COVID-19 Update for 6/11/2020

COVID-19 Antibodies

Lilly is co-developing two monoclonal antibody products with partners. Lilly estimates it could have an emergency use authorization for one of the products as soon this fall.

• Lilly is developing LY-CoV555 with AbCellera. LY-CoV555 is a neutralizing IgG1 monoclonal antibody targeting the spike protein of SARS-CoV-2. AbCellera and NIAID identified the antibody from a COVID-19 patient and Lilly developed a way to produce the antibody. Lilly initiated a Phase I trial to evaluate the antibody as a treatment for hospitalized COVID-19 patients at the beginning of June. Results are expected by the end of June and positive results will lead to a Phase II trial. 

• Junshi Biosciences created an engineered monoclonal antibody for the treatment of the COVID-19 virus (JS016). The monoclonal antibodies are being co-developed with Lilly. The monoclonal antibody entered a Phase I trials in June 2020.
• Because LY-CoV555 and JS016 bind to different sites of the COVID-19 spike protein, Lilly is planning to test the two antibodies in combination in the treatment of COVID-19.
• Lilly is also working on a third monoclonal antibody, that could enter clinical trials in mid to late summer.

Regeneron is engineering monoclonal antibodies for the treatment of the COVID-19 virus similar to the process used to create monoclonal antibodies for Ebola. REGN-COV2 is composed of two monoclonal antibodies that bind to different sites on the SARS-CoV-2 virus. 

• Two Phase I/II/III adaptive trials will evaluate REGN-COV2 in the treatment of COVID-19. The trials began in June. One study involves hospitalized patients, while the other will use a non-hospitalized patient population.
• Two additional adaptive trials will evaluate REGN-COV2 use in preventing COVID-19 in healthcare workers or first responders and in close exposures, such as families.​

AstraZeneca is developing a two monoclonal antibody combination and plans to initiate a Phase I trial sponsored by DARPA in August 2020. AZ selected the antibodies from six antibodies licensed from Vanderbilt University.