Immutep Limited (ASX:IMM) Executive Director and CEO Marc Voigt, Chief Scientific and Medical Officer Dr Frédéric Triebel, and Director Clinical Development and Regulatory Affairs Christian Mueller present on Immutep's latest clinical results.
Good morning, everyone. Thank you for joining us for another Immutep (ASX:IMM)
investor call to discuss more clinical results from the company's lead product candidate, eftilagimod alpha. Clive Tompkins in Sydney here, your moderator for today. At this time, all participants are in listen-only mode. We will conduct a question and answer session at the end of the presentation. I'd now like to hand the call over to Marc Voigt, Immutep CEO, to start the presentation. Marc, are you there?Marc Voigt:
Thank you, Clive, and welcome, everyone. Early in the morning in Australia, obviously late in the afternoon in the US, and close to midnight in Europe. So, we would like to thank all of you for joining us on the call today, and I hope that everyone is keeping safe and well with your families during the COVID-19 situation. Obviously, it's still impacting our lives.
On today’s webinar, we are excited to take you through the new positive data from our TACTI-002 trial which was just announced at the virtual ASCO conference. The data relates to our lead product candidate, about eftilagimod alpha, also known as IMP321, or as you will hear us call it, efti.
Joining me on the call today is: Professor Frédéric Triebel, who is Immutep’s Chief Medical Officer and Chief Scientific Officer. Frederic will talk about efti and its potential. We are also joined by Mr Christian Mueller, our Director Clinical Development and Regulatory Affairs. Christian will take you through the TACTI-002 trial andINSIGHT-004 results that were announced at ASCO.
Now, the disclaimer around forward-looking statements.
I would like to spend just a little time to give you an overview of LAG-3 and our product candidates. On slide 4, you can see the two broad effects that targeting LAG-3 can have: immunostimulation – increasing the body’s own immune response; or immunosuppression – decreasing that response.
Across these two categories, Immutep has four different product candidates: two in immuno-oncology, or cancer, and two in autoimmune diseases. Two of these products are exclusively worldwide outlicensed to GlaxoSmithKline and Novartis. In today’s webinar we will focus on our lead product candidate, efti, which is shown inside the red box in the top left-hand part of the slide. Efti is a unique antigen presenting cell activator, or APC activator, with LAG-3 as a tool to activate the dendritic cells via the target MHC II molecules.
Let’s delve into more detail about efti now and our program of clinical trials. Turning to slide 6, this is our diverse program of clinical trials for efti that are driven by Immutep. There are also other trials being run by our partners, but here we are concentrating on our trials. Our largest and most advanced study is AIPAC. We reported clinical trial results from AIPAC in March this year. Our other phase II trial is TACTI-002. Interim data from TACTI-002 has been very encouraging to date and we’ll go into more detail on these results on later slides. Efti is also being evaluated in solid tumours through our INSIGHT-004 trial which is conducted with Pfizer and Merck KGaA. We will be taking you through the first interim data from this trial today as well. Our melanoma trial for efti is called TACTI-mel trial and this study has already reported encouraging final phase I efficacy data. From our pipeline, you can see efti is being developed via multiple clinical trials for multiple indications, or diseases. This is very important for us as a biotech as it de-risks our outlook considerably.
On slide 7, here is a diagram of efti showing its structure in the top left-hand corner of the slide. Efti is a soluble recombinant fusion protein. It is an antigen presenting cell activator, or APC activator, meaning it is able to activate dendritic cells that process and present antigens for recognition by the T cell receptor on T lymphocytes. Its mechanism of action is unique and first-in-class as a MHC class II agonist, which strengthens its value for Immutep. It’s important to note that efti is not a blocking antibody, but a unique antigen presenting cell activator. The diagram on the right-hand side shows the typical mechanism of action of an immune checkpoint inhibitor. This mechanism "releases the brakes" on the T cell by blocking the LAG-3-MHC class II interaction. This is not how efti works. In the left-hand diagram, you can see that efti stimulates the immune system by activating the dendritic cells which leads to an increased number of monocytes, dendritic cells, natural killer cells and both CD4 and CD8 T cells. Efti’s mechanism is essentially ‘pushing the accelerator’ on the immune system cellular responses.
