Luca Issi: Maybe on IMT, I think you’ve been highlighting the opportunity adjuvant and neoadjuvant settings. However, I wonder if you could comment on what’s the plan in the metastatic settings, is there a place for IT to metastatic settings? And maybe related to it, are you planning to update the metastatic head and neck cancer data set that we have seen at 2021? Any color there much appreciated.
Stephen Hoge: Great. Thank you for this question. So I think we do think that INT can go both earlier and later in terms of its use. And it’s a challenging question about which one do we prioritize in the short term. I think there’s a huge opportunity we perceive, we believe, in adjuvant. That is where you hear all of our current activities. That’s our focus. That’s where we’re trying to move into pivotal studies, very, very quickly Phase 3 studies. But if you look to adjuvant, we do have adjuvant experience. You pointed to the head and neck data. We also have from our Phase 1 to management melanoma, there’s actually some adjuvant — sorry, the metastatic melanoma, metastatic non-small cell lung cancer. And I think situations where we think the burden of the tumor, the size of that tumor is a little bit of a barrier to the potential active activity of any immune therapy.
In fact, generally, immune therapies have struggled in later-stage disease and where the real power of the technology, its safety tolerability profile, potential benefit probably is upstream. So while we are following closely the metastatic space and we did see some intriguing signs in the metastatic head and neck study that you referenced, we are right now waiting for a little more data to decide whether or not we want to go into those metastatic settings in the short term with our partner, Merck, of course. The other area that I referenced is the earlier stage. And so Stage 3, Stage 2 disease, disease where immune therapies are not traditionally used right now, but we’re a well-tolerated approach like INT that we believe does provide a boost of specific T cell responses against the cancer may have a unique benefit.
And again, that’s a place that we’re eager to explore the INT approach with our partner mark in the very near term. We don’t have at the present as substantial an effort going into those two areas, but we could pivot very quickly. So for now, what we’re focusing on is the pivotal studies in adjuvant, we’re watching very closely the evolution of our data in metastatic, and we’re trying to think about how we could move whether biomarker enabled or otherwise into earlier-stage diseases. I’m sure we will find ways to explore all of those areas if there’s a potential for benefit for INT and then it’s just now a matter of working down the opportunities as fast as we can.
Luca Issi: Fantastic. And maybe if I can follow up. When is the earliest that you can have the COVID plus flu combo potential in the market?
Stephen Hoge: I’ll comment very quickly, but the combination vaccine — so the first point is we want to need to get the flu approved. I think in the Vaccines Day, we talked about our expectations, our hope are to have the COVID-flu combo approved and launched in 2025.
Operator: One moment for our next question. Our next question comes from Geoff Meacham with BoA. Your line is open.
Alec Stranahan: This is Alec on for Geoff Meacham. So given the breadth of your clinical pipeline and the potential opportunities for new vaccines, how does Moderna prioritize assets or indications to go after? Once the data has, let’s say, proof of concept for its line disease, what is your clinical strategy in terms of targeting additional bacterial indications? And then just finally, how are you thinking about capital deployment for the INT program?
Stephen Hoge: I’ll take the first question. I’ll take all three, I think, but I invite my colleagues to Kevin. So — so first on how we think about opportunities. It’s a great challenge we have. We’re obviously seeing a very high success rate as we transition into patient populations or pivotal studies across our pipeline. And the short version of it is we look for places where we think our technology through its modalities is well validated. And so we have a highly differentiated probably success in that next indication and where there is a large unmet need in that indication. If there’s a large unmet need medically, there is usually a large unmet need financially in terms of health care systems, and that’s ultimately the kind of value we want to deliver into it.
So that’s how we approach it. That can be infectious diseases. That’s how we think about expanding our respiratory franchise. That’s how we’re thinking about expanding our latent franchises. That’s how we’ve established POC there. And what you’re going to be seeing us do in rare diseases, as we are already doing, is that same sort of expansion as we start to see proof-of-concept in the rare metabolic disease space. And then, of course, you asked a question about INT and maybe I’ll just jump to the third part of your question, which is how do we think about capital allocation in terms of in INT. There are very few things that have a larger burden of disease, social cost of financial costs of obviously morbidity and mortality than cancer. And we do believe that INT has the potential to be a transformational treatment in that space.
And so we got to figure out how to do is how do we responsibly, but aggressively grow that investment across a range of different places where we believe that INT will work. Now we have one significant advantage in that exercise, which is we have a partner in Merck, who has a high degree of conviction around this as well as we talked about, and we are co-investing with them. And so from a capital allocation perspective, we start together looking at what are the indications where there is an opportunity, unmet need in oncology with INT. As I said before, big focus right now is in adjuvant, but of course, we’ll be looking at metastatic and earlier stage disease as well. Last question, I think I’ll address is the middle one, which is how do we think about line POC and what does it unlock in terms of bacteria.
I think we’re very keen to address Lyme because of the unmet need associated with Lyme disease, particularly in the northern — in Europe and the United States. But it is a very interesting one for us to demonstrate a bacterial — antibacterial vaccination, we already have a substantial discovery pipeline looking at other bacteria that if we can demonstrate proof of concept in line that we will bring forward very quickly. I won’t provide updates on those specific targets as that is still preclinical research. But you rest assured, our approach in bacteria will look like our approach in respiratory or latent or INT or rare diseases, which is as we see proof-of-concept. We will double down quickly with other programs that we think have high probability of success.
Operator: Thank you one moment for our next question. Our next question comes from Simon Baker with Redburn. Your line is open. Simon, your line is open. You can ask your question. Do you want me to remove some from the queue?
Lavina Talukdar: Yes, you can go to the next question. It will be our last question. Thank you.
Operator: Thank you. One moment for our next question. Our last question comes from Hartaj Singh with Oppenheimer. Your line is open.
