Welcome to Mendus Q2 Report 2024. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answer session, participants are able to ask questions by dialing pound key five on their telephone keypad. Now, I will hand the conference over to the speakers, CEO Erik Manting, CFO Lotta Ferm, and CMO Jeroen Rovers. Please go ahead.
Good morning, everyone. Welcome to the Mendus Q2 2024 business update. My name is Erik Manting, CEO at Mendus, and today I'm joined by our Chief Medical Officer, Jeroen Rovers, and our CFO, Lotta Ferm. As a summary of the second quarter of 2024, we raised roughly SEK 69 million in April through the exercise of warrants that were associated with the financing that we carried out in 2023 with participation of all major shareholders, management, and eligible board members. We're very happy with our current shareholder base and also with the fact that they all contributed to this part of the financing. We also had some board changes and importantly, a new chairman of the board in the person of Sven Andréasson . We're very happy Sven was willing to step up to this role.
He is someone with a very broad experience, both in Europe and the U.S., and has been on both sides in the pharmaceutical industry and the biotech industry, and brings a lot of also business development expertise. So we're happy with Sven as new Chairman. Very importantly, in the second quarter, we did a lot of immunological research on the samples we collected in the ADVANCE II trial, and we presented those data at the CIMT and EHA conferences, and they confirmed proof of concept that vididencel acts as an active immunotherapy in AML, and we'll spend some time in the coming slides on what that exactly means.
Also, very importantly, we announced in the first quarter a collaboration with the Australasian Leukaemia and Lymphoma Group , ALLG, and also Ethics Committee approval to start the AMLM22 CADENCE trial, which is a combination trial with our product, vididencel, and current standard of care in AML. Following the Ethics Committee approval, we immediately engaged in starting up the trial, which means that we ship material to Australia, and we work with the clinical centers to make them ready for including patients in this trial, and we'll provide an update in the coming slides. We have, as a very important part under the late-stage development strategy for vididencel, engaged in a manufacturing alliance with NorthX Biologics, which is a manufacturing organization based in Sweden.
The reason it's so important is that we need to be ready for large-scale production to support our clinical trials going forward, and also in the end, for commercial launch, and you want that to be the same process, so working with NorthX Biologics to establish a large-scale manufacturing facility, and in the end, also large-scale GMP manufacturing, is something that is a very important pillar under our strategy. And we have, in the first half of the year, already completed the manufacturing facility, but now also performed the first large-scale runs, which we completed successfully as part of setting up this facility. We presented positive data from the ALLISON trial in ovarian cancer at the ESMO Gynaecological Cancers conferenc e. We'll discuss those in detail.
And also, in July, we announced that we have established a collaboration with Institut Bergonié, which is a leading cancer center in France, to study our intratumoral primer, ilixadencel, in soft tissue sarcomas. As financial highlights, we have a strong cash position of SEK 130 million , which provides us with cash runway into the third quarter of 2025, based on current activities, which means also the activities we will discuss today. We had a relatively limited cash burn of SEK 22 million in the second quarter, and the reason it is lower than the net result is that, the investments that we have made to establish the manufacturing with the manufacturing alliance with NorthX Biologics have been prepaid. So they are, as we are progressing that alliance, costs, but they don't weigh on our cash burn.
Finally, we carried out a reverse stock split, which was resolved at the annual general meeting and effectuated in June. Moving to our lead program, vididencel in AML. Acute myeloid leukemia or AML is a very aggressive blood-borne tumor. The only way to suppress it is with very intense chemotherapy, and also there's hardly any cure. The only cure actually that... or treatment that is potentially curative is completely replacing the patient's immune system with a donor immune system that's called the hematopoietic stem cell transplant or bone marrow transplant. The biggest problem with AML is actually relapse due to residual cells, and patients that are not able to undergo a transplant are particularly sensitive to relapse, and that's related to residual disease or measurable residual disease, in short, MRD.
Even after transplant, patients relapse, so relapse is also the main reason for transplant failure. Five-year survival is very low in AML, and it means that there is a big need for therapies that will basically maintain disease-free periods for these patients much longer than what's the current situation. We are developing vididencel as an AML maintenance treatment. It's meant to provide longer periods of relapse-free and overall survival, and also very importantly, maintenance therapies should be able to deliver this without harming health or quality of life. There's currently no approved immunotherapies in AML. There is a big impact of immune checkpoint inhibitors in solid tumors. It's a class of drugs that does provide for long-term survival in a range of solid tumors, but they have simply not been effective in bloodborne tumors.
