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Moderna times & China’s future: a BioCentury podcast

Nov 17, 2020 | 2:36 AM GMT

Now that Moderna and partners BioNTech and Pfizer have set the bar for efficacy in COVID-19 vaccines, what’s next for the rest of players in the hunt? On the latest edition of the BioCentury This Week podcast, BioCentury editors discuss what the data mean, what the likely timelines are, and what the read throughs could be to other vaccines. They also discuss “China speed” and other takeaways from a survey of Chinese biopharmas conducted by BioCentury and BayHelix and discussions by panelists at the BioCentury-BayHelix seventh annual China Healthcare Summit.

Washington Editor Steve Usdin, who covered the data and its implications for Monday’s issue of BioCentury, argued that as Moderna Inc. (NASDAQ:MRNA) and BioNTech SE (NASDAQ:BNTX) and Pfizer Inc. (NYSE:PFE) gear up to seek emergency use authorization for their respective vaccines, new data about temperature stability give Moderna’s mRNA-1273 vaccine a “huge advantage” over BNT162b2.

Usdin and Executive Editor Selina Koch discuss the impact that the trials may have on other vaccine trials: Will companies be able to persuade people to enroll in these studies when they know that there are highly effective vaccines that could soon be authorized, or will they be compelled to study their vaccines in South America and other countries outside the U.S. and Europe?

Editor in Chief C. Simone Fishburn notes that one of the things she heard repeatedly last week from industry is that the BioNTech-Pfizer readout elicited “a huge collective sigh of relief.”

“I’m not actually sure that the public really realized that industry wasn’t even sure it could make a vaccine; there’s never been one against coronavirus before,” she said.

Fishburn says that the biopharma community is in broad agreement that “if these vaccines work the others will because it’s the same science behind it.”

That allows companies to think tactically, she says, for example, by trying to differentiate based on side effects, logistics, subpopulations, and/or dosing. 

“Companies can now start to think in terms of does it prevent transmission? Can they improve with one dose versus two? Can they go into subpopulations?” Fishburn says, adding that “in all cases, you need to be providing something in the next vaccine class that is not just efficacious for 90%.”

Koch adds: “I think these differentiation factors you're both pointing out will become more important over time.”

Turning to the China survey, Fishburn says a key takeaway is that China is not waiting around for the West to “get comfortable with the idea that China is going to be a big player in biopharma.” Chinese biopharmas believe that they will be able to lean on China’s investors for the cash they need to fund their growth; however, the companies are likely going to continue to kick start their pipelines via in-licensing assets from West as their homegrown products mature.

“A year in Europe is like a month in China,” Sofinnova Partners’ Antoine Papiernik said on a China Healthcare Summit panel to discuss the BioCentury-BayHelix survey. As a result, the rate at which the U.S. and European biotech ecosystems developed may not translate to China, where the flood of money from private and public markets has given innovators the firepower they need to rapidly build pipelines and take products to market.

A transcript of the episode follows.

[00:00:00] Jeff Cranmer: A week after BioNTech, and Pfizer release very promising interim data for their COVID vaccine, Moderna this morning has unveiled its first interim phase III data that looks very good. Welcome to BioCentury this Week, I'm Jeff Cranmer, Executive Editor at BioCentury, and I'm joined by

[00:00:25] Selina Koch: Selina Koch, Executive Editor.

[00:00:27] Simone Fishburn: Simone Fishburn, Editor in Chief,

[00:00:30] Steve Usdin: Steve Usdin, Washington Editor,

[00:00:31] Jeff Cranmer: Thanks for joining me guys. In addition to digging into the Moderna data, today we'll discuss the key takeaways from a survey of Chinese biopharmas conducted by BioCentury and our partners BayHelix. We'll also dig into some comments by panelists at the BioCentury BayHelix 7th China Healthcare Summit about what the Chinese biopharma landscape might look like in five years.

