INDIANAPOLIS (WISH) — Synthetic antibodies could be key in buying the nation time until a coronavirus vaccine hits the market, according to researchers at Eli Lilly and Company.
News 8 interviewed Molly McCully, spokesperson with the company, about the LY-CoV555 monoclonal antibodies developed by Lilly, the possible mechanism by which they treat the coronavirus and how they measure up against drugs currently being used such as remdesivir and dexamethasone.
Q. What are monoclonal antibodies? How are they developed and how do they work to combat COVID-19?
McCully: Monoclonal antibodies are directed against the spike protein of SARS-CoV-2, the virus that caused COVID-19. They are designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially preventing and treating COVID-19.
LY-CoV555 emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and tested by the scientists at the NIAID (National Institute of Allergy and Infectious Diseases) Vaccine Research Center. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.
Q. Recent research shows human antibodies can fade in as little as two months in COVID-19. How might monoclonal antibodies compare to this?
McCully: This will depend on what the approved dose will be. However, at the doses Lilly is evaluating in our trials, we expect it to last at a minimum one month with the potential to provide protection for up to eight-12 weeks. We expect to further refine these estimates in our ongoing clinical trials, with important data currently being collected on the efficacy of the antibody to neutralize the virus in patients in the treatment and prophylactic settings.
In a recent interview with Science, Lilly VP, Ajay Nirula, said monoclonal antibodies have the potential to be an important bridge until a vaccine is available and are likely to be more effective than remdesivir and dexamethasone. Dr. Anthony Fauci echoed this statement. Can you explain why?
McCully: Lilly believes antibody therapies may hold promise because they’re designed specifically to attack this coronavirus whereas these other drugs weren’t (they were existing drugs being used for other reasons and are now being studied as potential treatments for COVID-19).
They may be particularly important for groups hardest hit by the disease, such as the elderly and those with compromised immune systems. Neutralizing antibodies will be an important “bridge” to widely available vaccines, as well as a treatment option when vaccines are not completely effective or are given too late.
Q. What are the next steps to test safety and effectiveness?
McCully: LY-CoV555, Lilly’s lead antibody, is now in the final stages of clinical testing.
The Lilly-sponsored BLAZE-2 study is a first-of-its-kind COVID-19 trial and is being conducted in partnership with the NIAID network, the COVID-19 Prevention Network (CoVPN) and several long-term care facility networks across the country. The study will enroll up to 2,400 residents and staff who live or work at facilities that have had a recently diagnosed case of COVID-19 and who are now at a high risk of exposure. The rapid spread of COVID-19 among residents of long-term care facilities combined with the higher mortality rate for the elderly creates the urgent need for therapies to prevent COVID-19 in this vulnerable population. Lilly will deploy its mobile research unit fleet in response to outbreaks of the virus at long-term care facilities across the U.S. Lilly created these customized mobile research units to support the on-site study. These units include a custom retrofitted recreational vehicle (RV) to support mobile labs and clinical trial material preparation, along with trailer trucks that will deliver all clinical trial supplies needed to create an on-site infusion clinic.
The National Institutes of Health, along with numerous partners, is leading an effort titled Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV). The goal of the public-private partnership is to develop a coordinated approach to prioritizing and speeding development of treatments and vaccines. LY-CoV555 is the first therapeutic to be tested in two ACTIV trials evaluating monoclonal antibodies. In ACTIV 2, it is being tested as a treatment in the outpatient setting (those with mild to moderate COVID-19) and in ACTIV-3, it is being studied in treating hospitalized patients with COVID-19.
News 8’s medical reporter, Dr. Mary Elizabeth Gillis, D.Ed., is a classically trained medical physiologist and biobehavioral research scientist. She has been a health, medical and science reporter for over 5 years. Her work has appeared in national media outlets. You can follow her on Instagram @reportergillis and on Facebook @DrMaryGillis