Good afternoon and good morning, everyone. Welcome to Immunovia's Key Opinion Leader event. My name is Patrick 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 a threshold of launching our first product, Imray 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 health care 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 Doctor. Steven Perera, Doctor. James Farrell and Doctor. Jeffrey Burns.
Thank you all 3 for joining us today and for sharing your views with us. The moderator for the panel discussion will be Doctor. 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, Doctor. King, will indicate when he opens to questions from the audience. Questions can be submitted via e mail by clicking the e mail 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 and informative webinar for all of us. And 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 IMRAPAN can D in the U. S. At immunovia, Inc. As a laboratory developed test. IMRAE BANKAN 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 diagnosis of pancreatic cancer is at late stages of the disease when it is too late and the cancer is no longer resectable. Imrepan Candi 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 clear number. Financially, IMO Nova is in a strong position.
We had SEK 425,000,000 at hand at the end of quarter 1, 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 $4,400,000,000 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 IMRAPANCA 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 I or II, the 5 year survival significantly improves. It goes to 50% survival rate after 5 years compared to less than 5% when pancreatic cancer is in stage 3 or 4. Today, the median survival rate for newly diagnosed pancreatic cancer patient is 4.6 months. And the reason for this is simply that 80% of all pancreatic cancers are detected too late in Stage 34.
I would like to take a moment to remind you of the Performance data of our IMbrey Palcan 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 familiar hereditary control group. Accuracy was 94%, specificity of 98% and sensitivity of 87%. However, more interestingly, we see that the detection of early stage pancreatic cancer that is stage 12 Versus a control group of familiar hereditary individuals, we had an accuracy of 92%, Specificity of 98% and the 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-nineteen pandemic to prioritize corona 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 strengthened the team in the U. S. We already have a strong team in place, of course. We are adding 2 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 2nd payer study and here we work closely with Doctor.
Parker from Precision of medicine. In terms of the road to market, we obviously launched our test as an LDT for Immunovia Inc. And 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 familiar 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 aid in diagnosis in high risk groups. And 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 Doctor. Thomas King, our Medical Director, who will moderate the panel discussion. Tom?
Thank you, Patrick. I'm Doctor. Tom King. I am the Medical Director at Immunovia Inc. I am a Board certified pathologist who has been in practice in the United States for over 30 years in both academic medical centers, Private practice and in pharma biotech.
And I'll be moderating today's discussion with our distinguished panelists, Doctor. Jeffrey Burns, Doctor. James Farrell and Professor Steven Perera. 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. Doctor.
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. Doctor. 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 8 years and now I've been in private practice for the last 7 years. It turns out that in most parts of Europe, until just very recently, in the Czech Republic, concierge medicine was not available. And 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. So in the United States, 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 As the care physician. And I think Immunovia really will fit in well for that personalized care that I will continue to deliver to my patients.
Professor Ferreira, would you introduce yourself, please? Thank you for being here.
Thanks very much. Good afternoon, everyone. I'm a consultant gastroenterologist based at 2 major teaching hospitals in Central London, which are affiliated with University College London here in the UK. I'm also a pancreatic cancer researcher, and I lead a national early detection research alliance, Which is focused on early cancer detection in the NHS National Health Service setting. And that has contributed to validation of the PANCAN D test.
I think we're all aware, as Patrick has mentioned, of pancreatic cancer's shocking statistics. And as you know, up to now, we've not had a simple test for diagnosing and Issue is a particular one in the UK, where up to 50% of people in some urban settings are already diagnosed with pancreatic cancer when they come to actual emergency with late Symptoms. So we certainly need better effective treatments and being on the frontline here in COVID during the COVID 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 PANCANDI, we now have a simple test, which is accurate as we've heard. And from a UK perspective, as part of the Oil 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 a nuance of type 2 diabetes, it's an area of active interest here in the UK with a nationally funded study.
Patients With pancreatic cystic lesions, we normally undergo imaging and endoscopy screening, which we're no longer able to meet requirements for The current situation and 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 nonspecific symptoms, both in primary and secondary care. We wouldn't normally be investigated along urgent suspected cancer guidelines. Here in the UK, we have a 2 week Maximum for people with suspected cancer symptoms need to be investigated.
That's mandatory. So we're interested in that group. And in conjunction with refining current decision support tools, which again is a UK 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, widely used. And we're also interested in understanding the barriers to biomarker implementation within the U. S, which is different within the UK, which is, of course, different to U.
