Welcome to today's presentation from Scandinavian ChemoTech, where we have invited the company's medical director, Suhail Mufti, to give an update on the clinical strategy of the company. Suhail, can you just start with giving a brief introduction of yourself, and then go ahead with the presentation, please?
Thank you so much, Jonathan, for the introduction and starting the presentation for today. Starting from myself, I'm Dr. Suhail Mufti based in India, and I'm the medical director for Scandinavian ChemoTech. I'm basically an oncopathologist and cancer researcher with an experience of over 15 years into cancer research and in oncopathology for 20 years.
I have been involved rather, in a lot of clinical development products in the oncology space, both from the drug side and the medical device space as well. I have an experience in the FDA market, in the European market and in the rest of the world as well in the Asia Pac region.
I do have a lot of experience into the regulatory space in India and as we know that the regulatory space in the Europe and India and for the medical devices has changed recently a lot. We would be working on that. Thank you so much for the opportunity for today to present Scandinavian ChemoTech's clinical development plan. In this presentation.
I will not go much into the basic sciences of the technology, which is a Tumor Specific Electroporation. I will start this presentation with the studies which we are doing at the moment, which are the marketed indications, and then we'll go through the translational research which we are doing, the biomarker research which we are doing at different in different countries.
I will end this presentation with a little bit about the immunology part of the Tumor Specific Electroporation, how the immunological advances over the last few years have given space to technologies that like TSE to work alongside drugs and actually boost the immune sensitization of the tumor and make other technologies or other drugs effective as well. I'll come in detail and let's dive into the presentation. Tumor Specific Electroporation is a technology from Scandinavian ChemoTech, which is a reinvented technology, a patented technology called IQwave.
This is a dynamic electroporation and a reversible electroporation for the tumors wherein the major change which has happened with electroporation or electrochemotherapy is the multimodal, the multi-directional electric fields which are created and the decrease in the cold spots, the decrease in areas which were left behind by the older electroporation technologies.
Using the IQwave customized handheld tool, the oncologists can now choose different distances between the electrodes to suit the size and the location of the tumor. You can see on the left, I have kept a picture of a superficial tumor, and on the right, you can see the deep tumor, the pancreatic tumors, which we are treating now.
In the middle, we are a team working with the Ukrainians, even in difficult times, working with them on some of the difficult cases they have. This is the landscape of the Tumor Specific Electroporation studies which we are doing across the world.
We have the marketed indications, we have the CE marking in Europe. Marketed indications are across the superficial as well as the deep tumors. We are in the skin, head and neck, breast, sarcoma, and also the deep tumors also are marketable, and they vary from country to country. In Europe, India, Africa, we are in the market in the deeper tumors as well.
We are doing the post-market clinical follow-up studies after the CE marking, and we generating real world evidence as well, which we are data mining using AI technologies to create better predictive models. As we know that in oncology, the predictive models and the nomograms are very important to select the right type of patients who would response better than others.
We are creating that with the current ongoing practice, the clinical practice, which oncologists are using it in different regions of the world, as well as during the investigator-initiated clinical trials as we have those in say, All India Institute of Medical Sciences in Jodhpur. We have upcoming in Rwanda, and we have upcoming in Kenya as well. As far as the translational research is concerned, and which is always for any research-based company is always ongoing.
We're trying to understand the potential of the technology to with using the biomarker studies, how efficiently it's converting the cold into hot tumors, like the pancreatic tumor. We're doing those biomarker studies, translational studies, to find out the efficacy in the bone tumors, spinal tumors, deep-seated solid tumors, like we have the pancreatobiliary tumors.
We have retroperitoneal sarcomas, where getting a good resection, a clean resection is very difficult, and there is most of the times leftover tumors. In the clinical validation space, we're doing studies for combinations of TSE with the immune checkpoint inhibitors, and that's planned in Rwanda, that's planned in Kenya, and also we're taking that to India.
There has been interest in various institutions in U.K. as well for doing combination studies along with immunotherapy. There's available literature at the moment that electroporation can actually, and electrochemotherapy per se, can actually create a radiosensitizing effect because of converting a cold into a hot tumor with the new antigen release.
We are looking at where TSE would be positioned, and it has a good opportunity. There's a good opportunity to create radiosensitization, just like chemotherapy may do it. Actually the doses of the radiotherapy may decrease for solid tumors. The other interesting area which we are looking at is the intratumoral immunotherapy.
Since it's a reversible and a dynamic technology, it's possible to take, say for example, the Interleukin-12, the plasmid-based DNA electroporation, which is already into multiple studies, and there are many more in Intratumoral immunotherapy which is coming up.
Newer paradigms are also in the pipeline where we are trying to get TSE technology, and there's a immense potential of that getting into earlier paradigms, into earlier treatments. I took a lot of time on this slide, this would have been sufficient. I would welcome questions after this presentation anytime, our contact details would be available.