That's why there's such a high medical need for new immunotherapies that could address this need for novel maintenance treatments. The ADVANCE II trial, as a summary, is a trial that was treating 20 AML patients in a first complete remission after high intensity chemotherapy, but still with measurable residual disease. We treat these patients with 6 intradermal injections of vididencel, and we did this trial with 10 participating hospitals throughout Europe. The active study phase has already been completed, and patients are now in long-term follow-up. This is the data we last presented. It's at a median follow-up of 31.6 months, and what you will appreciate is that a large group of patients is actually in long-term survival.
Actually, the majority of patients is still alive in the long-term follow-up, and median relapse-free survival currently stands at two and a half years. What we have now performed in the last months and presented at the CIMT and EHA conferences is a much more detailed analysis of the immune responses following vididencel treatment. What we were able to show is that vididencel has a very broad impact on the immune system. We had already in previous presentations at conferences shown that the product leads to T cell responses against specific tumor-associated antigens like WT1, PRAME, and RHAMM in the majority of patients.
But what we were now able to show is that, first of all, there is a difference between patients that respond very well to the treatment, and patients that relapse despite the treatment, and that has to do with the baseline health of the immune system. But what we were also able to show is that vididencel generally improves the immune status of patients. And finally, and this is the data we presented at EHA last June, we could show that those patients that have good immune responses, meaning T cell responses at multiple time points, but also above median levels of B cells, so the cells that make antibodies, they were all in a long-term survival curve.
This is very important because it provides proof of concept that vididencel indeed acts as an active immunotherapy in acute myeloid leukemia, and that the immune responses are relevant because they result in long-term survival benefits. As a summary of that concept, it's important to understand the difference between active and passive immunity. Active immunity is something your own immune system builds up. It also comes with immunological memory, and it provides long-term protection against disease. It's very different from passive immunity, which you get from injecting antibodies or, for example, also immune cells that have been manufactured outside the body. They will deliver an immediate response, but they are not long-lasting.
Now, the fact that we see after vididencel treatment, these broad immune responses associated with durable disease control in the majority of patients, is proof of concept that vididencel indeed acts as an active immunity, leading to long-term immune protection in this case, the majority of patients in the ADVANCE II trial. Currently, the only approved AML maintenance treatment is a drug called oral azacitidine. It's a chemical drug, and what you see here is a picture from the registration trial, phase II trial for oral azacitidine. And what you see is that there is a discrepancy between the placebo treated group, the blue group, and the red group, so the azacitidine-treated group, but it's a temporary difference. So the chemical drug slows down the disease, but it doesn't cure it.
There is an attractive side to azacitidine, and this is documented in literature, but azacitidine has an effect on cancer cells and makes them more immunogenic, and that is a good combination with immunotherapy, such as vididencel, and therefore, we expect a potential synergistic effect in the combination, and we've also seen initial promising data in our own preclinical work, and also some initial positive data in our phase I trial, so there's a good basis to combine vididencel with oral azacitidine to currently improve AML therapy. As a big step forward, we have set up a collaboration with the Australasian Leukaemia and Lymphoma Group . It's a very renowned clinical research group. It's a big group of Australian and New Zealand-based, but also a few Asian centers that are collectively called ALLG.
They were also one of the leading research groups in the trial we previously showed, that got oral azacitidine approved, and they have already set up a large trial that allows companies to do research in combination with oral azacitidine, and Mendus is now one of those companies that is working with ALLG, and we are combining vididencel with oral azacitidine in the AMLM22 CADENCE trial, or in short, CADENCE trial. Now, the CADENCE trial is a two-stage trial design. Initially, we aim to open up nine clinical centers in Australia, and treat 40 patients for an initial safety analysis of the combination, vididencel and oral azacitidine. Subject to a positive safety evaluation, that stage will be followed by another 100 patients for efficacy segments. This is a large trial.
