Good afternoon and good morning, everyone. Welcome to Immunovia's Key Opinion Leader event. My name is Patrik Dahlen. I'm the CEO of Immunovia, and it's a pleasure to welcome you all today, both our audience on the webinar and the eminent experts that we will listen to in the panel discussion. We, Immunovia, are standing on the threshold of launching our first product, IMMray PanCan-d, a blood test for early detection of pancreatic cancer as a laboratory developed test, or LDT, in the U.S. by Immunovia Inc. This means that clinicians soon will be able to use the test, and the purpose of this event is to provide a better understanding of how our test will be used. It will also be an opportunity for you to ask questions to the invited key opinion leaders who are all seeing patients in different parts of the healthcare system.
The aim of this event is that they will share their perspectives on why this test is important for different high-risk groups. The panelists are Dr. Stephen Pereira, Dr. James Farrell, and Dr. Geoffrey Burns. Thank you all three for joining us today and for sharing your views with us. The moderator for the panel discussion will be Dr. Thomas King, our medical director from Immunovia Inc. We will be taking questions from participants throughout the event, so please submit your questions to the panelists at any time you like. The moderator, Dr. King, will indicate when he opens to questions from the audience. Questions can be submitted via email by clicking the email icon below or by phone. We urge you to focus your questions on clinical and scientific matters, and the panelists will answer all questions.
If there are Immunovia business-related questions, we, that is Tom and myself, will address those at the end of the seminar. I really look forward to a very productive and informative webinar for all of us. Again, thank you all for joining. Before I give the word to our moderator and the panelists, I would like to give an update on Immunovia. These are our disclaimers and forward-looking statements, and I encourage you to read these at your leisure. Immunovia is at an historical point in time. We are ready to launch IMMray PanCan-d in the U.S. at Immunovia Inc. as a laboratory developed test. IMMray PanCan-d is the first test available for early detection of pancreatic cancer, and it is a blood-based test, which will make it easy to use compared to current imaging methods.
Early detection is important, as today, more than 80% of all diagnoses of pancreatic cancer is at late stages of the disease, when it is too late and the cancer is no longer resectable. IMMray PanCan-d will be launched as an LDT from Immunovia Inc., and the testing will be performed by our lab in Marlborough. We will start as soon as we have obtained a CLIA number. Financially, Immunovia is in a strong position. We had SEK 425 million at hand at the end of quarter one 2021, and we are fully funded for the commercial rollout of the test. Obviously, our short-term focus is on the U.S., and we're working hard on a plan for Europe, a plan that we will communicate later this month.
We have a goal to obtain 30% market penetration in the risk groups and the markets where we roll out our test. As we are first to market, we think this is a reasonable standpoint to take. The overall market size that we target in the U.S. and Europe combined exceeds $4.4 billion. I wish to take this opportunity again today to remind everyone how important of a mission we're on here at Immunovia. With our blood-based test, IMMray PanCan-d, we will provide an entirely new solution to early detection of pancreatic cancer. Early detection of pancreatic cancer is critical for improving the survival of pancreatic cancer patients. When pancreatic cancer is detected in stage one or tw, the five year survival significantly improves. It goes to 50% survival rate after five years, compared to less than 5% when pancreatic cancer is detected in stage three or four.
Today, the median survival rate for newly diagnosed pancreatic cancer patient is 4.6 months, the reason for this is simply that 80% of all pancreatic cancers are detected too late, in stage three and four. I would like to take a moment to remind you of the performance data of our IMMray PanCan-d test and share with you the results of our final validation study that we presented in March. We obtained excellent results for all PDAC patients versus a familial hereditary control group. Accuracy was 94%, specificity of 98%, and sensitivity of 87%. More interestingly, we see that the detection of early-stage pancreatic cancer, that is stage one and two, versus a control group of familial hereditary individuals, we had an accuracy of 92%, specificity of 98%, and a sensitivity of 85%. These are absolutely outstanding results.
We're very proud of these results, and we've gotten good response from experts with regards to the performance of the test. In terms of CLIA, I can share with you that we filed our application in April. Normally, we would have expected to obtain a CLIA number in 30 days, so well within May month. We hear from CLIA office that they have been forced, due to the COVID-19 pandemic, to prioritize COVID testing laboratories, and they have a backlog in terms of handling applications. At this stage, we do not have a more firm date for when to expect a final go from CLIA. However, we continue to believe that it should be imminent. We continue to strengthen the team in the U.S. We already have a strong team in place, of course. We are adding two new lab technicians.
We're adding a quality assurance specialist, and we continue to build our marketing team, customer support, and the market access team. Naturally, we will continue to monitor progress, and we're ready to increase our efforts and resources in the U.S. as we progress. We're also launching our second payer study, and here we work closely with Dr. Parker from Precision for Medicine. In terms of the road to market, we obviously launch our test as an LDT for Immunovia Inc. As usual, the test will be paid for out of pocket by the persons who take the test. This is standard practice in the U.S., and we will seek a PLA code for the test. We will conduct a series of studies to demonstrate test performance and show clinical utility. These studies will be conducted in the U.S., obviously, by U.S. investigators.
From these studies, we will compile the dossiers that we will present to the payers and use in our coverage negotiations with the payers. We argue, supported by our consultants and the relevant medical community, that our test is not a screening test for the general population, however, rather a test for surveillance of risk groups, either high-risk groups for familial hereditary nature or symptomatic patients that display vague and worrisome symptoms linked to pancreatic cancer. For this reason, we do not anticipate a lengthy process time for reimbursement, as our test is either diagnostic and/or an aid in diagnosis in high-risk groups. We fully expect that the majority of the payers' agreements would be in place by end of 2022. With this, I would like to turn over to Dr. Thomas King, our Medical Director, who will moderate the panel discussion. Tom?
Thank you, Patrik. I'm Dr. Thomas King. I am the Medical Director at Immunovia Inc. I am a board-certified pathologist who's been in practice in the U.S. for over 30 years in both academic medical centers, private practice, and in pharma biotech. I'll be moderating today's discussion with our distinguished panelists, Dr. Jeffrey Burns, Dr. James Farrell, and Professor Stephen Pereira. I'd like to thank all of our panelists for participating in this program and for you as well for dialing in to participate today. I hope that the discussion will be informative and helpful for all of you. We will be accepting your questions, I want to remind you, for our panelists throughout the program. You can submit them by clicking the email icon under the screen or by calling in to our operator, who will be waiting to assist you.
I'd like to begin by asking each of our panelists to introduce themselves and give a brief sketch of their clinical practice and interests. Dr. Burns, would you like to start and also say a few words about concierge medicine? I think that would be helpful since this is not a common practice type in Europe. Dr. Burns?
Thank you, Tom. Thank you, everyone. As a family physician, often known as a general practice physician, I've been employed by the U.S. government as they put me through medical school and did my residency in California with the U.S. Air Force. I've been employed by Mass General Brigham as a primary care physician for eight years, and now I've been in private practice for the last seven years.
It turns out that in most parts of Europe, until just very recently in the Czech Republic, concierge medicine was not available. In fact, a practice just opened named Concierge Medicine Europe in Prague. The intent of concierge medicine is to really bring down the patient panel size so there's a much more small doctor feel for the patient, and that you are available to your doctor around the clock, that you have same-day appointments, that you have much more of a personalized and tailored presentation. In the U.S., we often would call someone like myself a primary care physician. I prefer to use the acronym PCP just the same, but it's a personalized care physician. I think Immunovia really will fit in well for that personalized care that I will continue to deliver to my patients. Yes. Professor Pereira, would you introduce yourself, please?
