Breaking News with Dr. Saskia Biskup

Dr. Saskia Biskup is my hero, the doctor I attribute to my success in beating Glioblastoma for nearly eight years. Many of you know her as the innovator behind the "CeGat vaccine" or the vaccine in Germany. Dr. Biskup will explain in detail how the vaccine works, why she is specializing in GBM now but how she dreams this technology will one day help with many cancers. And she shares the news about the vaccine coming to the US in clinical trial in 2026. Please listen and share and let me know what questions you have afterwards. I will work on getting this into video format with captions as well.

Saskia Biskup, MD/PhD, is co-founder and managing director of Cecava. After inventing the neoepitope vaccine technology, she applied it to patients suffering from tumors of various origins in her doctor’s office in the setting of individual treatment attempts. Building on this experience, she co-founded cecava with her husband, Dirk Biskup (PhD), to conduct clinical trials to ultimately prove the efficacy of this novel therapy and to enable its approval for the benefit of cancer patients.

As a specialist in human genetics, Saskia is head of her own Center for Human Genetics and founder of the Medical Care Center for Diagnostics, Prevention, Oncology, and Gastroenterology (both in Tübingen, Germany). She is also co-founder and managing director of CeGaT GmbH, a leading global provider of genetic analyses for a wide range of demands in medical practice, research, and the pharmaceutical industry. In 2011, she was recognized as one of the ‘100 Women of Tomorrow’ by Germany’s Federal President, and in 2014, she received the Women Innovators Prize from the European Commission.

Between 2012 and 2014, she was medical director at the Institute of Clinical Genetics at the Olgahospital (Klinikum Stuttgart).

Saskia holds an MD and a PhD in genetics from the University of Würzburg.

https://cecava.com

https://rebeccadevine.wixsite.com/thatbrainyblonde/why-germany

Transcript

Speaker 00: 0:08

Hey, it's Rebecca. Welcome back to the Brainy Blonde Podcast. You guys, today is the day we have all been waiting for. Well, I know I have, and I'm pretty sure you have too. I am interviewing my hero, Dr. Saskia Biskup. Everyone who knows my story knows that she is absolutely the hero of my story. She is the person that I attribute to my success in beating glioblastoma for nearly eight years. Dr. Saskia Biscup is the woman behind what everyone calls the CeGAt vaccine or the vaccine in Germany. And it is the greatest hope that we all have right now to cure the hardest to cure cancer, glioblastoma. And she's been doing this for a while. If you hop over to my website, you can see a video I have there. And it shows her winning the Innovator of the Year Award for the EU in 2014. Dr. Saskia Biscup is here to answer all the questions we could tackle in one interview, tell you how the vaccine works. It'll really help you understand why it works for some people and doesn't for others, what the restrictions are, and why she's able to do it in Germany. And the big news is I'm so excited. The clinical trial coming to the US and it's soon. I can't wait for you to listen. I can't wait for you to hear Dr. Saskia Biscup talk about all of the things that I've wanted to share with you in her own words, because sometimes this science gets me tongue-tied. And let's be honest, she's my hero, so I get tongue-tied around her anyway. And you could just hear it from her. You can hear Saskia tell everything that's that I want her to tell you that you've been asking to hear about the exciting innovation in all cancer, to be honest, but starting with glioblastoma. So let's take a listen.

Speaker 01: 2:20

Yeah, it's a pleasure to be part of your podcast. Thank you for for having me.

Speaker 00: 2:26

Thank you for being here. It means so much to me. And I would love for you to explain to the people listening to this podcast from your own point of view what the treatment is, and just see if we can clear. And I have a ton of questions for however much time you have that people have sent me that I would just love for you to answer if you could. Of course. Wonderful. So I think probably the first thing would be if you wouldn't mind, I know you've told this a hundred times, but just for all the people on this specific podcast, all of whom are well, I shouldn't say all, but most of whom either have glioblastoma or are caring for someone with glioblastoma. And then sometimes people with lower grade tumors or lung cancer or breast cancer or other cancers where they're not getting any hope for good treatment are reaching out in desperation. So maybe if you wouldn't mind just talking about how the vaccine works and what it does.

