Moderna will apply ‘same intensity’ for cancer vaccine as it did for COVID, CEO says

In this article:

Moderna CEO Stéphane Bancel speaks with Yahoo Finance's Anjalee Khemlani about the company's MRNA skin cancer vaccine trial with Merck and the pipeline for producing cancer vaccines.

Video Transcript

ANJALEE KHEMLANI: Welcome back to Yahoo Finance Live. I'm Senior Health Reporter Anjalee Khemlani. A potential vaccine for some forms of cancer showing promise following a study and is heading into additional testing. The breakthrough announced by pharmaceuticals Moderna and Merck just this morning.

The preliminary trial is a result-- results are a breakthrough both in mRNA technology and cancer. Joining us to discuss this CEO Stephane Bancel of Moderna. Stephane, thank you so much for joining us today. Pleasure to have you back on.

STEPHANE BANCEL: Thank you. Good morning. Thank you for having me.

ANJALEE KHEMLANI: So let's talk about this really exciting morning for you-- less than two years after you proved the mRNA concept, you now prove again potential further uses of it. Tell us about this breakthrough with the skin cancer personalized vaccine with Merck.

STEPHANE BANCEL: Sure. So as you know, we built this company believing it would be either a failure or a company with a lot of drugs. It made no sense to us scientifically this would be a one-drug company, because mRNA is an information molecule. And so we're very excited today, first, for patients to bring this incredible new clinical data.

What we did is because of the advance in the medical field is we wanted to test the hypothesis at the time-- could we teach your t-cell in your immune system how to recognize the cancer, your cancer, that they were missing? And so we say we need to run a big experiment in the clinic to test-- again, the best drug in the market gets you drugs from Merck, and to see can we do better or should we go home.

And so we did a very Moderna trial, which it was powered-- meaning enough people to know a true answer. It was randomized, like a good study should be done. And the control arm was Keytruda. What we showed this morning is we showed a 44% reduction of risk of recurrence of cancer or of death-- that's [INAUDIBLE] drug. That's a hazard ratio of 0.56.

That is higher than my best expectation. And we know it's real. Why? Because the P value of the study is very, very low. It's 0.0266-- very, very low. So it's real.

So what is exciting for us is we're going to go very quickly into a phase III to get this drug in melanoma to patients as fast as we can. But what's even more exciting to me is we've proven the mechanism that Moderna's mRNA technology can teach cancer patients' t-cell how to recognize cancer. So what does that mean? That I believe this should be used in many more cancers.

And so we are working with Merck to look at what are all the other cancers we should run directly phase free in parallel, like Merck did way back then in Keytruda, to try the technology in many, many more cancers because we think the mechanism should hold. And that's why having a strong balance sheet-- we have $17 billion of cash-- is amazing at this moment, because we're going to invest in many, many trials in cancer, many billions of dollars of R&D, but also invest in manufacturing so that we can build plants around the world to deliver in just a matter of weeks a drug just made for your cancer.

ANJALEE KHEMLANI: Yeah, let's talk about that because, obviously, you have a partner now. You started off with the COVID vaccine alone and building out that infrastructure, including for manufacturing. And so now, you're looking at a partner with Merck which has invested $250 million in this, but is going to be sharing as well on the profits.

And you're also taking charge of that manufacturing yourself. So how does that fare differently? And what are you looking at ahead in terms of timeline with all of this on your plate?

STEPHANE BANCEL: Sure. So we partnered with Merck because of Merck's leadership in immuno-oncology. Keytruda is an amazing drug, is a wonderful thing for patients, but it doesn't work for everybody. And so the question is, how can you combine it with Moderna's technology, have a better outcome for patients? That's what we shared this morning.

So with Merck, what we're going to do moving forward is share the R&D costs for all the phase III we're going to do, which are going to be many of them and it's going to cost several billion dollars to run all of these over the next coming years. We're going to set up the manufacturing piece to make a personalized product because it's very different than to make very big pot of money like we did for the COVID-19 vaccine.

We need to make a lot of little quantities for every patient, a different product for everybody. And on the commercial front, we'll share the cost and the profit will be shared 50/50. So it's just part of Moderna's platform coming into music. We have now around 40 vaccines that are in development-- infectious disease vaccine.