Thank you for being here.
Thanks very much. Good afternoon, everyone. I'm a consultant gastroenterologist based at two major teaching hospitals in Central London, which are affiliated with University College London here in the U.K. I'm also a pancreatic cancer researcher. I lead a national early detection research alliance, which is focused on early cancer detection in the NHS, National Health Service, setting. That has contributed to validation of the IMMray PanCan-d test. I think we're all aware, as Patrik has mentioned, of pancreatic cancer's shocking statistics. As you know, up to now, we've not had a simple test for diagnosing. The issue is a particular one in the U.K., where up to 50% of people in some urban settings are only diagnosed with pancreatic cancer when they come to accident and emergency with late symptoms. We certainly need better effective treatments.
Being on the frontline here during the COVID-19 pandemic over the last several months has shown that the picture of delayed and missed pancreatic cancer diagnosis is the worst I've seen, I think, in my career so far. I think with IMMray PanCan-d, we now have a simple test, which is accurate, as we've heard. From a U.K. perspective, as part of the Early Detection Research Alliance, we're particularly interested in its use as an adjunct or an alternative to current imaging and endoscopy screening programs for people with new-onset type two diabetes. It's an area of active interest here in the U.K. with a nationally funded study. Patients with pancreatic cystic lesions who normally undergo imaging and endoscopy screening, which we're no longer able to meet requirements for in the current situation. Also, obviously, individuals with a strong family history of pancreatic cancer.
Again, we're not able to meet requirements for annual endoscopic ultrasound in that group, and there's obviously a potential for changing to biomarker tests. I think its biggest potential impact is likely to be in patients with so-called vague or non-specific symptoms, both in primary and secondary care, who wouldn't normally be investigated along urgent suspected cancer guidelines. Here in the U.K., we have a two week maximum before people with suspected cancer symptoms need to be investigated, and that's mandatory. We're interested in that group, and in conjunction with refining current decision support tools, which again is a U.K.-specific thing based in primary care, where risk factors such as age, smoking, family history, are combined with symptoms to alert general practitioners to patients with suspected cancer.
In wider use, and we're also interested in understanding the barriers to biomarker implementation within the U.S., which is different, even in the U.K., which is, of course, different to the U.S. and other countries. I think I'll stop there, and I'll hand over. Thanks.
Okay. Thank you. Thank you, Professor Pereira. Dr. Farrell, last but not least, please introduce yourself.
Thank you, Tom. Good morning, good afternoon, everybody. Thanks for the invitation to participate. Thanks to Immunovia for setting this up. My name is James Farrell. I'm a professor of medicine at Yale School of Medicine here in New Haven, Connecticut. I'm very similar in my clinical practice, and I think training to Professor Pereira. I'm primarily a gastroenterologist involved in the world of interventional endoscopy, which involves procedures of the endoscopic nature, which allows us to take care of patients with a wide variety of pancreatic diseases, including pancreatic cancer. Unfortunately, more often from the palliation and treatment side rather than initially from the early diagnostic stage. It also gives us introductions into the world of pancreatic cysts, high-risk individuals.
I am predominantly a clinician with a strong research focus in the area of pancreatic disease, now in the realm of early detection, but in a previous life, more so on the treatment side. Very similar, again, to Dr. Pereira, we are involved with a high-risk patient screening program, pancreatic cyst disease, and are also now beginning to jump into the world of new onset diabetes as high-risk groups for that. Also coming from the perspective of translational medicine and trying to understand the development and validation of biomarkers.
Excellent. Thank you. I thought it would be best to begin our discussion with a bit of an overview for the audience of the current situation in pancreatic cancer detection and diagnosis. Dr. Farrell, maybe I can pick on you first. What do you feel are the major challenges in diagnosing and managing pancreatic cancer today?
Some of this has already been mentioned, Tom. From our perspective here in the U.S., at least. The numbers of pancreatic cancer are rising, so we're up to about 50,000 cases per year for a population of 330 million or so. In terms of COVID incidence, it's a lower volume issue. In terms of cancer-related deaths, it's currently on its way to being the second most common cause of cancer-related death in pancreatic cancer. A lot of those reasons go into. Yeah, there's a true increase in the incidence, probably related to age, obesity issues for sure. As you know, there has been also tremendous progress in other cancers with respect to treatment and even early diagnosis. A lot of it is kind of a relative change. We're in a scenario where there are treatments for pancreatic cancer.
Yes, we've talked about the patients presenting late, but the treatments are only slightly incrementally better. They're certainly not being that dramatic blockbusters. I'm not an oncologist, there really haven't been that many blockbusters in the last couple of years from the perspective of treating patients. Again, the majority of patients, unfortunately, present with locally advanced, where it's not a surgical resection disease or metastatic disease, where it certainly isn't a surgically resectable disease. I think the world, in terms of the medical oncologist look to us as gastroenterologists, patients look to us and say, "Well, what's going on in the world of early detection?" There is a real need here to try and crack this nut from an early detection. For sure, there will be developments in treatments and immunotherapy and all those things.
Really, the issue is can we crack this and can we improve survival through early detection? Maybe Stephen could allude to some of those challenges that we have with the early detection approaches.
Yeah. Thank you, James. Dr. Pereira, would you like to have additional comment?
We have a similar situation, of course, in the U.K. I think there's a big unmet need for improving public awareness for symptoms and signs of pancreatic cancer. That's really been hugely successful in many other cancers, of course, with breast cancer screening, with colon cancer screening. Really, very few people know where the pancreas is or indeed what sort of symptoms to look for. I think that's an important thing. We know from our own studies, and others, for example, we have access here to two databases of symptoms in patients going to their general practitioners of 40 million patients and 15 million patients, which we're currently looking at.
We know from those data, which we published on a couple of years ago, that patients with pancreatic cancer have had symptoms which could be attributable to their cancer at least 12 months before a final diagnosis, and I think there's certainly room for improving the pathways for those patients. Here in the U.K., based on clinical decision support tools, which I have mentioned, the National Institute for Health and Care Excellence requires that patients with a pre-test likelihood of having a particular cancer of more than 2% should go to appropriate imaging urgently, and that's within two weeks. The great majority of patients with pancreatic cancer do not fulfill those criteria and go down a slow route. I think there's a great potential for bringing in biomarkers in that group to triage patients to particular tests. Obviously, contrast enhanced CT as the first test for pancreatic cancer.
Yeah. I think we've all seen patients or known individuals who've developed pancreatic cancer and then been bounced around for one year or more before they actually get a diagnosis. So I agree with you. I think it's really important to prioritize. As Patrik mentioned, we expect to launch IMMray PanCan-d soon as a laboratory-developed test at Immunovia Inc. in Marlborough, Massachusetts. And as he said, we recently reported the results of our pivotal blind validation study that demonstrated a sensitivity of 85% in early stage, Stage one and two pancreatic ductal adenocarcinoma, with 87% sensitivity in all stage pancreatic ductal adenocarcinoma, with a specificity of 98%-99%. Dr. Pereira, do you feel that these performance characteristics would be useful for evaluating individuals at increased risk for Pancreatic Ductal Adenocarcinoma based on their genetic or familial history?