S. And other countries. So I'll stop there and I'll hand over.
Okay. Thank you. Thank you, Professor Ferreira. And Doctor. 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 To Professor Perera, I'm primarily a gastroenterologist involved in the world of interventional endoscopy, which involves Procedure is 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. So 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.
And very similar again to Doctor. 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, but 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 Discussion with a bit of an overview for the audience of the current situation in pancreatic cancer detection and diagnosis. So, Doctor. 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. But from our perspective here in the United States at least, The numbers of pancreatic cancer are rising. So we're up to about 50,000 cases per year for a population of 330,000,000 or so. In terms of total incidence, it's a lower volume issue. But in terms of cancer related deaths, It's currently on its way to being the 2nd most common cause of cancer related death in pancreatic cancer.
And a lot of those reasons go into, yes, there's a true increase in the incidence probably related to age, obesity issues for sure. But as you know, there has been also tremendous progress in other cancers with respect to treatment and even early diagnosis. So a lot of it is kind of a relative change. And so 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 small incrementally better.
There's certainly not been that dramatic blockbusters. I'm not an But there really haven't been that many blockbusters in the last couple of years from the perspective of treating patients. And again, the majority of patients unfortunately present with You know, locally advanced where it's not a surgical resection disease or metastatic disease, where it certainly isn't a surgical resectable disease. So I think the, you know, the world, I mean that in terms of medical oncologists look to us as gastroenterologists, patients look to us And say, well, what's going on in the world of early detection? And so 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. But really the issue is can we crack this Can we improve survival through early detection? And maybe kind of Stephen could allude to some of those challenges That we have with the early detection approaches.
Yes. Thank you, James. Doctor. Doctor. Breyer, would you like to have additional comments?
We have a similar situation, of course, in the UK. I think there's a big unmet need for improving public Awareness for symptoms and signs of pancreatic cancer, and that's that's really been hugely successful in many other cancers, of course, With breast cancer screening, with colon cancer screening. But really, very few people know where the pancreas is Or indeed what sort of suitors look for. I think that's an important thing. And we know from our own studies and others, For example, we have access here to 2 databases of symptoms in patients Going to their general practitioners of 40,000,000 patients and 15,000,000 patients, which we're currently looking at.
So, but we know from those data, which we published on A couple of years ago, the patients with pancreatic cancer have had symptoms which could be attributable to their cancer at least 12 months before final diagnosis. And I think There's certainly room for improving the pathways for those patients. Here in the UK, based on clinical decision support tools, which I had mentioned, The National Institute For Clinical Excellence requires that patients with a pretest likelihood of having a particular Cancer of more than 2 percent should go to appropriate imaging urgently. That's within 2 weeks. But 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 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 a year or more before they actually get a diagnosis. So I agree with you. I think it's really important to prioritize. As Patrick mentioned, we expect to launch IMRAPAN can 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 1 and 2 pancreatic ductal adenocarcinoma with 87% sensitivity in all stage pancreatic ductal adenocarcinoma With a specificity of 98% to 99%. Doctor. Ferreira, Do you feel that these performance characteristics would be useful for evaluating individuals at increased risk for pancreatic ductal adenoid carcinoma Based on their genetic or familial history?
I think it's a highly accurate test based on that, I think I'd answer that in 2 ways. 1 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, to health authorities view those kind of levels of detection as Acceptable for testing in the world. The other and what I mean what that is is that if you ask a patient, you know, if you had a test Which was 90% accurate for cancer. Would you like to have that test? And the clinician at the same time, Would you act on that test and send that person for appropriate imaging?
And the answer to those questions are, of course, yes. And the other Which of course is important is that based on that those sensitivities and specificities, it's eminently possible to Do confirmatory implementation and implementation studies in defined cohorts to prove clinical and cost effectiveness. So for example, with those you need only a couple of 1,000 patients for example to test in a particular cohort of people with a particular risk Pancreatic cancer. So we can now go on and do those do those additional studies in an NHS setting to confirm effectiveness and acceptability and
Thank you. Doctor. Burns, would you like to comment for your practice?
So I think again that so many Patients that get referred to genetic counseling or to, you know, especially clinics like Doctor. Farrell's. You know, They're in the queue. They know what they're doing. But, you know, to really do take a family history to see somebody's risk and then, you know, like, 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 to 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.
I think my patients will be as well.
