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Moderna CEO Stephane Bancel & Regeneron CEO Leonard Schleifer on a Coronavirus vaccine

By Jacob Wolinsky. Originally published at ValueWalk.

Stephane Bancel easing program Covid-19 Testing

CNBC’s Meg Tirrell interviews Moderna CEO Stephane Bancel & Regeneron CEO And Founder Leonard Schleifer From CNBC’s Healthy Returns Summit Today


Q1 2020 hedge fund letters, conferences and more

And Leonard Schleifer

Following is the unofficial transcript of a CNBC interview with Moderna CEO Stephane Bancel and Regeneron CEO and Founder Leonard Schleifer live from CNBC’s Healthy Returns virtual summit on Tuesday, May 12th.

TYLER MATHISEN: Our next discussion is with the leader of two companies that are on the forefront of trying to develop both treatments and vaccines for COVID-19. I’m going to ask now a poll question before I introduce our guests and our interviewer, and here we go. So we’re asking you now: What is most likely to make the biggest impact in the effort to control the pandemic this year? Is it a vaccine? And is it a new drug? Is it a repurposed drug?

Or could it be a cocktail of drugs? So, we’re talking about a short timeline there, and which is going to be more important in treating this pandemic over the remainder of the year. And to do that and to discuss that, and more, let’s bring in Stephane Bancel. He’s the CEO of Moderna, and Len Schleifer is the co-founder and CEO of Regeneron. And my friend and partner here today, Meg Tirrell, will do the interview.

MEG TIRRELL: Hi. Thank you so much. And Stephane and Len, it’s great to see you both today. Thanks for being here.

STEPHANE BANCEL: Thanks for having us.

LEN SCHLEIFER: Thank you for having us.

MEG TIRRELL: All right. I want to start where — and Tyler just mentioned timelines, because both of you are doing projects at timelines we have never seen before. You know, Stephane, you just got fast-tracked as a nation this morning from the FDA for your vaccine for COVID-19, which almost seems a little bit ceremonial, given the speed you were already moving with this program. And Dr. Fauci mentioned in his testimony this morning it’s only been something like 62 days from when you guys envisioned this project together to now, when you’re already in human clinical trials and already talking about starting your phase 2.

And, Len, with your new drug approach with an antibody development, you already set the record in Ebola for nine months from envisioning the project to getting it to human testing, and now you aim to break that in five months for your antibody drug for COVID-19. So I want to ask you both, how are you doing this, shattering these timelines, even from the timelines you’ve set at the beginning of this project? Len, let’s start with you. What are you doing differently here that is allowing you to speed this up so much?

LEN SCHLEIFER: Sure. So thanks for having us, Meg. Let me just start out by saying that what we’re going to talk about here is reflective of decades of investment. People who know Regeneron and have followed us for a while knew that the first 25 years of the company, we actually lost money every single year. But we continued to invest in technology, and the technology is getting better and better and better.

And we’ve used this technology as a way to make human antibodies. What the immune system normally does when it’s faced with a virus, it makes antibodies, because it wants to fight this invader. When we have an effective vaccine, hopefully Stephane and others will bring that to the market, a vaccine tricks the body into making these antibodies. But no matter what, it takes some time and it takes some work on the body.

So even on day one, you’re not ready to go when you’ve seen a new bug. It takes a while. We can make these antibodies — in our new technology, as you said, normally it takes years and years to do all this. We sped it up with Ebola, we knew that there was a big problem. And the Ebola opportunity taught us a lot of things, and we can set the land speed record of getting into patients in about nine months.

Now we hope to do it in five months. Our team is just entirely focused. The day that we had the sequence, they were on this new virus, they were making what they needed to make; they were putting the virus into the magical mice. We were doing things in parallel, we were taking risks; and this, I think, speaks to the fact that everybody has to understand, this only happens when you have a robust biotechnology industry that has invested in technology and biology for decades.

MEG TIRRELL: Absolutely. Stephane, tell us a little bit about what you’re doing differently here. And in terms of envisioning the trials, even taking place on top of one another. As you get certain data from one, you’re starting the next. How are you managing to compress these timelines in such an unprecedented way?

STEPHANE BANCEL: So, I think it’s a bit similar to what Len just said, first, the technology. We have, as you know, Meg, invested for now nine years in the technology, maybe 600 or 700 million dollars, just going into pure science. This is the tenth vaccine we are putting into clinical studies, so it’s been a lot of learning there. We have worked with Dr. Tony Fauci’s team on the Middle East Respiratory Syndrome, a rare coronavirus, you know, for almost two years now at our manufacturing plant.

