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spk04: At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. I must advise you that this conference is being recorded today, November 11th, 2021, and I would now like to hand the conference over to your first speaker, Joy Bessinger, Senior Vice President, Investor Relations and Corporate Strategy. Please go ahead.
spk01: Thank you, Operator. Good morning, all. I'm Joy Bessinger, Senior Vice President of Investor Relations and Corporate Strategy for IMB. And I'm pleased to welcome you to IMB's third quarter clinical and operational update conference call. I am joined today by Andrew Hall, our Interim CEO, Dr. Jeremy Graf, our Chief Scientific Officer, and last but certainly not least, Pira Labbe, our Chief Financial Officer. During this call, we will be discussing statements and our business outlook. Any forward-looking statements made today are pursuant to and within the meaning of the Safe Harbor provisions of applicable securities laws. These comments are based on current expectations of management regarding future events and operating performance and should not be seen as guarantees of future performance or results. All forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks are discussed in our continuous disclosure documents filed in compliance with applicable securities laws in Canada and the United States. The press release, the MD&A, and the financial statements have all been posted to our website at imv-inc.com. If you wish to receive a copy of these documents, please do not hesitate to contact us. Please note that we will be taking questions from sell-side analysts only today. And with that, I will now turn the call over to Andrew. Andrew?
spk03: Thank you, Joy. And welcome everyone to IMV's clinical, operational and third quarter results call. I will first provide an update on our corporate strategy. Jeremy will then discuss recent highlights of our clinical, translational and foundational programs, followed by Pierre, who will give a brief overview of our financial results before we take questions. IMV is undergoing a pivotal transition. we are realigning our corporate strategy to focus on IMV strengths and core competencies in immune oncology. First, and with the highest priority, we remain committed to accelerating Maverick PEPMA-S and DPX-MAGE towards registration by confirmation of their clinical benefits to patients. We also look to enhance the value of both products by exploring other therapeutic combinations beyond checkpoint inhibitors and indications supported by our ever increasing understanding of tumor biology. A second leg of our strategy is to leverage the versatility and unique mechanism of action of the DPX platform. The goal here is to develop a comprehensive portfolio of immune educating therapies that are improved by the combination when in formulation with DPX. We see this as a plug and play model in which we may in license a program, strengthen it, and then return it to the collaborator for further development. The third leg of our strategy is to enhance our technology platform to enable therapeutic combinations beyond peptides. Our recently announced collaboration with Medicago is an example of this. We're in collaboration. We will evaluate the combination of their VLP technology with our DPX platform to confirm enhancement of the therapeutic profile. This collaboration and others to be announced will confirm the value DPX creates when combined with VLPs, mRNAs, small molecules, and even protein therapeutics. The final part of our strategy is to actively monetize our non-immune oncology programs. So to focus IMV exclusively in oncology. This shift of focus will be supported by an increased foundational research effort and peer reviewed strategy led by Jeremy. In the coming months, we will continue showcasing our science at scientific congresses and through publication to demonstrate the robustness of our platform's mechanism of action, as well as the safety, efficacy, and importantly, durability of our clinical candidates. Building on the clinical data and transformational information we accrued this year, we are initiating trials that will take our lead compound forward towards registration. So with this clarity on strategy, we also strengthened our management team with two experienced industry professionals. Joey Bessinger, who introduced this call, joined IMV as Senior Vice President, Investor Relations and Corporate Strategy. And Dr. Heather Hirsch joined IMV as Vice President, Translational Research. Both Heather and Joey are US-based. Heather from our new office in Cambridge. Her background in translational analysis and her expertise at CRISPR, Johnson and Merck will certainly help our research and importantly business development footprint in the Boston area. We are pleased with our recent progress. We've enhanced the versatility of our DPX delivery technology and continued the validation of Mavarapipmin S in patients with advanced recurrent ovarian cancer and with relapsed and refractory DLVCL. I'll now pass the call over to Jeremy to dig a little deeper into the scientific progress we've made. So I'll pass it to you, Jeremy.
