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212. Bull, Bear & Beyond – Mendus: executive interview
13 Plays7 days ago
In this interview, Erik Manting, CEO of Mendus, discusses the company’s recently launched programme in chronic myeloid leukaemia (CML). Erik covers the current CML treatment landscape and unmet needs in the space, alongside how lead asset, vididencel, has the potential to address these challenges. We also discuss what next steps for Mendus’s CML programme may look like, should vididencel’s initial Phase Ib study be successful, as well as the potential commercial opportunity in CML, reflecting on the recent announcement that Merck will be acquiring Terns Pharmaceuticals for $6.7bn. The interview also includes a summary of Mendus’ key milestones and catalysts to watch out for throughout 2026 and beyond.
Mendus is a Sweden-based immuno-oncology company specialised in the field of allogeneic dendritic cell biology. Its leading clinical candidate is vididencel, an off-the-shelf cell-based cancer vaccine, which is being evaluated as a potential maintenance treatment for acute myeloid leukaemia (AML), CML and ovarian cancer.
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Transcript
Introduction and Interview with CEO Eric Manting
00:00:07
Speaker
Hello and welcome to this Edison TV executive interview. Today we are speaking with Eric Manting, Chief Executive Officer at Mendes. Mendes is a Sweden-based immunology co-opathy focusing on accident immunotherapies to address tumor recurrence and improve long-term survival in cancers.
00:00:23
Speaker
Today we're going to be focusing on Mendes' program in chronic myeloid leukemia or CML. Eric, thanks very much for joining us today. Good to see you, Aaron. Thanks for hosting me. So to kick things off, we saw recently in your annual reports the living with CML story, which helps us understand what an individual patient experience looks like for this disease.
Differences Between CML and AML Treatments
00:00:45
Speaker
So before we dive into, say, the company's clinical programs, could we start with an overview of what CML is, how it's currently treated, and then the unmet needs in the space?
00:00:56
Speaker
Of course, yeah. So, as you remember, we um started our program in acute myeloid leukemia, which is a very deadly disease. And survival is the main objective in the treatment of AML.
00:01:12
Speaker
It means that we apply our immunotherapy after the chemotherapy has done its job and brought the disease down. But in order for patients to survive, you have to activate the immune system to control the residual disease.
00:01:25
Speaker
And the main and only thing we're looking at in the end is survival.
Improvement and Quality of Life in CML Treatment
00:01:30
Speaker
CML is a very different story. Actually, survival in patients that have been diagnosed with CML has improved due to the availability of current new treatments to being very similar of that of the overall population.
00:01:47
Speaker
So survival is not so much the challenge in CML. It is much more about quality of life. And in CML, ah what has been the big difference in terms of getting the disease under control, because in the past, both diseases actually were treated in the same way. And there is still only one truly curative approach.
00:02:10
Speaker
which is immunotherapy in the form of an allogeneic hematopoietic stem cell transplant or bone marrow transplant. But that's a very dangerous procedure. So in AML, it is still commonly used.
00:02:22
Speaker
In CML, only in very rare exceptions when people are very poorly responding to ah current treatment. So what is current treatment? There is an important... discovery in CML that makes it stand out actually as one of the best examples and maybe the only example where it has been so clear cut of a disease that has a specific driver mutation that you can also specifically inhibit. And that's called BCRA. It's an oncogene.
Challenges with Tyrosine Kinase Inhibitors
00:02:50
Speaker
And that oncogene is strongly associated with CML to the point that if you have specific inhibitors of that protein, you basically suppress the disease to the level that people can live with it. And it's it's called a deep molecular response.
00:03:08
Speaker
And it basically stays under control as long as you keep taking your drugs on a daily basis. And these drugs are called tyrosine kinase inhibitors, and they bind to the BCR-ABL protein and they inhibit the protein and thereby also ah the disease.
00:03:24
Speaker
The TKIs, they come with all kinds of side effects. Plus, of course, it's not great. You have to take this kind of medication on a daily basis. which in itself is a burden, and it's also a big, of course, financial burden.
00:03:39
Speaker
But patients have serious side effects. And the reason we did the interview with a young CML patient, a lady called Sulva, who is now also in our annual report, it's also on our website, if you are interested, in what sometimes these particular patient cases ah mean for the life of patients that have been diagnosed and treated for CML.
00:04:02
Speaker
It's a pretty, it can be a pretty serious ah day-to-day struggle. And ah that is the part we are addressing in CML.
Innovation with VD-dencil and Clinical Trials
00:04:10
Speaker
And in CML, it's much more about quality of life. We want to stimulate the immune system with our product, VD-dencil, to the point that the immune system can basically take over the role of the TKIs by suppressing the disease on the immunological level so that people can more safely stop their TKIs without the disease coming back.
00:04:30
Speaker
And that is, in a nutshell, Aaron, what we're trying to to accomplish. Fantastic. So Mendes' CML program is now underway with the first patient recently enrolled. Could you summarize this first clinical trial for us? And then should the results be successful, help us understand what the subsequent steps might look like.