Well, I think it's a highly accurate test based on that, and I think I'd answer it in two ways. One is from a patient and clinician perspective, we've done work with stakeholder meetings as part of our National Alliance and know that groups ranging from patients to clinicians to health authorities would view those kind of levels of detection as acceptable for testing in the NHS. What I mean by that is that if you ask a patient, "If you had a test which was 90% accurate for a cancer, would you like to have that test?" The clinician at the same time, "Would you act on that test and send that person for appropriate imaging?" The answer to those questions are, of course, yes.
The other thing which, of course, is important is that based on those sensitivities and specificities, it's eminently possible to do confirmatory validation and implementation studies in defined cohorts to prove clinical and cost-effectiveness. For example, with those, you need only 2,000 patients, for example, to test in a particular cohort of people with a particular risk of having pancreatic cancer. We can now go on and do those additional studies in an NHS setting to confirm effectiveness and acceptability.
Thank you. Dr. Burns, would you like to comment for your practice?
I think, again, so many patients that get referred to genetic counseling or to especially clinics like Dr. Farrell's, they're in their queue, they know what they're doing. To really do take a family history, to see somebody's risk and then, oh, that's great. You have people that have pancreatic cancer. I wish we had early detection. I wish we had a way to monitor you earlier. We're just sort of waiting for that shoe to drop. It's very fatalistic for the patients and even to counsel them in that way with this new tool and to say, well, actually, there is something that we can do, and there is something we can do sooner. I'm very encouraged, and I think my patients will be as well.
James, would you like to comment as well?
I think when you look at the current state, and I know that we're not really primarily talking about a general population asymptomatic approach, but when you see what's going on in clinical practice, for good or for bad, it's reliant on an older technology, the CA 19-9, which doesn't really have a particularly good sensitivity or specificity but is kind of used often in this scenario. That's a much bigger discussion than today. It is great to have an opportunity to see kind of updated 2021 technology improve the possible signature for pancreatic disease. Ultimately, I think we would all want this world to go to general population screening. Also, obviously, we're talking about going in the direction of symptomatic management.
Again, specifically to your question about the high-risk groups, I think really for the folks listening in, when we talk about high-risk groups, in our minds at least, we're thinking about people who are at a higher risk than the general population.
We're talking about groups who are, by and large, asymptomatic. The three big groups that we think about, again, are just the familial cohort with or without a genetic mutation that they carry, pancreatic cyst, and diabetes. It's really the first group that we have the most information on from perspective of these types of biomarkers. This group, we believe, has a higher rate of developing pancreatic cancer, be it showing up in either an early-stage cancer or a Pre-Invasive Lesion. One of the issues with even CA 19-9 and any sort of potential suitor to this field is literally what we're talking about, which is the operating characteristics. To remind people that when you don't have great operating characteristics, you end up with for sure missing things and for sure over-calling things.
Those are really a central issue here that we have to keep in mind. When you start quoting sensitivity of the region of 85% for stage one and stage two cancers, that's actually a pretty good number, but probably as important, so that basically means that you're going to find those early cancers. Almost as important then maybe from a societal perspective, the very high specificity, so that if the test is positive, that it turns out to be cancer, is also important because what that means is in an enriched population, it decreases the chance that there's going to be false positive tests, which will really be a kind of a societal deterrent for something like this in terms of justification.
In summary, I think when you look at these initial numbers that are coming out, when you look at this, when you compare it to what's out there already, as we get a growing understanding of high-risk groups, particularly the genetics and familial group, this is a very promising point in history to be at.
Thank you. I certainly agree that specificity is very important because not only in terms of the cost and inconvenience of the workup of false positives, you have the psychological burden of getting a positive test, which is certainly substantial. Professor Pereira, any further comments for you, particularly in terms of specificity?
We know that we don't have a test for the general population.
Right
Swiss trial published on that. If you look at people over the age of 50 and bring in a test which is almost perfect, 99% sensitive and specific, you can pick up almost every patient with pancreatic cancer, but in 100,000 patients, you'll have 1,000 false positive patients. There's a societal and a patient cost to that in terms of anxiety generation and obviously financial costs. The other thing I would say, again, we have a real need, particularly in the risk groups that James mentioned. We've, again, published on our experience with screening individuals with an increased risk of pancreatic cancer in 300 patients followed up for many years and only found one patient with pancreatic cancer after several hundred endoscopic ultrasounds and MRI scans.
It really is the current screening programs for pancreatic cysts and in individuals with a strong family history are expensive and invasive, and there is a need for non-invasive, accurate tests for those groups.
Thank you. Dr. Burns, how important is test specificity for you in your practice?
Well, I think it was, as it's mentioned, trying not to freak our patients out with a false run and a test that says it's positive and they're already hearing the worst, and then it's turned out not to be. You really want to be able to reassure them ahead of time that the likelihood, if the prior testing criteria have been met, the likelihood of it being a true positive is strong and that we want to act on it because it's all about doing it early. By waiting and then having a test, because I'm not sure about this test, it's a new test, it's a year later, we've already heard a year later is late-stage cancer for that person. I think we're going to get a fair amount of early adoption with people that are adequately concerned and that are proactive.
Part of what American healthcare has become, unlike what is happening in the U.K., is we're very reactive to our care. People have symptoms. People have issues. They've had their first heart attack. Let's try to prevent their second heart attack. We really haven't moved very far into proactive care, and I think this Immunovia test really is certainly at the vanguard of moving proactive care to the right high-risk group, certainly not the general population, I don't abide that. Really allowing it to trickle down to primary care where a lot of this risk can be assessed and adequately deemed because diabetes is that third group.
That new onset diabetic is an epidemic, and if we can dial in a little bit more of the characteristics of these new onset diabetes patients and their risk for pancreatic cancer and have something to weed it out very early on, I think that's going to save a lot of heartache and a lot of cost to the American healthcare system, and it's going to forward this type of proactive approach.
Thank you. We have a question from the audience. It's clear to me about the importance of early detection, but I'd like to understand a bit more about how the treatment plan differs in different stages of pancreatic adenocarcinoma, both from the patient's experience point of view, but also from a cost point of view, if possible. That is there a stage where you would avoid invasive surgery? Dr. Farrell, maybe you can begin.
Sure. Broadly and hopefully succinctly put, which I have issues with, but I think about pancreatic cancer in terms of three stages of presentation. We think about a stage where it's confined to the pancreas, away from significant blood vessels, has not spread to the liver. Broadly speaking, we call that an early resectable stage. Those are patients who do better. Those are the sorts of patients that we are trying to find through these sorts of programs. The next stage up is what's called a locally advanced stage, whereby it's still confined to the pancreas, but it's involving significant blood vessels, important blood vessels. There's no overt evidence that it's spread outside the pancreas. Down the road, it may become one, and those patients are typically treated with chemotherapy and/or radiation therapy.
As we mentioned before, not particularly great options like you would hear with other diseases currently like colon cancer, kidney cancer, and so on, so forth. The final stage is called metastatic disease, where it's spread to the liver, and for sure those patients are not candidates for surgery. There's really no point removing the primary tumor and leaving additional tumor at metastatic sites. Again, chemotherapy is an option for those patients. When you look at survival across those three groups, optimistically, we think about 5-year survival as maybe 50% for the 1st group in really good hands and good centers, but then jumps down to 20% and 10% for the 2nd groups and even smaller again.
