Good afternoon, everybody, and welcome to the Ultimovacs webcast. During this webcast, we will be talking about the results from the NIPU trial that was just recently presented at ESMO. But also, a little bit about the press release we had this morning on our second trial, the INITIUM trial, and some of the changes we implemented there. As you all know, we had some, like many other companies in Madrid, problems with a lot of streaming due to the bandwidth. So we are taking this opportunity to address some of the topics that we covered there, but also take the opportunity to talk about some of the questions, the topics that we have been receiving so far.
So, you know, I have to say that these are very, very exciting times for cancer patients, but also for companies working in the space of cancer vaccines. We have now two companies that, for the first time, have shown in randomized competitive trials that cancer vaccines work. One of those companies, Moderna, with their individualized vaccine, has shown that in study that they did in melanoma patients, they showed some efficacy there. So very exciting for the field of individualized vaccines. And of course, Ultimovacs, that with the results presented and shared during ESMO, shows that a universal vaccine like UV1 has really a role and shows efficacy in combination with immunotherapies versus these immunotherapies.
This is really, for us, a company with five clinical trials in Phase II, the first study that shows and proves the concept. The proof of concept that UV1 as a cancer vaccine works, has an impact in the efficacy in treatment of these patients, despite the fact, as you will see, that mesothelioma is probably one of the worst and most difficult cancers to treat. If we can move to the next slide. As you know, as a publicly listed company, I need to show you this one. If we continue to the next slides, we will cover... I will just cover some introduction. Jens will cover the NIPU results and the INITIUM update, and then I will come at the very end, summarize the webcast, and then we will open the space for Q&A.
So if you haven't yet asked your questions, please do it through the system, and we will try to address and answer as many as possible at the very end. So if we can move to the next slide. Next. So let's start by talking about NIPU, and of course, Jens, as I mentioned, will go into details. But I think there are some key takeaways that are important to really bring at the very beginning of this webcast. One is that the study that we did in malignant pleural mesothelioma was always, from the very beginning, perceived as a challenging indication. Yes, as I mentioned, mesothelioma is probably one of the most challenging cancers to treat.
But the fact is that based on the clinical trials results, the KOLs and the lead investigators from the study found that it's positive. As you know, we had some results from progression-free survival back in June, where we didn't meet the primary endpoint. But the fact is that these days, both key opinion leaders and regulatory authorities accept and recognize that PFS is a very poor endpoint in mesothelioma, because these patients progress and die unfortunately very fast. So it's clearly overall survival, the gold standard, and also the reason why the authorities ask that in Phase III studies, overall survival is the primary endpoint.
The fact is that, UV1 in the NIPU study showed that really, UV1, when combined with ipilimumab, nivolumab versus ipilimumab and nivolumab, showed that we really bring a benefit in terms of overall survival. And based on these results and the experience from very, very, top, worldwide experts in mesothelioma, they really recognize the value of these results, and they were the ones to recommend that we should bring UV1 to the next phase of development. After being exposed to the data and understanding this disease, we, totally agree with them, and we will be covering during this webcast, what are we doing at the moment and planning to do?
As this morning, the press release on INITIUM stated, we have been informing the market that patients in the INITIUM study in malignant melanoma, in combination with ipilimumab, nivolumab, basically, the patients have not progressing or dying as was expected based on historical trials. This, of course, is very good news for melanoma patients. But we, after moving the guidance on these results for several times, we really decided to present a protocol amendment to the authorities, and this was accepted. And basically, we are gonna start looking at the data, analyzing when the last patient that was enrolled, this was in July 2022, passed the 18 months follow-up.
That is gonna be mid-January, and then it will take us 2-3 months to go through all the data, analyze it, and then be able to provide you with an update.
You know, in the March, April timeframe. Of course, as also mentioned in the press release, this protocol amendment that we discussed internally and with advisors, and submitted to the authorities, were accepted by these authorities as valid to implement. So, with this, I'll give the word to Jens to go really now into more detail on the results.