Speaker 01: 3:18

Yeah, and you have to stop me because this is not so easy to explain in a few sentences. Maybe I can go one step back. I'm a medical doctor and I'm specialized in genetics. And I think the major concept of what we do is that tumor cells harbor mutations in their genome. So these are positions in the genome that differ to the genome of the normal cell in the same human. And unfortunately, when cancer happens, the cancer cells are not recognized by the immune system, although they should look different. And so, with my technology, and you know that my husband Dirk and I, we founded CeGat, a sequencing company 16 years ago, my main focus is to characterize and analyze tumor cells. We want to understand why they grow, why they divide, where they differ. And once I have this information, we review the information in interdisciplinary boards. And then we try to find treatment that is targeted to this specific type of tumor. And like you say, it can be prostate cancer, it can be breast cancer, it can be lung cancer. And now you know we are specialized on brain cancer, but the technology works for every cancer. And once we see, and actually we're trying to understand the Achilles Heel of the tumor, where can we actually find a tool to stop the tumor cells from growing? And there are different options. You know, there's surgery, there's radiation, there's chemotherapy. Many patients have other targeted treatment options, inhibitors or antibodies. And so our vision always has been that every patient gets access to sequencing, which is not trivial. Many patients do not even get access to the data. The second vision is from us is that every patient gets access to an interdisciplinary expert team. Because, you know, not every doctor knows everything, and so we need to bring in human intelligence. We have to connect human brains, we are supported by artificial intelligence in the meantime, but we try to come up with the best plan for each individual patient. And some patients are in early stages of the diseases and other patients are in a late stage of the disease. And still we need to find targeted treatment if a patient has a wish to do something. And now the sec the third thing that I think is important is that we want that every patient gets access to an immune approach. Because since 2018, when the Nobel Prize was given for the finding that immune cells actually sometimes fail to recognize cancer cells, the treatments that are approved, like checkpoint antibodies, for example, they only help 30% of all cancer patients in the world. So we have to do something for the other 70% of patients who do not get access, or where this type of treatment fails. And here the fully personalized immune approaches come in, and there are different types of immune therapies. And now we are talking only about one specific subtype, which is a so-called neoantigen peptide vaccine. And this is designed based on the mutations we know from sequencing. And now it comes back to my profession as a geneticist. I know the mutations, and we have the data and the algorithms and a lot of knowledge on how to design a personalized vaccine. And so now I come to your point. Many patients approach us and ask, can I get access to a personalized vaccine? So sorry for this long explanation, but it was important, I think, to explain.

Speaker 00: 6:50

It's super important. And I think you explained it really clearly. When you talk about sequencing, because I don't even think some people fully understand that, you're talking about the mutations that are in the tumor or the mutations that people are born with that are inherited from their parents.

Speaker 01: 7:07

Well, this is an excellent question. And when we sequence, we always compare the normal genome of one individual to the tumor genome. And that comparison is crucial because 20%, approximately 20% of all patients with cancer have inherited a variant that predisposes to cancer. But not every predisposition is actually causing the cancer that lies in front of us. So only if I sequence the normal genome and the tumor genome in parallel, I can see the variants that are in the normal genome, I can see the variants in the tumor genome, and then I can bring this together. And that is crucial for me as a geneticist to counsel families. If you ask me, is my cancer caused by my cancer predisposition, I have to have an answer for you. So coming back to your question, we need to know both. We need to know whether a patient has inherited a variant that predisposes to cancer, and we have to know whether this variant caused this cancer. And then we have to understand the biology of the cancer. So we have to bring all this information together.

Speaker 00: 8:14

And I think when you say all of that and that you have an interdisciplinary board, because one of the questions that I get from people, and of course they're desperate and they're scared, because especially with a lot of these cancers, time is really important. They're like, why does it take so long? And I think that's what you're explaining is you can't just use artificial intelligence, you can't just run it through a computer, you have all of these brilliant minds coming together, and it's very personal to each individual. Correct. Okay. That makes sense. And then just for people to understand, there's dendritic cell vaccines, there's other kind of cancer vaccines. Can you briefly explain how those differ from what you are doing with your approach?