We're working with one of the best centers in the world, so we're very happy that we've entered into this collaboration. What I mentioned earlier, in the second quarter, we have been particularly focused on getting the trial up to speed. Following ethics committee approval, the clinical team and the regulatory team has worked closely with the hospitals, and the CMC team has made sure that the material is in Australia, ready to treat patients, and we expect the first sites to open in September. Now, it adds up to a path to market that we are preparing for. We have the monotherapy data, the proof-of-concept data from ADVANCE II.
We are entering into the start of the CADENCE trial, and that will deliver a larger set of data in combination with current standard of care, with oral azacitidine. In parallel, we are preparing for pivotal stage development, and the reason we do this is we want this product to be ready for pivotal stage development. We are currently in a preparation phase, which means that we are preparing the eventual registration trial protocol. We're also seeking regular feedback from the regulatory agencies, so the EMA and the FDA, and we want this program to be translated into a clinical trial protocol by mid-next year. In parallel, we are developing the large-scale manufacturing. So the manufacturing has to be there in order to not only support the trial, but also in the end, to allow for commercialization.
We are currently in the implementation phase of moving our process. That's a large-scale manufacturing process we have developed at Mendus, to the manufacturing facilities at NorthX in Sweden. One of the other things we did in the first half of the year is extensive market research. We looked into the maintenance opportunity for vididencel in acute myeloid leukemia, using both public sources, but also a broad series of interviews with key opinion leaders, so doctors, experts in the field in both Europe and the US. We came to an estimated addressable market based on the current therapeutic setting of around $3.7 billion, and this is an indication that the market is sizable.
The reason is that the need for maintenance therapies is so broad, and also that so far, we have not seen any restrictions related to our product in the type of patients we can treat. So it's not limited to, for example, specific mutations. This is really a drug that can address the broader maintenance market and also comes with an attractive market opportunity, and then next to the current setting, which is the setting after chemotherapy, there's also additional maintenance populations that we could address, and that includes the setting post-transplant. Again, also after transplant, there is a lot of relapse, it's actually the main cause of transplant failure in AML. And also there's a new group of patients which is not treated with high-dose chemotherapy, but with a combination of azacitidine and a new drug called venetoclax.
And also those patients now have a better chance of a first complete remission and would require maintenance therapy. So there's a broader market opportunity next to the current, already attractive market opportunity. So as a summary and outlook for the AML program, the proof-of-concept data, that is a combination of the survival data and the immunomonitoring data that I just described, supports the mode of action of vididencel as an active immunotherapy in AML. We are already in the process of expanding clinical development in combination with current standard of care, oral azacitidine, in the collaboration with ALLG, and the first sites of the AMLM22 CADENCE trial will open in September for recruitment of patients.
In parallel, we are preparing the registration trial protocol for vididencel and AML, including the feedback from regulatory agencies. It's supported this exercise by an already strong regulatory dossier, and we are implementing the large-scale manufacturing in our collaboration with NorthX Biologics. We should be ready for, let's say, entering the program into late-stage clinical development, which is something we can do by ourselves. We're in a partnership, but we want the program one way or the other, to be ready mid-next year. The near-term milestones from the AML program are the survival update from the ADVANCE II trial that we expect to announce in the fourth quarter, so we are still following up those patients in the long-term follow-up phase of the trial. The start of the patient recruitment of the CADENCE trial, with the first sites open in September.
Moving to ovarian cancer. As a general principle, we were just interested to see if we could make ilixadencel work as a product in an indication outside of AML, and we chose ovarian cancer because it's one of the deadliest gynecological diseases, again, due to tumor recurrence, so the initial treatment, chemotherapy and surgery, is generally not enough to get rid of the disease, so together with the University Medical Center in Groningen, we've set up a trial with 17 ovarian cancer patients to see if we could trigger relevant immune responses in ovarian cancer. We provided an update of that trial in June at the ESMO Gynaecological Cancers conference . The trial is fully recruited with 17 patients, and at week 22, the majority of patients that was treated, so 10 out of 17, still had stable disease. The other seven had image-confirmed recurrence.
We're following up those patients now in long-term follow-up, to see a potential clinical benefit from the treatment. What we have established in the meantime is that vididencel is triggering immune responses against a broad range of antigens that have been shown to be relevant for ovarian cancer. And the product also has a confirmed very good safety profile in this indication. So the part of immunogenicity and safety is very good, and we also aim to have the primary analysis based on the immunomonitoring of all 17 patients in the fourth quarter of this year. Clinical benefit is dependent on the long-term follow-up, and we will, of course, also provide updates on how that is developing. As a summary, the safety and feasibility of ilixadencel in ovarian cancer is confirmed already in the ongoing phase I trial, the ALLISON trial.