Thank you so much, Carlos, and, good morning and good afternoon to the listeners. Thank you for joining. So in this part of the presentation, we will have a presentation of the previous and current, treatment of mesothelioma, a few words about the disease, the NIPU trial, and how the NIPU trial fits into the current treatment landscape, and further development of UV1 in, in the mesothelioma setting. The results from the NIPU trial and, and the way forward for UV1 in mesothelioma. So if you can move to the next slide. The NIPU trial is an investigator-initiated trial. It was initiated by Professor Åslaug Helland at the Oslo University Hospital, and this hospital is also the sponsor of this trial.
Also participating in the NIPU trial, from the pharma side, is Bristol-Myers Squibb, providing ipilimumab and nivolumab to the trial, and Ultimovacs providing the vaccine. There are several well-known investigators participating in the NIPU trial. I could, for example, mention Anna Nowak, which is the writer of the modified RECIST 1.1 criteria used to assess the images in mesothelioma. The trial was conducted in the Scandinavian countries, Norway, Sweden, and Denmark, in Spain and in Australia, and it started to enroll patients in June 2020, and final enrollment of this trial was in January 2023. Moving on to the next slide. So mesothelioma, malignant pleural mesothelioma, is one of the most challenging cancers to treat. It's a cancer that is caused by exposure to asbestos.
It has a very long latency time, from 10-50 years, and it's mainly men that will get this disease, around 75% of all patients. Most patients with mesothelioma are diagnosed with advanced disease, and they have poor prognosis and few therapeutic options. For most patients, surgery is not an option. That means that even if the patient can be operated, it will give no extra benefit to the patient due to complications. So most patients with mesothelioma, they will be treated with medical intervention, from the early start. Nothing much has happened within this field for the last decades. The chemotherapy used as standard care in first line was established back in 2003, 2004, as a combination checkpoint treatment, and that has been around for the last 20 years.
Over the last few years, also, checkpoint inhibitors has come to this indication. One approval with ipilimumab and nivolumab in 2020 in the U.S. with the FDA, and 2021 in the EMA region. But despite both chemotherapy and ipilimumab and nivolumab as two different first-line options for these patients, this is a truly unserved population which needs more medical attention. If you look to the picture to the right, you can see the current first-line treatments, the chemotherapy with a median overall survival just above 1 year, and Ipi/Nivo with a median overall survival 1.5 year. When these patients progress, and they are then moved into second-line treatment, and as of now, no current second-line treatment with therapeutic intention is approved for this indication.
The patients receive palliative treatment with the monotherapy, chemotherapy agents to solve pain and also growth of, tumors that can interfere with the vital organs in the body. Moving on to the next slide. Then back in 2017-2018, there were two small trials or two trials that were published, with ipilimumab and nivolumab in malignant mesothelioma, and they showed signs of efficacy. Those two trials were named MAPS2 and INITIATE. Based on these two trials, Åslaug Helland and her colleagues started to discuss a study with checkpoint inhibitors in the mesothelioma field, and also, we were contacted as a vaccine developer to participate in that study. As I mentioned earlier, the study started to recruit patients in 2020.
In parallel to that, big pharma has already started to develop this Ipi/Nivo combination, BMS, in first-line treatment of mesothelioma patients with the CheckMate 743 trial. In this trial, Ipi/Nivo were compared to chemotherapy. The trial didn't show any difference in PFS, but a 26% reduction in risk of death was observed. Based on this, overall survival numbers, the Ipi/Nivo combination was established as a standard of care, both in the U.S. and Europe, in 2020 and 2021. The 4 months difference in median overall survival was of important to patients. After this study on these drugs were approved, there were suddenly two groups of drugs here. So on the one side, the chemotherapy that has been around for 20 years, and the new standard of care with CPIs only.
Or, and the INITIUM trial, sorry, for the NIPU trial, this is quite interesting because even if we were working in phase II, and we had to work in phase II at the point the study started, because there were no approved CPIs in this field. We have shown in the NIPU trial that adding UV1 on top of this now approved standard of care in first-line, we can add even more efficacy for patients. I will come back to those results. Also, for the completeness of the development in this field, other companies have started to develop the CPIs as a standard of care in mesothelioma. Most of them in combination with the chemotherapy. In the IND227 trial, where chemotherapy ± pembrolizumab on top, were tested in first-line mesothelioma patients.