Speaker 01: 8:54

Yeah. So when I talk about immune therapies in general, I think it's the revolution has been to involve the immune system in the fight against the disease. And so there are different types of immune therapies. And for example, the checkpoint antibodies are the immune therapy that was the treatment is approved for many patients now. And the discovery goes back to the Nobel Prize in 2018 to overcome a resistance that protects cancer cells from the immune attack. And now the strategies that you mentioned, for example, dendritic vaccines or mRNA vaccines or peptide vaccines or DNA vaccines, they all have the same aim, which is to induce a T cell response. So the T cells are part of the immune system, they are part of the learning immune system. And so the T cells can actually get trained to recognize, for example, a mutation. And if we use a peptide containing a mutation that's unique to a cancer cell, we can train a patient's immune system to build a T cell. And the same thing can be done with dendritic vaccines or with mRNA vaccines or DNA vaccines. And so all these approaches are aiming for the same, the affector cell, the T cell. The problem is that sometimes this strategy is failing because the mutations are not presented on the surface of the tumor. And then all these approaches fail. If dendritic vaccine fails or an mRNA vaccine fails or a peptide vaccine fails, all these other strategies might not be helpful. But if you, for example, combine a vaccine with a checkpoint antibody or with a CAR-T or with another approach or with an NK cell, other types of immune cells, then it can become successful again. But what we are trying to understand is not only the mutations of the tumor, we are also trying to understand how the tumor escapes an immune attack and what can be done to overcome this resistance. So it's very, very complex. Very complex.

Speaker 00: 10:56

Okay, so one question I see a lot of people asking is can you do a combination of one of the off-the-shelf vaccines and the CeGAT vaccine, or do you not recommend people do both?

Speaker 01: 11:10

So, first of all, I'm not in a position to recommend treatment because I'm only the geneticist. And I always say to a patient, I'm happy to be part of your team, but you need a head coach. And the head coach usually is the main oncologist, the the oncologist who is navigating the patient. And then I can come on the team as a geneticist, I can provide data, I can bring in my platform technology. And this actually is not CeGat. So CeGat is the diagnostic company. And now we have CeCava. CeCava is the Center for Cancer Vaccines. And with CeCava, we are now very active in the US in order to start clinical trials. And so when I speak about the head coach, I think the head coach needs to know whether there are specific treatments that are most suitable for this patient or whether there are clinical trials available to this patient. And if all this is not an option, to say, well, there is a group in Germany, and you can contact them and they have a technology that might be relevant to you. And then I think you you know, I mean, you know me for so long. We always want to be part of the team and want to make a decision together with a patient. And so we can only bring our technology on the table, and then we can discuss whether this is with whether that makes a lot of sense.

Speaker 00: 12:31

And I'm sure you know, like you could see me light up because you're talking about about Cecava, which is looking to get into the US. And this is something I know you've been working on for a long time because I live in the US, this is something I'm super passionate about. How much can you tell us about that and and what's happening?

Speaker 01: 12:48

I can tell you everything about it. I can um I'm I'm happy to do that. So I'm most grateful to every patient, especially you. I mean, you have been in our program for the longest time. And if you were not so brave in the beginning, where your doctors were not even knowing what we are doing and whether this is going to help you, your gut feeling and your passion and your determination that this is something that could be of help to you. And with all the other patients that I've seen in the meantime, we were able to get results that we would have never seen. And so now we have a data set that is unusual because usually, when you develop a technology, you try it in cell culture, and then you bring it into a model system, and you need years of work and lots of money, and and then you enter phase one, phase two, phase three. And now with our patients and having this data, seeing you, and you know, um a few more patients in a similar situation, we learned that what we do is actually safe. So, in a usual phase one, when you when you have gone through preclinic and dose finding, and then you want to bring this in in a human, you need to first make sure that this is safe. And we know the technology is safe for many years. And then you want to see that you are able to train the immune system. And so we do use a technology we call immune monitoring, so we measure T cells in the blood. And so the next step was to see that we have an effect in the blood, and that is what we published last year: the observation that when patients develop an immune response against the peptides, they live longer. This is not claiming anything, this is just a real-world observation. And now, what we are trying to do is the next logical step to do a randomized controlled clinical trial in order to bring our approach one step further. And without you and all the other patients, we would not be there. We would we would be 10 years behind in early steps. And now what we try to do is using this knowledge to be faster to make the technology available to patients in the US to generate more data, to generate data that the FDA would accept on the way to approval. And this is where we are now with Tsekama. We have lots of support in the US. We are all the clinical centers we are working with since a long time want to participate. And now the major challenge, as you can imagine, is to get the funding. And so this is where we stand at the moment. And we we are moving, we are currently writing the application to the FTA to start the first phase, and we are planning to enroll the first patient in the second quarter of 2026.