00:04:48
Speaker
Yes. The first trial focuses on what we call suboptimal responders. So despite the fact that most of the cases ah of new diagnosed newly diagnosed CML respond well to TKIs, tyrosine kinase inhibitors I mentioned before,
00:05:09
Speaker
um and ah the disease goes down from an active phase to a chronic phase, and you basically suppress the disease with your TKIs, there is different levels of molecular response.
00:05:23
Speaker
Only patients that have a very deep molecular response over multiple years at a certain point in time can try and stop their TKIs and thereby try to accomplish a treatment-free remission, which is what we just discussed.
00:05:38
Speaker
But there's also a very substantial group of patients with an estimated 20-30% of the patients in CML that have a suboptimal response. So in other words, they don't reach these very deep molecular responses, and they will also never be able to do a TFR attempt.
00:05:54
Speaker
And that is the patient population we are currently focusing on. And it means two things. First of all, of course, we try to um also get that patient population that is and suboptimally responding to TKIs, at least currently available TKIs, into a deeper molecular response, and thereby also maybe helping them in the end to do a TFR attempt.
00:06:19
Speaker
But the original ah thing we are looking for is safety. And then, of course, it's ethical to start in the patient population that is with a new product, our product, and suboptimally responding to current available and registered products.
00:06:35
Speaker
But secondly, also because the disease levels are slightly higher as compared to patients with an optimal response, you also have a better chance to pick up what you call an early monocular response. So you can measure the BCR-ABL gene and you can follow in that way also very precisely the levels of disease. And of course, when the disease levels are a little bit higher, you have a better chance of picking up early molecular responses after patients are being treated with our product. So that is the main objective of the phase one trial, safety, early molecular responses, so feasibility.
00:07:11
Speaker
The second trial we will start, and we will start it in parallel. So in this case, we will not wait for the whole phase one trial to be completed. It's a trial with up to 24 patients. We assume it will take roughly 12 months.
00:07:24
Speaker
um But we don't want to wait for that whole period before we can start phase two trial. And the phase two trial will focus on a different patient population. That will be the patients that have an optimal response, so a deep molecular response, and because they've had it over multiple years, they can do a TFR attempt.
00:07:43
Speaker
And the specific patient population in that context is ah the second TFR setting. It means that they have already had an earlier failed attempt.
00:07:55
Speaker
They will try again, and then the failure rate is actually quite high, around 75%. already in the first year. So it gives us, again, a good starting point to pick up a potential efficacy signal with our product, of course, next to continued safety
Commercial Landscape and Industry Moves
00:08:11
Speaker
monitoring. and The fact that we have now enrolled the first patient is, of course, a big milestone because it's the first time we administer the product in a new indication being CML.
00:08:21
Speaker
But it is, of course, a process we continue to follow carefully and because the the the main advantage of our product versus other available therapies, including hematopoietic stem cell transplant, and also to a certain extent, looking at the side effects of chronic TKI usage is safety. So we also always want to make sure that but the product has an excellent safety profile in the indications that we treat.
00:08:44
Speaker
Excellent. So we're taking a step back now. CML has been in the headlines recently following the announcement of Merck's acquisition of Tern Pharmaceuticals over for $6.7 billion. dollars Can we hear your thoughts on this transaction perhaps and then help our audience understand what the commercial opportunity for Mendes could be in this space?
00:09:04
Speaker
Yes, I think um the the main starting point ah is maybe to think about the patient population that is affected by CML, because that also, to a certain extent, of course, determines the commercial ah value for for it for pharma companies and drug developers, including ourselves.
00:09:25
Speaker
And the patient population in CML has been growing consistently because patients stay alive. So in CML, we're talking about prevalence, people living with CML and that are in principle under successful treatment.
00:09:41
Speaker
That is going through the roof. So in America and Europe only, we are talking already about 300,000 patients. And it's a growing patient population and with a plateau that is ah estimated to be in the end around 450,000 patients.
00:09:58
Speaker
Globally, we're talking about 5 million patients today and a prevalence plateau of around 10 million patients. So it's a very big indication. And these people take these TKIs on a daily basis. um The first generation TKIs specifically ah in the CML setting was Gleevec, a drug developed by Novartis.
00:10:21
Speaker
That is now coming off patent. And then there's second generation TKIs that are a little bit more potent. And now there's third generation TKIs and the one product which is on the market is a drug called Scamblix or Asimunib, which has been launched a couple of years ago by Novartis.
00:10:39
Speaker
And what is now happening is a classic battle between first in class and potentially best in class. Novartis is quite bullish about Scamlix and have predicted end of last year peak sales ah of about $4 billion dollars for this product.
00:10:58
Speaker
And so it's a big market and people realize that now. the compound that Merck has acquired via Terns has a similar mode of action. It actually binds at a specific site on BCR-ABL protein. They're both called allosteric inhibitors of BCR-ABL.