spk02: Thank you, Andrew. I want to take a few moments to focus on the DPX delivery platform. As Andrew has indicated, It allows us to contemplate products that are both centered on oncology and on non-cology therapeutic opportunities. Our focus, to reiterate, is on our strength, which is immuno-oncology. But let's talk a little bit about this unique immune-educating therapy, DPX. What we mean by that is we are able to pack the staked cargo within the DPX delivery platform to instruct a very specific immune response. In the case of our lead product, Mevra Peppermute S, The cargo we've packaged are the antigenic peptides from the tumor protein, Survivan. Survivan is almost universally upregulated in advancing cancers, including diffuse large B-cell lymphomas and advanced recurrent ovarian cancers, and provides a very powerful target for this immune-educating therapy. We have demonstrated with this lead product clinical benefit in multiple indications. You know about the advanced recurrent ovarian cancer clinical benefit that we've recently reported. You know about diffuse large B-cell lymphoma. Other indications are clearly showing us clinical benefit as well. Importantly, all of this clinical experience in now more than 300 patients has provided for us an exceptional safety profile. When we think about the versatility of the DPX platform to educate an immune response to any particular cargo, we can recognize that we have had a history with infectious disease agents. And I think the most important of those projects was the DPX RSV program. That program actually advanced through a phase one study and showed immune responses that lasted more than a year after vaccination. It is incredibly important to recognize that the DPX platform drives specific immune responses and immune responses that persist across time. That persistence is essential to getting clinical benefit. As Andrew mentioned, the DPX platform can deliver multiple cargo, including messenger RNAs, small molecules, virus-like proteins, virus-like particles, and whole proteins. I think it's important also to recognize how DPX-based delivery is different than other lipid nanoparticle technologies. In our case, DPX is a lipid in oil formulation that creates a very distinct uptake by the immune system. In addition, we know that this product is easy to manufacture It is relatively cheap to manufacture. It is lyophilized and does not need cold chain storage like other vaccine approaches. It is very stable. The lead product, mebrapepamut S or MVPS, has a five-year stability. So there are a lot of commercial advantages to the DPX-based platform as well. Let's talk about the advantage that the DPX packaging provides for educating an immune response. On the left-hand panel of this particular slide, we're actually interrogating whether DPX, when compared to a conventional emulsion formulation, does a better job at educating and inspiring an immune response, a T-cell specific immune response in this case. You see the graphic represents SFUs. Those are spot forming units. Those reflect T-cell reactivity. On the left-hand portion of the left panel, you see when we package peptides to the mouse surviving protein in a conventional emulsion formulation, those peptides do not do a very good job at activating T-cell reactivity. You see very few spot-forming units. By contrast, if we take those very same peptides and package them in DPX, this is now the right-hand side of the left panel, You can see a robust increase in spot forming units or T cell reactivity. We can similarly look at a humanized mouse model. This is a mouse model that's built to reflect one of the HLA antigens from humans. We can therefore use the actual clinical product, Mavropepamute S, in this setting. see very clearly in the first bars that when we use the DPX-Survivac or MVPS product, we get a very robust T-cell response. When instead we package those very same human peptides in the conventional emulsion or CE-Survivac package, we do not get that robust T-cell response. We also see this reflected in the clinic. The peptides we've packaged into the Mavropepamute S product are actually peptides we licensed from Merck KGAA. In Merck's hands, with those particular peptides, they reported that 14% of their advanced cancer patients showed a surviving specific T cell response. In our hands, in advanced cancer patients, we now show nearly a 65% T cell reactivity. Importantly, we see defined clinical benefit across multiple cancer types in our clinical history, as reported in the Lennertz et al publication, They were only stable disease. So we know both from preclinical work and we can look at clinical work to assess that. In fact, the DPX platform using the very same peptides is more capable of instructing a specific and durable immune response than if the same peptides were packaged in a conventional emulsion formulation. This week. We'll release a poster at the Society for Immunotherapy of Cancer, a very important conference for anyone in the immunotherapy of cancer field. The data that will be released are from our phase two recurrent ovarian cancer patient trial, DECIDE-1. And what we show in this is a continued data set providing evidence that we are infiltrating the tumor with both activated T and B cells That's critically important for an anti-tumor response. We show that benefit in patients is more obvious in those who already had some limited immune response to their tumor to begin with. And we now also begin to recognize