Speaker 00: 15:38

Oh my gosh, this is the fast news. 2026 will be will this be considered a phase one trial then, or is it now do you get to go straight to phase two because of your observational studies in Germany?

Speaker 01: 15:51

Another excellent question. So I was very naive to think that we can be much faster and go directly into phase two. But what I now I'm learning is that we need to prove that our production is working in an FTA setting. Oh to make sure that every patient gets the vaccine on time. So the quality, the delivery, this all has to be set up. And it's much more plausible if we show this in a in 10, 15 patients, and can we can actually show that this is done by us, the whole pipeline is working before we start enrolling probably 300 patients. And so it makes sense to go through phase one and we will not lose a lot of time. While we start phase one, we will already prepare for phase two, and then we will randomize the problem I have, but I we have to do it, is the randomization. I I thought we could use historical data because you know with glioblastoma, especially the with the unmacylated MGMT promoter, we know that the chemotherapy isn't working well. And this treatment has been approved more than 20 years ago. So why would we have to enroll patients? Now we have to tell them you don't get the vaccine, which knowing that the vaccine in the worst case has no effect, but potentially is a big chance, is really difficult to tell a patient that potentially that this patient is not getting the active compound. But this is what's happening. Phase one is to test the pipeline, and phase two is the randomized trial.

Speaker 00: 17:20

Okay. I think that's I you say you were naive. I was kind of hoping the same thing that the history that you have from doing this for almost 10 years in Germany would allow you to bypass that. But I understand. And it is going to allow it to move faster and be more efficient. And I'm I just I have goosebumps. I'm so excited that it's going to be actually available in the United States in 2026. So phase one trial is about a dozen patients, and then the phase two trial, you'd be able to have maybe 300 patients. Is that my understanding you correctly?

Speaker 01: 17:53

Yeah, this is what we are aiming for. So at the moment, we have we are in the process to finance phase one, and we will do this. We say family and friends. So it it will we are looking for partners that want to stay with us on a longer journey because, as I said before, it's a platform. Once we have done brain cancer, we will move into pancreatic cancer and colorectal and breast and prostate and so on. And so we are not interested in individuals giving us money and then once they see it successful, just jump out. So the second phase will require a lot more money, and we are then looking for institutional investors, but they would only come in, um, to my understanding, when we have entered phase one. And then we will go potentially go public. And so it will be for me, it's the hope that many more people can participate in this story, and also allows patients to participate, to be part of Tsekava, and and then to to be part of our journey in order to bring this technology into a formal approval.

Speaker 00: 19:01

Okay, so those of us listening, people like me, we're not institutions, we probably can't help with phase one or phase two. Maybe someone listening can. We'll make sure they know how to reach out. But but when you get to phase three, you're thinking it will go public and then we can buy shares. Is that what you're saying to support and just to invest in this? I mean, you know how I believe in this. Obviously, I'm walking, living person showing how successful this treatment can be and just knowing that you can live a full life after a diagnosis like this is you know on the horizon. Gives I I know it gives me so much hope. I know it's going to give so many people hope. And I'm just thrilled to hear how quickly things are moving. When you say family and friends, you're talking about people who are already getting treated with you, being able to be treated in the United States. Is that what you're saying? Or am I misunderstanding?