[00:00:59] But first, it's the talk of BioTwitter, mainstream press you name it Moderna's data is out today. What do the data mean, what are the likely timelines, and what are the read-throughs to other vaccines. Steve, you've been covering this since last night?

[00:01:16] Steve Usdin: Yeah, and this morning with a press call that featured an all star cast Tony Fauci, Francis Collins, Stéphane Bancel, the CEO of Moderna, and some others. I think everybody's familiar with the top line data that Moderna released based on their interim analysis their mRNA vaccine was 94.5% effective. Importantly there were 11 severe cases of COVID and they were all in the placebo arm. Tony Fauci said on the press call this morning, that both the Moderna and Pfizer vaccine readouts far exceeded his expectations, and that they vote very well for other vaccines that are based on viral vectors, or soluble protein technologies that Operational Warp Speed (OWS) is backing in the United States.

[00:02:01] Selina Koch: So I think a really interesting question a lot of people have said the window for testing other vaccines might be closing then as EUA approaches for these first two, what do you think about that Steve?

[00:02:12] Steve Usdin: So they talked a little bit about the big issue of unblinding of the patients who are in the Moderna, and the Pfizer vaccine trials. Basically said that they will have to be unblinded at some point. At the earliest it could come would be when the EUAs are issued, which I think is likely to be toward the end of December. But it could be delayed until the vaccines are widely available to the public, and that's likely to be sometime in the March, or April time frame. So those trials are going to be completed the Moderna, and the Pfizer vaccine trials will be completed as expected. The real question is what impact is that going to have on other vaccine trials. Is it going to be possible to persuade people to enroll in trials of other vaccines when they know that, that there are highly effective vaccines that have already been authorized. It's still an open question, my feeling is that any of the phase III trials that have already started or that are going to start very soon in the United States have a very good chance of being completed. But that it's going to be really problematic to do any vaccine trials after that. There was some discussion on the call this morning Tony Fauci suggested some alternate designs that they might for future vaccine trials randomize participants to get either one, or two doses of a two dose vaccine, or that they might do non-inferiority trials. I think that non-inferiority trials are really not going to happen because they would have to be enormous, and that's not going to be feasible. The one dose versus two dose thing seems also very problematic to me.

[00:03:57] Selina Koch: And one other avenue I guess they didn't discuss is whether or not companies who are a little further behind might just take their trials to a different country where there's not an EUA yet. I know some are focusing in on South America.

[00:04:10] Steve Usdin: That's definitely a possibility of getting foreign data, yeah.

[00:04:14] Simone Fishburn: So I think just to take a step back, one of the things I heard a lot last week is actually from the industry point of view this is a huge collective sigh of relief. I'm not actually sure that the public really realized that industry wasn't even sure it could make a vaccine , there's never been one against coronavirus before. And so I think what this does is it actually now changes it a little bit more like what you started to think about Steve which is tactical -- first of all deployment, but also advantages that one vaccine might have after another. It seems very likely everybody agrees that if these vaccines work the others will cause it's the same science behind it. And it means that the virus is amenable to immunization against, alter protection against which remember hasn't been done for coronavirus before. So I think that what that means is that companies can now start to think in terms of does it prevent transmission, can they improve with one dose versus two, can they go into subpopulations? The question about going to other countries, they can definitely do that to enroll. But in all cases you need to be providing something in the next vaccine class that is not just efficacious for 90%.

[00:05:32] The other thing I want to say is talking with people I had a podcast actually also with Mene Pangalos from AstraZeneca last week. Industry is not dialing back on this, nobody really believes that once you get the vaccine you then aren't going to need any of the other things. There's still going to be people who can't take the vaccine, some who won't take the vaccine, there's still a need for therapies. There's a sort of expectation that until this is really... I'm going to use your word clobbered from one of your stories Steve, until this is really clobbered pharma's do not want to take their foot off the gas on this.