00:11:14
Speaker
um And there may be certain advantages to the Tern 701 compound versus the ah product which is now on the market, Siminib. But of course it will have to find its way to the market, whereas the product is already on the market.
00:11:31
Speaker
But that is now driving this this big interest in the field, that it is a big field in patient number. These drugs still have a rather high price level. So if it's a big commercial opportunity.
00:11:44
Speaker
And of course, with Novartis now having shown that there's still innovation possible in CML with this new class of TKIs, you have a kind of classic battle between first-in-class and potentially best-in-class compounds with now Novartis and Merck both having their own compounds.
00:12:00
Speaker
So the CML program fits into a wider strategy and for Mendes aiming to maximize the clinical utility of the lead candidate, Vida Densil. So could you just recap for us um maybe the other programs and the other disease areas?
00:12:15
Speaker
Yeah, what i I think I should start with, Aaron, is how we position in the CML field ah versus TKIs, because this is what's happening in the TKI landscape. And the ah continued switching of patients to newer, better, more effective, safer TKIs is driving the innovation in that part of the chronic phase CML.
00:12:39
Speaker
But in the end, what we discussed initially, which is treatment-free remission, it's something very different. It means that with these new and better TKIs, you will get more and more patients in a deep molecular response next to the fact that the patient population itself is growing based on prevalence.
00:12:55
Speaker
But the question is, what is next? And of course, what is next is the opportunity of patients that have those deep molecular responses to successfully stop their TKIs. And this is where we come in. So with the programs we just described,
00:13:09
Speaker
we want to show proof of concept that with a safe immunotherapy, you can basically replace the need for lifelong TKI usage. And as soon as we have shown that, that will be huge because it will allow a lot more patients to safely and successfully stop their TKIs once they have reached that point of a prolonged deep molecular response. so that is how we fit in. We are actually dovetailing on this very large and growing TKI field.
00:13:37
Speaker
And hopefully, of course, allowing many more patients to live a healthy life without being dependent on daily daily medication.
Future Steps and Trials in AML and CML
00:13:45
Speaker
So that is where we fit in. ah With respect to the other programs that we are currently doing, we have a number of trials ongoing. The ADVANCE-2 trial, which is an AML in post-chemotherapy. So patients have already reached a first complete remission, and we give them this immunotherapy to basically establish in a safe way, of of course, ah prolonged disease-free and overall survival. Now, that is a clear signal that we have picked up, so that long-term follow-up we presented end of last year at the ASH conference was already at 55 months median follow-up. So it's a very stable picture ah with already now ah
00:14:26
Speaker
and multiple patients having reached five-year survival. So that's a growing number. We are now already with nine patients beyond five-year survival. But that's, I think, a good... stable picture that we continue to follow. Then we have the combination trial with oral azacitidine. Oral azacitidine is also approved for that same setting.
00:14:44
Speaker
So we are combining it in a randomized control trial called the cadence trial. As soon as we have the first 20 patients in, and that's a growing patient number, we are now at around 16 patients. But as soon as we have 20 patients, we can do an initial ah top-line readout of that trial ah based on safety, early molecular ah responses, and immunological data and like we've also done in the ADVANCE-2 trial, the single-agent trial. And we have announced recently that we will start a trial in the second half of this year called the DIVA trial, which is in combination with venetoclax.
00:15:20
Speaker
And the main reason we are doing that is that venetoclax is based on clinical success, a more and more dominant first-time treatment in AML. And we expect that to be a growing phenomenon in the sense that a broader and broader patient population in AML will be treated with venetoclax instead of high-intensity chemotherapy.
00:15:40
Speaker
So we need to adjust the combination of our product to the first-time treatment landscape because we are a post-remission treatment. We first need chemo or venetoclax to do its job before we can help the immune system take longer-term immune control over the disease.
00:15:56
Speaker
So that is a trial which will be very important also with respect to our path to market. All of these trials in AML will lead to the situation mid next year in 2027, where we can look at the trial data, but also ah look at how the first lung treatment landscape has shaped up to define the optimal path to market. So that's going on in AML, and we will expect to report ah ah the data around the cadence trial once we have availability of the first 20 patients. in the trial.
00:16:27
Speaker
um With CML, the phase one trial is now starting. We expect to have the initial safety data and also some early molecular response data in the second half of this year.
00:16:38
Speaker
And that will also be the trigger of the phase two trial. Also, those two trials ah in the first half of 2027 will already give us a wealth of data to establish feasibility and proof of concept in CML. So that is the way the the program is shaping up, Aaron.
00:16:56
Speaker
Fantastic.
Conclusion and Further Resources
00:16:57
Speaker
We've covered a lot today and that that brings us to a close. But if our audience would like to learn more, we direct them to the Edison website where our research on Mendes is freely accessible. Eric, thanks very much for joining us today.
00:17:09
Speaker
Thanks, Evan.