All right, let's go ahead and get started. My name is Ashleigh Acker, a Biotech Analyst on Allison Bratzel's team here at Piper Sandler. It's my pleasure to introduce our next presenting company, Immuneering, and I'm not sure, Ben, are you going to go through the presentation?
Yes.
All right.
Yeah.
Welcome, Ben.
Great, well, thank you very much for the introduction. Thanks to the whole Piper Sandler team for having us here, and thanks to everyone for being in the audience, both here in the room and online, and I'm joined by our Chief Medical Officer, Igor Matushansky, Chief Business Officer, E.B. Brakewood, and our Chief Accounting Officer, Mallory Morales, and I'm Ben Zeskind, our Co-Founder and CEO. I'll be making forward-looking statements today, please see our disclosures for more information. Immuneering, our goal is to improve the durability and tolerability of cancer treatments with innovative deep cyclic inhibitors, and I think we're making a lot of exciting progress towards that goal that we've shared really over the past few months.
We've talked about, in September, we talked about extraordinary overall survival data and favorable tolerability in our ongoing Phase 1a study of atebimetinib plus modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer patients, really demonstrating, we believe, the potential for a best-in-class profile. W e'll walk you through those data, but certainly that's very exciting. We have a Phase 3 in first-line pancreatic cancer, and that's expected to begin dosing patients mid-next year. W e're working towards that. Additional Phase 2 combinations we're going to begin evaluating next year as well. And then a preclinical pipeline of deep cyclic inhibitors that we're quite excited about that really use this same approach to try to get at both the durability and the tolerability that I think really are needed in cancer treatments today. And certainly, in the past few months, we've done a recent financing and strategic investment.
We're honored to have great investors, great shareholders, great strategic partners that provide us with runway into 2029 with multiple catalysts along the way and really outstanding value creation opportunities for both patients and for our shareholders. So, as we announced in September, with a cutoff of August 26, 2025, we're seeing really extraordinary overall survival data at nine months in first-line pancreatic cancer patients. What you can see here is 94% overall survival at six months and 86% overall survival at nine months. These patients, we believe, just aren't dying at the rate you would expect, which is really great news. And I think the real question is, how robust is this? Clearly, these are great results, but how robust are they? Do they rest on kind of a shaky foundation, or are they on kind of a solid ground?
I think what you'll see here is it's really quite robust. So, starting with the end, so this is 34 patients. I t's enough to really say something. Let's look at how this compares to what you would expect for a typical standard of care chemotherapy based on the pivotal study. H ere, we're plotting the cross-trial comparison with the pivotal study, the MPACT study of gemcitabine/nab-paclitaxel as the most common global standard of care in first-line pancreatic cancer. It is a cross-trial comparison, take it with a grain of salt. But just to give you a sense of what would be expected, you can see that at six months, with the standard of care, you see about 67% overall survival, whereas we're seeing 94%, a 27-point separation.
And then at nine months, we see 86% overall survival, whereas you would typically expect 47% with the standard of care. T hat's a 39-point separation. Really encouraging to see that separation widening over time. And we believe that's the durability that we've really designed atebimetinib to achieve. I think really this separation with what you would expect from the standard of care, that really lends robustness to what we're seeing. This is not a small difference. It's a big difference. I think what also lends robustness is the 95% confidence intervals. E ven if you want to be an atebimetinib skeptic, even if you want to take the most pessimistic view of atebimetinib that's statistically justifiable, you would take the bottom end of our 95% confidence intervals.
Even there, we see a 10-point separation from standard of care at six months that actually grows to a 19-point separation at nine months. Really encouraging to see that separation. Now, as I mentioned, gemcitabine/nab-paclitaxel is the most relevant comparison because it is the most common global standard of care in first-line pancreatic cancer. It is the type of chemotherapy that we are combining with. There are two other approved standard of care treatments in first-line pancreatic cancer. We think it is also worth looking at the comparison there in terms of overall survival. Excuse me. Here, we are plotting, again, the cross-trial comparison, t ake it with a grain of salt. We are plotting our data for overall survival against the pivotal studies for not only gemcitabine/nab-paclitaxel, but also FOLFIRINOX in green, the PRODIGE study, and NALIRIFOX in red, the NAPOLI-3 study.
You can see, while they're all kind of intertwined, we're clearly separated from all three of them. T he fact that we see this separation not only from gemcitabine/nab-paclitaxel, but from all three of those standard of care treatments based on their pivotal studies, we think lends further robustness to the results that we announced in September. And we're just really excited about it. Now, look, overall survival is the gold standard. Nothing matters more to patients than how long they live. This is typically what drugs are approved based on in pancreatic cancer, and it's the most important thing. W e're thrilled about that. That said, there are a number of surrogate endpoints that people use to kind of try to approximate what the overall survival is going to be before they have it. But they're still helpful to assess the robustness of an overall survival result.
We're really encouraged by what we're seeing on those surrogate endpoints. So, for instance, with progression-free survival, we see 70% PFS at six months, 53% PFS at nine months, again, all as of the August 26 data cutoff. With regard to overall response rate, we see a 39% overall response rate. That's all confirmed. I n June, there were some unconfirmed in there. Now, they're all confirmed. That compares very favorably to the 23% ORR in the MPACT study. We see an 81% disease control rate versus 48% in the MPACT study. And you can see the vast majority of patients have lesions that are shrinking. Now, atebimetinib doesn't necessarily shrink lesions quickly. It's a little bit like the old fable, the tortoise and the hare.
