Ladies and gentlemen, thank you for holding and welcome to the IMV Inc. Q3 2021 earnings call. 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 one on your telephone. I must advise you that this conference is being recorded today, November 11, 2021, and I would now like to hand the conference over to your first speaker, Joy Bessenger, Senior Vice President, Investor Relations and Corporate Strategy. Please go ahead.
Thank you, operator. Good morning, all. I'm Joy Bessenger, Senior Vice President of Investor Relations and Corporate Strategy for IMV, and I'm pleased to welcome you to IMV's third quarter clinical and operational update conference call. I'm joined today by Andrew Hall, our Interim CEO, Dr. Jeremy Graff, our Chief Scientific Officer, and last but certainly not least, Pierre Labbé, our Chief Financial Officer. During this call, we will be discussing statements in our business outlook. Any forward-looking statements made today are pursuant to and within the meaning of the safe harbor provisions 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. With that, I will now turn the call over to Andrew. Andrew?
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's strengths and core competencies in immuno-oncology. First, and with the highest priority, we remain committed to accelerating Maveropepimut-S and DPX-SurMAGE 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, where 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. With this clarity on strategy, we also strengthened our management team with two experienced industry professionals. Joy Bessenger, 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 Joy are U.S.-based, Heather from our new office in Cambridge.
Her background in translational research and her expertise at CRISPR, Janssen, 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 Maveropepimut-S in patients with advanced recurrent ovarian cancer and with relapsed and refractory DLBCL. I'll now pass the call over to Jeremy to dig a little deeper into the scientific progress we've made. I'll pass it to you, Jeremy.
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-oncology therapeutic opportunities. Our focus, to reiterate, is on our strength, which is immuno-oncology.
Let's talk a little bit about this unique immune educating therapy, DPX. What we mean by that is we are able to pack distinct cargo within the DPX delivery platform to instruct a very specific immune response. In the case of our lead product, Maveropepimut-S, the cargo we've packaged are the antigenic peptides from the tumor protein survivin. Survivin 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, now in 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 to a phase I 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, Maveropepimut-S or MVP-S, has a five-year stability. 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 survivin 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, Maveropepimut-S, in this setting. We can see very clearly in the first bars that when we use the DPX-Survivac or MVP-S 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 packaged into the Maveropepimut-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 survivin-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 Lennerz et al. publication, they were only stable disease. 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 II recurrent ovarian cancer patient trial, DeCidE1. 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 antitumor 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. We now also begin to recognize potential mechanisms of resistance in patients who do not get benefit from Maveropepimut-S. We expect ultimately the translational data from the ovarian cancer trial, this DeCidE trial, as well as the clinical data, will 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 maveropepimut-S with Merck's Keytruda plus or minus intermittent low-dose cyclophosphamide.
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. 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-SurMAGE product. What's intriguing about this product is this is our first foray into combining peptides to two different tumor-specific proteins, the survivin 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. 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. 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, DeCidE1, 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 Cancer Institute. It allows us to interrogate deeply tumor tissue from breast cancer patients who overexpress survivin 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. 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?
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 a $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.
For the third 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 $2.5 million for the G&A. The increase in R&D spending was due to startup costs for the phase IIb VITALIZE trial in DLBCL, an increase in manufacturing and development costs for Maveropepimut-S and DPX-SurMAGE, 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&A 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 30, 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, DSUs, and warrants that were outstanding. Please note that the financial statements for the three- and nine-month period ended September 30, 2021, and the related MD&A are available on SEDAR and on EDGAR. Thanks for your attention. I will now turn the call back over to Andrew for his closing comments before the Q&A session. Andrew? Andrew, you may be on mute.
Pierre?
Yes.
Perhaps I'll take this upcoming oncology milestone.
Okay, great.
Sounds like we're having some technical difficulties. 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 we think is very exciting, by the end of the year. For MSI-High cancers as well, some very intriguing signals that we'll update in December. Then, of course, we're working on the ovarian cancer trial to redesign our way towards registration based upon the success we've had in the phase II recurrent study design.
Lastly, the breast cancer trial with our partners at Providence, we think we'll be able to release the first results from the clinic in the middle of next year as well. 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. 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 time frames. With that, I think we can begin to take questions and answers.
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. Once again, it is star and one if you wish to ask a question. Your first question comes from the line of Brandon Folkes of Cantor Fitzgerald. Please go ahead.
Hi. Thanks for taking my questions and congratulations on the progress. Maybe just one for me. Can you elaborate on your expectations around timing of when you expect to meet the FDA to finalize the design for the ovarian cancer trial? Just it'd be great to hear your updated thinking on sort of patient population and trial design there. Thank you.