When you think of the percentages of what those groups actually are, we think for that first group, it probably only represents about 10%-15% of patients, honestly, and for the other two groups, maybe an equal 40%. Those are the challenges. I hope that kind of helps the person who asked the question.
Thank you, James. Professor Pereira, would you like to add anything?
It's the same here in terms of patient proportions and approaches. The other aspect of the question was, is there any alternative to surgery? I think an unexplored area so far is certainly surgery is the gold standard for small pancreatic cancers that appear resectable on imaging, and that's a standard approach. We are entering a realm of better and better imaging, functional imaging. We're all hoping to be able to see smaller and smaller early cancers with appropriate imaging and maybe even precursors to that. We don't yet know how biomarkers will operate in that group. Obviously, people are having more and more scans. That may again be a role for the PanCan-d test. James and I and others have been involved in trying to develop ablation techniques for small lesions, which may not be cancerous, particularly in the cyst field, et cetera.
There are some possible other approaches coming online over the next few years, but certainly surgery is the gold standard and will remain so for cancer.
Okay. Thank you. A few more questions from the audience. Do you see IMMray PanCan-d as being strong enough to change clinical guidelines in the United States? James, I think probably the best to answer that.
I guess the first point to say is that there are some well-established clinical guidelines at a national level that have now moved into more decisions and guidance on diagnosis and early diagnosis and surveillance. What I mean by that is that in prior times, these guidelines focused almost 100% on treatment and what options are available for different stages. The first thing to say is that there are guidelines, they are taking an interest in early detection and diagnosis, and even looking at high-risk groups. I think it depends on how the data plays out and how the pivotal studies play out, and how even post-marketing surveillance plays out to the point of saying that it would become a formal recommendation within those groups.
I think people are beginning to understand that we have several guidelines for surveillance of particularly high-risk groups, such as pancreatic cyst and the genetics groups. What we're beginning to appreciate is the issue that the success of that is very much limited by resource issues. Dr. Pereira mentioned how often can patients really be getting good quality endoscopic ultrasound? How often do they want to show up? How often can we be getting them MRIs and CT scans? There's a real need to look at non-invasive blood tests to try and replace that or streamline it and stratify patients. I think that might also be a direction that this could go in from guidelines perspective, because it's better, a bit like the colon cancer story, although not identical in certain ways, it's more important that a patient have some test than no test.
With colon cancer, we're running into issues, again, of resource availability.
The attractiveness of, for example, the stool studies right now, it's not that it's the perfect or best competitive test, but it is a test that brings people, brings physicians, brings patients into the forum. I'm optimistic that guidelines will address the role of markers in diagnosis, because they will have to, because these guidelines are now addressing issues of diagnosis.
Thank you, James. Professor Pereira, another question from the audience. What do you think would be needed from PanCan-d in terms of further development to make it widely adaptable?
Well, if I go into that from a U.K. perspective, we have a National Health Service and a minority of patients, predominantly in the larger cities with private healthcare, and obviously that includes London. With commercialization of the PanCAN test, that'll be available to patients should they wish to purchase that. That won't have very much impact in the National Health Service, and they won't be paid for by the National Health Service at present, as that would be my understanding. Patients in the U.K. have had free access to healthcare for many decades and are not used to paying for tests, although that is changing a little bit with some of the genetic profiling on offer for patients with cancers who want to know more about their cancers, but it hasn't been accepted by NICE.
I think what we would want to see is an assessment of the technology by NICE, and I know that we have had discussions with NICE to get that started. The likely outcome of that will be that the assay in the National Health Service should continue to be tested in good quality clinical trials. An example of that would be post-commercialization implementation of the assay in a randomized study, for example, against standard of care, and then showing that there's a clinical effectiveness in terms of improving diagnosis and that it's cost-effective compared with the standard pathway. Those types of studies we're in discussion about and eminently doable with the sensitivity and specificity that you've quoted.
Okay. Thank you. Operator, do we have any questions on the call, on the phone?
Yes, we do have one question on the line at the moment, and that's from the line of Viktor Sundberg of ABG Sundal Collier. Please go ahead. Your line is open.
Yeah. Hi, everyone, and thank you for hosting this panel. My first question is related to the UK Collaborative Trial of Ovarian Cancer Screening that was published in The Lancet a couple of days ago. I don't know if you have seen it, but they found 47% more cancers in stage one compared to no screening. However, there was no survival benefits with early detection, leading the authors to conclude that mortality should be the primary outcome maybe of larger trials that investigate screening or surveillance for patients to find cancer early. I guess my question is, do you believe that a mortality-based outcome study is needed in pancreatic cancer to avoid lead-in length time biases? I guess my question is especially related to the NOD group.
Yeah
which could be 1.5 million patients, and also the hereditary and familial risk groups that we have been discussing today.
That's an excellent question. The UKCTOCS cohort is based here at UCL, and we've been looking at that in detail over the last few years for pancreatic cancer and other cancers as well. It's the largest randomized trial in the world. It's been very useful in trying to detect biomarker profiles years before clinical diagnosis of pancreatic cancer in a group of post-menopausal women who were part of an ovarian cancer screening program. Obviously, no one is doing that. I wouldn't equate the outcome of ovarian cancer with pancreatic cancer. I'm not sure that we can expect the same conclusions that UKCTOCS have arisen from the trial of using CA125 and with ultrasound in conjunction with biomarker profiles. I can't speak for NICE. I expect that a biomarker which is showing utility in terms of improving stage disease, it will be effective.
I know that because the Cytosponge trials, which were led by Rebecca Fitzgerald here, they're studies which have really gone on for 20 years, from conception to implementation into the NHS as a test. It involves swallowing a small sponge, which then takes cells from the lower oesophagus to determine if a person has a precancerous condition of the lower oesophagus without the need for endoscopy. Those studies were not based on mortality. They were based on detection and improved detection of high-grade changes of the oesophagus in people having a non-invasive test. I think if we can show that the improved staging of pancreatic cancer, from stage three, four disease to stage one to two disease, is improving with implementation of a biomarker test, that would be very important.
That's actually one of the goals of the National Health Service five year plans, is to improve overall early-stage diagnosis to 75%. That's not going to be possible for pancreatic cancer in five years, but that's what the overall goal is in all cancers in the U.K.
Viktor, did you have another question?
No, I think that could be interesting to hear other KOLs' perspective as well, if that's possible. I have some other questions as well, but I don't want to take too much of your time.
Okay.
Thank you. Jump back in the queue.
Well, certainly, it's an open question. What we know now is that early-stage disease has longer survival. Will that translate into durable cures if we can really detect the disease early? I think that's an open question, right? We don't know for pancreatic cancer at this time until there's a way to detect cancer early enough to be able to address it in terms of survival. James, would you like to comment?
I think it is a key question. I think mortality as an outcome is the direction that we should be aiming for. I think we're at a point where I feel like even though there's been tremendous work in the realm of pancreatic cancer for the last 10 or 15 or 20 years, really intense work at a molecular level to understand it, I still feel we're at the beginning. We're at the beginning of these long journeys where maybe colon cancer, maybe Barrett's esophagus are now at least coming to those points. I mean, that's a hope, which is not always a great strategy, but it's a hope. That's really what's going on. We're just getting started, meaning we're trying to figure this out. We're trying to figure out the high-risk groups. We're trying to figure out how to even study the high-risk groups.