I would now like to hand over to our CSO and CMO, Frédéric. Frédéric discovered LAG-3 and is considered a pioneer, or “rockstar”, in the immunotherapy space. He will go into more detail on efti and then talk about our TACTI-002 trial. Frédéric.Professor Frédéric Triebel:
Thank you, Marc. We’ll now talk about our phase I trial, INSIGHT-004 which combines efti with avelumabanti-PD-L1 therapy.
Turning to slide 9, our INSIGHT-004 study is a dose escalation trial of efti in combination with avelumab. We are conducting the trial in Germany in collaboration with Pfizer and Merck KGaA, and it is being run under the protocol of the wider INSIGHT trial by IKF. INSIGHT-004 has two cohorts of 6 patients with solid tumours participating. Patient recruitment was completed last month. Participants are receiving either 6mg or 30mg of efti in the combination therapy, every 2 weeks for 6 months. There is then a 6-month follow up period where patients receive just avelumab.
Looking at slide 10, we are pleased to report that the combination treatment is safe and well tolerated by patients. There were no Dose Limiting Toxicities and no new safety signals with the standard dose of avelumab. In the top table, we detail the most common side effects which include pain and nausea up to grade 3 level only. In terms of adverse reactions, efti has only been associated with 1 so far and that was an injection site reaction.
We’ll now talk about our other phase II trial, TACTI-002 which combines efti with an approved anti-PD-L1 therapy. Slide 12 gives you an overview of the trial design for our ongoing phase II TACTI-002 which we are conducting in collaboration with Merck Sharp & Dohme, known as MSD. TACTI-002 is testing the combination of efti with MSD’s drug KEYTRUDA, also known as pembrolizumab, in up to 109 patients. The study is a multi-national, open label trial with a Simon’s 2 stage design. The advantage of this design is it enables us to expand the cohorts as positive responses to the combination therapy are observed. TACTI-002 is a PD-L1 all comer study, meaning that patients could participate without being pre-screened for their PD-L1 expression. PD-L1 status is a well-known predictive marker for response to pembrolizumab monotherapy and will be measured centrally later on.
We have three types of cancer patients participating in the trial.
In Part A we have patients with advanced/metastatic Non-Small Lung carcinoma and they are treatment naïve, so they haven’t received any previous treatments for their metastatic disease.
Part B enrols patients with advanced Non-Small Lung carcinoma who have progressed on PD-1/PD-L1 therapy, which has been shown on two consecutive scans, so a real refractory setting.
And Part C patients who have recurrent metastatic Head Neck Squamous Cell carcinoma after failure of platinum-based therapy.
The primary endpoint for TACTI-002 is Overall Response Rate, or iORR. The endpoint is measured by iRECIST, which is the accepted standard for measuring responses in trials involving only immunotherapies.
We are pleased that recruitment has progressed for the trial even in the current environment where COVID-19 is generally slowing patient participation in clinical trials across the globe. However, we anticipate that recruitment may slow down TACTI-002 going forward due to the closure of hospitals in certain countries that have been most affected, such as Spain and the United Kingdom. The most up to date recruitment numbers are detailed on the slide and you will be aware that we have already been able to expand to stage 2 for two Parts of the trial (under the adaptive design) due to encouraging overall response rates in Part A and Part C. Lastly, we should mention that the trial is taking place across Europe, Australia and the US, where efti received its first IND approval last year.
Moving now to slide 13, here we are looking at interim safety results from stage 1 of all three Parts. This data reflects results from the 76 patients who were enrolled in the study at the time of the data cut off, which was 30 April 2020. The results are continuing to build efti’s very favourable safety profile and no new safety signals have been observed in combination with pembrolizumab. Just over 40 per cent of patients had one or more adverse events that were grade 3 or higher. There have been no treatment related deaths. Overall, we continue to be very happy with the safety profile reported from efti.