Andrew, are you back with us? Do you wanna take that or do you want me to take it? Sounds like he is still not maybe back with us due to technical difficulties. Brandon Folkes, this is Jeremy Graff. 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 DeCidE1 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.
As we carry this forward, we wanna look more towards registration. The path to registration involves working in patients who really have run out of options. These are the platinum-resistant patients in particular.
Great. Thanks. One more if I may. Just on the realignment you talked 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.
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 maveropepimut-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 survivin peptides didn't show clinical benefit, did not drive a robust T-cell response in more than 14% or so 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. 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.
Great. Thank you.
Thank you. Your next question comes from the line of Joe Pantginis from H.C. Wainwright. Please go ahead.
Everybody, good morning. Thanks for taking the question. First, obviously, you guys, you got a lot of activities ramping up at the company, and you guys are quite busy. 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.
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 if we drive Maveropepimut-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.
Got it. That's very helpful. Then actually, Jeremy, as part of your prepared comments, I want to link your comment on the DeCidE1 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. I wanna link that to, you know, your overall goal to look at additional combinations beyond checkpoints or anti-PD-1s, I should say. You obviously have a little bit of a tease there with the aromatase inhibitor for the breast cancer study. 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 of that.
No, it's a very good question. Andrew, do you wanna take that, or you want me to jump in with that one?
I would love for you to jump into that, Jeremy. Apologies to everyone.
Okay.
It seems the technology jumped into the role of answering the back half of the question. Jeremy, please take it.
Yeah, Joe, 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 DeCidE1 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, survivin, but we also recognize that within that platform, we have components that activate and educate and enable immune response and that pull into the fray a response by CD4 helper cells. We think that in a 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 formal immune response because they kill tumor cells and release antigens, so you can get more of the antigen spreading you're talking about. 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 could 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?
It certainly does. Thanks a lot, guys.
Yeah. No problem.
Thank you. Your next question comes from the line of Nick Abbott of Wells Fargo. Please go ahead.
Morning. Thanks for taking our questions. Listen, Jeremy, you know, you've teased us a little bit with your slides and statement, something like, I believe, pretty exciting data from the basket study shortly. Have you and Merck made go/no-go decisions for the bladder MSI stage two and ovarian stage one, the tumors at those decision points?
We have certainly been discussing with Merck the data from those, but 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 wanna?
Yeah. Thank you. 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? It was a tease set intentionally, and we do look forward to communicating that information in the very near future.
Okay. Thanks. That's a very interesting way to put it. Anyway, my next question sort of goes back to some of this translational data from the study. I get that, you know, if you have an inflamed tumor, you're more likely to respond immunologically. And yeah, on the other side of it, you're driving an immune response with MVP-S. Do you have cases where you get a strong immune response to the vaccine that's not translated to clinical benefit because, 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 preexisting inflammation in order to get a strong immune response to MVP-S?
That question can go.
I think you went straight to me, Andrew. You might be bowing out again technically. Okay. Nick, I think it's a very distinct question. We certainly see in the majority of the patients dosed with Maveropepimut-S that we are generating a specific survivin-specific T-cell response. We now also appreciate that response, in many cases, involves B cells too. That tells us 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. I think you'll recognize very readily that there's more to clinical benefit than just creating a survivin-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. 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. To the point I think that Joe may have asked earlier, we think there are ways that 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 MVP-S, but for a later product.
Yeah. Yeah, that makes sense. Just maybe building on that then. This initial confirmatory trial wouldn't be selecting patients based on, you know, tumor inflammation, for example?
No, we wouldn't. We will be-
And then-
if you will, homogenizing the patient population to be the persistent patients where we have seen a very profound clinical activity.
Okay.
But-
Last question for me. It goes back, I guess to the point you made about in-licensing, adding value, and then returning the asset. I mean, I'm sure you do have a preferred strategy, but is the goal here really to generate near-term revenue? For example, you almost do this at-risk, you meet their criteria, and then you return the asset for near-term revenue. Are you seeing this as an opportunity to, you know, participate in upside from, you know, this new enhanced product, either just from royalties or even, you know, commercialization of the product? Is it in the mix or all about? I guess, what are your initial objectives from this program?
Thank you for the question, Nick. Before I get too detailed on the answer, can I confirm that you can hear me?
I can hear you, yeah.
There we go.
I don't know about anybody else.
