novartis and Teva have committed to ramping up production of hydroxychloroquine, a medication used to prevent and treat forms of malaria, after research showed encouraging results in its potential to fight coronavirus. The pharma giants have all said they will manufacture and donate tens of millions of tablets in the hopes that the medicine can be redesigned to treat coronavirus. The University of Minnesota launched a trial March 17 of hydroxychloroquine as a treatment for COVID-19. The companies are also looking into the possible use of chloroquine, a related drug.
• The World Health Organization (WHO) is putting together a multi-nation trial to speed up research on coronavirus treatments. The SOLIDARITY trial aims to generate data that can be used to determine which treatments are most effective, if they reduce mortality and time spent in the hospital, and if any patients receiving the drug required ventilation or admission to an intensive care unit.
  The trial’s design allows more drugs to be added as they become available at participating hospitals. It will consist of five arms:
  • Arm one: study of standard of care
  • Arm two: study of Gilead’s antiviral remdesivir
  • Arm three: study of lopinavir/ritonavir combination
  • Arm four: study of lopinavir/ritonavir/interferon beta combination
  • Arm five: study of chloraquine

Ten countries have already confirmed that they will participate in the trial: Argentina, Bahrain, Canada, France, Iran, Norway, South Africa, Spain, Switzerland and Thailand. The U.S. has not yet signed on for the trial.

• Regeneron said that it has isolated hundreds of virus-neutralizing human antibodies that could be used as either prophylaxis before exposure to the virus, or to treat those already infected. The antibodies were identified from mice genetically modified to have human immune systems. Human clinical studies could be underway by early summer.
• Vir Biotechnology and Biogen are working together in the development and clinical manufacturing of human monoclonal antibodies that could be used to treat COVID-19. Vir has already isolated a number of antibodies from patients that survived SARS infections. Due to the urgency of the outbreak, the companies have already begun research while they hash out the details of their arrangement.
• Sanofi and Regeneron announced that a phase 2/3 clinical trial of their rheumatoid arthritis med, Kevzara (sarilumab), is ready to enroll patients. They hope to repurpose the medicine for treating inflammatory immune response caused by the virus.
• Gilead’s antiviral drug remdesivir is currently going through phase 3 trials in China and a phase 1 trial in the U.S. The drug could be ready in the fall if it works, but is difficult to manufacture.
• AmnioBoost recently announced its intentions to evaluate AmnioBoost, its amniotic fluid concentrate, to see how it fares against the virus. The company said it believes the product has potential in treating acute respiratory distress syndrome, the main killer in COVID-19 infection.
• Roche has made progress in efforts to repurpose its immunosuppressive drug Actemra (tocilizumab) for treating the coronavirus, gaining FDA approval for a phase 3 trial. The study, which the drugmaker said will likely begin enrollment in early April, will test the drug’s safety and efficacy in treating hospitalized adult patients with severe COVID-19 pneumonia.