The, all the clinical projects which I just now has, I mean, briefly talked about, we have the regulatory EU, head and neck, breast cancer, skin melanoma, liver, pancreatic, and prostate studies which are there. We have started our journey from 2015, we are at the moment into getting the studies launched in different countries.
In pancreatic, we've already done the cases in Ukraine there would be studies coming on in different regions as well. We have studies in AIIMS Jodhpur for breast, and we have for head and neck. They're also doing it into their usual clinical practice, so we're collecting case reports, we're collecting real world data, we have the pancreatic, as I just said. We have from Ukraine, Rwanda, India, and USA coming up.
Combinations into immunotherapy and also intratumoral immunotherapy. Last but not the least, veterinary oncology is a major interest for us, and it's already into practice in different regions of the world. In Europe, it's in U.S. as well, and it's also coming up in the Middle East.
It will be important to mention that we are working in a space where solid tumor market was valued at $209.61 billion in 2021, and expected to reach a very, very good figure of $901.27 billion by 2029. This is the overall solid tumor market which we are working into.
Definitely a technology like TSE would have a good market share if proven to be applicable for most of the tumors. Okay. A little bit more detail about the pancreatic cancer. Actually, this is exciting for us because the recent evidence which has come from Ukraine for our patients who are doing good for the last close to six months now, with an improving ECOG score over time and their usual routine has improved. Initial studies, the outcomes were, like, more than 50% with a single application.
The tumor size reduction was more than 50% after a single sitting of TSE. The investigators at the LISOD - Israel Oncology Hospital in Ukraine are really optimistic about the outcomes and the patients are improving and it's in the public domain as well. We have upcoming studies coming in Africa and Rwanda, which would be started this year. We hope to complete them by the next year, 2024, 2025, and reach to the commercialization and post-market clinical follow-up stage.
We have interest from institutions, university, academic partners in the USA, and they are at a clinical protocol development stage. We would be taking that forward this year as well. In India as well, there are many institutions where we have done the feasibility, and we are going ahead with studies, investigator-initiated studies, because the product is already approved for pancreatic cancer in India.
We are also looking at developing the probes by minimally invasive techniques with different companies, and this would be a major game changer as far as TSE technology or the electroporation technology is concerned. Again, to mention about the pancreatic cancer market trends, the global pancreatic cancer market will be valued at around $2,125.57 billion in 2023, and it's consistently growing at 13.5% of CAGR to top at $7,541.09 billion in the next 10 years.
This is a major cancer, a major concern, because we don't have a good response from most of the therapies which we are using for pancreatic cancer at the moment. In the next 6-12 months of our R&D portfolio, of course, we would be generating a lot of data, which can be mined, using AI calibration and we'll be creating predictive models, immuno-oncology, and other biomarker studies would be done during investigator-initiated studies.
They're already happening in AIIMS Jodhpur and Kenya, and we'll be creating nomograms for predictive analysis of TSE. Pain control is also a throughput area for us in the next 6-12 months. For deep-seated tumors like pancreaticobiliary tumors, liver, prostate cancer, and retroperitoneal sarcomas, along with others, we're taking forward in the next 6-12 months.
12-36 months, we're developing more probes, so that we can go percutaneously into deeper and deeper tumors. We're developing probes for much better probes for oral cavity and cervical cancer as well. We're working with robotic companies to develop stereotactic treatments, using TSE.
Veterinary oncology is helping even in the human space because there are a lot of biomarker studies which are planned for the veterinary oncology and would also create the translational reference for human studies as well. Having both the veterinary segment and the human segment at ChemoTech is actually a win-win situation for getting the product to the market as fast as possible.
In the next three to five years, we would be continuing our translational research, and that's something which most of the R&D companies do across the life cycle of a product. The clinical research for combination with IQwave and newer molecules which are amenable, we won't just rest. We're not restricting ourselves to bleomycin or cisplatin.
We're looking at other molecules as well which are amenable to the Tumor Specific Electroporation. This is a major area of our research as well. The other area of plasmid-based electroporation and gene delivery, and that would be the Intratumoral immunotherapy, which is coming up in a big way. Many, many researchers are working on this. We have also invested into working in this space, and that is for three to five years for us to get into the validation stage.
That was regarding our clinical development plan in a very brief manner. Then, coming to the very basics, what is electroporation? What is Dynamic-Electro Enhanced Chemotherapy? It's just, the, creating safe electroporation without a lot of necrosis, focusing more on the apoptosis, pyroptosis, and necroptosis, type of cell death rather than the necrotics type of cell death.
