NEW YORK – Dr. George Yancopoulos, President and Chief Scientific Officer of Regeneron Pharmaceuticals spoke with The National Herald about the latest developments in the fight against the coronavirus. He told TNH that Regeneron is working on two approaches, one for a “vaccine substitute or passive vaccine” while a permanent vaccine is being developed, and the other a possible treatment for the most severely stricken patients using Regeneron’s anti-inflammatory drug Kevzara which is already approved in the United States for treating rheumatoid arthritis. A Kevzara study has already begun with over 100 patients enrolled.
Of the passive vaccine, Dr. Yancopoulos said, “it could be a great stop-gap measure that could change the course of this epidemic. Ultimately it would be great and best to get an active vaccine, but this could be something that could really help a lot of people and could stop the spread. It could allow health care workers to do their job without worrying about being infected. It could really make a difference for a lot of people and change the spread of this disease,” by giving people temporary immunity of some weeks or months, thus ‘flattening the curve.’
Dr. Yancopoulos explained, “basically a vaccine is when you inject a dead virus or attenuated virus, as it’s called, into somebody and you hope you get a permanent immune response out of that, but it takes a while to get vaccines to really be able to be used widely and effectively because sometimes getting these immune responses can be tricky,” he said.
“Sometimes you can get the wrong kind of immune response, and it can be actually dangerous. It can make the disease worse, so that’s why Dr. Anthony Fauci who is the head of the NIH’s NIAID [National Institute of Allergy and Infectious Diseases], the part of the government that worries about vaccines, has said it could take a year or two to get an actual vaccine.” He added, we don’t really do vaccines, but the reason why there is a lot of interest in what we’re doing is that we can provide approaches that can work and actually change the course of this epidemic before a vaccine can become available.”
“We have two separate approaches. One is actually, you can think of it almost as a vaccine substitute: your body makes what they call an immune response which are antibodies that your own body makes that will stick to and kill the virus. We can actually artificially clone the exact kind of immune response that you want, that is the anti-bodies against the virus. We can make those outside the body and we can clone them and grow them in large bioreactors and purify them and give them to people and it’s like they’ve been vaccinated except they’ve been provided with the optimized immune response you would want a vaccine to give. You don’t have to take the time to develop a vaccine to do it – in a way it works immediately and is more effective than a vaccine, but the problem and the reason we still need a vaccine is that it doesn’t create permanent immunity. We’re artificially providing the anti-bodies to the person and they will only last a month or two then you have to re-inject them.”
He further explained, “that’s why it’s so important ultimately to get an active vaccine, as they call it.” This approach is called a passive vaccine because the patient’s body doesn’t itself make the antigens. The substance is obtained from people who have fought the virus, but there is not a large enough amount “so that we could make enough of it to treat critical care workers, health care workers, people on the frontline, people at high risk such as children with cystic fibrosis, or other lung problems or the elderly” he explained.
Nevertheless, “it could be a great stop-gap measure that could really change the course of this epidemic,” he reiterated. “That’s one of the two approaches that we have, this vaccine substitute, this passive vaccine which is a stop-gap measure until we get an actual vaccine.”
Regeneron’s other coronavirus initiative involves the anti-inflammatory drug Kevzara. “It has gotten a lot of interest and people are hopeful that it could change the course of history. As you know, the reason people are so concerned about the coronavirus is that a small percentage of people can get very serious lung disease and in fact it’s actually killed quite a few people, the lung disease; that’s why we’re scared. If it was just like a common cold or so forth, it wouldn’t be as much of an issue but since we have no treatment for it and a small percentage of people get a very serious lung disease that can prove fatal, it’s raising a lot of concerns and unfortunately, it’s also devastating our health care system even though it’s only a small percentage of the people who get this problem. So many people are getting infected that this leads hundreds if not thousands going to the hospitals needing intensive care beds, needing ventilators, and we really don’t have the resources to do that.”