Also, in this trial, no difference in PFS was spoken, but a 21% reduction in the risk of death was observed in this trial. Median overall survival for the chemo arm was 16.1 versus 17.2 for the chemo plus pembrolizumab arm. Moving on to the next slide. So, our study, or we are participating in, the NIPU trial, is a second-line trial. This is the first randomized trial in mesothelioma designed to investigate the impact of a vaccine, the UV1 vaccine, on top of checkpoint inhibitors. And this time it's on top of the checkpoint inhibitors of combination ipilimumab and nivolumab, which is approved now as first-line treatment. The design of the study is standard for Phase II, with a statistical power of 80, one-sided alpha of 0.1.
The primary endpoint of the study was progression-free survival per blinded independent central review. The way of presenting the results was by presenting multivariate hazard ratio. For the secondary endpoints, overall survival, the same statistics were applied, and that was pre-described in the protocol. Other secondary endpoints were objective response rate and safety. As you can see from the figure at the bottom, all patients received chemotherapy up front. On progression, the patients were randomized to arm A or arm B. All patients were true second-line patients. All patients received Ipi and Nivo, and in the intervention arm, 8 doses of the UV1 vaccine on top.
The study was an event-driven trial, waiting for 69 endpoints to occur, which happened in the spring this year, and the PFS data was reported in June. After that, all patients will be followed for 5 years, and the first overall survival results were presented at the ESMO conference last weekend. Moving on to the next slide, just to give you some information on the patients in this study. So this is the demographics from the NIPU trial. As you can see here, for sex, around 75%-80% of the patients were male, due to occupational exposure to asbestos. That is what you commonly see among workers within the building construction, et cetera. Age of patients are a little bit below or above 70 years.
The ECOG status, around 70% of the patients had an ECOG status 1. That means that you can do daily activities, but with some more efforts, as compared to ECOG status 0. Within the mesothelioma, there are several different histologies. The most common one is epithelioid. You can see 74% in the intervention arm and 79% in the control arm in this study. PD-L1 is also a relevant marker for mesothelioma. We observed, or the investigators observed a higher percentage of patients with a PD-L1 low, below 1%, 50%-55%. Unfortunately, one-third of the patients did not have a sample that could be analyzed in the trial. Moving on to the next slide. The safety. We have earlier also statements on the safety for the UV1 vaccine.
In this trial, we did not see any difference in serious adverse events between the arms. UV1 plus Ipi/Nivo, 36 patients, 61%. Ipi/Nivo, 35 patients, 59%. To us, this is really important. As you know, the Ipi/Nivo combination has been reported to be quite toxic to most patients. So if you want to add something on top of this, effective, but somewhat toxic combination, you need to add drugs that add little new safety. The UV1 vaccine has proven to add little safety in the combinations. We have done trials and are conducting trials right now. Moving over to the effect or efficacy in this trial. So for overall survival, we did see a 27% reduction in risk of death with the addition of UV1 on top of Ipi/Nivo, as compared to Ipi/Nivo.
This gave a hazard ratio of 0.73, with a one-sided p-value of 0.0985. This is within the pre-defined threshold for statistics in the NIPU protocol, and therefore, this can be looked upon as statistically significant. Median overall survival was 15.4 months, with the UV1 on top of the CPIs, versus 11.1 months with Ipi/Nivo alone. For objective response rate, we did see a doubling of the response in the UV1 arm versus the control arm, with 31% versus 16%, giving an odds ratio of 2.44. For progression-free survival, the primary endpoint was reported back in June. It did not show statistical significance for the primary with the BICR assessment.
In sensitivity analysis, also predefined the protocol with local assessment of the images, it was found a hazard of 0.6, which was highly significant. There are also different ways to look at efficacy parameters, like the overall survival. So the primary or the readout, the predefined readout for this study was defined as, as the multivariate hazard ratio, as we report in the upper part of this figure. It's also common to present the overall survival in Kaplan-Meier plots, as you can see on the next slide. Sorry. So this is the Kaplan-Meier plot, and in the Kaplan-Meier plot, the percentages of patients alive in either study arm over time is shown. At the time of the cutoff of data, patients were observed for a median observation time of 17.3 months back in August.