The immunomonitoring data are positive. We are seeing tumor-directed immune responses in the majority of patients treated. Primary readout in the fourth quarter based on the immune evaluation of all treated patients, and so potential survival benefit, dependent on what we will see in the long-term follow-up of these patients, which is ongoing. Then shifting to ilixadencel. It was a product that already had shown safety and signs of clinical efficacy in a broad range of hard to treat solid tumors. We had two challenges with the product, which was, one, we wanted to improve the manufacturing, which we have taken care of, but secondly, also, we needed to reposition the product.
The main reason was, and that's a broader lesson learned for the field as a whole, the cancer immunotherapy field, is that it is very difficult to improve on the immune checkpoint inhibitors as a class of drugs. Immune checkpoint inhibitors have made a big impact for the cancer immunotherapy field. Then a lot of trials were performed to see if other immunotherapies could improve their efficacy, and that has not materialized. So we need to think different on how to approach solid tumors with immunotherapy. And what we have done with ilixadencel, which is an intratumoral primer, is we've basically learned all the lessons from the trials we have performed, which is both monotherapy data, but also data in combination with other drugs like tyrosine kinase inhibitors and checkpoint inhibitors.
It's safe in those combinations, but also we've taken that other lesson into account, meaning that we were looking for tumors that are currently not responding to immunotherapies, specifically immune checkpoint inhibitors, and soft tissue sarcomas is one of those tumor types that is in that category and which could benefit from ilixadencel as a means to engage the immune system in the treatment of those tumors, in combination, potentially with other drugs. That was the background. We have been looking for a long time to do a good quality trial with ilixadencel to prove this concept in soft tissue sarcomas, and we've now taken a major step in the collaboration with the Institut Bergonié, which we announced last July. I will hand it over to our Chief Medical Officer, Jeroen Rovers, to describe in more detail the collaboration and the trial.
Yeah, thank you, Erik. It's a pleasure to be able to give a bit of the background of the next clinical trial, which we're initiating in collaboration now with a group of French cancer centers. They are collaborating in this, what we call REGOMUNE trial, but I'll give you a bit of the background in the next slide. Again, soft tissue sarcomas, to reiterate what Erik was just saying, is one of these tumors which is still very hard to handle. It's a rare type of tumor which arises mostly from soft tissue like fat, muscles, blood vessels, et cetera. And typically, they are not discovered at an early stage, but slightly later. Often, they are already metastasized, which makes them even more difficult to handle.
When they're small, you can still resect them through a surgical procedure, for instance, or irradiate them, but unfortunately, the majority of these tumors is not, say, eligible for that. This cancer often recurs, and it's poorly responsive to the available therapies such as chemotherapy. It also has shown, thus far, to be poorly responsive to, say, immunotherapy. This is typically one of these indications where we feel that the intratumoral immunotherapy approach, which we are able to provide through ilixadencel, might make a difference. We announced mid-July, so just before the holiday period in most countries, that we are initiating this collaboration with Institut Bergonié. This is an institute in Bordeaux, France, and I'll show you some of the details later.
The collaboration means that we will add a cohort to an existing trial, which is run by Institut Bergonié and several other cancer centers in France. This is the REGOMUNE trial, and that's a phase I, II trial, where they are combining already two existing and approved drugs, in solid tumors, which are regorafenib, which is a TKI, the tyrosine kinase inhibitor, and avelumab, which is a immunotherapy, so it's a checkpoint inhibitor, a PD-L1 inhibitor, in this case specifically. So if we look at the, collaboration, then, like I said, Institut Bergonié is one of the leading cancer centers in France. In this case, it's in Bordeaux.
This trial is a multi-center trial, so it's a collaboration of seven major French cancer centers, where they are recruiting patients for different, say, indications into this REGOMUNE trial. In the trial, the intent is to see how the combination of a tyrosine kinase inhibitor and a checkpoint inhibitor might improve, say, cancer results. This trial is already supported by the providers of these two, say, approved drugs. Regorafenib by Bayer and Merck provides avelumab, and Mendus will provide, say, ilixadencel, to set up a cohort where we combine these three products. It actually means that ilixadencel will be administered to soft tissue sarcoma patients twice, while they are being also treated with both the TKI, regorafenib, and also the checkpoint inhibitor, avelumab.