You can see how this strong safety profile compares to other treatment regimens in the table on the right-hand side. In the combination with prembro, we do not have any treatment related deaths, and we only have 4 per cent adverse events leading to discontinuation. This bodes very well for patients and for our engagement with the regulatory bodies.
I would now like to hand over to Christian Mueller to take you through the unmet medical need and efficacy results around this trial. Christian.Christian Mueller:
Let´s start with one of the most important indications; 1st line non-small cell lung cancer where almost 2 million new cases are reported every year. Despite recent improvements especially with checkpoint therapy (partially plus chemotherapy) there is still a high unmet medical need especially for patients with a low PD-L1 expression who account for approximately 70 per cent of the total population. And I believe all of us are aware that efficacious treatments like pembro plus chemo havequite a number of side effects and burden for the health care systems. With Part A in TACTI-002 we are exactly targeting one of the biggest markets in oncology and I would like to show you some very encouraging data in the next couple of minutes.
Looking at slide 15 now, this slide outlines the baseline characteristics of patients in stage 1 of Part A. These are the patients in the first cohort of Part A with 1st line non-small cell lung cancer. The table on the left-hand side describes the patients participating in this part of the trial. The average age is 65 years, we have more men participating than women and most are former or current smokers. A little over half of the patients had squamous type of diseaseand little less than 50 per cent had non-squamous type. Most importantly,looking at the table on the right, we can see that participating patients had a PD-L1 expression similar to historical controls. ~ 70 per cent of patients had a PD-L1 expression level of less than 50 per cent and there is no over-representation of patients with high PD-L1 expression, which is important as this marker is predictive for efficacy of pembro.
Turning now to the efficacy results of this patient population on slide 16. We are delighted to report an overall response rate of 53 per cent according to iRECIST and disease control rate of 82 per cent. In the waterfall plot on the right you can see that there are responses among all subgroups of PD-L1 expression. Those patients that have reported a response are indicated by the green bars. We have detailed the PD-L1 expression distribution in table in the bottom right hand corner of the slide which makes this more visible.
Looking at slide 17, on this slide we illustrate the individual patient’s responses over time through a spider plot. Here each coloured line represents one patient and the development of the target lesions over time. The colour of the line indicates which PD-L1 expression category they belong to. Red - < 1 per cent; orange 1-49 per cent, green >= 50 per cent and black – not evaluable. The lines with an arrow indicate that the patient is still continuing with the combination treatment. As you can see, 7 patients have arrows and are continuing therapy at the data cut-off date, after more than 9 months. The median progression free survival is estimated to be 9+ months. Achieving a PFS estimate of more than 9 months and a 53 per cent ORR in 1st line NSCLC patients is very encouraging! We will take a moment to reflect on comparable ORR and PFS figures on the next slide.
As mentioned, we’d like to provide some context for results by comparing them to available treatment regimens. There are different approved and tested options for these patients each of them with different drawbacks. Double chemo for long the Standard of Care has a low ORR with 20-30 per cent, short PFS and OS and is relatively toxic. Pembro plus Chemo has improved PFS/OS and ORR but comes at the price of substantial toxicity and short DOR compared to IO products alone. Ipi plus Nivo is only slightly better than doublet chemo alone but carries a lot of costs for the payers. Pembro alone is efficacious in high PD-L1 expressors but for pts with medium PD-L1 expression ORR is low as well so is PFS. And pembro was officially never really tested in large trial in PD-L1 negative pts (which are allowed as per our protocol). Based on the results we have presented today, efti offers higher response rate than pembro alone despite PD-L1 negative patients are allowed in TACTI-002 without substantial additional toxicity. We believe efti offers a compelling potential treatment option in 1st line NSCLC and unique opportunity for differentiation for big pharma PD-1; PD-L1 therapies. Just to remind everyone: as of now three PD-1/PD-L1 therapies have been approved. They arepembro, nivo and atezolizumab. We expect more will come.