And 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 CA19-nine, 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. So it is great to have an opportunity to see kind of Updated 2021 technology, improve the possible signature for pancreatic disease. And 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 symptomatic management. But again, specifically to your question about the high risk group. So 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 by and large are in the dark here, who are by and large A asymptomatic and the 3 big groups that we think about again are just the familial cohort With or without a genetic mutation that they carry pancreatic cysts and diabetes. And it's really the first group that we Have the most information on from perspective of these types of biomarkers.
And 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. And one of the issues with even CA99 and any sort of potential suitor To this field is literally what we're talking about, which is the operating characteristics. And to remind people that when you don't have great operating characteristics, Characteristics, you end up with for sure missing things and for sure over calling things. And those are really a central issue here that You have to keep in mind, when you start quoting, you know, sensitivity of the region of 85 For stage 1 and stage 2 cancers, that's such a pretty good number, but probably as important. So that basically means that you're going Find those early cancers.
But almost as important than maybe from a societal perspective, The very high specificity, so 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 kind of a societal deterrent for something Like this in terms of justification. So 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 mean, I certainly agree the 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 Certainly substantial. Professor Pereira, any further comments for you, particularly in terms of specificity?
Well, I think we know that we don't have a test for the general population and as we 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, for every Every you can pick up almost every patient with pancreatic cancer, but for every in 100,000 patients, you'll have 1,000 false positive patients. So 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, you know, again, we have a real need, particularly in the risk groups that James mentioned, you know, we've again published On our experience with screening individuals with an increased risk of pancreatic cancer, in, you know, 300 or 100 patients followed up for many years and only found one patient with pancreatic cancer, but after several 100 Endoscopic ultrasounds and MRI scans. So it really is, you know, the current screening programs for pancreatic cysts And for and in individuals with a strong family history are expensive and invasive and there's a need for non invasive accurate tests for those groups.
Thank you. And Doctor. Burns, how important is test specificity for you and 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 turns out not to be. You really want to be able to reassure them ahead of time 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. And By waiting and then having a test because I'm not sure about this test, it's a new test. To a year later, we've already heard a year later as You know, late stage cancer for that person. So, 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 This 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, but 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 health care system. And it's going to forward this type of proactive approach. Thank you.
And 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 ductal adenocarcinoma, Well from the patient's experience point of view, but also from a cost point of view, if possible. That is, is there a stage where you would avoid invasive surgery? Doctor. Farrell, maybe you can begin.
Sure. So broadly and hopefully So, simply 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. And broadly speaking, we think about 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 Important blood vessels. There's no overt evidence that it's spread outside the But down the road, it may become 1. And those patients are typically treated with chemotherapy and or radiation therapy. As we mentioned before, not particularly great options like you will hear with other diseases currently like colon cancer, Kidney cancer and so on and 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. And again, chemotherapy is an option for those patients. When you look at survival across those three groups, optimistically, we think about 5 year survival Maybe 50% for the 1st group in really good hands and good centers, but then jumps down to 20% 10 Percent for the second groups and even smaller again. When you think of the percentages of what those groups actually are, we think That first group, it probably only represents about 10% to 15% of patients honestly.
And for the other two groups, maybe an equal 40%. So those are the challenges that kind of helps the person who asked the question.
Thank you, James. And Professor Ferrer, would you like to add?
Yeah. It's the same here in terms of patient proportions and approaches. And the other aspect of the question was, Is there any alternative to surgery? And I think, you know, an unexplored area so far is that certainly surgery is the gold standard for Small pancreatic cancers that appear resectable on imaging, and, you know, that's that's a standard approach. But, you know, We are entering a realm of better and better imaging, you know, 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 having more and more scans that may again be a role for The PANCANT D test. And there are and James and I have and others have been involved in trying to develop ablation Techniques for small lesions, which may which may not be cancerous, particularly in the cyst field, etcetera. So there are there are some possible other approaches coming online over the next few years, but Certainly, surgery is the gold standard and we remain so for cancer. Okay.
Thank you. And a few more questions from the audience. Do you see pan candy 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 National level that have now moved into more decisions and guidance on Diagnosis and early diagnosis and surveillance. And so 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. So 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 cysts and the genetics groups. What we're beginning to appreciate is the issue of that is very much limited by resource issues. So Doctor. Ferrer mentioned how often can patients We'll 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? And so there's a real need To look at noninvasive blood tests to try and replace that or streamline it from stratify patients. And I think that might also be a direction that this could go in guidelines perspective because it's better, a bit like the colon cancer story, although not identical in It's more important that a patient have some test than no test. And so with colon cancer, we're running into issues again of resource availability. And so the attractiveness of, for example, the school 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 form.