[00:06:06] Steve Usdin: One other thing I want to bring up from today's data that was really important also is the Moderna's done stability testing that shows that their vaccine can be stored for 30 days in a regular refrigerator, and for 60 days in a freezer at temperatures that every hospital and actually every house in the United States has. That's a huge advantage over the Pfizer vaccine that has to be stored at minus 80 degrees C, and I think it's going to be a differentiating factor. The other thing that's going to be a differentiating factor for all of the vaccines I think is going to be the adverse event profile. So Moderna presented data that suggested that none of the adverse events associated with their vaccine were really serious, they didn't put people in the hospital. But a large number of people had adverse events on the second vaccination that were really unpleasant, and I think that would keep somebody at home in bed for a day or two.

[00:07:04] Simone Fishburn: And that actually speaks to the two sides of the tactical thing because individuals don't care how it was shipped right, that's the company's problem. But if you've got individuals who actually have a choice, you know would you take Moderna's now if you're going to get a potentially bad reaction and be laid out for two days. Or would you rather wait a couple of months for a vaccine that won't do that you don't care how it's shipped. The companies and the government whoever ends up distributing it that's a big deal for them. So that's sort of what I meant about with now you're trying to get differentiation or advantages based on not efficacy, but all the other bits that go with it like side effects, logistics.

[00:07:41] Steve Usdin: The other thing that's going to be huge, and I don't know whether it's going to be differentiated among the different vaccine candidates, is going to be duration of response, it's something we're not going to know for some time. But obviously if any of the vaccines can differentiate themselves favorably by providing a longer duration of response that's going to be huge also. And we don't know from the business standpoint whether all of these vaccines are going to be a one shot proposition like they are for example you know with a smallpox vaccine, or are they gonna be seasonal vaccines like influenza vaccines, or are they going to be more like the chickenpox and shingles vaccine where you get a vaccine at one point and then you need to get a booster some years later. And that's going to have enormous implications commercially and practically

[00:08:38] Selina Koch: I think these differentiation factors you're both pointing out will become more important over time. When I try and envision the early days of rollout say March, and April when these first two start to become available, I don't know how much the differentiation will matter then. Because I still think we're going to have a scarcity of just doses. And I think you know wherever you are you're going to get the one that's available to you there right?

[00:09:00] Steve Usdin: That's exactly right, that's what they said on the call this morning. Matt Hepburn from Operation Warp Speed (OWS) somebody asked him whether people are going to be able to choose between the two vaccines, and he said "that's very unlikely".

[00:09:11] Simone Fishburn: I agree Selina.

[00:09:12] And the companies themselves I want to be very clear, the companies are not at least publicly talking in a competitive manner at all, they're really talking in an additive manner. Good, we'll get you know Pfizer's CEO tweeted congratulations this morning to Moderna, as I said AstraZeneca was delighted actually with the news. I do think that the next efficacy shoe to drop though will be... the bar has been set for these other modalities, it is still technically possible that adeno virus or other modalities don't hit the 90%. And this is actually more of a validation of an mRNA strategy. Steve, I think you've talked about the fact that there's more than just these two mRNA vaccines out there actually. So there could be some change we've seen there, would you rather take an mRNA one at 90%, yes, if the other ones come in at 75%.

[00:10:02] Jeff Cranmer: What are the expected benefits of these other modalities, for instance say they're not as efficacious what might they offer?

[00:10:10] Steve Usdin: The big thing is that J&J is testing a single dose vaccine. That would be a huge advantage. In the United States it would be a big advantage. In developing countries where it's difficult to get to people, and it's difficult to track them, and remind them to come in for a second dose and so on... it would be an enormous advantage.

[00:10:30] Simone Fishburn: I agree, I think that's about it. At the beginning of this or halfway through this coronavirus period we would have said that the mRNA vaccines have never been in people before, and so safety might be a differentiator. But obviously we're hoping for maximal safety on these ones and that there isn't a difference on that front.