We feel confident that the combination is feasible in applying, and based also on the fact that we have already previously conducted clinical trials where we combined ilixadencel with regorafenib, for instance, but also with a checkpoint inhibitor, and the latest of that is, of course, the ILIAD trial, where we combined ilixadencel with a checkpoint inhibitor and has shown that it's safe to have these two different immunotherapies work together, so in summary, for ilixadencel, like Erik already explained, we have conducted in the past several clinical trials. They were shown sign of clinical efficacy in typically some hard to handle, to treat solid tumors, like the renal cell cancer.
And we're now moving into the clinic again with ilixadencel to show, or to try to show the effect of ilixadencel in soft tissue sarcoma, which is a very hard to treat tumor, as indicated. And the collaboration with Institut Bergonié will evaluate this combination. And we will prepare, in the next few months, together with Bergonié, for this cohort in this trial to be approved so that we can start treating patients next year. And I will hand over back to Erik for the continuation.
Thanks, Jeroen. As concluding remarks, we now see, as a combination of the survival data and the immunomonitoring data, a very important proof of concept for vididencel in AML, where it provides a potential solution for a very high medical need for normal maintenance treatments, and particularly important is the fact that vididencel acts as an active immunotherapy with a good safety profile that is able to deliver durable clinical responses in AML. That drives us to prepare the program for pivotal stage readiness. That will be an important catalyst for our corporate development, and that includes also the manufacturing side of things, but also it's an important catalyst for potential opportunities, so for the registration trial, to make sure we have the protocol ready and to make sure that the program is ready to enter that phase, is currently top of our mind.
The market research we performed in the first half of the year confirms the attractiveness of the AML maintenance market for vididencel, and also there is a potential to broaden that market potential by addressing additional AML maintenance populations. Our other pipeline programs, which is the ovarian cancer program and the ilixadencel clinical program that we described today, but also our preclinical and NK-cell program, are all well-positioned to deliver all additional upside. We have multiple milestones until the year-end, which is the survival update of the ADVANCE II trial with the long-term follow-up update of the patients in the trial.
The start of the patient recruitment in the CADENCE trial and the primary analysis of the ALLISON trial, but also in the background, of course, there's a lot more activity ongoing related to our manufacturing alliance and related to the preparations for the pivotal trial, for vididencel. So with that, I would like to conclude the update and hand it over for Q&A.
If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad. The next question comes from Chien-Hsun Lee from Pareto Securities. Please go ahead.
Hi, good morning, and thanks for the business update. So a few questions from me. Can you tell us a bit more about the interaction you have with the regulatory authorities regarding the pivotal AML trial? And, is there any clarity on the potential timeline, the amount of patients? Thank you.
Thanks, Chien. Jeroen, do you want to answer that question?
Yeah, I think it's well known, of course, that interactions with regulatory authorities are often a time-consuming process, so we are in the midst of that process, so we cannot provide you with any outcome of, say, the discussions held. The outcome of these interactions from both EMA and FDA will be known towards the end of the year.
Okay. Thank you. Maybe another question. So, since you have shown a promising linkage between vididencel triggering active immune responses and the survival benefits, can we expect this kind of immune response to be further studied in the CADENCE trial?
Yep, that's correct. So the first part of the CADENCE trial will of course also include, say, the immunomonitoring assays as we have performed also in the ADVANCE II study. And so we will definitely be able to compare the kind of immune responses we saw in the ADVANCE II trial with the kind of immune responses we hope to see also in the combination with oral azacitidine.
Okay, perfect. Yeah. Thanks for taking my questions.
Thanks for joining us, Chien.
The next question comes from Soo Romanoff from Edison Group. Please go ahead.
Hi, congratulations on your collaboration with the institute. Given that it's not a Mendus-sponsored study. When can we expect to hear an update on the trial? And assuming that the data is supportive, what would the next steps for the program be?