potential mechanisms of resistance in patients who do not get benefit from mevropepimutase. We expect, ultimately, that the translational data from the ovarian cancer trial, this DECIDE trial, as well as the clinical data, Allow us to design a trial that we're actively in the midst of designing now so that we can start this trial next year. I want to also update our relapsed refractory diffuse large B cell lymphoma trial. The trial name is Vitalize. It is an open label study. We initiated this trial earlier this year at multiple sites. It is designed to evaluate the combination of mebrapepamute S with Merck's Keytruda plus or minus intermittent low dose cyclophosphamine. The protocol is ultimately designed to confirm we think the eye-popping overall response rates we saw in the SPIREL trial. In that trial, patients who were PD-L1 positive at entry showed nearly an 87% objective response rate. So this trial is designed to help us appreciate that therapeutic efficacy in this very advanced diffuse large B-cell lymphoma population. As I said, multiple sites are activated in North America. We're screening patients now. We expect to be able to talk about the first results from this trial in the middle of next year. I next want to focus on the next product. Andrew had mentioned, of course, the DPX SIRMAGE product. What's intriguing about this product is this is our first foray into combining peptides to two different tumor-specific proteins, the SURVIVAN protein and now the MAGE A9 protein, both of which are commonly upregulated in bladder cancers. In preclinical data that were released at the recent EORTC conference, we were able to show that both in an acute phase and a chronic phase, we can generate specific T-cell responses to both tumor antigens. So this delivery technology is able to build a more diverse and we think robust immune response to cancer. We expect that this is now the springboard to a trial we begin with these investigators in bladder cancer, by the year's end. So let me review where we are with our immuno-oncology portfolio. You know DLBCL has initiated this year and we are anxiously awaiting first patient into trial. That is a combination with Keytruda in partnership with Merck. We are taking the translational and clinical data from our recently completed ovarian cancer trial to decide to formulate the right trial design to take forward into next year. We will shortly release what I think are pretty exciting data from our basket trial in combination with Keytruda. We are now beginning to screen and initiate patients in a breast cancer neoadjuvant trial. This is a partner trial with Providence, with the Providence Center. It allows us to interrogate deeply tumor tissue from breast cancer patients who overexpress, survive, as part of the means by which the tumor evades the efficacy of aromatase inhibitors. We're very excited about that trial and its imminent start. We're very excited about it because it allows us to look more deeply into exactly what immune education by DPX means. And lastly, as I spoke of with bladder cancer, we expect to begin a trial in non-muscle invasive bladder cancer here by the end of the year. With that, I'll turn the presentation over to Pierre. Pierre?
spk00: Thanks, Jeremy. Good morning, everyone. First, I would like to remind you that all our numbers are in U.S. dollars. During the third quarter, we completed the $25 million financing, which gave us the runway to reach the key milestones Jeremy just discussed and take us through the end of the third quarter of 2022. We are also very excited by the fact that we opened our U.S. corporate offices in Cambridge in August, which will serve as an early footprint to expand our U.S. presence in the scientific community with potential collaborators, but also, most importantly, with investors. quarter of 2021, we incurred a net loss and comprehensive loss of $10.4 million or $0.30 per share, which compares to a net loss of $5.4 million or $0.08 per share for the same quarter of last year. The increase in loss is mainly explained by an increase in R&D expenses of $700,000 and a $2.5 million for the G&As. The increase in R&D spending was due to start-up costs for the Phase 2b vitalized trial in DLBCL, an increase in manufacturing and development costs for Mavropepimet S and DPX Cermage, and an increase in headcount. This increase was partly offset by a decrease in development costs for the preclinical development of our DPX COVID-19 following our shift in strategic focus. For G&E expenses, the increase of $2.5 million in Q3 2021 is largely due to an increase in salaries and non-cash stock-based compensation associated with planned hiring and also changes in executive leadership, foreign currency loss, and an increase in legal, professional, and recruitment fees. As of September 30th, 2021, we had $36.5 million of cash, and as previously mentioned, Based on our current plan, we expect that this cash position will be sufficient to fund operations through the end of the third quarter of 2022. As of September 30, 2021, the number of issued and outstanding common shares was 82 million, and we also had a total of 16 million stock options, ESU, and warrants that were outstanding. Please note that the financial statements for the three and nine months period and the September 30th, 2021, and the related MD&A are available on CDAR and on NDR. Thanks for your attention. And I will now turn the call back over to Andrew for his closing comments before the Q&A session. Andrew.