Yes, the ultimate goal would be to do pivotal studies that show impact on mortality to get at these issues of lead time bias and so on that affect all these sorts of studies. I think one piece of interesting information that is small that kind of has me thinking about is that, and again, it's a limited data set, but from a high-risk population, showing that for some reason, patients that are detected at an early stage in high-risk surveillance programs do better than patients who present sporadically at the same stage. Small numbers, but an interesting signal. I don't have a simple explanation for you as to why, but maybe it has to do with the symptom presentation versus asymptomatic presentation. That is kind of a cause for hope.
It also brings up kind of an issue for pancreatic cancer, which is we talk about early stage, but we would love to also be talking about precursor stage and pre-invasive stage. That's really what we would want to be talking about to make a significant dent here. Again, really probably through the cyst world, hopefully there'll be some advances in that. The cyst world collides with the high-risk world. Again, I feel like we're at the beginning of this, and it's a long process and a long haul, but there have been some small, important signals.
Thank you, James. James, another question for you from the audience. How many patients are currently enrolled in surveillance programs for familial hereditary PDAC in the U.S.? Do you have a sense of the numbers?
That's a great question. I don't have the absolute number. I know that there are several large studies, the largest of which in the U.S. is the CAPS5 program. In all honesty, the PanFAM study is also an equally large number. We're talking of several thousand, anywhere between 3,000-5,000 studies in these individual studies. They range across anywhere from six to nine centers. There are other health systems that have also evolved to develop their own surveillance programs. Again, this is for the high-risk genetics groups that are out there. Currently, with pancreatic cysts, several large prospective studies of the order that hope to enroll somewhere in the realm of 10,000 patients have taken off and are starting. Recently, a large NOD study was announced, and we're talking about numbers in the realm of 10,000-15,000 patients enrolled over 15 years.
Again, alluding to my prior comment, we're not in this for instantaneous gratification, we're in this for the long haul. These sorts of studies take these sorts of numbers and this amount of time, and I think a lot of us are willing to put that effort in and to be patient. It's a great question. I think, again, the clinical guidelines have supported surveillance programs in high-risk genetics groups, for sure, individual centers have their own programs. When it comes to formal prospective studies, the individual studies that are out there typically have anywhere between 3,000 to 5,000 patients enrolled.
Okay. No, thank you very much. Just for clarification, PanFAM is Immunovia's prospective trial to look at familial and hereditary pancreatic cancer patients to sample their blood and to follow them by imaging. I think, as you alluded to, there certainly is a collision of hereditary and genetic factors with cysts as well, since at least in the few PanFAM samples we've analyzed thus far, about a third of the patients do have cysts in their pancreas. We're hoping to be able to learn much more from that, and certainly, addressing pancreatic cysts is something we're very interested in the future. Okay. Thank you. Now, if I could go back to some of our other questions. How does genetic testing and counseling fit into the management of patients at high risk for PDAC and their relatives? Maybe, Dr. Burns, you could start with that question.
Sure. Again, if we're covering somebody's family risk, their own personal first-degree relatives, plural, is it important to get them tested? Yet, at the same time, that doesn't occur, so they go to a genetic center, and they go through family screening of sorts, and then there's an opportunity to be added further. Again, it definitely is throughput into centers that have likely a limited stream of counselors, have a limited stream of people to get in, travel distance. These are not tertiary or quaternary centers where this exists. Even though there's lots of healthcare, it's still a very small percentage of patients that are going to be able to get there readily.
It would be nicer, again, like the National Health Service has, where you can have some type of pre-predictive screening test that we have that's a bit more proactive and not just sort of whimsically, it seems, assessment.
Thank you. Professor Pereira, would you like to comment?
We are increasingly seeing people who've had DNA testing, for example, for breast cancer diagnosis or family history. Some of the issues that come up then is that there are several, certainly up to 20 different genetic risk factors for pancreatic cancer, which have been identified, although the quantitative risk for having an individual risk factor such as the BRCA2 gene, et cetera. There is lots of minor genetic changes as well, increasingly seeing people who get these long reports who then come to me asking for advice from the genetic counselor about, "What is my risk of pancreatic cancer, and what should I do about that in terms of surveillance or lifestyle changes?" That's becoming an increasing issue. I don't have an answer for that because we don't have the data for that necessarily.
We try to quantify the relative risk in terms of not only genetic profiling but also family history. We follow here in Europe. Well, we used to be in Europe. We're still in EuroPac. We follow the risk factors there, so having family members or a predisposing mutation and one family member who's had pancreatic cancer, or having three family members in different generations over time. If people fulfill those criteria, they go into a screening program of annual MRI, sorry, three yearly MRI, annual endoscopic ultrasound here. That's obviously an area of interest for bringing PanCan in.
Okay. James, in your surveillance program, how does genetics and genetic counselors interact with your patients?
Just to add to what's already being said, there has been a significant increase in standard cancer genetics programs throughout the U.S., primarily for breast cancer and colon cancer due to the kind of tremendous amount of information that's available for those diseases. Really, there's been this trickle-down into the world of pancreas because of awareness, because of education, because of all the research, that has then resulted in formal guidelines about not only who should undergo high-risk surveillance, the stories of the interplay between the family history of pancreatic cancer and the presence or absence of germline mutations, but also who should undergo genetic testing.
That has been built into the idea that if now someone has a diagnosis of pancreatic cancer, whereas in former times, we would do genetic testing of the tumor sample, again, this is a patient who has a diagnosis to help guide treatment. Now, there's a recognition that we should also be testing it and doing germline testing on those patients to help us identify these germline mutations with a view to reaching out to asymptomatic family members and talking to them about their risks. This is kind of flipping things around, and there are several ongoing studies, the largest of which one is called the CASCADE Study. This is called cascade testing, whereby an asymptomatic family member is invited to get genetically tested based on a family member in a very prospective and proactive way.
That's one way that we've noticed that things are certainly changing. Again, we still have to deal with the data and the recommendations to make sure it's correct. Of course, on a more global scale, as in certain parts of the world, but for sure, here in the U.S., for $99, you can get a portion of your genome tested, and that has opened up to these commercial firms, and that has opened up just a general interest in germline mutations. It's not, by all means, would be recommended for this sort of entity, but it has started the discussion and the awareness, and certainly, there are patients who get an interest in genetics and family history through that, and then we hear about them, and we do get them formally retested with the proper kind of CLIA-certified test.
This is definitely a very active area that's being pushed from many different directions.
Right. We certainly are in a changing environment now in the U.S., I think, in terms of that kind of testing and the availability of it. Dr. Farrell, how would you use a blood-based biomarker like PanCan-d in your surveillance program?
That is a very loaded question.
Yeah.
The simple way for me to start thinking about that is to start with the issue that there is a need. Without kind of getting into the efficacy issues right now, there's a huge need. I'm in one of these rooms that I need to activate my spotlight here. There's a huge need for this, and one of the concerns I have with high-risk surveillance in its current format is just the resource utilization, the volume of MRI scans, the volume of endoscopic ultrasound, and some of the cost issues that then ultimately may result in compliance issues, and we're beginning to see a bit of that. For sure, during the COVID-19 pandemic, we did know, we've actually just published on this. We didn't see a dramatic drop-off in patients coming in for procedures, but it became an issue. There's more financial issues.
