Biotechs around the world are sprinting to develop a viable coronavirus vaccine. But which will get to the finish line first? In this episode, Business Insider’s healthcare reporter Andrew Dunn takes us through the myriad of concurrent trials taking place and what this all means for potentially changing the course of the pandemic.
Jeffrey Freedman: Hello, and welcome to the RP HealthCast by RooneyPartners. I am your host Jeffrey Freedman. It seems like every day now we hear of promising new discoveries or potential cures for the novel coronavirus. Just last week, there was a study that came out of the UK out of Oxford University, about an older, inexpensive steroid that had preliminarily been shown to help patients on respirators, but it has not been shown to have any effect for people with milder symptoms. In fact just the opposite, it could potentially be harmful to those people with milder symptoms. The much-touted remdesiver, it’s been shown to have the opposite effect actually. It’s been shown to help people with milder symptoms recover quicker, but it has not been shown to help severely ill patients. The one thing we know for sure is that we just do not know enough about the disease and because of that we cannot find a potential cure right now. To make sense of all this, our guest this week is Andrew Dunn. Andrew is a healthcare reporter at Business Insider, covering the pharmaceutical and biotechnology industries. For the past several months, Andy has been reporting exclusively on the current coronavirus pandemic. His stories have taken an in-depth look at vaccine discovery and clinical trials for potential new therapies. Andy, it is a pleasure to have you with us here today.
Andrew: Yes, thanks for having me. Happy to do it.
Jeffrey: Great. Now before we get started on your in-depth novel coronavirus reporting. I want to take a step back and discuss how you got here. You join Business Insider from a solely healthcare-focused organization. A great organization called BioPharma Dive, was this a tough or weird transition being able to carve out a healthcare niche at Business Insider which covers everything?
Andrew: Yes, it’s been an interesting transition. BioPharma Dive is more on the trade publication side for business news. At Business Insider, one thing that was helpful as far as making a smoother transition was that I am still covering the same industry, so I am still covering the drug industry, pharmaceutical biotech companies, just the audience has changed.
Jeffrey: You joined Business Insider at a crazy time, I mean, it was a pivotal time. It was right before the coronavirus reached our shores here in the US and I think your first article or one of your first articles was back on January 23rd. It was entitled and I quote, “A vaccine for Wuhan Coronavirus could take years to develop based on our experience trying to fight Zika and Ebola.” Now, what were your thoughts back then? Starting with a new publication and then stepping into this global issue. At the time of that reporting, they are only six hundred thirteen people infected. Did you think it was a global issue back then?
Andrew: You mentioned that article, January 23rd that was my first week on the job. So I was going through a lot of the orientation stuff, what you typically know when you start up at a new company and basically between those moments I reported out that story. Basically that the gist of it was we were hearing some level of discussion about some vaccine efforts for this novel coronavirus and basically I was saying based on how Ebola went, Zika went if you look at other infectious diseases, vaccine development takes multiple years and many billion dollars usually to get something over the finish line. Sometimes it does not happen like Zika. There is no approved vaccine for that yet. Ebola there is one now, but I mean as far as the global issue in realizing how big of a new story this would turn out to be, I definitely did not realize that in late January early February. I think I was aware of the potential but it was hard for me to imagine how widespread it would become.
Jeffrey: Yes, and it really hits corona all the time in the news cycle and it has to be, but I think that experience you have or that interest you had in gene therapy, in gene-drug development probably led you into discovering and following Moderna who is working on that, right?
Jeffrey: Also you started early on, first reporting on Gilead and they were repurposing their experimental drug, which is now Remdesivir. So how do you get dialed into following these companies? You mentioned the gene therapy, what about Gilead and Remdesivir back in January?
Andrew: Yes, I mean I think that these were on my radar really early on. I think both those companies before this virus happened are just particularly fascinating companies. Moderna has been one of the buzz startups and biotech for the last decade and they have just raised these massive funding rounds to off of this vision really for a new modality of medicines. MRNA is the name of their platform, which is still an unproven technology, but they have raised these mask evaluations and just record funding rounds over the last ten years based on the potential for its platforms. So, that was a really interesting story before that COVID vaccine effort even began that I was interested in. Gilead likewise is one of the biggest biotechs in the industry. I think their market value is something like ninety billion dollars and they obviously have a really interesting business story. Again before coronavirus, they develop these transformative medicines for HIV and hepatitis C and are now sort of at a crossroads where a lot of their focus has shifted to immuno-oncology, some cell therapy medicines for cancer. I was really curious in a business story how do you transition from one of these focus areas to another and then obviously with remdesivir they are antiviral here. It is playing a fundamental role and immediate response to coronavirus. So that quickly became the focus too.