spk09: Andrew, you may be on mute.
spk02: Pierre? Yes? Perhaps I'll take this upcoming oncology milestone. Sounds like we're having some technical difficulties. So to reiterate what we said before, and I think to really affirm the milestones that are upcoming, for DLBCL, we expect to be able to release the first results from this important clinical trial in the middle of next year. For bladder cancer, I think from our combination studies in the basket trial, you'll see a clinical update that we think is very exciting by the end of the year. For MSI-HI, Cancers as well, very intriguing signals that we'll update in December. And then, of course, we're working on the ovarian cancer trial to design our way towards registration based upon the success we've had in the phase two recurrent study to sign. Lastly, the breast cancer trial with our partners at Providence, we think we'll be able to release the first results from the clinic soon. in the middle of next year as well. And then finally, we will be looking at our second product in a trial of non-muscle invasive bladder cancer. That trial should start by the end of this year. So we're very excited about these upcoming milestones. And as Pierre indicated, we think we certainly are doing well to be able to accumulate these data within the appropriate timeframes. With that, I think we can begin to take questions and answers.
spk04: Thank you, ladies and gentlemen. We will now begin the question and answer session. As a reminder, if you wish to ask a question, please press star and one on your telephone keypad and wait for your name to be announced. You can cancel your request at any time by using the hash key. And once again, it is star and one if you wish to ask a question. And your first question comes from the line of Brandon Fawkes of Cantor Fitzgerald. Please go ahead.
spk05: Hi, thanks for taking my questions and congratulations on the progress. Maybe just one for me. Can you just elaborate on your expectations around timing of when you expect to meet the FDA to finalize the design for the ovarian cancer trial? And then just it'd be great to hear your updated thinking on the patient population and trial design there. Thank you.
spk02: Andrew, are you back with us? Do you want to take that or do you want me to take it? Sounds like he is still not maybe back with us due to technical difficulties. So, Brandon, this is Jeremy. I think what we're in the midst of doing is designing the trial to account for what we need to do to go forward. We expect to be able to submit that trial to the FDA, the final protocol to the FDA, later this month or early next month to get approval and get feedback from the FDA on our path forward. The patient population, I think, was your second question. If you recall, our Decide 1 patient population was a mixed population of platinum-sensitive, resistant, and refractory patients. Now, we had clinical benefit in all three of those types of patients. But as we carry this forward, we want to look more towards registration. The path to registration involves working in patients who really have run out of options. So these are the platinum-resistant patients in particular.
spk05: Great, thanks. And one more, if I may. Just on the realignment you talk about, is this something you expect to maybe take a couple months, or is this something we should think about as a continuous ongoing process going forward? Thank you.
spk02: So the realignment to focus on immuno-oncology, I think that's what you're referring to. That is something we're actually in the midst of doing now. It's very easy with the versatility of the DPX platform to contemplate vaccines in a number of different therapeutic areas. And historically, the company has done that. I think what we recognize now is as we drive Maverick Peppermute S more deeply into the clinic, as we initiate our second immuno-oncology product, we have to focus on what we do best, which is immuno-oncology. That gives us, though, an opportunity to partner out our infectious disease programs and to partner with our platform to help enable immune education for other therapies that maybe didn't work so well. That is, in fact, the story of our lead product. The Merck KGAA surviving peptides didn't show clinical benefit did not drive a robust T cell response in more than 14 or so percent of the patients tested in advanced cancer settings. Those same peptides packaged into DPX have shown a different story. We get defined clinical benefit in multiple cancer types in advanced cancer patients, as well as patients who are not as advanced. We get activation of T cells in 65% of our patients routinely. And that's what our translational story has told us. So the focus on immuno-oncology And the ability to try to monetize the other programs, the infectious disease programs, is happening now and will continue to mature over the next few months.