[00:10:49] Jeff Cranmer: Steve, one question for you more on the political side: the Trump Administration hasn't participated in some of the global initiatives to guarantee a certain amount of doses of vaccines for developing countries. Do you expect a change from a Biden administration in terms of playing nicely in the sandbox?

[00:11:11] Steve Usdin: Absolutely. I've been in touch with two people who are on the COVID-19 task force, on Biden's COVID-19 task force. And they couldn't make an absolute commitment because nobody can until the transition has happened. They both said that they absolutely expect that the Biden administration will. Well one they've said that they're going to rejoin the World Health Organization, and two that they're going to participate in the COVAXX facility, and three that they're going to make some vaccine doses available outside the United States earlier in the distribution. They're not going to follow through with the Trump Administration's plan, which was basically to say that not one drop of vaccine leaves the United States until every single American who wants it gets it.

[00:12:01] Jeff Cranmer: And then practically speaking for these two vaccines what are the next steps, are they headed to an FDA advisory committee, and when might that be?

[00:12:13] Steve Usdin: So the next steps are that both of them are waiting to accrue the median of two months of safety data. What Moderna has said is that by the time they have the two months of safety data which they expect to come in the, "to be in the coming weeks" is the expression they used. They will also have hit the 151 events that they need to complete the trial. I think the same thing's likely to be the case for Pfizer. I would anticipate a joint advisory committee meeting to review both of these vaccines. It's possible that FDA will decide to have two separate meetings, but I can't imagine why they would do that. So I think that we're likely to see that in December, and then I think we're likely to see an Emergency Use Authorization (EUA) decisions for both of them in December, or at the very latest early January.

[00:13:02] Jeff Cranmer: All right, last word on this Selina?

[00:13:05] Selina Koch: Oh I was just curious if the strength of these data are going to be enough to overcome the sort of vaccine hesitancy out there, what will the demand be like?

[00:13:17] Simone Fishburn: I think we don't know that. I'm actually more worried at the beginning when I think you'll have people rushing, fighting to get the vaccine. There's a lot of people willing and anxious to take the vaccine who will suck up those first doses. I do imagine in this country, and in other countries that huge education campaigns around it, I have heard one person talking about the current plans not really being well-designed to go into the minority communities in places that also in particular needed. And that will need to be part of the strategy from the get go.

[00:13:55] Steve Usdin: That's something that the Biden team is really well aware of, and they're talking about strategies for example going into African American churches in the South of the United States and things like that.

[00:14:06] And the interesting phenomenon if you look back at the H1N1 vaccine is that when it was in shortage there was tremendous demand to get it. And then as soon as it was widely available, people were like nah maybe we don't need it. And they didn't actually use up all of the doses that they have manufactured. I think we're in a different situation now because COVID-19 is so much more deadly. Maybe the very high efficacy of this vaccine also will reduce some of the pressure for having a massive vaccination. If these vaccines provide sterilizing immunity, which is to say that somebody who gets vaccinated then can no longer transmit the disease to someone else. Then you would be able to achieve herd immunity with somewhat lower levels of immunization than you would need with a less effective vaccine.

[00:15:00] Jeff Cranmer: That would be wonderful. All right, thanks for your thoughts guys, moving on.

[00:15:05] Last week, BioCentury and BayHelix wrapped up the live portion of our 7th Annual China Healthcare Summit. It's the first time we've done the event virtually which means there's still time to register, and view the content which is excellent! It includes, McKinsey's Annual Biopharma Report, with exclusive data on the China market and where it is headed for investors. And it also includes an IP panel on the new China patent amendments and what they mean for both China biotechs and Western biopharmas doing business in China. Now this panel gives you the rare chance to hear from the former top IP judge in Beijing. All sessions are available until December 11th, and you can register it Coming out of this we ran a survey on the outlook for China biopharma, and the biopharma ecosystem in the years ahead. One quote that resonated with me especially as an editor at BioCentury, came from one of our panelists antoine Papiernik, who is managing partner at Sofinnova Partners he said "A year in Europe is like a month in China, we see this in every sector." Simone, what were the key takeaways of the survey?