You can hear me, good. Okay. Sorry for the technological difficulty. The answer to the question is, in the short term, we would be looking to create non-dilutive revenue through this mechanism. 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. That it is, in the short term, I think, a mechanism of us creating a revenue stream that's non-dilutive. 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 we may selectively hang on to fulfill a deeper pipeline of clinical assets.
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. It's something that we and Jeremy's team particularly are building out at a very effective speed to turn very quickly.
Thank you.
Thank you. Your next question comes from the line of Paul Stephenson from iA Capital Markets. Please go ahead.
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?
Thank you for the question, Paul. The broadening of the availability certainly increased the recruiting speed of the hepatocellular carcinoma in that arm of the basket trial. We still are not at a point where we've achieved stage 1 for that particular grouping. However, we have seen data that is encouraging in that space. We would not want to commit to the publication of a presentation of that data publicly because we don't have the full complete data set. I'll ask Jeremy to maybe comment with a little bit more clarity on the details there.
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.
Okay. Appreciate the color. Just in terms of, you know, looking at the patient stratification options out of the translational data that you guys had from DeCidE1, 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 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?
Thanks, Paul, for the question. I'll let Jeremy add extra detail. 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 sub-select patients for, I think we need more trials with more information to better elucidate that effect.
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?
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 recruit those patients who are most likely to get that. In this case, trying to track CD3 and CD8 infiltration 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 a DLBCL trial, that ring fences a population that's very responsive to the therapy. 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. That includes, of course, the platinum resistant patients. It's a great question, but CD3, CD8 as a pre-marker, if you will, for inclusion, would be a difficult CDX to develop.
Yeah. That makes sense. Glad to get confirmation there. Thank you, guys. One last one for me, if I may. Just in terms of, 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 combination. 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 conjectural 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?
It's a great question. Andrew, I'll handle this, and you can stack on top of it if you'd like. 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. I think if you're looking for actionable targets there that might help reverse that inherent resistance in the tumor then, you might look at CD276. Our translational team identified CD276. It effectively works as a type of immune checkpoint. It's upregulated in the patients who are not getting benefit. There are very early stage therapies against CD276, 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 MVP-S in combination with such a checkpoint inhibitor. That might open up the landscape of MVP-S benefits for a greater population. Make sense?
Yeah, absolutely. I really appreciate the insight there, Jeremy. Thanks guys for taking my question and congratulations on the progress.
Thanks, Paul.
Thanks.
Thank you. Your next question is a follow-up from Nick Abbott from Wells Fargo. Please go ahead.
Hi, Jeremy and Andrew. Thanks. Thanks for taking the follow-up. First one is on DeCidE1. You know, as a basket, there were a couple of ovarian cancer cohorts in the basket trial, 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? Then I have a follow-up. Thanks.
Yeah. No, I'll tell you and nice to meet you.
Sure.
Sure, Jeremy, go ahead.
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 effectively that's what we see as well. We're trying to understand in 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 could package that together. You're spot on with what we're trying to do because it helps frame the way we think about MVP-S in ovarian cancer. Andrew, did you want to add to that?
Your statement is better than I would make it, Jeremy, but just to say that the tissue we collected in that basket trial is obviously going into the full-fledged 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. It's not as if it's in any way translationally flying against what we've seen in the DeCidE trial.
Okay, thanks. Because I guess from what you saw in DeCidE1, then you would expect to see enhanced clinical activity in patients who have baseline inflammation, low tumor inflammation for the Keytruda-treated combination, the pembro combination.
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 what kind of T-cell reactivity we get in those patients. We see that universally, you know, that we activate survivin-specific T cells in any patient really with MVP-S therapy. We're looking at the persistence of that response. There are all sorts of reasons, of course, that the immune system is corrupted in advanced cancer patients, that things may not work. We're trying to appreciate that not only in the basket trial, but in every trial that we run. You'll see in fact that all of the trials going forward will have an even stronger and heavier translational component to crystallize what we need to learn about this product on our march to registration.
Okay, thanks. Just the last one from me, just going back to some big licensing assets. Have you in-licensed one of those yet? And if not, do you intend to communicate with investors when you do?
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.
Okay. Thanks Andrew. That's all from me.
Thanks. 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 gonna 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 Maveropepimut-S towards registration, as well as exploring new indications and combinations. We're committing to communicate this information set through peer review 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 you everyone for your time today. I thank you for listening in, and have a lovely rest of your Thursday. Cheers, everybody.
Thank you, ladies and gentlemen. That does conclude your conference for today. Thank you for participating and you may now disconnect.