spk05: Great. Thank you.
spk04: Thank you. And your next question comes from the line of Joe Tempat-Linis from HUN. Ben White, please go ahead.
spk08: Everybody, good morning. Thanks for taking the question. First, obviously, you guys, you've got a lot of activities ramping up at the company, and you guys are quite busy. So I guess I wanted to focus on the manufacturing readiness, you know, what you have, what you still need to do, or you're all set to go for all the different studies you're looking at.
spk02: Yeah, Joe, I think this is a great question. Andrew, if you come back in with the technical difficulties, feel free to chime in, but I can handle this too. Joe, I think it's important for us to recognize that we drive Maverick Peppermute S forward. We have to seek a commercial-ready vendor. We're doing that, and we expect here in the not-too-distant future to be able to show first batches from that commercial-ready vendor sometime maybe in the middle of next year. Currently, we have enough inventory for the product we've been working on to fulfill the needs that we have for the clinical program that we've laid out.
spk08: Got it. That's very helpful. And then, actually, Jeremy, as part of your prepared comments, I want to link. your comment on the DECIDE data where you said, obviously, that the best T cell responses came from people that had some, or patients that had some underlying baseline immune responses against the tumor. So I want to link that to, you know, your overall goal to look at additional combinations beyond checkpoints or anti-PD1s, I should say. You obviously have a little bit of a tease there with the aromatase inhibitor for the breast cancer study, but I guess, you know, what sort of approaches are most exciting to you that could potentially even include patients that don't have an underlying baseline immune response that, you know, you could have a good combination that could increase things like epitope spread and further immune responses. Sorry for the long-winded aspect.
spk02: No, it's a very good question. Andrew, do you want to take that or do you want me to jump in with that one?
spk03: I would love for you to jump into that, Jeremy, and apologies to everyone. It seems that technology jumped in the road of answering the back half of the question. Jeremy, please take it.
spk02: Yeah, Joe, so I think there are a lot of different ways that we want to leverage the translational data. The translational data are the data that help explain for us exactly what our product is doing. As you pointed out in the DECIDE translational data, we're seeing our best clinical efficacy in patients that had some modicum of an immune response to begin with. That's not atypical for immunotherapies, as you know. Keytruda really works best in patients that generally have some level of an ongoing immune response. When we think about our DPX platform, we think about not only the antigenic peptides that instruct a specific response to a specific tumor target, in this case, survival, but we also recognize that within that platform, we have components that activate and educate an innate immune response and that pull into the the fray, a response by CD4 helper cells. We think that kind of larger, more comprehensive response amongst more than just CD8 T cells is critical for clinical efficacy, and we think there's plenty of room for us to look at those components and understand whether or not we can leverage different aspects of those components to drive a different type of response. It's a bit of a vague answer to your question, but if you think more specifically, There are lots of different ways, for instance, to activate innate immunity. Those ways may be things we could package into DPX going forward. With existing products that we might combine with, you can certainly recognize that with some cytotoxics, you get a more fulminant immune response because they kill tumor cells and release antigens, so you can get more of the antigen spreading you're talking about. So our mechanistic understanding of our product allows us to contemplate combinations beyond checkpoint inhibitors that might include anti-angiogenics, Anti-angiogenics have a strong effect, for instance, in opening up the tumor microenvironment to the influence and infiltration by activated immune cells. You can imagine combining with perhaps other cytotoxics, and you can imagine combining with emerging immunotherapies that work on different checkpoints than the PD-L1 checkpoint. Does that help, Joe? Got it.
spk08: It certainly does. Thanks a lot, guys.
spk02: Yeah, no problem.
spk04: Thank you. And your next question comes from the line of Nick Abbott of Wells Fargo. Please go ahead.
spk06: Good morning. Thanks for taking our questions. First one, Jeremy, you know, you've teased us a little bit with a statement, something like release pretty exciting data from the basket study shortly. So have you and Merck made decisions, go-no decisions for the bladder at MSI, you know, stage two and about a cellular stage one? the tumors at those decision points?