Moving to slide 19, we’d like to just touch on the epidemiology of HNSCC for a moment. There are over half a million people diagnosed with this disease each year and approximately 350,000 develop metastatic disease. Despite all recent improvement especially with PD-1in 1st and 2nd line setting, stakeholders like patients, doctors, payers have the same unmet need as for 1st line NSCLC only more dramatic as response rates and Overall Survival rates are considerable shorter. The figure on the right show the Kaplan meier Progression Free Survival plot from the KN-040 study in 2nd line HNSCC indicating that at 5 months less than 30 per cent are still progression free.
Moving now to the results from the 2nd line Head and Neck Squamous Cell Carcinoma patients which are on slide 20. Patients are all pre-treated with platinum based chemotherapy and about 47 per cent have an ECOG of 1. Median age is 66 years old and 94 per cent are male. Here we detail the patient responses at the data cut-off date in the table on the left-hand side. We are very encouraged to report that data has evolved positively since the last readout atAACR. We now have staged all patients after treatment start and observe an ORR of 39 per cent. This is an improvement on the ORR reported in March which was just 33 per cent. As you can see in the waterfall plot responses are getting deeper. At the cut-off we had 1 complete response meaning that all target lesions have disappeared in this patient who is indicated by the blue bar. Partial responses are indicated by the green bars.
Taking a look at the spiderplot for this group, let’s turn to slide 21 now. You can see the patient with the complete response is again indicated by royal blue and had 100 per cent shrinkage of their tumour at 36 weeks of treatment. Besides the CR there are two other interesting cases here. One patient with a pseudoprogression who responded later and then a late response at 8/9 months. Eight patients are continuing treatment indicated by the black arrows. You may recall the PFS plot which was shown on slide 19had less than 30 per cent on the trial at 5 months. These results are remarkable and make us very optimistic about efti in combination with pembro for patients with this cancer type.
On slide 22, we provide some comparable results in 2nd line HNSCC to put our initial results into context with available therapies. You can see that patients treated with chemo or pembro as monotherapies, have modest overall response rates, all less than 18 per cent, and the median progression free survival is just over 2 months. In this context, efti’s performance combined with pembro, is remarkable. We are seeing a 39 per cent response rate.This response rate is higher compared to pembro on its own and doesn’t bring substantial additional toxicity as Frédéric has shown earlier. This makes it a very exciting potential new treatment option for patients and physicians. Given that the disease is so aggressive, the combination therapy also potentially holds some shortcuts on the way to registration.
Let me give you an example of the regulatory pathways ahead, via pembro, which was approved in 2nd line HNSCC by the FDA in 2016. Based on non-randomised data from ~ 200 pts, pembro was basically approved on the strength of its Overall Response Rate which showed that the responses were durable. FDA asked MSD to conduct a phase III while it was already marketed. Given the pathway and approval outcome for prembro, efti shows promising activity based on the initial results from TACTI-002 in two very interesting indications in metastatic cancer.
Marc will now provide some concluding remarks for our webcast. Marc.Marc Voigt:
Thanks Christian. This brings us to the end of the newest TACTI-002 results.
On slide 25 now, we are very pleased to discuss for the first time, the efficacy results from our three PD1/PD-L1 trials and bring them all together. Efti is being evaluated in up to 145 patients in six cancer indications from NSCLC and HNSCC in TACTI-002, to Melanoma in TACTI-mel and advanced solid tumours via INSIGHT-004. The growing pool of efficacy data we are gathering in each indication is adding value to Immutep day by day. In addition, efti has been evaluated in combination with two approved drugs: pembrolizumab and avelumab. We’ve been through many of the efficacy highlights in today’s presentation and we are happy to provide a summary of the relevant trials that our efficacy data should be compared to.
Efti is emerging as a strong potential therapeutic option in the immuno-oncology landscape. The results from TACTI-002 are very encouraging and compare well to what has been approved so far. In addition, Immutep has two different immuno oncology product candidates, one is already outlicensed to Novartis. This puts us in a good position when it comes to becoming the “next big thing“ in oncology. There are a number of other agonists and antagonists that also look encouraging. This brings us to the end of the clinical results that we have just reported at ASCO.