When we built the manufacturing plant, a lot of people, you know, said, you know, this is too early, you guys are crazy. And if we had worked with contract manufacturers, we couldn’t have moved so fast. And I think of course the FDA and the dialogue we’ve had with the FDA, which is almost actually daily, as we have questions, as we’re trying together to figure out how do we move fast but safely. In everything we do, safety is extremely important, and of course, even more with vaccines. Because you give vaccines to healthy people in your clinical studies, but also commercially down the road, if you get there.

And so safety is very important. So one of the things we’ve done is — you know, as phase 2 is going to start any day now is really to think about what is the minimum body of data we need given the risk-reward to start with phase 2, and what we agree was that safety was very important, so safety from phase 1. But in normal times, we would have waited for antibody levels, looked at total data, asked experts, and only then start to make the phase 2 material, if success in phase 1, and then recruit and start the site for phase 2. So here we say, look, lives are at stake. Let’s make the phase 2 material at risk during the phase 1. And let’s not wait for the immunogenicity; let’s just go into phase 2 as soon as we know the safety of phase 1 is positive.

MEG TIRRELL: And so you got the go-ahead from the FDA to start the phase 2 knowing the safety from the phase 1 is positive. When will we get to see those phase 1 data?

STEPHANE BANCEL: So as soon as the NIH and ourselves feel that there is enough data to be shared, so as you know, the phase 1 study is being conducted by Dr. Tony Fauci and his team. So as soon as we have data that makes sense, we will of course share it, we know everybody is eager to see the data. And I will say something about the clinical data. I mean, as you know in some — like cancer, that you know, Len and his company know very well, — are complicated to translate into human. But the infectious disease, as has been shown by many companies before us, if you get the right animal model, you can do a challenge into an animal where you vaccinate them and then you give them a very high dose of a virus, and you can see, you know, are we getting protection? And so that sort of clinical work should be published pretty soon now.

MEG TIRRELL: I’m sure we will be looking really to see that. Len, I wonder if you can tell us just a little bit about your confidence level in your antibody approach working. You know, when you talk to a lot of people who know the industry well, including Dr. Scott Gottlieb, who we had on earlier, he always brings up Regeneron as one of the companies he’s watching to give us a new tool, potentially come the fall. And you have done this, of course, for Ebola just recently, using your magical mice, as you called them. So you hear about there’s only a 10 percent success rate in getting a new drug across the finish line when you start the development. But where would you put your probability of success in COVID-19 for your antibody approach?

LEN SCHLEIFER: That’s a great question, Meg. I appreciate Dr. Gottlieb’s mentioning of what we do. I have to say that we’re pretty optimistic for two different reasons. The first reason is what we’re trying to do is simply to imitate what nature normally does. If you think about a newborn or a baby developing in utero, that baby doesn’t have a great immune system. So what does nature do? The mother sends her antibodies across the placenta so that if anything gets to the baby, that baby is protected by those antibodies.

That’s a passive transfer of her antibodies to the baby’s antibodies. After that baby is born, the first mother’s milk and subsequent to that, milk provides antibodies, because the baby’s immune system is really not up to snuff. So this passive transfer of antibodies is a very natural thing, and it goes on all the time, as I said, in those contexts.

But it was also shown — actually, the first Nobel Prize ever awarded for medicine or physiology was for immunology where von Behring had discovered that if you took people who were already exposed to diphtheria, they had an antibody that could be given to other people and it could help them recover from diphtheria. So the concept of passive transfer is something we’re just trying to imitate, so it gives us great optimism.

Now the second factor is, can we actually get good antibodies, and does our technology deliver this same type of passive transfer? We’ve been making half a dozen or more drugs with these mice. We know how to make the antibodies. And the most relevant antibodies we’ve made is a cocktail for Ebola, where we actually showed you could save lives, in a study that was done in the Congo.

And it was a study that was done really importantly, not an observational study, not a case control study, but a study that was done based upon randomized, controlled, well controlled data. Rhat’s the kind of data that gives you confidence. And when we saw that data, that study was stopped early because the data were overwhelmingly positive. In fact, in that study was Remdesivir, and Remdesivir really didn’t perform all that well relative to our antibody cocktail. So we have a lot of confidence that we can make the right antibodies, we can select the right antibodies. We know how to scale them up, that’s going on, and all we’re doing is imitating what’s known to work, giving antibodies like a mother gives a baby, like people have transferred plasma to people. This is not breakthrough conceptually; it’s breakthrough technologically.

MEG TIRRELL: Absolutely. And I was actually just reading about that diphtheria example in “The Great Influenza,” that amazing book by John Berry about the 1918 flu. It’s a great read, for anybody who hasn’t read it. We have got a viewer question I want to bring to you guys, from Gunner. He asks: What is the industry doing to partner with hospitals or clinical researchers who enroll these trials so quickly? Part of setting that land speed record, as Len put it, is reliant on getting study drug to patients. How are you both doing this? And we will start with Stephane.