So 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. And Professor Pereira, another question from the audience. What do you think would be needed from, pan candi in terms of further development to make it widely Tibor.
Well, if I could answer that from a UK perspective, we have a national health service And a minority of patients predominantly in the larger cities with private healthcare, and you know, and that obviously that includes London. So with commercialization of the PANCANT test that will be available to patients if they should they wish to purchase that and that won't be they won't have Very much impact in National Health Service, and they won't be paid for by the National Health Service at present, That would be my understanding. And, you know, and patients in the UK have had a had a they've had a free free access to health care for many decades and Not used to paying for tests. Although, you know, there is some that is changing a little bit with some of the genetic profiling on offer For patients with cancers who want to know more about the cancers where it hasn't been accepted by the by NICE. So I think what we would want to see is An assessment of the technology by NICE.
And I know that, you may 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 be, continue to be tested, in good quality clinical trials. An example of that is, 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. So those types of studies we're in discussion about and they're eminently doable with the Sensitivity and specificity that you've granted.
Okay. Thank you. And operator, do we have any questions on call On the phone.
Yes. We do have one question on the line at the moment and that's from the line of Vikt Sundberg of ABG Sundal Collier. Please go ahead. Your line is open. Hi, everyone, and thank you for hosting this panel.
So my first question is related to the U. K. 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 1 compared to no screening. However, there was no survival benefits in with early detection, Leading the voters to conclude that mortality should be the primary outcome maybe of larger trials that investigate screening or surveillance for patients to find cancer early.
So I guess my question is, do you believe that a mortality based outcome study is needed in pancreatic cancer to avoid bleed and length and biases? I guess my question is especially related to the NOD group, which could be 1,500,000 patients and also the hereditary and familiar risk groups that we have been discussing today.
Yes. No, that's an excellent question. And the UK CTOX 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 And it's been very useful in trying to detect biomarker profiles years before Clinical diagnosis of pancreatic cancer in a group of postmenopausal women who were part of an ovarian cancer screening program.
I think, you know, I wouldn't equate, obviously no one is doing that, but I wouldn't equate the outcome of ovarian cancer with pancreatic cancer. I'm not sure that we can Expect the same conclusions that UKC TOX have arisen from the trial of using CA125 And probably the ultrasound in conjunction with biomark profiles. So, I think I think I can't speak for NICE, but I expect that a biomarker which is showing utility In terms of improving stage disease, it will be effective and 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 esophagus to determine if a person has a precancerous condition in the lower esophagus without the need for endoscopy. And those studies were not based on mortality. They were based on detection and improved detection of High grade changes of the esophagus in people having a non invasive test.
So I think, you know, I think If we can show that the improved staging of pancreatic cancer, so From stage 3, 4 disease to stage 1, 2 disease is improving with implementation of biomarker tests. That would be very important. That's actually one of the goals of the National Health Service 5 year plans is to improve overall Early stage diagnosis to 75%. That's not going to be possible for pancreatic cancer in 5 years, but that's what the overall goal is in all cancers in the UK.
Victor, did you have another question?
No, I think that was it could be interesting to hear other KL's perspective as well, if that's I have some other questions as well. I don't want to take too much of your time.
Okay. Thank you. I'm going
to jump back in the queue. Yeah.
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. However, I think we're at a point where I feel like even though there has been tremendous Work in the realm of pancreatic cancer for the last 10 or 15 or 20 years, like really intense work at a molecular level, trying to understand it. I still feel we're at the beginning. And so we're at the beginning of these journeys where maybe colon cancer, maybe Barrett's Esophagus are now or at least coming to those points.
And so that's 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.
But yes, the ultimate goal would be to do pivotal studies that show impact on mortality to get 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 limited data set, but from a high risk population showing that for some reason, patients that Our detected at an early stage in high risk surveillance programs do better than patients who present Sporadically at the same stage. So small numbers, but an interesting signal. I don't have a simple explanation for you Why? But maybe it has to do with the symptom presentation versus asymptomatic presentation.
And so that is kind of a cause for Hope. But it also brings up kind of an issue for pancreatic cancer, which is we talk about early stage, But we would love to be also be talking about precursor stage and pre vaso stage. I mean, that's really what we would want to be talking about to make a significant dent here. And again, we probably through the CIST world, hopefully, there will be some advances in that. And the CIST world collides with the high risk world.