The median observation time exceeds the median overall survival for patients in this line of treatment, and therefore, this is an appropriate time point for the first readout of overall survival. In the figure, you can see the median observation time with a vertical red dotted line, and just before 18 months. As I mentioned on the previous slide, hazard ratio is a multivariate analysis. This means that you take into account differences in demographics between the two arms of the study. In this study, we take into consideration the different histologies or subgroups of mesothelioma patients, as these subgroups have shown different prognosis in different trials. A different analysis of the trial data is through a Kaplan-Meier plot.
One test that is associated with the Kaplan-Meier is the log-rank test, and this, both the Kaplan-Meier and the log-rank, is a univariate analysis. That means that these tests are not taking into account the different histologies in this trial. To look further at this diagram, if you move for one slide ahead, a few comments. So in this slide, you see the vertical line at 17.3 months, which is the median observation time in this study as of now. You also see that the curves are crossing around 17 months, and then we need to understand what does it mean at this time point? So let's look at the numbers between the figure here. So this is the number at risk.
At the start of the study, 59, and the number at risk tells you how many patients are seen alive at that predefined time point. So at time point zero, 59 patients in each arm, all the patients in both arms are observed alive. Six months later, you can see that the number for the intervention arm with UV1 is 47. In the control arm, it's 44. Next is 27 and 22. But something else also happened between six months and twelve months. Because the last patients were included in this trial in February, not all patients have been included in this study for twelve months as of August, when the data cutoff was.... This is illustrated on the graphs with these vertical lines, yellow on the yellow line and green vertical lines on the green line.
This means patients that have been censored, meaning that this is the last point you have data on this patient. But when these patients are observed for a longer time, they will migrate towards the right in this figure. Further, if you look at the numbers below, you see that the numbers are fast going down to one or zero over the next year. So beyond the red vertical line, there are a few patients that have passed 18 months, 24 months, and 30 months in this study. If you ask a statistician, they will always often say that when you look at the Kaplan-Meier plot, it's important to know the median overall observation time, because you should look to the left of the line.
So the data you see to the left of the vertical line is something that would like to be almost like this, with more uncertainty towards the red line than towards zero, observation time. Beyond or to the right of the vertical line, and all the data are still immature and need further maturation before we can say anything about this time period. As we view this graph, we see separation of the curves at around 16.6 months, and they stay separated until like 16 months or 15-16 months in this presentation. This is a relevant difference between the curves, and the calculation of the hazard ratio from these curves are the full line, the full curve from time zero up until 30.
So the reduction in death risk is 27%, but most of the information in that calculation is from the earlier part of the study, since most patients are there. To get more mature data, we need to wait more, and the investigators will certainly update on the overall survival in the years to come. Moving on to the next slide. So, the investigators in the NIPU trial, they have stated that they see efficacy signals and a good safety profile in this trial that need further development and investigations. We agree to that from Ultimovacs point of view, and our actions are to, of course, look further into the data. We need to provide the data with the regulatory authorities to discuss further development of UV1 in the mesothelioma indication.
We have already started that back in June, where we provided the June data to the authorities and received back orphan drug designation. It's also very important for us to understand third-party experts in this field, so that we understand the interest from the mesothelioma doctors in different territories like U.S., Europe, and Australia, to further develop this into a later stage trial. And lastly, it's also very, very important to understand the relevance of the Ipi/Nivo combination as a standard of care in first-line treatment moving forward. All these things we will discuss with different parties over the next months and proceed with the development of UV1 in mesothelioma. Moving on to the next slide, just this update on the INITIUM trial. So on the next slide.