He noted that “if you follow the epidemic in China and now more recently in Italy, it’s a horrible situation where doctors have to choose who gets the respirator and who doesn’t, and no doctor wants to be in that position. So it would be incredible if we could have a treatment for these people, the sickest people with coronavirus who have the lung problems, who have the greatest chance of succumbing to the disease. It turns out that when the epidemic was going on in China, they were just trying any available drug, anything they could imagine working, and somebody had a clever idea that maybe the problem with the lungs was not the virus itself causing the damage but the body’s immune response, inflammatory response. You’ve heard of auto-immune, inflammatory diseases like ulcerative colitis, rheumatoid arthritis, Crohn’s disease, when the body is attacked by its own immune system, so they thought there was an element of that to it. They decided to give an anti-inflammatory drug that was approved mostly for rheumatoid arthritis because the infiltration of the white cells in the lungs looked very much like the inflammation you see in the joints of people with rheumatoid arthritis. So they gave this drug and they claim in uncontrolled studies that it really helped people, and this generated a huge amount of interest because, really, they were trying everything, everything under the kitchen sink they were throwing at it, because nothing was working for the serious patients and most severe patients. This seemed to be working, so that generated a lot of excitement and they actually changed their treatment guidelines in China to include this treatment for the severe patients.”
“Obviously, these are anecdotal reports,” Yancopoulos emphasized, “uncontrolled studies, and unfortunately, a lot of the times when things look promising they’re not really as promising as people think. That’s why the FDA wants you to do well-controlled studies to prove that something works and that it actually doesn’t do harm. Sometimes people think things work but they’re actually harmful.”
The studies are needed “to understand how beneficial it is, how many people it could save, so we can really understand how this might be able to impact the course of this epidemic.”
In the United States, “it turns out only one other drug was related to the drug they tried in China and it was our drug,” Regeneron’s, “that was already approved in the United States for rheumatoid arthritis, so because of the dramatic need and the interest and the hope here, everybody from all levels of government and everyone in the ecosystem that’s involved in evaluating drugs, from the federal government to the FDA, the head of the FDA to Gov. Cuomo and the New York State health commissioner, everybody got together and they all worked with us incredibly closely, night and day, to get a controlled trial going so that we can really test it and see whether this really works. So we got such a study going in record time – it actually started last week. We’ve already enrolled over 100 patients and the hope is that within a few weeks or a month or two we will actually know whether we have a weapon for the most severely affected individuals, the ones with the lung disease.”
He described the effort as “a one-two punch to try to knock out the virus in the short term, one is a treatment for the most severe patients, the drug Kevzara, and also the effort with the vaccine substitute or passive vaccine that is going spectacularly well and we hope to be able to actually start testing this in human patients by June, which is really record time.”
“The reason why people are very excited about that approach – it is the same approach we used successfully against Ebola, which was a big story about a year or so ago – is that it gives people a lot of hope and confidence that we can do exactly the same thing here against the coronavirus.”
He also noted with pride that “it is of particular interest to TNH readers that the brilliant young scientist who has been leading our infectious disease efforts first developing the successful treatment against Ebola and working night and day to come up with this similar antibody treatment vaccine substitute for coronavirus is Dr. Christos Kyratsous, who happens to be – like me – from the northern part of Greece. We’re Greek Macedonians, the real Macedonians, and he, also coincidentally, like me, also went to Columbia, and we trained in the same department at Columbia. So now we’re counting on him to be leading this effort against the coronavirus.”
In conclusion, Dr. Yancopoulos told TNH, “obviously, there’s a need for a vaccine and there’s a lot of great companies working on it, some of the biggest companies in the world, like our partner Sanofi, Pfizer, Johnson & Johnson, they’re all working on vaccines, but as Dr. Fauci said, that’s going to be a year or two away. And we have two approaches that could change the course of this epidemic and maybe save a lot of people, save a lot of lives, and maybe, if they really are effective, give people a lot more peace of mind, and maybe allow people to start going back to more normal lives.”
Dr. Yancopoulos noted that the drug Kevzara was developed “in partnership with Sanofi, and while we are leading the effort to test it and doing this trial in the United States, Sanofi is leading the efforts in Europe and the rest of the world.”