I think some targeted therapies go sprinting out fast, and they shrink the lesions really quickly at first, but then they end up selecting for resistant clones, and the tumor comes roaring back, worse than before after a few months. We really designed atebimetinib to try to counteract that resistance, to really provide durability, w e're very much the turtle. The slow and steady wins the race, and I think you can see that in our spider plots, which I'm mixing my animals here, spider plots of the turtle approach, but you can see slow and steady wins the race. We see tumors that are shrinking slowly but steadily over time, and we think this is really ultimately beneficial for patients because we're not driving resistance in the same way.
It's much better for a patient, particularly with the tolerability that we have that I'll show you in a minute. It's much better for a patient to have a tumor that's shrinking over a very long time, and all that time, they're living their lives thanks to really favorable tolerability that we're seeing so far. I think these spider plots lend robustness to what we're seeing in the overall survival result because they really give you a picture of that long, slow, steady reduction in the tumor that's, I think, translates nicely to the overall survival that we're seeing. I mentioned the tolerability. T ake a look here. I think what's most notable is really there are only two categories of adverse events where we're seeing Grade 3 or higher events in more than 10% of the patients.
It's anemia and neutropenia, both of which are seen with the chemotherapy alone that we're combining with, and neither of which we see in the monotherapy setting, it's really not clear if atebimetinib is adding much in the way of Grade 3 or higher side effects on top of what you would expect for the chemotherapy alone, and this is certainly consistent with what we hear from our investigators, which is that this is generally a well-tolerated therapy. In fact, we've had investigators say in the monotherapy setting that patients sometimes feel almost like they're pre-diagnosis selves, which is really remarkable for a cancer treatment, but that's an important part of the deep cyclic inhibition mechanism, and that was one of our design goals from the start, was really to achieve both durability and tolerability, as I mentioned.
Baseline demographics, our populations were comparable to the populations in the pivotal studies on most metrics, except our patients were meaningfully older. So our median age was 69, whereas the patients in these pivotal studies were in their low to mid-60s. Two-thirds of our patients were over the age of 65, whereas it was half or less in the pivotal studies. T he fact that we're seeing this really nice long overall survival in an older population, I think just adds another layer of robustness to the results that we're seeing. So, as I mentioned, we're planning the pivotal study, the global randomized Phase 3. We've guided to first patient dosed in mid-2026. Overall survival is the primary endpoint. And we're really excited for this trial and what we believe it'll mean for patients. So, of course, the atebimetinib plus the modified gemcitabine/nab-paclitaxel is our top priority.
But we do also have Phase 2 patients being treated with atebimetinib plus modified FOLFIRINOX. This is another option, another chemotherapy that's used in the first-line setting. Generally provides slightly better overall survival, but with a little more toxicity. I t's generally used in younger patients with higher performance status. And then I'll also share a third-line case study from Phase 1. T hese are case studies that we shared in our earnings call a few weeks ago. The data is as of November 3rd, 2025. And this is a patient who came to us in the first-line setting, a 71-year-old female. And what you can see is that the lesion, which is a liver lesion, shrank to the point of being completely resolved, an unconfirmed complete response, again, as of November 3rd. I don't have to tell you that complete responses are relatively uncommon in chemotherapy.
In fact, if you listen to the recording of our earnings call a few weeks ago, you can hear the investigator who treated this patient saying that this is not something typically seen with chemotherapy alone just really encouraging to see that. And the fact that we're seeing these highly unusual outcomes in a totally separate group of patients than the ones in the gemcitabine arm, I think adds further robustness to what we're seeing in that combination. This was a patient at a different center, also on the FOLFIRINOX arm. And this patient essentially was metastatic but had enough really benefit from the atebimetinib treatment that the investigator was able to basically conduct surgery with curative intent. T his patient was able to go to a Whipple, which is not typical to happen once the patient is metastatic, but atebimetinib really made that, we believe, made that possible.
And again, if you listen to our earnings call, you can hear the investigator who treated this patient talking about how unusual this is and really relative to what would happen with chemotherapy alone. And we're thrilled. No radiological evidence of new disease in this patient, again, as of November 3rd. And then just to close us out here, this is another patient from Phase 1 treated with atebimetinib monotherapy. Started out with 18cm tumor burden. And again, you can see the tortoise and the hare. With atebimetinib, the tumor doesn't shrink quickly. It shrinks slowly but steadily over the course of many months, up to 18 months, and more than a 30% reduction in the tumor, complete resolution of a bone lesion in this patient. J ust really encouraging. There's more information if you look at our deck online as to how it works.
Happy to speak with anyone offline about that, but just to kind of conclude here, I think we're really looking to improve durability and tolerability with deep cyclic inhibitors. We've shown extraordinary overall survival, favorable tolerability. Our Phase 3 is moving forward. We plan to dose the first patient mid-next year, and I think with the financing and strategic investment, I've never been more excited about where we are and our potential to help patients with pancreatic cancer and many other types of cancer going forward with that, thank you all.