So the INITIUM trial is our sponsored trial, Ipi/Nivo plus minus the vaccine on top in advanced or metastatic malignant melanoma. 156 patients, included from June 2020 to July 2021. In the early projections for the trial, designed by our statisticians, it was assumed that the study would report first half of 2023. Back in April, we had not reached the needed number of endpoints in this trial, so readout was then moved to second half of 2023. In August, a few months back, we also reported that still number of endpoint was not reached, and it was then put forward to first half of 2024. So in this trial, the last patients now were included one year, one year and three months back, so 15, 16 months back in time.
The observation time in this trial has started to be quite high. From earlier studies with the Ipi/Nivo, we know that after a certain number of months, most patients that have efficacy with Ipi/Nivo, they are plateauing or the curve is flat in the PFS Kaplan-Meier plots. This is also something that is the fact for this trial. Over the last half a year, we have seen very little happening within acquiring new endpoints in this study, which is great news for the patients. We have discussed this now with our statisticians and also towards the authorities, and we have agreed that as of mid-January, it's okay that we have a cutoff in this study to have a readout of the primary endpoint.
At that point, all patients would have been in the study for 18 months, and the median follow-up in the study is 24 months. There has been no objections from the authorities in the U.S. and Europe towards this. In the study and for the study, this means that the study as such is not changed. The statistics in the study is the same at this, as it has been all the time. But the analysis will be performed with somewhat fewer endpoints. What is the impact with that? So by reducing the number of endpoints somewhat in this study, there is a slight tougher hazard ratio that needs to be reached. We have earlier announced that for a just positive trial in INITIUM with the statistics, we need a hazard ratio below 0.736.
As an example, if you have 7, 8, 9 fewer endpoints in a trial like that, you would need to be below a hazard ratio of 0.726. So from 0.736 to 0.726. So very small difference, and also this penalty is on us. So we need to make this a little bit higher hurdle to have a positive trial. Otherwise, the statistics in the study is the same, the alpha is the same, the power of the study is the same, et cetera. Readout in the middle of January, and after that, we will work with the or the data will be put together, and it's ready for presentation, 2-3 months after. So by that, I move on and turn it back to Carlos. Thank you.
Thank you, Jens. I believe this presentation by Jens addresses some of the questions that we have received. So if we can move to the next slide, because this is the exciting part about a small company like Ultimovacs, that despite having only 26 team members, has been really delivering a lot. And this is reflected, particularly when you talk about our Phase II program that really consists of five randomized studies. NIPU is the first. I think we are all very pleased that we can see that UV1 really makes a difference in patients that normally don't really have any other treatment alternative. Second-line mesothelioma patients, reality is that palliative treatment with chemotherapy and unfortunately progressing and dying very fast.
So the fact that we see a benefit of UV1 on top, in combination on top of a already immunotherapy, is very rewarding. And of course, creates excitement, because if UV1 has an impact on this very, very tough cancer in very advanced patients, of course, provides us with more hope and expectations for the next studies. And the fact is that, in melanoma, this is our lead indication, where INITIUM is performing. We already have a lot of other pieces of data. As you know, we recently communicated on the four-year survival on the first cohort of the UV1-103 study. Basically, patients since from the third-year follow-up to the fourth-year follow-up, no patients knowingly, you know, died.
So really, you know, showing this common that Jens mentioned, when patients respond and get to this flat part of the line, then this line remains quite flat. So this is really, you know, creates a lot of excitement for INITIUM that now we finally and clearly can read earlier. As Jens mentioned, you know, the number of events and the rate of new events was seriously analyzed several times during this period of time, and by expert statisticians. In reality, you know, theoretically, we could still be several years before we reach the seventh event.
So it made absolute sense to discuss this with the authorities and get their approval, because we believe that if it's confirmed that UV1 has a benefit also in these patients, this is also a way of bringing a new treatment alternatives for these patients. So, NIPU positive data showing that the UV1 as a vaccine works. The second company showing that, and the first one with the universal vaccine. INITIUM really showing that the patients are not progressing or dying at the expected rate, so very exciting. But we also have not that far away, you know, the FOCUS trial, where UV1 is combined with pembrolizumab, Keytruda from MSD, in also a very tough indication, first line head and neck cancer.