Yeah, so like indicated, we will now start together with Institut Bergonié the whole process of getting, say, the regulatory approval required for amendment of, say, the REGOMUNE trial, with the inclusion of the cohort incorporating ilixadencel. So it's expected that will take the rest of the year. And so once, of course, the study is able to start recruiting patients, we will inform everybody that this will happen. But you're right, it's a study conducted by Institut Bergonié in collaboration with the additional, say, cancer centers there in France. And it's up to them to execute on this. Let me add two elements maybe Soo, to the answer to your question.
First of all, I think what I tried to describe in the way we have repositioned ilixadencel, we have to adjust not only as a company, but also as a field to the new reality. Which is that the immune checkpoint inhibitors have had a major impact in the treatment of solid tumors, and it's been very difficult to improve the efficacy where they are effective, so we have to think very different. That is the main goal of the soft tissue sarcoma arm, which we will now want to include in the REGOMUNE trial. Because these soft tissue sarcomas are not responding to checkpoint inhibitors by themselves, so to see if ilixadencel can bring that impact in this group of tumors, will have, let's say, a broader effect on the way we see the possibilities for the product.
And that is a major step in the direction of the development of ilixadencel. And secondly, you're right, some of the trials we are doing, and particularly the CADENCE trial, the ALLISON trial, and also the REGOMUNE trial, are investigator-sponsored rather than company-sponsored. That makes them, first of all, very cost efficient, but also there is a reason why we are able to work with these very renowned centers. These are all high quality centers, and that's for all the trials we've been doing, both the ADVANCE II trial, which was with ten centers throughout Europe. The ALLG trial, with ALLG being one of the leading groups doing hemato-oncology cancer research, and now also with Institut Bergonié and also the other cancer centers, which includes centers like, for example, Gustave Roussy and Institut Curie.
It's a broad group of centers, but very renowned leading centers in cancer research. So the fact that these groups want to work with us also says something about the potential of the trial. So that's the other, the other element of the, of the collaborations we have set up.
Yeah, that's great, and it sounds like it's very promising. What's the rationale for participating in this very broad study? I think, where the combination arm with one of the seventeen cohorts versus an exclusive trial. Are you considering any other indications at this stage?
The long story short is, we first need to deliver proof of concept of what we just described, right? You want to do it in the most actual setting, so with the most relevant combination of drugs available. This is a trial sponsored by Bayer and Merck, with regorafenib and avelumab as a promising combination, and now we have the chance to demonstrate ilixadencel has an impact in that setting. It's a very high-quality trial, and the fact that it's part of a broader trial, of course, makes it interesting for context. The most important part is that we can treat up to 43 patients, which is a significant patient population in such a rare indication like soft tissue sarcomas, in this high-quality setting. In itself, the trial is very valuable.
The trial arm that we are now setting up with ilixadencel and soft tissue sarcomas, but also the broader context of the trial, both the quality of the centers, but also the support from the pharma companies, makes this a high quality setting to be part of.
Yeah, that's great. Thank you.
Thanks, Soo.
The next question comes from Christian Binder from Redeye. Please go ahead.
Hi, and thanks so much for taking my question. I just have one quick follow-up regarding REGOMUNE. I mean, you mentioned that it's very resource-efficient way for you to get some clinical data, of course. But can you elaborate a little bit more in terms of how much resources you will need to dedicate to that trial? Is it just supplying ilixadencel, or, for example, will there also be some financial commitment, and how that's gonna affect your burn rate and funding runway?
Yeah, like I said in the beginning, Christian, this is. We consider this part of our current activities, also the way we communicated it in the past. So we were planning for this trial, obviously. So the statements we make about our cash position and the cash runway include also the setting up and the start of the REGOMUNE trial. Secondly, the investigator-sponsored trials generally are a very cash-efficient way to get access to a large dataset without, let's say, fully paying for it as a company. But it depends, of course, on the willingness of the other side to work with us. So it's a mutual commitment, and it means that, we are supportive as a company. We need to deliver the drug. We're also very intimately working with the centers involved.
to make sure that the hospitals are trained and they know how to treat patients with our products. But also an important element which we have also described for the ADVANCE II trial and which will be part of the CADENCE trial, which is the immunomonitoring part, which is for us a very important element of assessing the effectiveness of our product, is also something that we will include in the REGOMUNE trial. So the basic concept that we want to prove is that in classes of tumors, and in this case specifically soft tissue sarcomas, where the immune system has difficulties finding the tumor, ilixadencel can make the difference. So also as part of the trial, we will work closely with Institut Bergonié to make sure that we can collect this kind of immunomonitoring data. And that is the way these collaborations work.
