Using the same technology which allowed it to develop a promising Ebola treatment, Regeneron plans to make an “antibody cocktail” for coronavirus that, according to a Tuesday release, should enter human testing early this summer.
The two-piece cocktail will come from a library of antibodies at Regeneron’s disposal. The New York-based biotech said it has isolated hundreds of virus-neutralizing, fully human antibodies from mice that were genetically modified to have a human immune system. Regeneron also obtained antibodies from people who recovered from COVID-19, the disease caused by the new coronavirus, which should “maximize the pool of potentially potent antibodies” that can go into the cocktail.
Regeneron said it’s prepping manufacturing facilities so that, once the top contenders are selected, clinical-scale antibody production can begin immediately. The company’s goal is to make enough drug so that, by the end of the summer, hundreds of thousands of prophylactic doses get made each month.
Researchers are hopeful this type of drug can combat the new coronavirus, either by preventing it from infecting people or by treating the symptoms of COVID-19. The idea behind Regeneron’s cocktail approach, for example, is that the antibodies will bind to and block the protein on the virus’ surface which lets it infect host cells.
As for why the cocktail will be made of two antibodies, Regeneron said in a March 17 statement that “a multi-antibody approach allows for targeting of different parts of the virus and may help protect against multiple viral variants.”
Other drugmakers are looking into how antibodies can be used against the novel coronavirus. Vir Biotechnology, a small San Francisco-based company, last week announced plans for a clinical development and manufacturing partnership with Biogen. The two will further a program investigating whether antibodies from people who survived SARS could serve as the foundation for a treatment, since SARS is also caused by a coronavirus.
Japan’s largest pharmaceutical company Takeda is taking a similar approach, though it intends to use its experience in blood plasma-derived therapies to isolate antibodies from patients recovering from the new coronavirus and transfer them to recently infected people to trigger better immune responses.
Meanwhile, multiple companies are engaged in vaccine work. The list includes big pharmas such as Johnson & Johnson and Sanofi, as well as biotechs Moderna, CureVac and BioNTech.
It’s unclear whether any of these programs will prove effective, though most experimental drugs fail. And those that do succeed often take years to go from early clinical testing to market.
Yet the industry appears to be mounting a significant response to the outbreak, given the threats the virus poses to the global health system. According to the World Health Organization, there were 167,515 confirmed cases and 6,606 deaths from the virus as of March 16.
On Regeneron’s end, its antibody cocktail program is the focus of an expanded partnership with the Biomedical Advanced Research and Defense Authority. The biotech said it’s working with BARDA to further increase production capacity.
“Given the tremendous interest and concern around the COVID-19 pandemic, we will be providing regular and transparent updates on our discovery and development programs,” George Yancopoulos, Regeneron’s chief scientific officer, said in the March 17 statement.
Regeneron and longtime partner Sanofi also recently announced that they will evaluate their marketed rheumatoid arthritis drug Kevzara in an international study of patients infected with the new coronavirus who develop acute respiratory distress syndrome. The trial will begin in New York and is slated to grow to 16 total U.S. sites with 400 patients enrolled.