So another pieces of data that again, hopefully will also be positive and continue to show this benefit and broad usage of UV1 in treating different types of cancers and in combination with different type of checkpoint inhibitors. We also have the DOVACC and the LUNGVAC trials that started later, and we'll be providing an updated guidance with the Q4 report from 2023. So all these different trials, the main objective for us is to show that UV1 works in different tumor types, very hard, like mesothelioma and head and neck, and you know, where it's more defined, like in melanoma, that checkpoint inhibitors work. But we still with a big percentage of patients not responding or progressing.
So, this is really all the pieces of data that we are expecting, that hopefully will confirm this concept of the broader usage. And then also, again, let's not forget that, as the treatment paradigm starts moving to, patients in early stages of disease, like in neo-adjuvant space, you know, before, for instance, melanoma or in lung cancer, before the patients have surgery to remove the tumor, that is also an area that we are exploring because it has a lot of potential due to the fact that UV1 is very safe and is ready to be administered, what is a very key important factor when you want to start treating patients earlier before the surgery. So moving to the next slide, I think I just want to summarize all this discussion with the NIPU.
Again, very good results, where we show that UV1 added to ipilimumab brings a benefit on top of ipilimumab that also had shown a benefit on top of chemotherapy. So hopefully, this will bring benefit for patients, you know, going forward. The clear message from the investigators, but also feedback from some of the key opinion leaders that we met during ESMO, very excited about the data, considering that nothing is really happening in these patients, led us to also agree with the recommendation from the investigators. Now we are already in the activity period, you know, of sharing the data with regulatory authorities, and also meeting, as Jens mentioned, with key opinion leaders to really discuss what is the way forward for UV1 in mesothelioma.
With the recent, you know, today's update on INITIUM, we are also then not too far away from the data in melanoma, that again, if it plays out as we hope, will be a very key piece of data and another milestone in the space of cancer vaccines and for the benefit of patients. So very exciting period for UV1 and for the team. Going forward, it's a very dedicated team, and we hope to continue updating you during this period of time, starting, you know, obviously, with the Q3 report and then as we move along. And then, we're really, really looking forward to the first part of the year, when we can share with you the data from INITIUM.
So I want to thank everybody for taking the time to be here, and we can move now to the Q&A part.
Thanks, Jens. Hans?
Some questions. I think, a few of them have been, properly addressed during the presentation, but we have some, some more. So, the first question, to you, Jens. You, you have clearly said that, it will be interesting to follow the NIPU patients to get more mature data. And, the question is then, when will, these updated NIPU results be presented? And also a related question, when can we expect more detailed analysis of subgroups, from the NIPU trial?
So the ambition for the NIPU investigators is more than one thing. So they want to analyze all the subsamples from this study and liquid biopsies and solid biopsies. They have taken different tissue samples and also feces samples. And they will do a lot of investigations to try to see if there is any associations between what they find there and clinical outcome for patients. Their ambition is to publish this in a publication as soon as possible, and also to update the overall survival, which will be followed for the next five years at the relevant international large conferences. As of now, I do not know which conference this is, but this is certainly something that we will find out in the near future.
The last data cutoff in this trial was August. So the common thing to do is often to let it go half a year or a year, and then look at the data again, to get some distance between the two observation points.
Thank you, Jens. There is one more related question to follow up from the NIPU trial. Following the discussion at ESMO, do you have any update on the number of rounds of Ipilimumab that two arms in the trial received?
No, and this has not been declared yet, but it was a discussion, and we have also discussed this with the investigators, and this is something they also are eager to identify. So, answer to that question will come, but I don't know the timing of that.
Okay. Thanks, Jens. Another question to you related to potential Phase III trial in mesothelioma. What's the path forward within mesothelioma? Has the standard of care now changed, so you have to do a new Phase II trials, or can you move on to Phase III trials?
So with the results from the NIPU trial in Phase II, the ambition is to move directly into a Phase I trial. The standard of care of IP- the first-line trial. So the standard of care is now in first line, so it is the first-line setting that is the interesting setting for the UV1 vaccine on top of Ipilimumab. And of course, we will also discuss the way forward towards a Phase III trial. But first, we need to discuss this with the authorities and also the experts in the field to understand the interest to move forward with this triple combination.