So 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. And James, another question for you from the audience. How many patients are currently enrolled in surveillance programs for familial hereditary PDAC In the United States, do you have a sense of the numbers?
Got it. 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 United States is the CAPS V program. But in all honesty, The panfam study is also an equally large number.
We're talking of several thousand, anywhere between 3000 to 5000 studies. And these individual studies, They range across anywhere from 6 to 9 centers. There are other health systems that have also Evolve 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.
And then recently, a large NOD study was announced, but and we're talking about numbers in the realm of 10000 to 15000 patients enrolled over 15 years. Again, alluding to my prior comment, We're not in this for instantaneous gratification. And so we're in this for the long haul. And these sorts of studies take these sorts of numbers in this amount of time. And I think a lot of us are willing To put that effort in and to be patient.
So it's a great question. I think, again, the clinical guidelines Have supported surveillance programs in high risk genetics groups. And so individual 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 3000 to 5000 patients enrolled.
Okay. Thank you very much. And 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. And 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. So We are hoping to be able to learn much more from that.
And certainly, addressing pancreatic cyst 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.
And maybe Doctor. Burns, you could start with that question.
Sure. Well, again, it's covering somebody's family risk, their Personal first degree relatives, plural, is it important to get them tested? But 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. But again, it definitely is Yes, throughput into centers that have a likely a limited stream of counselors, have a limited stream of people to get in, travel distance, Yes, these are not tertiary or quaternary centers where this exists.
So even though there's lots of healthcare, it's still A very small percentage of patients, they're going to be able to get there readily. But it would be nicer, again, like the National Health Service has, where you can have some type of Pre predictive screening tests that we have that's a bit more proactive and not just sort of whimsically, it seems assessment.
Thank you. And Professor Pereira, would you like to comment?
Well, we are increasingly seeing people who've had DNA testing for, you know, for example, for breast cancer Diagnosis or family history and some of the issues that come up then is that you know 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 factors such as the BRCA 2 gene, etcetera. There is lots of minor genetic changes as well and increasingly seeing people who You get these long reports. They 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 images? And that's that's becoming an increasing issue. I don't have an answer for that because we don't have the date of that necessarily.
We try to quantify, you know, the relative risk in terms of not only genetic Profiling, but also family history. And we follow here in the in Europe. We used to be in Europe, so we're still in Europac. We follow we follow the risk factors there. So having 2 family members or a predisposing mutation and one family member who's had pancreatic cancer We're having 3 family members in in different generations over time.
So if people fulfill those criteria, they go into a, a screen program of Annual MRI, sorry, 3 yearly MRI and annual endoscopic ultrasound here. And that's obviously an area of interest for bringing in pankanting.
Okay. And James, in your surveillance program, how does the 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 United States. So primarily for breast cancer and colon cancer through the kind of tremendous amount of information that's available for those diseases. And so 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 of these stories of the interplay between the family history of pancreatic cancer and the presence of absence of germline mutations, But also who should undergo genetic testing. And so 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 and 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.
So this is kind of flipping things around. And there are several ongoing studies, the largest which one is called the cascade study. So this is called cascade testing, whereby An asymptomatic family member is invited to get genetic tested based on a family member in a very prospective and proactive way. So 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.
And then, of course, on a kind of a more global scale, as in certain parts of the world, but for sure here in the United States, You know, for $99 you can get your portion of your genome tested. And that has opened up to these commercial firms and that has opened up Just in 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, but this is definitely a very active area that's being pushed From many, many, 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. Doctor.
Farrell, how would you use a blood based biomarker like panCann D in your surveillance program?
So that is a very loaded question. 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 and 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 pandemic, we didn't know, we 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. So 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. So the simple response to that is, well, let's replace it with a different tool and that tool will hopefully be a blood test. So that's the first thing to say. And when we talk to these patients who are Relatively young individuals in their 50s 60s.
And we're talking to them about, if they're buying into this and we're advising them this, This is somewhat a lifetime commitment, but it's somewhat daunting to think that you would be coming in for endoscopies and MRIs on an annual basis with all the costs. And so to kind of You know, 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. So 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 4 years or 5 years. And so that would be my goal for once when we see Data post marketing data and even some of the panfam data to understand that that's how we would incorporate it. So because that there's a real I think there's a real need for that.