Speaker 01: 19:54

So it's about people who are able to take risks. So we don't want to take money from people who would have a problem with losing this money because you know every clinical trial is a risk. So this is important that we have partners who not only can afford to help us, but could also stay with us. So are not depending on getting the money back quickly. We are not interested in in investors who just see us as a, yeah, you know what I mean. We have a vision and we will not stop our vision until every single patient gets access to a fully personalized treatment. And so we we have a longer journey in front of us. And so we we need partners in the beginning who can stay with us through a longer period of time. And since we are spreading the risk, we are doing brain cancer, which is really difficult. Um but we know you, we know several other patients where our technology has proven to be able to work, but we have more easy diseases to tap to treat. If, for example, if you want to do a clinical trial for breast cancer, it will be much more expensive. So I think we need to go step by step. But the technology is so potent to help in other cancers, and it will be much easier. If we are successful with brain cancer, and we are this is our first priority, you know, glioblastoma. And once we are successful in glioblastoma, it it will be much easier to go to the other tumor entities. So I think for many investors, in the end, it will be a very good investment, but we need some time to go through the process.

Speaker 00: 21:33

Okay, that makes sense. So when you're talking about the partners, you're talking about investor partners who are supporting this and really believe in this and who are going to see this through, which of course makes sense. And when when you're doing the clinical trials, are you uh I don't know. So would this would the vaccine start after what is considered still standard of care, that first six weeks concurrent radiation and uh timazolamide, or is this instead, or do you know any of those things yet?

Speaker 01: 22:01

Yeah, I can tell you because we already finalized the protocol. Okay. Immune approach always makes most sense when you come in as early as possible. And the reason for that is that the immune system just didn't recognize the tumor. And but you know, many patients are just in a great shape when they get the diagnosis, they have done lots of exercise, they eat healthy, so it just comes and then hits a patient really hard. And so it's not that the immune system is per se a fail, but it just did not recognize the tumor. If you go through treatments like surgery and radiation and chemotherapy, in the end you can maybe kill the tumor at least for some time, but you also destroy relevant parts of the immune system. Now you have to find a compromise because you cannot revolutionize treatment. Um, if my hope would be to get rid of all the destructive treatments, it's it's not an option because you know when you get diagnosed, the tumor can be really big. And so what we are going to do is we will include newly diagnosed patients with glioblastoma with a unmasylated MGMT promoter, and they will undergo surgery, and then they have the tumor resected, and then we do the MGMT test, and then we enroll patients and start sequencing from the tissue that is taken from the surgery, and then we try to be really fast. So once a patient has recovered from surgery, has undergone radio chemotherapy, potentially also one cycle of chemotherapy, and then we start with the vaccine. We try to be faster, yeah, but still we need some time. But the clinicians say it's important that patients get surgery, radio chemo, so that they're not doing nothing until we are ready with the vaccine. And that I can understand. Maybe in the future these tumors are discovered earlier and we have other options, but this is how how we are doing it right now.

Speaker 00: 24:05

That makes sense. So even the expedited version of doing the sequencing, the tumor board review, everything is probably takes maybe what eight or ten weeks or something. I don't know. But you in that time, they don't want patients not to do anything yet at this point. They still want the standard. So people who have inoperable tumors, will they be eligible for this as long as they can do a biopsy? No, it's just the ones who've been resected. Okay.

Speaker 01: 24:30

But you know that every patient has an option to find out, independent of a clinical trial, whether this is an option. And and and then it comes back to the head coach again, the head coach oncologist who is able to put every option into the clinical situation context and can then review and say you might not be included in a clinical trial, but you can approach the team in TBN to ask whether they are able to manufacture a vaccine for you. And yes, of course, technically it's uh not a problem, but as you know, patients need to afford it and they need to travel because I I'm not allowed to ship the vaccine to the US when it's outside a clinical trial.

Speaker 00: 25:09

Yes, of course. That's always a question people have. Why do we have to go there? And that's that's just the law. That's the law for to protect us. But so they would have to make sure they qualify. People will ask me, Well, why did I get rejected, or why do I not qualify? Well, it's not a rejection. You're only going to let patients travel and take the money if you think this is going to be an effective treatment for or not let them, but advise them. You're not going to advise someone to try this treatment unless you think there's a good chance that it will be effective, right? Absolutely.