Today, we announced a big pillar in oncology with Moderna- with really amazing data. I think this is like immunotherapy. 2.0-- the checkpoint, the PD1, PD 111.0, but I think it's a new revolution in immunotherapy. We share that R&D day in September very promising data in rare genetic disease in the liver of kids.

We have cardiology data up to phase II innovation program. And yesterday, our partner, Vertex, announced that the FDA gave them a green light to go into the clinic to test mRNA inhaled for cystic fibrosis as a start, but we could use that technology in health for other respiratory disease. And so the [INAUDIBLE] platform is really coming together. And we're very excited for what it means for patients.

ANJALEE KHEMLANI: Absolutely. Talk to me about that-- the market. Because you're looking at, to your point, you have partners for other products in your pipeline. Merck is a huge partner, has many indications for Keytruda-- so you have a lot of opportunity there. When do you anticipate you're going to start investigating this personalized cancer vaccine in some of the other indications?

STEPHANE BANCEL: So we want to start as early as '23. So we're currently working with Merck to first start up the phase three for melanoma, for which we have a phase two data that came out this morning. And we are working with Merck to prioritize what are all of the tumors we want to go into with this combination of Keytruda and Moderna cancer products? We will communicate those results as soon as we have it in some of our plans.

We will also publish the data, but we are already getting full speed. What I told our team when we get the data, I told the team it is like January 2020 COVID-like moment for Moderna. Meaning we know we have the technology. We have great data. The enemy this time is not a virus, it's cancer.

And I want us to go with the same intensity, the same level of investment, and the same rigor to save everything that we can to launch to do something as impactful for patients as we did with COVID-19. So many people are impacted by cancer today, and so every day matters to get those indications to commercialization to make sure people around the world can benefit from this amazing medical breakthrough as fast as possible.

ANJALEE KHEMLANI: Yeah. And just to clarify for people that don't know, this is being provided to patients or given to patients in combination with Keytruda after surgery. And that's why it gets that vaccine indication, right? What about earlier stage? And what about pre-cancer? Are we looking at moving in that direction? Does this set the stage for that?

STEPHANE BANCEL: So pre-cancer, not with this current approach because we need the tumor to be able to sequence it and to read where are you mutation of your cancer. But you're right-- we can go earlier in cancer type. We can also go later in terms of metastasis, potentially. We could potentially try where Keytruda does not work, because maybe Moderna and Keytruda together might give some results for patients.

So there's a lot of opportunity to try here. And again, we're going to be quite aggressive in trying a lot of things in cancer, because the safety profile is very similar to Keytruda alone, which is another big breakthrough that we're not talking enough about. As you know, in immunotherapy, a lot of combination drive a lot of toxicity issues. But the safety profile is very similar to Keytruda alone.

We shared at ASCO, the big oncology conference, a few years ago, a very good safety profile. It's exactly the same technology as [INAUDIBLE] so when you think about it from a medical standpoint, it's quite amazing. It's the same chemistry to make the mRNA. It's the same chemistry for the lipid around it. And it's the same manufacturing process. So this is where you see the power of a platform playing out here.

ANJALEE KHEMLANI: Yeah. And I know that you made a name for yourself with looking at clinical trial diversity. I'm assuming that you're going to look at that as well. But also, I wonder about how you're planning on moving ahead when it comes to the targeted population. Are you planning on advancing some of that clinical trial focus?

STEPHANE BANCEL: 100%. So if you want-- now today, the good news is because the technology we adapt for every cancer, we can go after a lot of different variety of cancers. We might also look into earlier things that are very, very early. So it's just things we're going to explore is can you go into liquid biopsy to start looking for cancer cell and cancer signal way before you even have a way to diagnose it with other technology?

Because as soon as we have a cancer cell, we can design the product for you. You just need the one. And so there's a lot of things with breakthrough technology in diagnostics space, in sequencing that will enable us to do better. Therapies, too, that we should not forget is this is Moderna 2019 technology.

We have made a lot of progress. So we want to incorporate that new technology-- we're updating the operating system into the product. So could we even do better than what we shared this morning? I think it's possible.

ANJALEE KHEMLANI: Absolutely. Well, we'll have to keep an eye on that. And certainly, I know it's too early to talk about this, but also on that price target. So we'll see how that all pans out. Thank you so much-- Moderna CEO Stephane Bancel.

STEPHANE BANCEL: Thank you.

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