There's going to be a practical To really get away from the resource utilization that we have with, again, this very specific high risk genetics population.
Yes, that makes sense. And Professor Ferreira, 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.
Yes, Michel. I mean, perhaps I could just add to James' one as well because we don't have Cost issues for patients in having surveillance with MR and endoscopic ultrasound, but 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, you know, I think we're missing a lot of people who don't like to come to hospitals. They don't like to have invasive tests.
And I think There's a great potential to improve the application of non invasive test in high risk groups. And also, you know, we are learning in the familial pancreatic cancer groups that there are there is a way to stratify people based on their family history and genetic Following into low and high risk and so maybe maybe, you know, future programs will be high risk. We're looking at them very carefully, you know, with imaging and endoscopy ultrasound Or in people who've got a raised, raised panca and d test, etcetera. So I think those are things for that group. For individuals with symptoms, is that what you had asked me beforehand?
We know that I mean, a minority of people go down the rapid assessment pathway and we need to improve that. We've got a big innovation in the UK, which started again at our university with rapid diagnostic centers in 2016 and that's going to be rolled out nationally when I think it gets a little bit under control. And that's going to be that's an avenue for general practitioners Who have concerns about their patients, who don't fulfill the 2 week wait criteria to still have the patient assessed In an urgent manner. So we will have a new way of being able to access individuals For testing, that would be a particular place maybe if we're putting blood tests as well. Nevertheless, you know, 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 centimeters.
They often have late stage symptoms like jaundice, you know, going yellow in the previous few weeks. And, you know, Certainly, there's a great potential for bringing a non invasive test, not only in secondary care in terms of triaging patients to CT, etcetera, But also in primary care, and we're really actively trying to see how to apply biomarkers in a primary care set of 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 3 of you here today to give, Really very different perspectives, but the true perspectives of what you're facing in your practices. I think you bring up also an important point that Probably the number of individuals in actual surveillance programs, at least in the United States, is a fairly small fraction of individuals who really are a genetic or familial high risk. And some of that may be the onerous issue of going in for imaging.
As you'd mentioned in the UK, there's been some migration away from the National Health Service and to private pay. I think in the U. S. That's been accelerated. Certainly, my own insurance policy is $7,000 deductible.
So, you know, paying for a test is something I'm quite used to doing. So, the landscape is changing. Doctor. Burns, How would you use a test like PAN Candid in your practice?
So again, there's going to be something where patients, you know, 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 2 medical schools, teaching nurse practitioners, physician's assistants Over these last 20 years, so keeping up with medical literature or academic, my patients expect that. And so having 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 mean, I have a handful, almost a dozen people that Just by that I've been thinking about offering this test to, in my practice is, you know, 300 patients. So that these are people with high risk, That have new onset diabetes, that their parent died of pancreatic cancer. We don't know genetic stuff.
So it's 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 2 of them and you can take I wouldn't live very well without an ovary. You can't live without a pancreas.
And all of these rescreenings are done because we don't want to mess with the pancreas. A surgeon that does surgery on the It 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. So to do any surgery or any procedure on the pancreas usually puts the patient in a lot of risk and pain. And so to have an opportunity For studies to say, oh, we're going to take a breast off, we're going to take a lump out, we're really loathed to do that with the pancreas because of how Upset it is as an organ and how devastating it can be is just a consequence of a corrective procedure. So 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 can I look forward to counseling my patients about?
That makes sense. A question from the audience as well. Even with the tests such as pan candide 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 is 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. Doctor. Burns?
Again, it is 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 much higher number of patients that will have a false positive. So that in a general screening kind of way that's why things aren't appropriate right away. Time you want to catch what you can. And it's Again, patients can still have imaging.
This test doesn't is it diagnostic by itself? This doesn't say prepare for surgery, you've got a positive pan can test. Yes, this says, hey, guess who's getting a referral to Doctor. Farrell's clinic, and then go from there. So it really helps streamline the process.
It doesn't It is not a nail in the coffin.
Doctor. Farrell, how would you answer that?
Yes, 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 the higher risk groups, the hope is that the Positive risk to 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, getting that sort of realm. I think that's 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. Again, there is no such thing as a perfect test. There Probably never will be the perfect test for anything that we try to do. But this is certainly better than a lot of the other tests that we even routinely use in this fashion.
CA19-9s 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. But I think again, the hope is and just kind of looking at the numbers That we're probably getting into the ballpark where it becomes an acceptable issue. And 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.