[00:16:30] Simone Fishburn: Right, well thanks Jeff. First of all acutally I should just say it was not coming out of it but actually going into the conference. We did this survey ahead of time and then discussed it with some of the panelists. Actually you know what Antoine said resonated with the entire rest of the panel who reinforced that. And it is really shown by the responses in the biotechs, who we asked to say what they think the China biopharma landscape will look like in five years time. And the bottom line is China is not waiting around for the West to get comfortable with the idea that China is going to be a big player in biopharma. They are aggressively moving ahead, these are incredibly, motivated, energized innovators there. I think they are pretty optimistic, they feel like even though right now China, until now I should say Chinese companies have been thought of as mostly doing me too's, or biosimilars.

[00:17:29] If you look at what we've called the money magnets, and we did some analysis of this and we call them "money magnets" -- companies that have raised more than a $100 million in the last seven years actually since the thing began. So if you look at the top companies they believe -- almost overwhelmingly -- they believe that they will be working on first in class, or at least fast followers in five years time that's going to dominate the landscape. More than 50% of them think that innovative biologics will be bringing more revenues than biosimilars, about a third or just on the 30% think there'll be equal, and you know only 20% think that biosimilars are gonna still be ahead. My might take home is really two parts of this, on the one hand China has a lot of money in the China ecosystem. And the biopharmas think that they are overwhelmingly think that they are going to be able to fund their own growth. So they think that either China led syndicates, or China only investors 96% of the respondents thought that most of the VC funding was going to come from there. They're not waiting for the U.S. VCs or the European the game. And 90% of them plan to be going to China VCs to get involved.

[00:18:40] They are however much more expecting to be dependent on the West for licensing deals. And these sort of fall into two strategies here broadly speaking. On the one hand they expect in-licensing mostly to come from the U.S., and they are looking to in-license late stage assets so that they can kickstart their pipeline, bring in revenues, and then use that money to fund development of their own innovative pipeline. And then on an out-licensing basis they are looking to go to the West they are planning to prioritize worldwide rights, because many of them just don't have the basis really to market to commercialize worldwide. So there is still a sort of dependence on the West in that way.

[00:19:28] One thing other than that in terms that I thought was really interesting was Christian Hogg of Chi-Med, he said eight years ago they did a deal with AstraZeneca on one of their compounds, and that molecule is now in registrational trials. They decided to partner with them but they wanted to take it forward themselves. He said their employees, their investors, no one put up with that kind of a timeline anymore, no one's going to go into a deal if they think it's going to take them eight years to get one of the top assets to registration. There's just a lot more, emphasis on speed. Yeah, so I thought it was both ambitious and optimistic view from China biotechs.

[00:20:06] Steve Usdin: Just one thing really quick from the panel that I did about the outlook in Washington, the consensus there was that U.S. Policy toward China toward inward investment from China into the United States, and toward export controls to China is not likely to change soon in the Biden administration.

[00:20:27] Simone Fishburn: And that does actually relate to IP reforms, and regulatory reforms in marketing reforms in China. A lot of these have been making a lot of headway and there's still a feeling that they have some ways to go. Really the emphasis of IP reforms and regulatory reforms was pretty evenly split on what was most important. But I think that there's certainly some way to go in terms of aligning expectations for IP, and regulatory control between the West and China.

[00:21:00] Jeff Cranmer: All right, that's all we have time for this week. You'll find this story complete with all the data on our website, as well as Steve's story which he is still building out with more intelligence on the vaccines. That one is in front of our paywall.

[00:21:14] All of our podcasts are available at our website, Spotify, Stitcher, Apple, and Google.

[00:21:20] Music for all of our podcasts is provided by Kendall Square Orchestra, which connects science and technology professionals and other members of the greater Boston community to collaborate, innovate, and inspire through music while supporting causes related to healthcare and education.

[00:21:41] We'll see you next week.

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