Jeffrey: All right, so let us fast forward almost five months or six months later to today. Now in these short few months, we went from as you said January six hundred and thirty confirmed cases worldwide and eighteen deaths to approximately eight million confirmed cases and half a million deaths worldwide over a quarter that number coming from the United States alone. Now, aside from face masks and social listening, I hope we are further along, for protecting ourselves from this. Now, where do we stand with these, it was back in January, promising medical discoveries and I would love to be able to unpack them one at a time. Now first, can you define the difference between a vaccine and a treatment?
Andrew: Yes, so vaccine and treatment, it might be helpful, there are three big buckets that at least I think through as far as distinctly different when you think about the pharmaceutical industries response to this virus. So first you have repurposed treatments, which are basically medicines that already exist. We already know their safety profile. They are used in other indications. So, this is something like remdesivir would fit in this group. It was tested against the Ebola virus in humans several years ago. It did not work on Ebola very well, but it did show that it was safe which was valuable and being able to quickly test this in COVID. The second bucket is sort of these therapeutics where you are crafting drugs to fight this virus. That is kind of a middle ground approach of repurposed drugs you are going to have available immediately and we could start testing in January, February and March. Therapeutics are just now entering the clinic. So we are seeing some antibody-based drugs. Some drugs are based on the blood of COVID-19 survivors. These medicines are now sort of entering human testing in June, July, August with the goal of some of the earlier efforts being available this fall or later this year. The third major bucket is obviously vaccines ideally will prevent infections, massive administer vaccines to healthy groups of people. It gives them the immune response or prepares them with an immune response if they are exposed to the virus, their bodies can fight it off and not become infected and even a partially effective vaccine would be massively helpful and a partially effective vaccine will be something that reduces the severity of the disease. So taking that vaccine you might still be infected but there is a much lower chance that you will end up in the hospital and hopefully that can weigh down to mortality rates with this virus. So those are kind of the three main buckets and I am happy to go into more detail on each of those if you want and we could start with repurpose treatments and kind of go lay the land there.
Jeffrey: Yes, that is great. So, I mean we spoke about your initial reporting back in January on Remdesivir, right? So especially in light of this week’s announcement of the dexamethasone trial and the FDA’s decision to discontinue testing hydroxychloroquine. Where does Remdesivir stand?
Andrew: Yes, so Remdesivir, again the antiviral developed by Gilead Sciences. That showed in late April a positive result, a modest benefit for hospitalized COVID patients. That was a massive deal, it showed that this virus is druggable to some extent. It gave doctors something in their tool kit that they could use to try to help some of the sickest patients and it is shown some level of antiviral activity so actually fighting the virus itself instead of getting the other repurposed drug that just showed a clinical benefit. The other day, a UK ran study came out and said dexamethasone which is a type of steroid, which is a cheap generic pretty widely available medicine that showed a mortality benefit. That kind of went a step beyond remdesivir as showing for a specific group of patients specifically COVID patients who need oxygen support, it lowered the risk of death for them. So that seems to be potentially a very effective treatment for very late stage critically ill patients. One caveat that is very important with dexamethasone is this was all from a press release from these researchers. We have not seen any peer-reviewed published data, but even with that said, the UK’s National Health Services already approved the drug for use in the UK at least for COVID patients. So, science is moving from remarkably quick at times on stuff like that but when you look at the landscape overall, these are not game-changing medicines, remdesivir and dexamethasone. There is a lot of talk about hydroxychloroquine, which is a malaria pill that was first approved in the 1950s and a lot of people with arthritis or lupus use it, that is gotten a lot of attention because President Trump has brought it up time and again throughout March and parts of April I believe. Many studies now have shown that to not be effective in treating COVID-19. There’s also been some research that suggests. It is not effective in preventing COVID-19. So there are still a lot of studies going on for each of these medicines. That is kind of the lay of the land and I think doctors are now kind of trying to figure out the best way to use these. If remdesivir and dexamethasone are both in the toolkit, does that lend itself to a combination of the two? Or, would it be better to treat earlier with remdesivir? If they progress to a later stage then start using dexamethasone? So these decisions of sort of clinical decisions are being worked out in real time just as sort of the clinical research is coming in, which is completely unusual. Normally you have the clinical research happen, the findings are published in a journal, doctors have the time to really study those results, chew them over to bait them internally at medical conferences and among themselves and then they make clinical practice decisions. We have really seen that process eliminated. We see stuff published in a press release now and then the same exact day, it is pressed released, the UK government approves the medicine and says they are going to treat all patients in clinical practice with this new medicine. It’s been fascinating to watch. It is a very fast-moving space and I expect that will only continue over the next months.