Yes. So both patient selection for being at high risk, So having a fairly reasonably high pretest probability and also preparation in terms of understanding what the test can do and what it can't do. Yeah. Pierre, would you like to comment?
Sure. Yeah. So, you know, 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% Pre test likelihood of having pancreatic cancer. And in that group, you have a 1,000 people in a group like that. You'll have 50 false positives with this test, It's not very many and you'll pick up 18 of the 20 patients with cancer, which is fantastic.
So I think those kind of figures We know from stakeholder meetings that they're acceptable to patients and they're also acceptable to providers of imaging and things like that. Yeah. The other area which I think it'll have it'll have an impact potentially is in the group of people with a lump in their pancreas, So 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% to 15% of the time. But 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 in the majority of people with a cancer of the pancreas, which looks like a cancer of the pancreas but is Receptable will still be needed to get tissue confirmation, for, you know, for downstream decision making for Chemotherapy and genetic testing, etcetera.
Yeah, absolutely. And for pathologists such as myself.
So, we
very much appreciate the tissue. Operator, do we have any questions waiting on the line?
Yes. We have further one from Victor Sandberg of ABG. Please go ahead. Your line is open. Yes.
Hi. Thanks for taking an additional question. So in terms of a prospective study, what would you What kind of data would you like to see for the PANFAN1 study that could lead you to conclude that IMRAE could be, say, practice changing for detecting pancreatic cancer early for this group Of patients. And also, it would be great if you could add some color on what added value does The design give you as clinicians compared to their retrospective data that you now have seen that, of course, have strong data. What biases could we remove with the prospective study design, I guess my question is?
Yes. And James, maybe you can comment on that.
Well, I think the first thing to
say Yes. Go ahead.
Sorry. The first thing to say about in terms of comparison between retrospective and 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. So, 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 It's obviously going to be better.
So 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, these issues of False positives, following patients through longitudinal information. I think something that will hopefully come out of Panfam study is issues of when might markers be positive before obvious Development and sorry, 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 correlate, such as on a CT or MRI or even endoscopy ultrasound. And so we do get signatures from that from Other more invasive types of biomarkers, so it will be interesting to see in the panfam cohort whether the signature is positive A year, 2 years, 3 years prior to it.
And similar, those are kind of areas of questions of interest for pancreatic cysts as well as the new onset diabetes story. So I hope that answers your question. I think it's perspective for sure mirrors what we're actually doing in clinical practice. I think the lead into the development 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 the 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. So 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.
Yes. I mean, it seems to me that's the only way we can really address the issue of whether, you know, Of pannons, which you don't see as clear, morphologic lesions or cysts within the pancreas. I don't know any other way that we I can address that, Ben, by looking back at earlier samples from these patients and seeing if the test is positive. So I think to me, that's one of the most important things we may get from Canfin. And Professor Pereira, would you like to comment as well?
I think James has covered that. I think we're looking at appropriate trials in different patient cohorts and we have certainly Feasible to design studies in hospital based group of patients to show clinical and cost effectiveness And have answers to those quickly. And 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 or several months is so much smaller. And those kind of studies have been done Successfully with different study designs like nested case control designs and bringing in the biomarker in one region And looking at its impact compared to another region of matched patients. So, we're currently looking at issues like that.
Okay. Thank you. And initially, IMRAPAN can be 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 pan candy in your practice or surveillance program? Maybe we could go
to Doctor. Burns first.
Again, 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 don't always You know, I'm not ordering the most expensive laboratory possible for their cholesterol screening. You know, there's a cost effectiveness 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 And 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, for again, for the high risk group of patients, these are 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 here, issues as 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.
But 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 kind of more realistic discussion for this sort of price range. But again, listen, I think we would like everything to be free.
Absolutely. And in the U. K, it still is, at least largely, Doctor. Perra.
That's right. I think in the UK saying that we will be looking at the impact of implementation of Pancandex in the US And other health environments because 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. You know, we have a specific, not we, but Nationally, Cancer Research UK and other big bodies have a cancer biomarker roadmap, you know, going on from Small single hospital studies to national implementation studies and that kind of implementation fits 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. And the question is, What is the broader view on how disease specific tests such as panCAN D would interact with broader pan tumor tests such as Galleries, so Which is designed for general population screening rather than a high risk screening. And Professor Ferrer, maybe you could speak first.
