Antibodies are the proteins the body makes to fight infection.
Since the Victorian era, scientists have used this natural protection for treatment.
During the 1918 flu pandemic, doctors demonstrated that convalescent plasma – blood plasma filled with antibodies from patients recovering from the disease – could fight the flu. Convalescent plasma has been used to treat severe flu, MERS and SARS, and now some American doctors are also starting to see some success in treating Covid-19.
Since there is not enough donated plasma to treat all patients, modern medicine can fill the gaps and perhaps even improve the process. Scientists can create so-called monoclonal antibodies: laboratory-made antibodies created specifically to target an infection.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and a member of the White House Coronavirus Working Group, said these therapies will be essential in the fight against Covid-19.
“Right now, we have a major impetus on a program for the development of monoclonal antibodies, convalescent plasma and hyperimmune globulin, which are all based on the same principle of using an antibody directed against the virus for prophylaxis or treatment, “Fauci said in an interview with JAMA on June 8. “I think you’ll see it’s going to be for both. We would like to have available to those at risk – the elderly and those with underlying conditions – either monoclonal antibodies or convalescent plasma. It’s a very, very high priority. ”
Currently, there are at least 102 Covid-19 antibody treatments at various stages of development, according to David Thomas, vice president of industrial research at BIO, the professional association representing the biotechnology industry. Thomas is doing the research that goes into his organization’s Covid-19 therapeutic development tracker. He said there are so many treatments under development, it’s hard to follow.
“I never envisioned it growing up so fast, so fast, and I have worked in all therapeutic areas, from Alzheimer’s disease to cancer, and to see a pipeline of this size and scope is incredible” said Thomas.
Thomas said some therapies are designed to treat the side effects of Covid-19 such as inflammation. Others are designed to kill the coronavirus itself.
Compared to other diseases, research and development of Covid-19 treatments is advancing at “speed of light,” said Thomas.
Four monoclonal antibody treatments designed to treat and possibly prevent Covid-19 infection were already tested in humans in June.
Indianapolis-based pharmaceutical giant Eli Lilly has two. One was developed in collaboration with AbCellera, a biotechnology company based in Canada. Another was developed with Junshi Biosciences.
The antibody developed by Lilly with AbCellera called LY-CoV555 is now in a phase 2 clinical trial in non-hospitalized patients. This study is currently recruiting patients. Lilly said that in the future, she will also test additional antibodies and experiment with different combinations to see which one works best.
Regeneron is testing its antibody cocktail in patients in the United States. The New York-based biotechnology company is recruiting inpatient and ambulatory patients with Covid-19 in the initial safety / virology phase of the trial, spokeswoman Alexandra Bowie said this week. The company expects to have preliminary data in one to two months. They’re stepping up manufacturing to create hundreds of thousands of doses by August 2020, dedicating their entire manufacturing facility in New York State to the effort.
There is also another effort from Tychan, a Singapore-based biotechnology company, which has launched a phase 1 clinical trial in hospital patients. The company said this part of the trial would take approximately six weeks.
It is likely that if all goes well in the opening sentences of the trials, therapies could move on to the next phases this summer, the companies said, and treatments may be available by the fall. Although, according to some scientists, not everything works as expected in real life.
“Sometimes the antibodies that work in the laboratory and neutralize really well are not as effective when used in animal or human models, so it’s always a little tricky,” said Phyllis Kanki, professor of immunology and infectious disease at Harvard. TH Chan School of Public Health. Sometimes it can take a while to get the right antibody cocktail, said Kanki.
Thomas of BIO, however, said the industry has accumulated a lot of expertise in developing antibody therapy over the years in creating treatments to fight cancer and autoimmune diseases.
In addition to therapies specifically designed to fight the new coronavirus, companies are also looking to reuse some of their existing monoclonal antibody treatments as potential Covid-19 treatments.
Novartis, for example, is participating in a phase 3 trial of the drug canakinumab against the coronavirus. This interleukin-1beta blocker is approved by the FDA to treat certain rare types of periodic fever syndromes, also called auto-inflammatory syndromes.
The company hopes that canakinumab can be used to treat patients whose Covid-19 infection has caused a condition called cytokine release syndrome, or cytokine storm. where the body’s immune system overreacts to the infection and harms the body. This trial is currently recruiting patients from the United States.
China-based biotechnology company I-Mab said it also hopes to get results by August from its trial of an antibody therapy, which it is currently testing in patients with cytokine storms, so that she could potentially offer treatment in early fall.
Humanigen’s lenzilumab also appears to be fighting cytokine storms, according to a small study by scientists at the Mayo Clinic. This phase 3 trial is underway.
Several other therapies are still being tested in the laboratory. South Dakota company SAB Biotherapeutics announced plans to start human trials with its plasma-derived antibody treatment in cattle in July.
Most experts believe that the world could have antibody therapy sooner than a vaccine, although vaccine development is also progressing at a record pace.
“There is a lot of excitement about what these antibody therapies can do, animal level anyway,” said Thomas. “They were showing neutralizing activity and we are seeing a lot of positive data. “