Thanks, Jens. 2 questions to Carlos regarding Phase III trial in mesothelioma. Have you been considering, or will you be considering initiating a Phase III trial in mesothelioma before the readout of INITIUM? And also related, is there an option to move into Phase III in mesothelioma without a partner?
Yeah, no, it's thanks for the question. You know, I think that, as a basic, we have as a policy in the company and as a goal to operate as an independent company. So we are continuing with all the other activities as if, you know, we want to make sure that we initiate a Phase III as soon as possible. But of course, all these activities that Jens also mentioned, discussing, sharing the data with the authorities, getting feedback, talk with, talk with KOLs, you know, present, discuss then what will be the protocol. These are the activity, activities that take some months. So, I can, I can tell you for sure that no Phase III study is gonna, in mesothelioma, is gonna be initiated before the INITIUM data. That's, that, that is for sure.
What I can tell you is that regarding if it's gonna be with a partner or by ourselves, I think as I mentioned, having been on the pharma side, as a negotiator, you know, they also appreciate that not tested. So all the activities that we'll do in discussing with the authorities are valuable for us as a company, but also in discussions with potential partners, because what they want is really to initiate these studies as soon as possible. Basically bringing new treatments and get the product approved as soon as possible, to extend the number of years that under patent protection, they it can be commercialized. So all the activities that we are doing are not only in the interest, of course, of Ultimovacs, but also as a potential partner.
If it's gonna be us or a partner to run the study, it's gonna be depending on all the discussions we may be having in parallel as we move with these activities.
Thanks, Carlos. Then a question to Jens, related to INITIUM. As we now move the focus from the NIPU trial in mesothelioma to the INITIUM trial in unresectable or metastatic malignant melanoma, do you see any read-across from the NIPU trial into expected results in INITIUM? And also, is there a risk that the challenges of PFS as a surrogate endpoint in mesothelioma could that be a similar issue in the INITIUM trial?
So, difficult to tell about the future when we have not been there, but, just some reflections around that. So, it seems like in mesothelioma, a smaller proportion of patients respond to checkpoint inhibitors. So there's fewer patients with true effect to the CPIs that are in a part of the primary endpoint. Most patients doesn't respond to the treatment and therefore produce endpoints without contributing from one arm or the other on the primary endpoint. This is different in melanoma, where most patients or a higher proportion of the patients are responding to CPIs. So if there is a difference between the control arm and the intervention arm in a melanoma trial, it will more certainly be seen on the PFS endpoint.
This has been seen in other trials, with CPIs, combi therapy versus monotherapy, et cetera. So we expect to see a different readout of PFS in melanoma. When it comes to, if these results can be in a way, informative for the readout in other trials, so by intention, we have participated or sponsoring trials in different indications to understand the biology and mode of action of the vaccine in different biologies and different indications. So when we see here a reduction in risk of death of 27%, we see that as an interesting efficacy for patients. This is a Phase II, but we still believe that the data are of value, and it gives us increased hope that this is also what we will see in the other trials moving forward.
Thanks. Then a couple of questions related to statistics in the INITIUM trial to you, Jens. Regarding the INITIUM statistics, to what level are the statistics compromised since you have seen the expected number of events that led to the statistical plan?
To be clear on this, the INITIUM trial, the statistics in the INITIUM trial is the same today as it was one month back and as it was in the beginning of this start study. The statistical analysis plan for this trial has been around for a long time, and that is the same plan now as earlier. The alpha is 0.1, one-sided, the power is 80%, and we had pre-planned 70 endpoints in this trial to do the calculations. Based on the development in this study, where the study is maturing without acquiring new endpoints. We are waiting over time for the endpoints now, and as we stated a few slides back, the median observation time will be around 24 months in January.