Yeah. That's a really interesting question. The previous CEO of Cancer Research UK, Harpal Kumar, is now a is part of GRAIL and Those studies are coming into the North London community within the next several months. So, there'll be data coming into the UK setting in symptomatic individuals and asymptomatic individuals that My understanding of looking at essays like that that Evin so far published and 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 Diminish in early stage disease and there may be more data coming from that. So it may be that certainly For pancreatic cancer that there'll be a need for more specific, more pancreas cancer specific assay or Maybe utilizing PANC N D as a confirmatory biomarker in individuals with a positive test in that.
I don't know the answer to that. I think we're all waiting for more data.
Okay. Thank you very much. And I think
we have used GRAIL testing already. And it's a methylation of DNA fragments For organ specific or region gland specific cancers. And again, the idea is that it's methylation of DNA. So It's a single type of test where pan can ND and these others are inflammatory markers and other matrix type testing. So you're not just getting organ specific or other, say glandular cancer data in this way.
They are very different.
Okay.
And one more question from the audience, 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 PANCND themselves? And I'll answer that first for myself. My mother died of pancreatic cancer, so I would personally. And don't answer this if you feel uncomfortable, but James?
Yes, it's an uncomfortable question, but 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 and even a blood test, I think it's useful.
So 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 kind of 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, You know, and we know, again, we are very pancreatic centric clinicians and researchers. You want to go with the best test for the patient in front of you. And so 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, 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 I think they will have Certain needs in different environments, so maybe for general screening of the population and so on and so forth. But for those of us who are dealing with patients who have concerns or were about the risk for pancreatic cancer. I think reaching for tests that have just kind of the best data for that particular clinical scenario is will be my approach until, I see data to the contrary.
Okay. Professor Ferrer?
I don't have anything to add, I think, to what the others have said.
Thank you. Another question, are you and this sort of 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 or detrimental or detrimental to the healthcare system In terms of putting many more individuals into the balanced programs? Hard question to know, I think.
Yes. I mean, I we can just jump in and tell you, I mean, people have studied the psychological effects of surveillance. And by and large, it's more positive, again, particularly in again, 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. And that's kind of what's the fine line there.
And it is an issue of patient counseling and patient selection. But 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. And I think time will tell.
Okay. We're in an environment of more testing In general, I think there are 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 mesoscopic ultrasound.
So, there'll be more need for non invasive tests, just for surveillance as well.
Well, it would 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 public, Leah, acknowledged. And most of these people are dying during their highest productive And earning years, 50s 60s, when they are contributing most to society. So I think that even if we are screening and catching These folks are putting into the surveillance. They're very highly valuable people at the peak of their career and the community will benefit From their assessment.
Thank you. And I want to thank all of our panelists. Thank you so much for participating today. But our time is just about up. And at this point, I'd like to turn things back over to Patrick 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 Doctor. Perera, Doctor. Burns, Doctor. Farrell for participating this morning, this afternoon in this Key Opinion Leader event.
Very, very interesting discussion. And 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 sort of key questions that you always have as a company that's been working on a test like Imrepan Candi. First of all, You always have to your first question is, is there a clinical need for the test that you will be providing? And I come away very confident with a very clear message that there is not only a need But there is a huge need and huge unmet medical need for a test like IMRa pancandi 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.
So, I think from an immunovia point of view, I think we got a very clear and resolute response on that And I'm very, very, very thankful for that. Then, 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? And 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 Compliment and we can potentially enhance how surveillance is done with IMRaIPANKND.
And 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. So, from that point of view, I think we come away confident that We will make a difference. Obviously, the 3rd last high risk group that we did not discuss that much, but it came up a few times. It's obviously the new onset diabetes group where We hopefully later this fall will be able to generate some data With regards to IMRE Bankendi's performance in the cohort of Swedish new onset diabetics where we have participated in collecting some 6,000 samples from Swedish and new onset diabetes and we'll get the first insight into the performance of IMREIP and Kandi in this particular group. The 3rd aspect From Immunovia's point of view is obviously the sort of go to market and marketability and the sort of business aspects.
And here, obviously, things like getting a clear approval, which we would have expected to have already and we think is imminent, is important. But obviously, also developing strategies to get the reimbursement in the U. S. It's an absolute key for us. And 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.
And then 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. And therefore, the inclusion criteria are tight, etcetera. 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, it's certainly not what we are intending to do with Imre Pankandi at this instance. We're coming up on our time and 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. So thank you very much. Thank
you.