spk02: We have certainly been discussing with Merck the data from those. We have not yet, I don't think, made definitive decisions, and that's what we hope to be able to walk through here shortly so that we can communicate more fully what the exciting data from the basket trial look like. Andrew, do you want to?
spk03: Yeah, thanks, Jeremy, and hi, Nick. The current state is the conversations with Merck are at a near point of precipice where we will be able to share publicly the information from this trial. The question that we're working through is what happens next? How do we then move everything forward in a way that's positive with respect to both the collaboration and to the assets involved? So it was a tease set intentionally, and we do look forward to communicating that information in the very near future.
spk06: Okay, thanks. That's a very interesting way of putting it. Anyway, so my next question is that it sort of goes back to some of this translational data from this site. I get that, you know, if you have an inflamed tumor, you're more likely to respond immunologically. So are you On the other side of it, you're driving an immune response with NDPS. So do you have cases where you get a strong immune response to the vaccine, yet that's not translated to clinical benefit because it's, you know, the tumor doesn't have that inflamed phenotype, and so you're not able to get those T cells into the tumor? Or do you need that level of existing, preexisting inflammation in order to get a strong immune response to NBPS.
spk03: That question can go straight to me.
spk02: I think you meant straight to me, Andrew. You might be bowing out again, technically. So, Nick, I think it's a very interesting question. We certainly see in the majority of the patients' dose of mebrapetamide S that we are generating a specific survival-specific T cell response. We now also appreciate that that response we're creating more stimulation with a wider array of immune cells, which leads to, we think, a better overarching effect. Now, it is also true that we can create T cells that we can see in the periphery, in patients who ultimately don't show us clinical benefit. And I think you'll recognize very readily that there's more to clinical benefit than just creating a survival-specific T cell response. As you noted, oftentimes the microenvironment in different patients or microenvironmental differences between lesions within different patients creates a barrier even to the most robustly activated T cells that they simply can't penetrate. So our current data really reflect that where patients have already infiltrating T cells, in other words, where the microenvironment is already conducive to the influx of activated T cells, that's where we have our greatest benefit now. But to the point I think that Joe may have asked earlier, we think there are ways that we can we can tweak the DPX platform going forward that would allow us perhaps to have a greater impact upon that immunosuppressive tumor microenvironment. That would certainly not be for MVPS, but for a later product.
spk06: Yeah, yeah, that makes sense. So just maybe building on that then, so this initial confirmatory trial, you wouldn't be selecting patients based on you know, tumor inflammation, for example.
spk02: No, we wouldn't. We will be, if you will, homogenizing the patient population to be the resistant patients where we have seen a very profound clinical activity.
spk06: Okay. The platinum resistant patients. And then last question. I mean, it goes back, I guess, to the you made about in-licensing, adding value and then returning the asset. Do you have a, I mean, I'm sure you do have a preferred strategy, but is the goal here really to generate near-term revenue? So, for example, you almost do this at risk, you meet set criteria, and then you return the asset for near-term revenue, or are you seeing this as an opportunity to participate in upside from this new, the enhanced product, either just from royalties or even commercialization of the product? Or is it a mix of all the above? How do you, I guess, what are the next, what are your initial objectives from this program?
spk03: And thank you for the question, Nick. Before I get too detailed in the answer, can I confirm that you can hear me?
spk06: I can hear you, yes. I don't know about anybody else.
spk03: You can hear me, good. Okay, sorry for the technological difficulties. The answer to the question is in the short term, we would be looking to create non-dilutive revenue through this mechanism. So the idea of bringing a product in for a short period of time improving it and then transacting that product back to the originator with perhaps improved therapeutic potency or improved therapeutic tolerability. But it is in the short term, I think, a mechanism of us creating a revenue stream that's non-diluted. In the long term, and you can look at and you know all of these examples, but a number of other companies have taken this model forward where some assets they may selectively, we may selectively hang on to to fulfil it a deeper pipeline of clinical assets. And the flexibility we believe that we have by the versatility of the platform, Nick, provides us an opportunity to very quickly turn this sort of strategic vision into a near-term reality, and then a long-term strategy to fulfill a deepening of IMV's therapeutic presence. And it's something that we and Jeremy's team particularly are building out at a very, very effective speed to turn very quickly.