On slide 28, I would like to summarise and talk about what news lies ahead for Immutep, as there are still many results on the horizon for 2020 and into 2021. We anticipate reporting Overall Survival results from the patients who participated in our largest clinical trial of efti, AIPAC. We also expect to report more data from TACTI-002 throughout 2020, including the first data from the patients in the 2nd line NSCLC group. We will report our regulatory progress and of course progress from our multiple partnered programs where we receive milestone payments. Next year, we expect to report final data from the first two Parts of TACTI-002 and final data from INSIGHT-004. Overall, we are gathering a large pool of data around our lead product candidate, efti, not to mention the progress with our other three product candidates. Immutep has a very exciting outlook.
So this brings us now to the complete end of the formal part of the webcast. I would like to thank Frédéric and Christian for their presentations and their contribution here, and I now will pass back to Clive for questions from the analysts on the line.Clive Tompkins:
Our first question comes from Tanushree Jain at Bell Potter. Tanushree, can you go ahead, please.Tanushree Jain:
Thanks for taking my questions and congratulations, Marc, Frédéric, and Christian on such an encouraging set of data. My first question is around the PFS for both the Part A and Part B results from TACTI-002. So we've got an estimated PFS of nine-plus months for part A. Can you confirm that data cleaning is the reason we haven't locked that in finally?Marc Voigt:
So, I'll hand this over to Christian.Christian Mueller:
Thanks for the question. There are different reasons for that. The main reason is that we haven't seen enough events, and then certainly as you say, we are about to clean the data and don't want to correct it later on. And you can expect to see that later at ESMO[European Society for Medical Oncology].Tanushree Jain:
And just on the part C, in terms of the patients who are still on treatment, it looks like we should have a PFS there as well. Can you give any comments on that?Christian Mueller:
It has not been read out yet.Marc Voigt:
But we are on it, just to add to that. We are on it. You are right. We just want to report data where we are 100 per cent certain. I think it's fair to say that the PFS is tracking well also for Part C, but we don't want to state a number yet because the data should be fully cleaned for that part as well.Tanushree Jain:
Marc, just on the landscape, and I guess some of the other presentations in non small cell lung cancer, including the TIGIT that came out at ASCO, it looks like the chemo plus pembro combination in 1st-line non small cell lung cancer is really unchallenged at the moment. So, given that backdrop, I guess from the efti-pembro combination, the results that you're seeing, can you perhaps give some strategic direction as to whether you could perhaps help Merck maintain that leadership position? Or do you think some of the other contenders could benefit from combining with efti, should results continue in this direction?Marc Voigt:
Yeah, thank you. I believe, first of all, the combination was with pembrolizumab, but the principle should apply to other anti-PD-1s as well. Anti-PD-L1 maybe also. You are right. The pembro chemo combination also, from our point of view, if you look at some of the data, is not really challenged. The TIGIT results have been nice, I believe. As one saw in a randomised setting a difference, even though the absolute results maybe not challenging pembro really or pembro plus chemo.