We do give intratumoral chemotherapy. We give it systemic. The intra, intracellular, the chemotherapy or intracellular chemotherapeutic concentration is increased, say for bleomycin, up to 8,000 times. This is the, multidimensional pulse, which I was talking about, which decreases the cold spots. The device calculates, the potential in multiple directions so that we don't have cold spots, and the electroporation is perfect.
After every pulse, the dynamic pulse reduces to risk the burns which are there with irreversible electroporation, which is more of an ablation. We are not doing ablation at all. We are focusing more on the immunological effects on the tumor and of the drug, which we are using along with electroporation.
That's what TSE does rather than the older type of devices. This is what we can see that we have if using a large potential, we're using, we can see necrosis very close to the electrode. You have in the whole corona of the electroporation, you have necroptosis, you have apoptosis, and then you have the reversible electroporation.
We are in the space of reversible electroporation, which is more related to a lot of apoptosis, necroptosis, and also pyroptosis. There is a, as I said in the previous slide, there's a dynamic pulse which reduces the risk of burns as in the as seen in irreversible electroporation.
Now, this is the complete gap analysis of our clinical development plan of wherein there is we have analyzed the gaps which were there with irreversible electroporation and the older static electroporation technologies. There, if we had time today, I would have gone through this in much more detail. If I summarize this gap analysis, there is a complete change in tumor-specific electroporation compared to the previous ones.
The advantages of TSE revolve around less necrosis or minimal necrosis, more of necroptosis, pyroptosis, and very regulated type of necrosis and apoptosis. We can use it in a cytoreductive or neoadjuvant setting compared to the irreversible technologies or the older reversible electroporation technologies.
There's not much of potassium release. It can be done in a very safe manner for the larger tumors as well. There's not much of ionic disturbances or tumor lysis syndrome, which may be a risk in deeper tumors with irreversible electroporation or even with larger tumors which are superficially. All those risks have been mitigated by the Tumor Specific Electroporation technology.
Of course, we have a lot of favorable economic operators as well. This is a cartoon which is showing that there's a lot of new antigen release, and the new antigen release is comparable when it comes to the Tumor Specific Electroporation.
The new antigen release is almost the same or comparable to irreversible electroporation, but it's much more safer because in the ablation technologies, you actually destroy the lymphatics and the lymphatic system with the T-cells as well, which has been proved by multiple studies, as has been proved for radiotherapy as well.
The sensitization of the tumor or the lymphatic system or the T lymphocytes through the dendritic cells is much efficient when it compared to irreversible electroporation or even with radiation therapy. We have studies...
In the biomarker studies, we have some studies they're ongoing to prove this because talking about this compared to radiotherapy is a very tall claim, but we have seen favorable results in our biomarker studies so far. If I summarize the future direction of TSE and the ongoing research in a few lines.
I can say the combinatorial treatment approaches in earlier paradigms of TSE, along with, say, anti-PD-1, anti-PD-L1 antibodies, anti-CTLA-4 and antibody-drug conjugates, which are coming up in oncology in a big way now, and the targeted therapeutics.
There could be combinations of the two, and there is recent evidence that once you convert efficiently the cold to hot tumors and leave the lymphatic system much more patent compared to ablation technologies, the response to the checkpoint inhibitors and other types of immunotherapies would be much better, and that's what TSE does. It's also as a radiosensitizer, so we can do it before radiation, and that needs studies, and this is again a paradigm, earlier paradigm created, which has not been ever before.
Predictive models and nomograms would actually help us stratify the type of patients and reach to the type of patients, who would have the best of response. That's what we are doing in ongoing investigator-initiated studies and real world evidence, which would be submitted to the regulatory.
AI calibration of therapy, of course, is the same thing almost, which helps in the predictive models. Newer indications like bone, spinal, deep-seated tumors, even though some of these are approved in some regions, but we're working across the globe and of course to the U.S. market as well.
Pancreatic, esophageal and retroperitoneal sarcomas, would also be a major area for our focus. Robotic technologies is a very important thing for us to do because we need to go into, and since we have seen a very favorable response in Ukraine for pancreatic, we would like to have minimal invasive procedures integrated with TSE so that we can have...
If we have a response of 50% with a single sitting, if we go two or three times, then, that would be a better way of treating pancreatic tumors or pancreatic neuroendocrine tumors, retroperitoneal sarcomas, if we have an opportunity of reaching the tumor multiple times, minimal invasive way.
This is a major area of our research and working with other companies as well. Thank you so much for today. I'm open to questions. You can send them now or you can email it to us, and we'll get back to you as soon as possible with our responses. Thank you so much.
Thank you. Thank you very much, Suhail. I will just mention that for those that want to address questions to Suhail, you can use ir@chemotech.se as the email address. IR, as in investor relations, @chemotech.se. Thank you very much for today.
Thank you so much. Thanks, Jonathan.