spk06: Thank you.
spk04: Thank you. And your next question comes from the line of Paul Stewartson from IA Capital Markets. Please go ahead.
spk07: Good morning. Just calling in for Chelsea. Thanks for taking my questions. I'm just wondering if you have any update on the hepatocellular carcinoma enrollment progress since you opened up the eligibility a little bit. Is that something that we're going to be able to see stage one in December?
spk03: So, and thank you for the question, Paul. So the increased or the broadening of the availability certainly increased the recruiting speed of the hepatocellular carcinoma arm of the basket trial. We still are not at a point where we have achieved stage one for that particular grouping. However, we have seen data that is encouraging in that space. We would not want to commit to the publication or the presentation of that data publicly because we don't have the full complete data set. I will ask Jeremy to maybe comment with a little bit more clarity on the details there.
spk02: No, I think, Andrew, you've answered the question well. I don't think stage one there is truly complete, so I think it would be premature to release those data within the next month.
spk07: Okay, I appreciate the color. And just in terms of, you know, looking at the patient stratification options out of the translational data that you guys had from DecideOne, in terms of these metrics like, you know, CD3 positive, CD8 positive, T cell infiltration, Is that something that you're able to do what you could do in DLBCL with a companion diagnostic? Or is this, you know, obviously it's not as well characterized as something like, you know, PD-L1 expression. But what are kind of the options for patient stratification there?
spk03: Thanks, Paul, for the question. I'll let Jeremy add extra detail, but it's not going to be as elegant as DLBCL. There is no PD-L1 separator in ovarian cancer, as everyone that's explored this field over many, many years knows all too well. What we're really encouraged about is the response we're seeing is somewhat predictable. We're seeing it in a certain subtype of population that we are confident will inform our trial. Now, whether or not that turns into a stratification criteria or a criteria that we can subselect patients for, I think we need more trials with more information to better elucidate that effect. But we are really encouraged by the predictability of clinical response for a subtype of patients in a disease that, frankly, in that refractory and resistant population is non-responsive to a huge amount of therapies that have been trialed there. Jeremy, do you have a comment?
spk02: Yeah, I think, first of all, Paul, I think it's a great question. I think we want to understand if there are ways to reinvents patients who are most or presence in tumor tissue ahead of time might be a difficult companion diagnostic, but it certainly helps us to understand where we see response. By contrast, as Andrew indicated, if you've got PD-L1 positive patients, for instance, in our DLBC1, DLBCL trial, that ring fences of population is very, very responsive to the therapy. So I don't think that we'll be able to take the CD3 and CD8 as a companion diagnostic, but it is incredibly informative information for us. It helps us to package what we need to package for the trial and to focus on the patients that are seeing the greatest benefit from our DECIDE trial and that that includes of course the platinum resistant patient so it's a great question but cd3 cd8 as a pre uh as a pre-marker if you will for inclusion would be a difficult i think a difficult cdx to develop yeah yeah that yeah that makes sense um glad to get the confirmation there thank you guys and one last one for me if i may um just in terms of
spk07: You know, the resistance pathways, it's great to see those data and kind of look at a little more granular on how that functions. You know, I'm just curious, you talked a little bit about what the translational data means from the activity side for possible combinations. Could you talk about the resistance side? Are there any agents that come to mind? I don't think there are any Wnt inhibitors that are approved, but the pathways that you saw showing up. Do you see any, you know, obviously this is a bit conjecture down the road, but do you see any possibilities for early kind of, you know, combo targeting of any sort of blockade on the resistance pathways?
spk02: It's a great question, and Andrew, I'll handle this, and you can stack on top of it if you'd like. But, you know, as we look at the Wnt pathway, that certainly seems to be more active in patients that don't get benefit. That's not surprising. We know the Wnt pathway is an immunosuppressive pathway. But I think if you're looking for actionable targets there that might help reverse that inherent resistance that a tumor would have, you might look at CD276, our translational team. as a type of immune checkpoint. It's upregulated in the patients who are not getting benefit. So there are very early stage therapies against 276, certainly not from us, but from other folks that are developing these therapies. It's possible to contemplate down the road that we might take our MVPS in combination with such a checkpoint inhibitor. That might open up the landscape of MVPS benefit to a greater population. Does it make sense?
