Companies Press Ahead with COVID-19 Antibody Therapies
Although the world is eagerly awaiting news of an effective and safe vaccine against COVID-19, several companies are moving ahead testing therapeutic antibodies against the disease.
Monoclonal antibodies are used to treat cancer, rheumatoid arthritis and many other diseases. They are essentially immune cells that have been found to activate against a specific type of cell, whether it’s a specific type of cancer cell or a specific virus, in this case, SARS-CoV-2, the virus that causes COVID-19.
Quite a number of companies and organizations are currently testing these therapies, which are generally faster than the development of a vaccine. They could potentially be given to high-risk individuals, such as health care workers, the immunocompromised, and be provided with a month or two of protection. They could also possibly be used for people living with an infected individual, or to people early in the disease who have been recently diagnosed.
Groups and companies working on this include the CoVIg-19 Plasma Alliance, which has been joined by a number of companies, including Biotest, BPL, CSL Behring, LFB, Octapharma and Takeda, to accelerate development of a plasma-derived hyperimmune globulin therapy against COVID-19. Eli Lilly is working with Junshi Biosciences on multiple antibodies and has indicated the possibility at least one of them might be available for use by September.
Regeneron Pharmaceuticals, with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), launched Phase III trials of REGN-COV2, the company’s two-antibody cocktail for the treatment and prevention of COVID-19.
There are specifically two trials. A Phase III trial will study if REGN-COV2 can prevent infection in uninfected people who have had close exposure to a COVID-19 patient. The drug has also been advanced into the Phase II/III portion of two adaptive Phase I/II/III trials evaluating the cocktail in treating hospitalized and non-hospitalized patients with COVID-19.
A Phase I trial in 30 hospitalized and non-hospitalized patients with COVID-19 received a positive review from the Independent Data Monitoring Committee.
The Phase III prevention study will be run at about 100 locations and enroll about 2,000 people in the U.S. The Phase II/III treatment trials in hospitalized patients will evaluate about 1,850 hospitalized patients and 1,050 non-hospitalized patients and is planned for about 150 sites in the U.S., Brazil, Mexico, and Chile. It will study virologic and clinical endpoints. Preliminary data is expected later this summer.
On June 11 and August 4, Regeneron published data testing its two-antibody cocktail in monkeys and hamsters. In the latest animal study paper, the authors say the cocktail in monkeys and hamsters demonstrated “that REGEN-COV-2 can greatly reduce virus load in lower and upper airway and decrease virus-induced pathological sequelae when administered prophylactically or therapeutically. Our results provide evidence of the therapeutic potential of this antibody cocktail.”
Essentially, the study took two approaches. One was to infect animals with the virus, then dose them with the antibody cocktail to see if it could halt the infection. It appeared to do this successfully.
The second approach was to dose the animals with the antibody cocktail, then infect them with the virus. This also appeared to prevent infection.
Another company working this angle is Sorrento Therapeutics, which has teamed up with New York City-based Mount Sinai Health System to develop an antibody cocktail called COVID-SHIELD. They also have a separate antibody program against COVID-19.
“A vaccine takes time to work, to force the development of antibodies,” said Myron Cohen, reported AP. Cohen is a virologist with the University of North Carolina. “But when you give an antibody, you get immediate protection. If we can generate them in large concentrations, in big vats in an antibody factory … we can kind of bypass the immune system.”
Janet Woodcock, director of the U.S. Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER), believes the antibody therapies are “very promising” and, compared to vaccines, could be available “fairly soon,” she told AP.
Eli Lilly has begun manufacturing its antibody therapy. “Our goal is to get something out as soon as possible,” and to potentially have hundreds of thousands of doses ready by fall, said Daniel Skovronsky, Lilly’s chief scientific officer.
Regeneron had success developing an antibody drug cocktail against Ebola, and Christos Kyratsous, a Regeneron microbiologist who helped lead that project, told AP, “The success with our Ebola program gives us some confidence that we can potentially do this again.”