I think, in my mind, and we're keeping an eye on this, if this affects compliance, then it affects the overall issues of how do we conduct effective surveillance programs. The simple response to that is, well, let's replace it with a different tool, and that tool will hopefully be a blood test. That's the first thing to say. When we talk to these patients who are relatively young individuals in their 50s and 60s, and we're talking to them about if they're buying into this and we're advising on this is somewhat a lifetime commitment. It's somewhat daunting to think that you would be coming in for endoscopies and MRIs on an annual basis with all the costs.
To kind of give them some hope or vision for what the future might hold, is the hope that we would have a blood test that would at least risk stratify certain groups in these, and we could decide which patients do or don't need yearly or bi-yearly studies. For me, I think that's where these tests will become very important in this population, so that we can identify subgroups of patients who really need a good going over with imaging, and then we can identify other groups of patients that we can truly leave alone for long periods of times, be it four years or five years. That would be my goal for when we see data, post-marketing data, and even some of the PanFAM data, to understand that that's how we would incorporate it.
I think there's a real need for that, and there's going to be a practical need for it to really get away from the resource utilization issues that we have with, again, this very specific high-risk genetics population.
Yeah, that makes sense. Professor Pereira, would you see using a blood test such as ours in terms of facilitating or more rapidly bringing patients into treatment for pancreatic cancer, whether they were early stage or late stage?
Oh, yes, sure. Perhaps what I just said to James as well, because we don't have cost issues for patients in having surveillance with MR and endoscopic ultrasound. We still find that the individuals who are coming in for those programs tend to be very health-conscious. They're non-smoking, they're non-obese, and so I think we're missing a lot of people who don't like to come to hospitals.
Okay.
They don't like to have invasive tests, I think there's a great potential to improve the application of non-invasive tests in high-risk groups. Also, we are learning in the familial pancreatic cancer groups that there is a way to stratify people based on their family history and genetic profiling into low and high risk. Maybe future programs will be high risk. We'll be looking at them very carefully, with imaging, endoscopy, endoscopic ultrasound, or in people who've got a raised IMMray PanCan-d test, et cetera. Those are things for that group. For individuals with symptoms, that was what you had asked me beforehand.
We know that only a minority of people go down the rapid assessment pathway, and we need to improve that. We've got a big innovation in the U.K., which started again at our university with rapid diagnostic centers in 2016. That's going to be rolled out nationally when everything gets a little bit under control. That's an avenue for general practitioners who have concerns about their patients who don't fulfill two-week wait criteria to still have the patient assessed in an urgent manner. We will have a new way of being able to access individuals for testing. That will be a particular place maybe for putting blood tests as well. Nevertheless, we know that the 90% of people with sporadic pancreatic cancer generally go down, have vague symptoms, come in late, and they usually have an average tumor size of 3 cm.
They often have late-stage symptoms like jaundice, going yellow in the previous few weeks. Certainly, there's a great potential for bringing a non-invasive test, not only in secondary care in terms of triaging patients to CT, et cetera, but also in primary care. We're really actively trying to see how to apply biomarkers in a primary care setting when GPs are seeing a patient every 7 minutes and need to try and assess all sorts of things with the patient, not just the risk of pancreatic cancer.
Yeah, I think that really highlights the stress on different types of practices, and it's great having all three of you here today to give really very different perspectives, but the true perspectives of what you're facing for practices. I think you bring up also an important point that probably the number of individuals in actual surveillance programs, at least in the U.S., is a fairly small fraction of individuals who really are at genetic or familial high risk. Some of that may be the onerous issue of going in for imaging. As you've mentioned, in the U.K., there's been some migration away from the National Health Service into private pay. In the U.S., that's been accelerated. Certainly, my own insurance policy is $7,000 deductible, paying for a test is something I'm quite used to doing. The landscape is changing.
Dr. Burns, how would you use a test like IMMray PanCan-d in your practice?
Again, there's going to be something where patients look to their doctor for guidance on appropriateness of testing. At the same time, I would be considered an early adopter. A lot of technology, traditionally, my patients know that. I'm teaching at two medical schools, teaching nurse practitioners, physician assistants over these last 20 years. Keeping up with the medical literature, academic, my patients expect that. Having access to a test like this that really is novel. It is tip of the spear. It is something that is appropriate. It likely won't be as aware or available to them as early as they would be in my own practice. I have a handful, almost one dozen people that I've been thinking about offering this test to.
My practice is 300 patients, so these are people with high risk that have new onset diabetes, that their parent died of pancreatic cancer. We don't know genetics though. They're not in surveillance, but these are people that would want to do more because they are interested in taking care of themselves. Hopefully, the listeners know that the pancreas is different than all the other organs around it. Unlike the ovary, you have two of them, and you can take it out and live very well without an ovary. You can't live without a pancreas, and all of these re-screenings are done because we don't want to mess with the pancreas. A surgeon that does surgery does their best not to touch the pancreas at any point during any surgery because the pancreas is a very reactive, angry organ, even when healthy.
To do any surgery or any procedure on the pancreas usually puts the patient in a lot of risk and pain. To have an opportunity for studies to say, "Oh, we're going to take a breast off, or we're going to take a lump out," we're really loath to do that with the pancreas because of how upset it is as an organ and how devastating it can be as just a consequence of a corrective procedure. To have a test that really, again, further characterizes who is it worth taking them the risk of a procedure to the operating room, I think is something I look forward to counseling my patients about.
That makes sense. A question from the audience as well. Even with the tests such as IMMray PanCan-d, with a very high specificity and good sensitivity, there still is a possibility of false positive results, as there is with any clinical test, I'll say, as my role as a laboratory director for many years. No test is perfect. Would that be a problem in presenting it to your patients or in managing them, the possibility of a false positive? Dr. Burns, you can begin.
You need adequate talking points and understand that, again, all tests are set for sensitivity and specificity. It was talked about before, when you take a large group of where the risk is low, that number becomes much greater, that you have a much higher number of patients that will have a false positive. In a general screening kind of way, that's why things aren't appropriate right away. Second time, you want to catch what you can, again, patients can still have imaging. This test isn't diagnostic by itself. This doesn't say, "Prepare for surgery. You've got a positive PanCan test.
As, "Hey, guess who's getting a referral to Dr. Farrell's clinic?" Go from there. It really helps streamline the process. It is not a nail in the coffin. Dr. Farrell, how would you answer that?
I think it's an issue. I think with proper discussion a priori with patients, it's one way to start to begin to address the issue. The other issues relate to what degree of false positivities that we're willing to accept with any diagnostic test. I think as we use and hope to use these tests for particularly in rich populations such as our high-risk groups, the hope is that the positive predictive value, which is the metric that I would be kind of interested to see how it plays out will rise to 0.4, 0.5, get in that sort of realm. I think for that patient population that is motivated but very anxious admittedly who are undergoing imaging, I think that might be acceptable, but it's going to have to be done with lots of counseling and discussion. I think in the general population, it's another beast altogether.
Okay.