spk07: Yeah, absolutely. I really appreciate the insight there, Jeremy. Thanks, guys, for taking my question and congratulations on the progress. Thanks, Paul.
spk02: Thanks.
spk07: Cheers.
spk04: Thank you. And your next question is a follow-up from Nick Abbott from Wells Fargo. Please go ahead.
spk06: Hi, Trevor. Thanks for taking the follow-up. And the first one is on to say, you know, as a basket, there were a couple of ovarian cancer cohorts in the basket trial that obviously did not meet the high bar set at the end of stage one. Are you able to look at learnings from those cohorts as well? Or rather, are you looking at learnings from those cohorts as well as you think about the next trial in ovarian cancer? And then I have a follow-up. Thanks.
spk02: Yeah, I'll take that. Sure, Jeremy, go ahead. I think we're looking at learnings from all of the basket trial arms, in particular the ovarian cancer arm because i think that provides insight for us you know in that case the basket trial was run in a number of different cancer settings with pembrolizumab pembrolizumab has really never gotten a foothold in ovarian cancer and and effectively that's what we see as well so we're trying to understand ovarian cancer in the basket trial, how that differs, what the patient's profile before treatment, maybe if we've got samples after treatment, what that looks like, so that we can package that together. So you're spot on with what we're trying to do because it helps frame the way we think about MVPS in ovarian cancer. Andrew, did you want to add to that?
spk03: So your statement is better than I would make, Jeremy, but just to say that the tissue we collected in that basket trial is obviously going into the fulminant translational investigation we're doing and it is part of the findings and encouraging, I would say, that we're seeing the same kind of predictability in this data set as we've seen in other data sets. So it's not as if it's in any way translationally flying against what we've seen in the DECIDE trial.
spk06: Okay, thanks. And then because I guess from what you saw and decide, then you would expect to see enhanced clinical activity in patients who had baseline inflammation, tumor inflammation for the titrative combination, the PEMRA combination.
spk02: Yeah, I think that's a reasonable assumption. That's part of what we're looking at. We're also looking at, you know, how, how What kind of T-cell reactivity do we get in those patients? We see that universally, that we activate survival-specific T-cells in any patient, really. With MVPS therapy, we're looking at the persistence of that response. There are all sorts of reasons, of course, as the immune system is corrupted in advanced cancer patients, that things may not work. And so we're trying to appreciate that, not only in the BASCA trial, but in every trial that we run. And you'll see, in fact, that all of the trials going forward We'll have an even stronger and heavier translational component so that we can crystallize what we need to learn about this product on our marks to registration.
spk06: Okay, thanks. And then just the last one from me, just going back to the sort of in-licensing assets. Have you in-licensed one of those yet? And if not, do you intend to communicate with investors when you do?
spk03: We have not yet enacted the strategy, Nick, but we are deep into conversations. And obviously, when we can make that public, we will look forward to doing that.
spk06: Okay. Thanks, Andrew. That's all from me.
spk03: Thanks, Nick, and thank you, everyone, and apologies for the small technological challenges in between the transcript and the question and answers. I'd like to close the call just by restating that our goal at IMV is clear. We're increasing shareholder value. That's our number one focus, and we're going to do that by building foundational science with the DPX platform and then by achieving milestones in a timely and predictable fashion. You can see we're leveraging our platform to create improved therapeutics. You can see we're building Maverick Pepman S towards registration, as well as exploring new indications and combinations. And we're committing to communicate this information set through peer reviewed vehicles, such as scientific meetings and publications. More importantly, We're seeking licensing opportunities for our non-oncology programs. We are focusing the organization into oncology so that we have a discipline and execution that is at least equal, if not leading across the industry. Thank everyone for your time today. I thank you for listening in and have a lovely rest of your Thursday. Cheers, everybody.
spk04: Thank you, ladies and gentlemen. That does conclude your conference for today. Thank you for participating, and you may now disconnect.
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