Eftilagimod, if the data continues to be that strong, could definitely be an option. Of course, there are always questions about how to address this in larger clinical settings. Also, one can think possibly also of a triple combination of eftilagimod, pembrolizumab and chemo. So, we believe, given the results we see to date, we definitely have a chance to improve the situation in 1st-line non small cell lung cancer.Tanushree Jain:
And just on the head and neck cancer, when do you expect we'll get a response by PD-L1 expression data on that?Marc Voigt:
I guess that will also be at ESMO if we have a chance to present there. Don't forget that the PD-L1 expression measurement is done under the control of Merck. So we'll be receiving the data from them.Tanushree Jain:
And just lastly from me, Christian, you mentioned the faster pathway in head and neck cancer, and I guess given the low survival rates there, I think there is definitely a more urgent unmet need there compared to non small cell lung cancer. Some of the examples that you did put up, they obviously had much larger set of patient population, like 174, etc. So, can you perhaps talk about what could be the fast pathway from here? I'm assuming you will still have to do a trial, but do you expect that to be more in terms of patient numbers similar to what you had seen previously with Keytruda?Christian Mueller:
Thanks for the question, a very important one actually. So, first of all, we believe that the data we have so far in stage one looks really, really encouraging. And we will take the data as soon as we have a bit of more flesh on the bones to the regulatory agencies and discuss with them. And we believe based on the current landscape in head and neck, and based on what has been seen in the past by the actions taken by the regulators and the options that have been given to other companies, that in this indication, there's such a high unmet medical need, you may have a chance with a non-randomised trial. The patient numbers and the actual design certainly needs to be discussed with the regulators in specific meetings. But as you say, it's certainly an indication with high unmet need, which always plays a role for regulators.Tanushree Jain:
Great. Thanks so much.Clive Tompkins:
Next question is from Dennis Hulme. Dennis is at Taylor Collison. Dennis, go ahead, please.Dennis Hulme:
Well, thanks very much, and congratulations to Marc and the team on the data so far. It's great to see the evidence for efti is continuing to build. And in relation to that, there's two cohorts of lung cancer patients which have almost completed recruitment, and I'm wondering when can we expect to see data coming through from those two cohorts? And can you just talk about what's the rationale about the anticipated timing of disclosing that data?Marc Voigt:
Thank you, Dennis. First of all, I believe that we have a chance, and this of course is always dependent on how the patients are tracking, also under the COVID situation and the recruitment, of course. We have a chance to see data at ESMO. Again, that is mid of September, mid to end of September, and will be entirely virtual again, as far as I'm aware. Please don't forget that we fully recruited the first cohorts or stageone of Part A in June last year. And then we presented first data at SITC, which was to a certain extent also immature. Unfortunately, it takes a while. We are very eager to put out data as soon as we can, but of course, it should be robust and it should also then be big enough, so to speak, to make a good difference. So we are working on it. It's in our interest to put it out. I believe we have a good chance to see it at the next big conference for us, which is ESMO.Dennis Hulme:
Great. Thank you. And then just moving across to the INSIGHT study, I've just been tossing up what I should make of the INSIGHT-004 data. On the one hand, 44 per cent response rate in a valuable patient is fantastic. On the other hand, three out of those four responders had tumour biomarkers that are typically associated with above average response rates, such as MSI high or high PD-L1 expression. So I guess, how should we think about that data and how it compares to what other products have achieved?Marc Voigt:
First of all, I would say the aim of the trial is safety, and we have achieved that. It's a phase one, exploratory character, one should not forget, with two different dosages of eftilagimod, 6 and 30 milligram. And we are actually very glad that we see activity here, especially as these patients typically do not have treatment options. So typical phase one, we see here hints of activity. I think it's worthwhile to look on a single-case basis as we have a variety of different tumours. And as Frederic pointed out, and he may want to add to that in a second, some of these patients are not typically immune checkpoint inhibitor sensitive, whatever it means at this early stage. But we have been very encouraged and I believe in general, it's nice to see, but Frédéric, you may want to go more into detail.Professor Frédéric Triebel:
Yes. I mean, these patients have been treated for only six months as it is a phase one, not for a year, as we usually do for phase two, and indeed we have seen a late response in Part A of TACTI-002 and a third one in Part C, patient responding after 8 months or 11 months. So it's difficult to say at the moment, but some of these patients responding to the combination have been treated for one or two lines. There are some kinds of niche indications not shown to be responsive to anti-PD-1 and certainly not to avelumab. So it's difficult to say these are four negatory cases, and out of the 12 patients, three have not been staged, so we may have other responses. We'll know more later on.Dennis Hulme:
I guess in relation to INSIGHT, what are the next steps after those last three patients have been evaluated? Would you look to expand any of the cohorts, particularly, for example, if you got a second responder in colorectal cancer or gastroesophageal junction cancer?Marc Voigt:
First of all, I would say from a safety point of view, and also let's say from anecdotal activity and this phase one also together then, of course, with the results from TACTI-mel and TACTI-002, there would be definitely the basis to further explore this combination. Of course, as you will understand, we have discussions around that, internal discussions also with the involved parties. So I don't want to make any public statement at this point in time.Dennis Hulme:
And just changing tack, are you seeing much impact of COVID-19 on recruitment and more particularly on patients having their follow-up tumour assessment scans?Marc Voigt:
In terms of recruitment, I think we are in the good situation that, on the one hand, AIPAC is fully recruited, that INSIGHT-004 is fully recruited, the 12 patients, and that we have more than 70 per cent recruitment of TACTI-002, indeed, it's a little bit slower than it has been before. In terms of the scans and the assessments, we evaluate this on an ongoing basis. There might be an impact here or there, but I believe as we have a global clinical trial, practically with Australia, which was not really interrupted by COVID-19. In terms of the hospital in the US and Europe, we have a relatively balanced approach, so any potential impact should be manageable.Dennis Hulme:
Okay. That's great. And so I guess, changing tack, not directly, but staying on COVID-19, can you touch on how the discussions about a potential study of efti within COVID-19 patients is progressing?Marc Voigt:
Yes, it's progressing. We have been approached by a PI to test efti also in the COVID setting. I mean, it's a good idea to strengthen the innate immune system, especially in order to prevent patients which are hospitalised but not in the ICU, from getting into the ICU. So, let's say a little bit earlier intervention, especially in the absence of a vaccine. You may know that we have also patent claims around that and that the potential of eftilagimod in infectious diseases is actually in our slides. Also in the patent claims. We are fully focusing on oncology. We are happy to support the efforts against COVID, and we will inform the market once there is more to say.Dennis Hulme:
Great. Well, thanks very much. That's all from me.Clive Tompkins:
Marc, we've got two more people asking questions. Next is Chris Redhead from goetzpartners. Chris, would you like to go ahead?Chris Readhead:
Yeah, quick point on the PD-1 and the solid tumours, quite a lot of those tumours, you get PD-1 expression, but doesn't relate to... It doesn't give you a response, right. The other point was chemotherapy, which I think is, if you look in the AIPAC trial, you saw some effects, some synergy perhaps when there was chemo there, but it seemed to disappear when you took the chemo away. Just kind of wondering how that would roll into some sort of triple therapy, where it does sustain the chemo. How would you think that would work?Marc Voigt:
First of all, I believe you're right in terms of your comments, and the second is that one should, of course learn and continue then with the clinical trial design, meaning giving the combinations. Let's assume there would be a triple combination, as long as it is feasible and justifiable. So one would definitely try to continue that then in larger settings. But we have not made any internal decision to go into the triple combination. We have, of course, a number of different parties we discuss with different things. Can't be more precise at this point in time. So there are plenty of ideas, and if we would move into that direction, then I think one would aim to give it longer together.Chris Readhead:
A quick thing. With radio therapy, and I think that if you look, quite frequently, if you see a synergy between chemo and IO, then you get similar synergies or stronger synergies with radiotherapy. Is that something that you're thinking about?Marc Voigt:
The potential of eftilagimod is very broad. So indeed, one could aim also to go with radiotherapy. Of course, we have to focus. We have to follow the signals we see. I mean, at the end of the day, we are treating the patient's immune system, not cancer directly. This opens up a great variety of different combinations. Our resources are of course limited, so this is why we are currently focusing on what we have presented in the past and today. And we'll continue to do that in the future, but if the setting is right, for instance, from a business development point of view, then yeah, there are a variety of different other ideas.Clive Tompkins:
Let me just wrap up. That's it. Yep. No more questions today. Marc, can I hand back to you please?Marc Voigt:
Thanks a lot, Clive, and on behalf of the Immutep team, I would like to thank everyone for joining the webcast today. Of course, especially also the analysts, but also all others supporting us. Immutep continues to report encouraging data around efti, and we look very much forward to keeping you informed of further readouts.
I mentioned already where the next potential stop could be, but I'm sure we have other things to say between now and September. A copy of the webinar will be available shortly on our website, Finance News Network website, and other media channels. Thank you very much, and goodbye.Ends