There is no such thing as a perfect test. There probably never will be the perfect test for anything that we try to do. This is certainly better than a lot of the other tests that we even routinely use in this fashion. CA 19-9s are falsely elevated all the time, and we've managed to live with them and understand the limitations of them and understand that if that results in additional imaging and that imaging is truly normal and so on and so forth, that that can be done. I think the issue will be just the magnitude of the false positive things. I think, again, the hope is in just kind of looking at the numbers that we're probably getting into the ballpark where it becomes an acceptable issue.
Again, we would be starting with this in a clinical trial scenario in a very well-controlled area to kind of figure out how this plays.
Yeah. Both patient selection for being at high risk, so having a fairly reasonably high pretest probability.
Yeah
Also preparation in terms of understanding what the test can do and what it can't do, or both.
Yeah.
Yeah. Pereira, would you like to comment?
Sure. Yeah, because we're looking at people, for example, with vague non-specific symptoms, and you can use various tools to identify patients with, for example, a 2% pretest likelihood of having pancreatic cancer. In that group, you have 1,000 people in a group like that, you'll have 50 false positives with this test, which is not very many, but you'll pick up 18 of the 20 patients with cancer, which is fantastic. I think those kind of figures are, we know from stakeholder meetings that they're acceptable to patients, and they're also acceptable to providers of imaging and things like that. The other area which I think it'll have an impact potentially is in the group of people with a lump in their pancreas.
When we see something which looks like a pancreatic cancer on a CT and take that patient straight to theater, we can be wrong in 10%-15% of the time. In combination with a positive PanCan-d test, that may increase the confidence of surgeons to be able to take patients straight to surgery rather than rely on people like James and myself to get diagnostic tissue before surgery. I think in the majority of people with a cancer of the pancreas, which looks like a cancer of the pancreas but is not resectable, we'll still be needed to get tissue confirmation for downstream decision-making for chemotherapy and genetic testing, et cetera.
Yeah, absolutely, for pathologists such as myself.
We very much appreciate the tissue. Operator, do we have any questions waiting on the line?
Yes, we have the third one from Viktor Sundberg of ABG. Please go ahead, your line is open.
Yeah, hi. Thanks for taking an additional question. In terms of a prospective study, what kind of data would you like to see for the PanFAM-1 study that could lead you to conclude that IMMray could be, let's say, practice-changing for detecting pancreatic cancer early for this group of patients? It would be great if you could add some color on what added value does a prospective design give you as clinicians compared to the retrospective data that you now have seen that, of course, have strong data. What bias could we remove with a prospective study design, I guess my question is.
Yes. James, maybe you can comment on that.
Well, I think the first thing to say.
Yeah, go ahead. Sorry.
The first thing to say about in terms of comparison between retrospective and prospective data that's there, because the prospective data and prospective controlled studies actually are very similar to what we would want to do in clinical practice, I think that's obviously the benefit of a prospective study to understand how this plays out in a longitudinal fashion and kind of closer to the idea of what happens if you get a positive test and following up with imaging and expecting. Yes, the retrospective data is good, but having prospective data that kind of mirrors what actually goes on in clinical practice with actual patient management is obviously going to be better. That's the first statement. I think the other issue relates to what would you expect to see in a study design.
I think you would want to understand the follow-through of all these issues that we're addressing in a prospective study, the issues of false positives, following patients through longitudinal information. I think something that will hopefully come out of the PanFAM study is issues of when might markers be positive before obvious development in patients who ultimately are diagnosed with pancreatic cancer, and markers turn out to be positive. Are there situations where they're positive and there's no obvious imaging correlates, such as on a CT or MRI or even endoscopic ultrasound? We do get signatures from that from other more invasive types of biomarkers. It'll be interesting to see in the PanFAM cohort whether the signature is positive one year, two years, three years prior to it.
Similar, those are kind of areas of questions of interest for pancreatic cysts as well as the nuanced diabetes story. I hope that answers your question. I think its perspective for sure mirrors what we're actually doing in clinical practice. I think the lead into the development of cancer, that period is something that we're all very interested in. Yes, these cancers develop as masses, but there's something else going on in the pancreas before it presents as a CT scan. It still may well be invasive cancer, but there's also pre-invasive stages, and if that could be captured on a signature, then life becomes even more interesting. That's why I'm optimistic about these studies. They take a long period of time, but when we do get signatures like this, I think it's very exciting.
Yeah, it seems to me that's the only way we can really address the issue of whether PanINs, which you don't see as clear morphologic lesions or cysts within the pancreas. I don't know any other way that we could address that than by looking back at earlier samples from these patients and seeing if the test is positive. I think to me, that's one of the most important things we may get from PanFAM. Professor Pereira, would you like to comment as well?
I think James has covered it. I think we're looking at appropriate trials in different patient cohorts, and it's certainly feasible to design studies in the hospital-based group of patients to show clinical and cost-effectiveness and have answers to those quickly. There's much bigger challenges in primary care, of course, when the proportion of patients with pancreatic cancer that a GP is seeing every month for several months is so much smaller. Those kind of studies have been done successfully, with different study designs like nested case-control designs and bringing the biomarker in one region and looking at its impact compared to another region of matched patients. We're currently looking at issues like that.
Okay. Thank you. Initially, IMMray PanCan-d will be available as a self-pay only until we acquire insurance coverage for it. Do you feel that this out-of-pocket cost to patients will impact the way you use PanCan-d in your practice or surveillance program? Maybe we could go to Dr. Burns first.
I think for the right patient, I don't think cost is an issue in my practice, and that's one of the benefits of having patients expect to, at times, pay for what they're getting. Certainly, I still curate tests for them. I'm not ordering the most expensive laboratory possible for their cholesterol screening. There's a cost-effectiveness assessment that is done, and when there's the only show in town, and this is what it costs, and this is what your risk is, people are willing to pay for it.
James?
I think it's a very important question. Obviously, we would all like everything to be free or as cheap as possible, goes without saying. I think in that context, again, for the high-risk group of patients, these are an incredibly motivated group of people. If they are seeing it as an isolated cost, then they have to look at their own finances for insurance reasons, there are issues, complex issues such as things called co-pays, where they have to pay a portion of what goes on. That would not necessarily be the situation here. If they're balancing it between this versus paying for a portion of an invasive imaging study or a CT or MRI, then it becomes a more realistic discussion for this sort of price range. Again, listen, I think we would like everything to be free.
Absolutely. In the U.K. it still is, at least largely, Dr. Pereira.
I think in the U.K., we'll be looking at the impact of implementation of IMMray PanCan-d in the U.S. and other health environments. That's an important amount of information that will come from that because that will be able to answer some of the questions of its impact on clinical decision-making by clinicians, of course. We have a specific, not we, but nationally, Cancer Research UK and other big bodies have a cancer biomarker roadmap, going on from small, single-hospital studies to national implementation studies. That kind of implementation fits right in the middle of the various stages going to adoption into the NHS for a new biomarker.
Okay. Thank you. Another question from the audience, the question is, what is the broader view on how disease-specific tests, such as IMMray PanCan-d, would interact with broader pan-tumor tests such as Galleri, which is designed for general population screening rather than a high-risk screening. Professor Pereira, maybe you could speak first.