STEPHANE BANCEL: Yes, so indeed, to achieve these type of timelines it’s about preparing early and extraordinary collaboration. So we talk to hospitals, you know, that we’re working with, you know, way ahead of the study. So if you again look back at phase 2, that’s going to start soon. We got the green light last week. We’ve been talking about getting it to the sites and — for quite some time. My team is actually spending most of the time now preparing for phase 3 that they say could start in early summer. And so we want to be ahead of the game, we want to really engage, get them engaged in the protocol design, get their input, so to get the best outcome as quickly as you can.

MEG TIRRELL: Len?

LEN SCHLEIFER: Stephane is right. Engaging the investigators is really critical. But I’ll say this. There’s two factors. We’ve been at this for a long time. There’s two factors in play always, always, always. One is, is there an unmet medical need? Obviously, there’s a huge unmet medical need here. And two is, is there a promise or belief that your approach might work? We, unfortunately — located in New York, we were in the epicenter of this pandemic in Westchester County, where our company is located. I’m happy to say we had very few cases at the company itself. But there were so many patients — and I must say, Governor Cuomo did a fabulous job of letting the public know — we were teetering on overwhelming the system. At any rate, because the system had so many patients, sometimes in clinical trials you’re lucky to enroll a couple of patients a week. That would be a lot sometimes. We enrolled, in the height of all this, for our earlier trials with Kevzara, over 100 patients in a single day. So I have to say that the combination of need, which is overwhelming, and promise, which I think people are able to assess, is what drives enrollment.

MEG TIRRELL: Well, I want to ask you a question about that, because one of the things we’ve observed before with drugs or vaccines developed for outbreaks is that the science is not fast enough to keep up with the infection. And often what happens is — we saw this early on with Ebola, we saw this with Zika, we saw this with SARS and to some extent with MERS that while there were products underway, the infections burned themselves out before the drugs or vaccines could be tested in areas where there was a lot of active infection. One potential solution to that and also to get results faster that’s been brought up by some respected epidemiologists, infectious disease experts and bioethicists, is what’s known as human challenge trials, the idea that you would actually give the virus to volunteers, to healthy volunteers, to test how well typically a vaccine works. This is something that we’ve never really talked about before in medicine in the United States. I wonder about both of your thoughts about this idea. And Stephane, since you’re developing a vaccine that is one of the furthest along, has the idea of human challenge trials come up?

STEPHANE BANCEL: Yes. So we have been discussing it. We have a team and a lot of advisors. We have challenge done before, for RSV, there’s been challenge done. And one of the key criteria from a medical standpoint is, you have medicines in case the vaccine will not work, to be able, of course, to ensure people don’t get disease or severe disease. Of course, in that case we saw with COVID-2, death. So, we want to be part of the dialogue.

There is a lot of consideration, obviously, from an ethical standpoint, which is priority number one. And there are several groups and several universities and I think the NIH, as well, is working on trying to write white papers and have the right experts around the table. I think — with general drugs were to show positive outcome in the clinic, which we always think about, I think such a tool would be a great component of how do you design such a study.

But in the case of Moderna, what I think might be interesting, because we need to also figure out what sort of dose of the virus you’re going to give, you need to have a GMP separate for the virus, it has to be well controlled so you understand your study. If you think about it, I mean, we are aiming at starting a placebo-controlled randomized — study in phase 3 in early summer. And if we do it large enough, which we believe we should be able to do because of the great sponsorship we had from BARDA where we get basically 483 million dollars to run very, very large study because we don’t know where the outbreak is going to be in early fall.

But if you think about it, if we’re going to run thousands and thousands of healthy subjects getting vaccinated and then into potentially the second wave in the fall, we should be able to get the efficacy rate down actually pretty quickly, maybe even faster than getting a challenge study set up properly, without all the ethical considerations. So we want to be part of a dialogue. We are open to any group that is conducting any such study. But we might be able to go as fast or faster by running the clinical study because we’re so close to doing so.

MEG TIRRELL: Len, what are your thoughts on the concept of that?

LEN SCHLEIFER: Yeah, it’s a great question. But let’s frame the problem so we can understand where the solution fits. What is the problem? If you’re doing a preventive trial, like we would like to do with our cocktail or Stephane would do with the vaccine, you’re relying on what is the background rate of people getting infected without your drug. If you put 5,000 people in the trial and you had a background rate of infection over the course of three months or something of 1 percent, you would have only 50 people, perhaps, that became positive in the placebo group. That’s if you had 5,000 people in that placebo group.