Speaker 01: 25:41

And of course, this is impossible to know. So this is why we rely on the experience of centers and and when they refer patients to us, it takes months before I see the patient for the first time. And so sometimes when you speak to a patient, the MRI can look totally different. And I'm I'm not a person, I'm not selling a vaccine. I'm not a shop where someone comes by and says, please manufacture my vaccine, and I come in a few weeks and I'm primarily a medical doctor. So I know from sequencing that there are many other options. So some tumors harbor what we call a fusion of two genes in GBM that sometimes happens. And there are compounds that are approved for other tumors, and in and so we need to know that. So and this is sometimes the situation that there's a medication sitting in the pharmacy next door, but it's approved for another tumor entity. And if we see that, we would not manufacture an experimental treatment that takes time and money when there's treatment available. So the first priority is to review, to see what options there are. And when we think that a patient will not benefit because our approach takes too long, traveling is maybe impossible, and money is a problem, we will certainly not do it. And then patients are sometimes unhappy, and but we try to do our best. And you know, we are a small entity, we are not a big hospital, so it's not like hundreds of patients come here, and we know every patient very, very, very well. And and so we really try to bring in the technology when it when it makes most sense.

Speaker 00: 27:15

And so when you do that review, do you I'll keep your metaphor, pass the ball back to the head coach and say these options will be better for your patient according to our tumor boards analysis analysis, or do you just say, we know there are better options, go back to your team and wherever you live. How does that work?

Speaker 01: 27:34

Primarily with the first contact, we try to find out who the head coach is in order to get an idea. And there are some referring centers where we do not have to question that. When they refer a patient to us and say, contact them, this is an approach that would work for you. We will not question this. But if a patient reads about it or is not really sure, then we need to find out who is the clinician because we are not saying you have to do this while the clinician is saying something different. So we really seek for the interaction and the exchange of information, and then the next step is the diagnostic step, and then we review. And sometimes this is weeks after the first contact, and then we need to review the images, we need to see where the patient is actually currently standing, and and then we need to see what the next steps could be.

Speaker 00: 28:25

Of course, that makes so much sense. And if someone is in a situation where in eight to ten weeks they would be unlikely to be able to travel, I'm sure that affects things. And what I hear a lot of skepticism out there from, and maybe it's I don't know what if it's competition, if it's lack of understanding. Is there a way for us or for me to help people advocate for themselves, or is there best avenue to go to I'll just say a better hospital and to go to somebody who's just a little bit more up to date with the possibilities instead of just saying this is all that's available as the standard of care, palliative care, this is all we have for you. I mean, I've I I I've just talked to so many young people in the last few months, one who just had a baby, one who was pregnant, one who is 24 years old. There's so many people with so much life ahead of them that are getting told by their team that the German vaccine or whatever they call it, the CGAP vaccine, don't waste your money. And I even heard that originally and I said, ha ha, no, don't even, I'm gonna talk to somebody else, right? But what what do you what do you suggest for me to tell people or for people to do to to find a better head coach, so to speak, then I hate to say better, but at a bigger hospital, a more renowned glioblastoma hospital?