That's an interesting question. The previous CEO of Cancer Research UK, Harpal Kumar, is now part of Grail, and those studies are coming into the North London community within the next several months. There'll be data coming into a U.K. setting in symptomatic individuals and asymptomatic individuals for that. My understanding of looking at assays like that, the evidence so far published, obviously there's probably more data on the way with that and also with CancerSEEK, is that relatively small numbers have been looked at in pancreatic cancer, and secondly, that the sensitivity of the assays are diminished in early-stage disease, and there may be more data coming from that. It may be that certainly for pancreatic cancer, that there'll be a need for a more pancreatic cancer-specific assay, or maybe utilizing PanCan-d as a confirmatory biomarker in individuals with a positive test in that group.
I don't know the answer to that. I think we're all waiting for more data.
Okay. Well, thank you very much.
Actually, I've used Grail testing already, it's a methylation of DNA fragments for organ-specific or gland-specific cancers. Again, the idea is that it's methylation of DNA, it's a single type of test where PanFAM and IMMray PanCan-d and these others are inflammatory markers and other matrix-type testing. You're not just getting organ-specific or other, say, glandular cancer data in this way. They're very different.
Okay. One more question from the audience that they say is a very direct and cheeky question. If the KOLs were at high risk for pancreatic cancer, would they be seeking out a test like PanCan-d themselves? I'll answer that first for myself. My mother died of pancreatic cancer, so I would, personally. Don't answer this if you feel uncomfortable, but James?
Yeah, it's an uncomfortable question. I will answer it. The short answer is, I think, you want as much information as possible. We come from an advantage of knowing the limitations of the different tests and strategies that are out there. I certainly am no longer the person who puts his head in the sand. I do want to know what's going on. Understanding the benefits and risks of an endoscopic ultrasound, an MRI, CT scan, even a blood test, I think is useful. I would be supportive of it in the situation of being high risk and will certainly, when looking at more of the data, be supportive of it for our general population. With also just a caveat, because I thought the prior question about the multi-panels is really a hot topic.
Again, specifically for our patients with high-risk genetics, if you just focus on that group, and even to some extent for the symptomatic patients. Again, we're very pancreatic-centric clinicians and researchers. You want to go with the best test for the patient in front of you. For patients in that group, having a test such as Immunovia that is really pancreatic-centric giving up the advantages of the multi-panel test that, yes, might be much better for colon cancer or breast cancer, which are big clinical needs and unmet needs, but to my knowledge, are not particularly good for pancreas right now in terms of numbers. I think that's how I see that particular discussion going, and that they will have certain needs in different environments, so maybe for general screening of the population, so on and so forth.
For those of us who are dealing with patients who have concerns or we're concerned about their risk for pancreatic cancer, I think reaching for tests that have just the best data for that particular clinical scenario will be my approach until I see data to the contrary.
Professor Pereira.
No, I don't have anything to add. I think the others have said.
Yeah. Thank you. Another question. This goes to issues like pan-cancer tests. Are you concerned implementing expanded screening or surveillance programs based on this, could this be something that could be socially detrimental or detrimental to the healthcare system in terms of putting many more individuals into surveillance programs? Hard question to know, I think.
Yeah.
Yeah.
We can just jump in and tell you, people have studied the psychological effects of surveillance, by and large, it's more positive, again, particularly if we're just talking about high-risk groups. I think, again, we have to be very careful with the issue of specificity and positive predictive values, that's what's the fine line there, it is an issue of patient counseling and patient selection. It's a reasonable question. I think all the different aspects, not just the cost and the clinical aspect, but even the psychological aspects of what we do are things that we do address and we do address in our studies. I think time will tell.
Okay.
Yeah. We're in an environment of more testing in general, I think.
Yeah.
A lot more opportunities for individuals who have concerns or symptoms to have tests that's going to lead to more imaging. It's going to lead to more detection of things like pancreatic cysts for us, so we're going to have more patients referred for surveillance. We won't be able to do that endlessly with MRI and ultrasound. There'll be more need for non-invasive tests for surveillance as well.
Well, but also remind us that there are movie stars, financial and technology leaders of large companies, academics are often taken with pancreatic cancer. They're very publicly acknowledged. Most of these people are dying during their highest productive and earning years, their 50s and 60s, when they're contributing most to society. I think that even if we are screening and catching these folks and putting them in surveillance, they're very highly valuable people at the peak of their career, and the community will benefit from their assessments. Thank you. I want to thank all of our panelists. Thank you so much for participating today. I think our time is just about up. At this point, I'd like to turn things back over to Patrik Dahlen to make some closing comments.
Well, thank you very much, Tom, for that. I, too, would like to start my closing remarks by really thanking Dr. Pereira, Dr. Burns, Dr. Farrell for participating this morning, this afternoon, in this key opinion leader event. Very interesting discussion. Tom, I think you did an excellent job as the moderator. I come away from this discussion with very clear answers to some of the key questions that you always have as a company that's been working on a test like IMMray PanCan-d. First of all, your first question is there a clinical need for the test that you will be providing?
I come away very confident and with a very clear message that there is not only a need, but there is a huge unmet medical need for a test like IMMray PanCan-d, and that early detection of pancreatic cancer is one of the key questions in pancreatic cancer today and one of the potentially most important steps forward in terms of making a huge difference in pancreatic cancer. I think from a Immunovia point of view, I think we got a very clear and resolute response on that, and I'm very thankful for that. Of course, the second question that we need to ask ourselves is that do we have a test that fulfills the need, and will it make a difference? I think we clearly hear that the test performance fulfills the requirements.
There is a very specific view that for the familial hereditary side, we can complement, and we can potentially enhance how surveillance is done with IMMray PanCan-d. When it comes to the symptomatics, we clearly hear that we can enhance and accelerate the diagnosis, either if it's in early symptom groups or in late symptom groups where even the slightest more information that we can give to the patient might accelerate the diagnosis and be helpful. From that point of view, I think we come away confident that we will make a difference.
The 3rd last high-risk group that we did not discuss that much, but it came up a few times, is obviously the new-onset diabetes group, where we hopefully later this fall will be able to generate some data with regards to IMMray PanCan-d's performance in the cohort of Swedish new-onset diabetics, where we have participated in collecting some 6,000 samples from Swedish new-onset diabetics, and we will get the first insight into the performance of IMMray PanCan-d in this particular group. The 3rd aspect from Immunovia's point of view is obviously the go to market and the marketability and the business aspects. Here, obviously things like getting a clear approval, which we would have expected to have already and we think is imminent, is important. Obviously also developing strategies to get the reimbursement in the U.S., it's an absolute key for us.
Here we continue to believe through our consultants as well as from our discussions with key opinion leaders that first of all, there is, in fact, reimbursement in place for individuals who are enrolled in high-risk surveillance programs and have a family and hereditary disorder. They do get reimbursement and payment for the cost. Secondly, I think it's again important to emphasize that from a reimbursement point of view, our test is not intended as a general screening population tool, but rather a very focused tool in order to follow high-risk populations. Therefore, the inclusion criterias are tight, et cetera, and we're clearly set aside from the very cumbersome criterias put forward for tests that are intended to use for the general population screening, which again, is certainly not what we are intending to do with IMMray PanCan-d at this instance.
We're coming up on our time. I would really like to again thank the panelists. I would like to thank you, Tom, for being such an excellent moderator, and I would like to thank the audience who dialed in to the webinar. I really, truly enjoyed the webinar, and I hope you did likewise. Thank you very much. Thank you.