And for the rest, yeah, we're just very proud we can work with these centers, and we're obviously very happy we can do so much with relatively limited cash burn, while generating valuable data for the company and for our products.
Perfect. Thank you so much. That was all from my side.
Thanks, Christian.
The next question comes from Antti Siltanen from Inderes. Please go ahead.
For taking my question. I wanted to first ask about now your understanding of the immune system activation after vididencel is increasing. So do you see a possibility to use this understanding for patient selection in the pivotal stage trial?
Generally speaking, and that's also, for example, the case with the immune checkpoint inhibitors, Antti, if a product is safe, there is no reason to exclude patients, right? Because you want to have the upside of the benefits. So checkpoint inhibitors, they are only effective in 10%-20% of patients in responding tumors, but still everybody gets them because the side effect profile is so beneficial of immunotherapies. And that is something which we also expect around vididencel. So the safety profile of the product is excellent, and also the differences we have seen both at baseline and then also in the way the immune system builds up immunity after vididencel treatment, is a very clear pattern, but it's not black and white.
It's not that you can really put your finger on saying, "This has to happen, otherwise the patient will not respond." So generally speaking, both based on the safety profile and the fact that there is a bit of a gray zone between patients that will respond and not respond, in the end, of course, with a clear-cut outcome, it doesn't at this point at least make us go in the direction that we want to exclude patients beforehand. Maybe, Jeroen, you want to add to that?
No, I think you addressed the key points here, Erik. I think it's clear that we observe this connection with immune responses and survival, but currently it doesn't allow us to pre-select patients which might get this success.
I think the only thing we have seen, Antti, and this is a crucial principle, which I hope we also explained in the slides, that explains the mode of action of vididencel and the positioning of our product, is the level of disease. So one thing that not only we, but also the field as a whole has learned, is that cancer disturbs the immune system to the point that it's very difficult to activate it. So the best chance you have of boosting the immune system is actually when the disease burden is low, and that's also a consistent factor that we have seen in our clinical trials in AML.
Understood. Thank you. Second question on ALLISON trial and ovarian cancer. So did you see any correlation there between immune responses and clinical outcomes?
Jeroen, do you want to comment on that?
Yeah, I think, Antti, it's a bit too early to be able to to comment on that because we are completing, say, the initial evaluation of the immune responses with the... for all 17 patients. To be able to see if there's a clear correlation with the clinical benefit, we need to follow them up a little bit more. So the majority of patients have to be followed up for, say, two years, to be able to to have, let's say, a more solid, say, conclusion on whether it has an impact on the clinical benefit.
Okay, thanks. And final question: could you remind me of the rationale for combining ilixadencel with the tyrosine kinase inhibitor?
Jeroen, do you want to answer that, or should I answer it?
Yeah, go ahead if you want.
Yeah. So what we expect, Antti, and that's of course also the broader setting of the REGOMUNE trial, is that there are benefits and synergies between different ways to influence the immune system to move, let's say, in the right direction against cancer. And tyrosine kinase inhibitors help to, let's say, reduce the tumor burden, but also seem to have a positive effect on the way the immune system works. Seems to kind of tune it in the right direction with respect to efficacy towards tumor cells. So there is an expected synergy. We have shown in our trials also that ilixadencel combines very well with both tyrosine kinase inhibitors and immune checkpoint inhibitors.
There is both, let's say, mechanistic, but also based on clinical experience, showing safety in combination, a good rationale to treat these very hard-to-treat tumors, in combination with actually both the tyrosine kinase inhibitors and the checkpoint inhibitors.
Okay, thanks very much. That's all from me.
Thanks, Antti.
There are no more questions at this time, so I hand the conference back to the speakers for any closing comments.
Well, I'd just like to say thanks, everybody, for joining. Also, the people listening in, we will be active in keeping everybody up to date. We're also looking forward to have more investor events in Sweden, which we will make some announcements shortly about the details. But, we're very happy to always be in touch with our investor bases. I hope we have given you a good overview of the activities that are going on, both visible, but also a lot of activities going on in the background. We're at a very exciting stage of the development of the company, and thank you for continuing to support us.