This is way beyond the curve of the Kaplan graph when it comes to ipilimumab. Most patients is on the flat curve. So we expect and have seen very few new endpoints over the last period of time. This observation has been discussed with the statisticians for the study and also with the authorities, and there is little more to gain waiting for the last endpoints to happen in this trial. Therefore, there was no objections from authorities to analyze the study prior to 70 endpoints. As I said earlier, so if you have a one-digit reduced number of endpoints in this trial, that will lead to very small different in the hazard ratio, you need to be below. With 70 endpoints, we need to be below 0.736.
If you have 7, 8 endpoints less in the cutoff analysis in January, you need to be below a hazard ratio of 0.726. So we - it's a little bit tougher for us, incremental. And the bias is on us. We are not going to any easier situation. It's somewhat tougher for us, but very little tougher. So there is no compromised statistics in this study, and we really look forward to the readout of the trial in March, April.
Thank you, Jens. Then another question that may be based on a misunderstanding that may be good to clarify. Could you give us some color on the number of events that you are expecting to see from today to January, assuming the reason for re-readout in January and not today is the need of your some extra events. Is there any possibility that you do not achieve these new events before January, and you have to postpone readout again?
So, we are from the start waiting for 70 endpoints, and as I said now, the maturation of the data in this study is ongoing over time. It was expected to read out in the first half of this year. Now, it's expected—we know that it will be read out in the first part of 2024. So the median observation time of patients in this study is well above what you could expect for a Phase II trial, actually 24 months, which is a median observation time that is far beyond the median PFS that you have seen in earlier trials with ipilimumab in this field, around 10-12 months. So we are not waiting for some endpoints.
We are waiting for a time point where all patients have been at least in the study for 18 months. That is something we wanted to achieve, and therefore, this readout will be in January. Nothing will change in this study, regardless if there are new endpoints coming in now, between now and January or not.
Thanks, Jens. Then there is one question on funding that I'm happy to cover. Is there a need to secure new funding before the readout of INITIUM? What we have been guiding for some time is that we have an expected financial runway to the second half of 2024. Specifically, we have guided that we expect to have a financial runway through the readout of INITIUM and through the readout of the FOCUS trial in head-neck cancer. So we don't see a specific need to pursue funding before INITIUM readout. We are comfortable with the current financial situation. Of course, we have positive expectations to the INITIUM readout. We also know we have a strong and large shareholders that have been supporting the company for a long time.
All in all, we are comfortable with the funding situation. I think any biotech company would always state that, of course, you will always consider your options with respect to funding. We have clearly stated that we have as a strategic target to enter into a partnership for UV1, and of course, we will ensure that we are, at any point in time, sufficiently funded and well-positioned in all respects to be prepared for different alternatives and have a strong negotiation position. But in conclusion, there is no specific need for any funding before the readout of INITIUM. I think we have only one question left for you, Carlos.
I see we are about to run out of time as well. So if you can give a high-level update on what the current ambitions are for partnering for UV1.
Thanks, Hans. Well, we, you know, we will continue with the usual process. We talk continuously with all the pharmas that operate in oncology. So we already started sharing with some of them. The data will continue. There are different business development partnering conferences coming, so we'll continue sharing the data, now the NIPU data and then INITIUM data. And the goal is that while we run all the other activities, in parallel, we bring these companies up to date with the news, with the data, and we assess their interest in entering into a partnership.
Because, as we stated previously, we believe that we can maximize the potential of UV1 and in the hands of a bigger player that can move forward several cancer indications on the base of this data that we have now in NIPU, hopefully with INITIUM. But also the fact, as we also said, that you know, now as a company, UV1 is manufactured in the commercial process. This is very important for a potential partner. So basically, with the data that we have, the data coming, and all the other pieces of the puzzle in place, we believe we are in a very good position to you know accelerate some of these discussions.
We will just continue doing what we do, and share the data is the most important piece.
No more questions.
Thanks to Jens for doing most of the work here, and thanks to Hans and Anne for coordinating all the activities. Of course, a big thank you to all of you that participated in this webcast, and that took the effort also to send us the questions. Hopefully, you know, we were able to address most of your questions, and if not, you know, please continue to send it to us. Next week, we have a Q3 report to webcast, so if needed, we can address some of those there. With this, I want to thank everybody, and also for your support, and have a good rest of the day. Thank you.