So you might have to have another 5,000 to show that you prevented half of those people because you want to go from 50 to 25, so you need a lot of people. So that’s the nub of the problem you’re getting at, that is when you’re trying to do prevention, you’re relying on the natural disease frequency. Now, if the frequency is high, you’re going into a nursing home or something like that, or first responders or health care workers, maybe you can do those types of studies; family members and so on. What the challenge study is trying to think about is, can we change the numbers?

So instead of having to study 10,000 people, you might be able to study 100 people. Think how much quicker you could get that done. Now, what are the challenges, if you will, of a challenge study? It’s really the challenge of the unknown. We do know, for example, that people who are young, who might be a good volunteer for this study, is people from 20 to 30 have a very low rate of very serious disease.

But we learn a lot about this virus every day, and we learn that there are late sequela that they are even seeing in children, this Kawasaki-like syndrome. So one has to have an ethical perspective that cannot be put forth by people like Stephane and myself, people who are highly conflicted, because we obviously want to go forward; we want to do this fast; we want to get results.

And that creates a conflict. We can only lay out what we know, and it will be up to independent ethical groups, perhaps the NIH, university scholars in this field, to weigh in. I’m sure there will be no shortage of people willing to volunteer. The question is not whether people would volunteer to do this; the question is whether — how the ethics come out. And we have to leave that up to the ethicists after providing them the information.

MEG TIRRELL: Really great points. I have to get to some more viewer questions, because we’re getting so many good ones. I’m going to stick on the subject of ethics a little bit, and this one really is about access once your products get developed, which we hope that they will and they will be successful. One person asks: Can you discuss how access programs for new vaccines or treatments for COVID-19 might be designed? Daniel O’Day, the Gilead CEO, of course, has said Remdesivir will be accessible, but details are scant. Of course, as we’re watching it roll out in the U.S., we’re seeing that it’s not getting everywhere it potentially needs to go, and there might not be enough. Do you have any thoughts or ideas on how these kind of access programs might be designed, Stephane?

STEPHANE BANCEL: Sure. So, what is clear, and I’m talking about the vaccine, is that we, at the global level, are not going to have enough supply. As I’ve said before on your show, I’m really rooting for every vaccine manufacturers, because I really hope that all of their programs get to the finish line. Of course, as we know, the odds that every program works are really low, obviously. But I really hope that we have three or four or five vaccines, because no manufacturers can make enough doses for the planet. And so, what is going to happen, I believe — and we are starting to have discussions with, for example, the U.S. government about it, which is how do we provide access? How do you prioritize?

And we believe this is not a company decision. This has been done by the clinical community, being coordinated across the country, and so we’re going to continue to work very closely, as we have done before with, you know, NIAID and with Dr. Fauci’s team, with the CDC, to figure out what’s the best plan for access within the country.

And what we make sure is every time we make a new lot of product and it’s approved by quality control and we think it’s a good lot, we will of course make it available and be basically hand-to-mouth. I cannot see that, as different vaccines potentially get to approval, we are going to be at least a year, year and a half, with really a tight, tight supply across the country and across the world.

MEG TIRRELL: And Len, I’ll give the last word to you. I can’t believe we’re almost out of time already. Given what you’ve observed so far, of how the system has worked for distributing Remdesivir in its early days, are you confident that if the United States government is helping with the coordination and distribution of your medicine, it will be done in the most equitable way?

LEN SCHLEIFER: Yeah, look, any medicine that we come up with to make a difference has to be both accessible and affordable. And the problem is not just within the country. Obviously, we think country first, but it really will be a global problem. Sometimes it will be a question of whether or not there’s even a distribution capability in some low-income countries around the globe, for example, if it requires a cold chain, something as simple as that. So I think that we have some challenges. We have the distribution capability to give out drugs. Whether you go to your local CVS or you go to your doctor, you can get a vaccine, you can get a subcutaneous shot, you can get an infusion in the hospital. The distribution aspect in the United States, the physical distribution, I think is more than adequate.

I do think that there will be a capacity issue. Like Stephane, we are not the only people who are trying to make an antibody cocktail. There are a lot of good, fine companies that are working on this. I know Lilly is at it, and there are others; and we need multiple successes, because the demand will far exceed the capacity. We simply cannot do this on an auction basis, whatever state or local area or company wants to pay the highest amount to get access. We can’t do it that way. We’re going to need some rational approach, and this is — when we’re in these types of emergencies, this is a role for governments; federal governments, governments around the United States, governments around the world, state governments. We have to make sure this is done equitable and does the greatest amount of good.

MEG TIRRELL: All right. Well, Len and Stephane, we will eagerly await more updates on your programs. Thank you both for being here with us today.

STEPHANE BANCEL: Thank you.

LEN SCHLEIFER: Thank you, Meg.

The post Moderna CEO Stephane Bancel & Regeneron CEO Leonard Schleifer on a Coronavirus vaccine appeared first on .

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