This story is republished from STAT, the health and medicine news site that’s a partner to the Globe. Sign up for STAT’s free Morning Rounds newsletter here.
MADRID — Moderna CEO Stéphane Bancel had every reason to be smiling and happy on a brilliantly sunny Saturday afternoon here in Spain’s capital. In a couple of hours, a decade of the Cambridge-based company’s research — boosted by a partnership with Merck — was going to culminate in the presentation of the first Phase 3 study to successfully demonstrate that a customized mRNA-based therapy called intismeran could improve outcomes for patients with melanoma.
“It’s an amazing feeling,” he told STAT from the sidelines of the European Society for Medical Oncology annual meeting. “We’ve been working on intismeran for 10 years. Most people in the field thought this was never going to work, and many people had tried cancer vaccines before. But we were convinced, so it has been really special to be able to see all this work by so many people coming together to help patients.”
In a wide-ranging interview, Bancel spoke to STAT about what’s next for intismeran, and how the drug’s success impacts the company’s R&D and business strategies. The conversation has been condensed and edited for clarity.
Where were you when you got the news about the intismeran study?
I was with a friend for his birthday. I have a very close friend who had a rapid onset of dementia, and it was his birthday. I was with him when I saw the phone ringing from David [Berman, Moderna’s chief development officer]. So I stepped out into a private room to go hear from David.
It was great. It was great. Like you, I’m sure, I have lost close people in my life to cancer, and so after 15 years at Moderna, 10 years in oncology, getting to a place like this means a lot.
For Moderna, the successful study outcome is a big step toward securing the approval of its first drug. The company was founded on the idea that mRNA could power drugs and vaccines. The latter you’ve done, the former has taken a lot longer.
It was always clear to me that mRNA was going to work for nothing, or a lot of things. The notion that it was going to only work for one or two vaccines made no sense to me. We needed to figure out the path, a bit like climbing a mountain without dying.
For me and for us, there was a sense that we cannot be the company who believes in mRNA but fails the world because we messed it up. If we didn’t take the right path scientifically, and we ran out of money because investors pulled the plug, but mRNA should have worked, that would have been on us. That was always petrifying to me, and it’s why we built the portfolio the way we did, with vaccines, cancer, rare diseases and autoimmune diseases. It was a way to de-risk, because we didn’t know what we didn’t know.
You suffered setbacks on the drug side, and there were doubters. With intismeran, do you feel vindicated? Is this Stéphane Bancel’s moment to say, ‘I told you so’?
No, truly, because I’m not wired like that. I care about patients. As you know, I don’t have to work, but I still work as hard as I’ve ever worked because what we do is really important for people and families. We have a rare disease [study readout] coming by the end of the year, so it’s going to be also a very important data point. So, I don’t spend any time thinking about whether I was right or wrong. I’m just thinking about what we need to do next for patients.
You’re here in Madrid to see the presentation of the intismeran data, but what comes next?
In melanoma, first, we’re working really hard — we started mid-August — with the Merck team to file the BLA [biologic license application] with the FDA. We expect this to be available for patients through an approval in 2027.
When do you and Merck expect to complete the FDA submission?
There’s no update. We’re working as hard as we can. Both companies have deprioritized other projects so that we can get more talented people to work on the filing, so that we can go as fast as we can.
And then, in terms of non-melanoma data, we should have renal cell carcinoma data at the end of the year, or early next year.
Moderna, from a business perspective, has been volatile. As everyone knows, you developed a Covid vaccine that generated billions of dollars in sales and delivered huge profits. The stock price soared. But then Covid sales fell, profits disappeared and Moderna was left with huge expenses and a plunging stock price. More recently, you’ve undertaken significant cost reductions to get spending under control. With all that said, is intismeran’s success another transformative moment for Moderna? How does it change the company?
We have to be really thoughtful about each of the businesses we are in, and they require different things. We’re going to stay very disciplined on infectious disease vaccines because we have to make that business profitable.
Intismeran is a very different ballgame. As soon as we had the data in August, our first step was to raise money because we need to study it in a lot of different places, just like Merck did with Keytruda. We know the clinical impact in the Phase 3 study is real and big, so we need to go and be aggressive. We need to explore the biology. There will be some risk, because it’s not going to work everywhere.
And in rare diseases, as you mentioned earlier, your lead drug, mRNA-3927, is in a Phase 3 study for propionic acidemia, with a readout at the end of the year. What is Moderna’s rare disease business strategy?
We’re going to wait for the signal at the end of the year. We’ve had kids on study now for three years with very good outcomes, so I’m cautiously optimistic. But again, it’s biology, it’s a Phase 3 study, so we’ll wait for when we have the data. And then we need to decide what we do from there, do we work more with partners or not?
You already chose to outlicense mRNA-3927, for propionic acidemia. In January, you sold the drug to the Italian drug maker Recordati. Why?
The Recordati decision was very simple: They already had a relationship with the doctors taking care of those children with propionic acidemia. Is it better for the world if we invest $70-$80 million to build another sales force to go see the same doctors? Or, should we invest that $70-$80 million into R&D and try to get another drug for the world?
For each of our businesses, we’re going to try to be thoughtful about the competitive landscape, the return on investment, the risks, and then we’re going to manage those businesses more discretely because they are very different.
I have to ask you about Moderna’s stock price, which soared sky high after the August announcement about the intismeran success. There are a lot of investors who believe the company’s current valuation cannot match even the most bullish intismeran sales forecast. Any comments?
The stock price has never been our meter for success. We see it as a consequence over time. We’re very big [Warren] Buffet fans in a sense. The market in the short term is a voting machine. In the long term, it is a weighing machine. Last year when our stock was at $33, I bought stock because options were expiring and I thought this is crazy. So, we always look at the long term. Where will the stock be in six weeks? I have no idea. But over time, I’m convinced that as we bring a lot of new innovation, as we drive value, the stock price will follow.
With everything you said about being aggressive with the intismeran opportunity, is Moderna now more of an oncology drug company and less an infectious disease vaccine company?
I still see us as an mRNA platform company, which is what we were on Day 1. Our job is to work on the science, and I’m going to tell you what we’re doing to keep moving — we’re going to figure out how the technology pieces work together to enable a medicine.
We’ve always had the same belief, and now we’re proving it, which is making the first medicine of a kind is really hard. Sometimes it takes you 10 years, but then the second, the third, and the fourth, because mRNA is information, you can go very fast with much lower risk. So, we want to keep figuring out where we can use mRNA to help people.
And where might that be?
The next big frontier we talked about last June is autoimmune disease. We have quite a number of programs. A crazy idea is could you use intismeran to teach T cells how to go and eat the bad B cells and really cut off autoimmune diseases at the knee?
With AI and robotics, we are also building a kind of flywheel for lipids to learn much faster than we did in the first 15 years of the company. We still don’t know how to take mRNA into the kidneys or into the lungs, or into the brain. We think there’s a very big white space of things that we think mRNA can do. We want to figure out how to do it. We know it’s doable.
It’s a question of time and computers and resources to get there. I have no idea if it will take another year or another five years of research, but we owe it to patients and society. The day it works, we can do a lot of mRNA medicines that cannot be done using recombinant biology or small molecules.
Stéphane, thanks for your time.
Of course. Thank you.