Jeffrey: Yes. Now you mentioned you did not think any of these were game-changers. Have you seen anything out there that has caught your eye that might be?
Andrew: I think this is kind of that second bucket. I think the repurposed treatments have a vital role here as their immediate options. Remdesivir, dexamethasone, some of the other treatment theories around IL 6 Inhibitors or Jak Inhibitors. These are immediately available and I think anyone with realistic expectations was hoping for something that could slightly help patients. I think the game changers are going to come from some of these therapeutics that are crafted against the virus based on several months of research, really understanding how the coronavirus works with the spike protein. We have a much better understanding now of antibodies, these virus fighting proteins as far as which ones really help fight the virus, which ones do not do as much. So, these therapeutics are now starting human testing and I think if some of them are successful, they are aiming to be ready this fall, which I think those are kind of the game changers, so you look at antibody therapeutics. These are companies like Regeneron, Eli Lilly, Vir Biotechnology, kind of leading the way with these and starting clinical testing.
Jeffrey: So on one hand, you have some fantastic vaccines. So like polio, mumps, rubella, things that have pretty much wiped out diseases as we know them and then, on the other hand, you have like influenza, which you need the vaccine every year because you get a different strain of flu every year and then you have other diseases like HIV that after twenty years of trying to create an HIV vaccine were unsuccessful. Why are we so sure we can create a successful vaccine for the coronavirus?
Andrew: That is a question I ask a lot of the vaccinologists that I talked with on kind of a daily regular basis and that it is an open question. I mean, I think there is a growing level of optimism the more we learn about this virus, that we will be able to vaccinate against it, that this is not HIV or Hepatitis C which are also RNA-based viruses like the coronavirus. But, something like HIV has some really complicated, this kind of goes above my pay grade, these mechanisms that it uses to kind of adapt to whatever situation it is in. At least from talking with a lot of researchers in the labs with these coronavirus vaccines, they are hopeful and they are not seeing signs like that. They are not seeing these red flags that suggest these efforts just would not work at all. So with that said then the question kind of becomes what level of effectiveness can we get with these vaccines. Are we going to end up with something like the flu market for vaccines where we have a lot of partially effective influenza vaccines and you already see most Americans are well aware of that and I think the vaccination rates for flu are fifty-sixty percent something like that. About half the country does not get flu shots anyways, and if they do it, they are usually partially effective but that kind of has some unique elements too as far as how the flu changes year-to-year and so on. The complicated thing is we do not know. This is a new virus. We will see how it plays out. It is hard to think too much ahead but there are a lot of reasons for optimism as far as there’s one hundred twenty-five plus vaccine research programs ongoing. I think about twelve right now are already in human testing. So this is moving remarkably quick and some really big pharmaceutical companies that have done this before have put forward pretty aggressive timelines as far as saying that they think they could have effectiveness data for a vaccine by maybe as early as this fall, if not early 2021.
Jeffrey: Okay, so if they have effectiveness data, that means that they came out with the trial at the end of this year. They are saying it could be effective, now they have to make it for a billion people or three hundred fifty million in the United States. How is that going to be distributed? Is it going to be a priority list? Is it going to be staggered? Is there any indication of this yet?
Andrew: Well, so recently at least for the US Government standpoint, some Senior Administration officials working on operation warp speed which is the Trump administration’s ambition to get three hundred million doses ready by January 2021, which is a timeline without precedent and vaccine development. It would just be historically quick, but with that said that these administration officials have said that they are planning to use a tiered distribution approach. So, you are looking at vaccinating the elderly people with pre-existing conditions, health care workers, people in roles like that would have a higher tier.
Jeffrey: Thank you so much for joining us today. This has been great.
Andrew: Well, thanks for having me, Jeff. I really appreciate it.
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