Speaker 01: 29:48

That's a that's a very critical point. At the moment, we are at a situation where the treatment is considered experimental, there's no evidence, and there has not been a trial. And we have to go through the process, and this is what we are doing. It just takes a lot of time. And another thing is that we know for sure that there's no magic bullet in GBM. There's no one compound that you take and then you're cured. And the problem potentially is that it will never be like this. And when I come again from my diagnostics perspective, when I look at these tumors, we call them, we say they are very heterogeneous. And that means that not every cell in the tumor looks the same. There are islands of cells that can look totally different to other parts of the tumor. And so when you think about this, it becomes immediately clear that you need a combination strategy. And when you start one treatment, the tumor will evolve, will change its genome, and will escape. So at the moment, most clinical trials are designed in a way that the company is focusing on their compound and the FDA is requesting to see the efficacy of the compound, which makes total sense from their perspective. But from a patient perspective, it does not make sense at all. If many different treatments would be approved, and I would do a genetic test and then protein test and so on, I could just put together for every patient a list of three, four, five compounds. And if they were all approved, we could just go to the pharmacy and order them. First of all, this is not the case. The options are very, very limited. Second, when all these different approaches are approved, at some point the development was so expensive that the reimbursement will be expensive. And so the insurance has to pay a lot for each treatment. And so if you add this up, you realize that it's impossible to finance that. So this is really a dilemma. If I would come only from a patient's perspective, I would do a very comprehensive diagnostic test, I would go through the board. Of course, I mean this is what we do. And then what we suggest is a combination for many patients. We suggest four or five different strategies in order to fight this terrible disease. And so now you see how complicated it is. And if a doctor says, don't do this, don't do that, from their perspective, they say it's not approved. So I cannot recommend it. I'm hired at a at the big hospital. If I recommend this, I'm against the guidelines, so I don't have a free opinion. If they would be a patient themselves, all of a sudden they think about it totally different. And so I think if you are a patient, it's so difficult. There are so many things you have to consider, and on top, you have to be the head coach because you find out that this is the only option to survive. And then you just have to build a team of people you trust. And these people then go through the process with you, and it will be never one person, it will be a team. But still, you need to trust one person to go through this. And and I have no better explanation, but I would just encourage patients to find a good team, and these can be family and friends. You need people who do the research for you, who meet the people, who who try to figure out what could be a good option. In the end, you're all by yourself. You have to find your own way. And this is what you have done, and this is what I admire because you that was your gut feeling, and you did it. The doctors told you don't do this, you still did it. And if the you would not have done it, you would not have known. And so I'm waiting. If I get the disease, I tell you, if I'm not in an urgent situation, I would reject chemotherapy completely, I would reject radiation, I would, but I can take the responsibility for myself. And if I die, and then that's okay because I have all the knowledge. And but a patient who has never heard about the disease, impossible. Sorry for the long answer, but I think it's it's very challenging.

Speaker 00: 33:59

I think that was very generous of you to be so frank, because a lot of people don't understand all of that nuance and why it's not a straight no nobody's hiding anything, keeping anything from you, nobody's trying to make a lot of money on this. It really is that difficult. And like you said, that when you're talking about the GBM being a heterogeneous disease or however you said it, like, because even if you have a recurrence, you might have to do the sequencing again, right? Because that tumor might not even be the same. So it's not that straightforward. That's, and as you know, that's why I would laugh that I felt like I had to be the one in charge, even though I was missing part of my brain, which isn't fair because my surgeon did a really good job. But it just feels like there's so much pressure on you as the patient after just having brain surgery to make these decisions while all these experts are arguing about what you should and shouldn't do. But that is really the way it goes. And I'm just so glad you were so honest about what you would do if if you were in my shoes. And and I think, you know, in a strange way, my mom for that, because had I not gone through it as a caregiver with my mom, I probably wouldn't have been so brave. But I was, I that's exactly what I thought. I was like, I'm doing it all the way and that I'm gonna try. I want to try this. This makes sense to me. And I absolutely believe in what you're doing, as you know. I had one other question for you about that, and I started getting emotional. So then I lose my train of thought. Oh, I know what I was gonna ask. And I don't know if you want to touch on this or not, but because I know you're a medical doctor and a geneticist, but you've been working with patients with glioblastoma for over 10 years. So many people like to hypothesize on what caused it, why they got it, and or if there's anything they could have do now or should have done to make sure this wouldn't happen in terms of lifestyle, eating, exercise. I mean, do you just even anecdotally have any thoughts on that or what people can do to support their healing? And or if they feel so many people feel like they did something wrong. You know, was it because they got a COVID vaccine gave? I'm like, no, was it your cell phones? You know, do you do you have any thoughts on any of that you're willing to share?

Speaker 01: 36:07

Of course. I can share you my thoughts. And I'm a geneticist. And I know and the human genome is so big. We are talking about six billion positions, and I don't know how many cells in one human. And so every it's so it's in the nature of us that we get cancer, and there will always be cancer. So we our our challenge is to early detect and to then find the right treatment. But when we live even longer, we will have cancer every second man, every third woman gets cancer during lifetime. And from a genetics perspective, this is I sometimes think this is it should have it should happen more frequently. And luckily, for many patients, the immune system is taking care of it and is eradicating cancer cells. So the geneticist says it's logic to get cancer. We we we actually get cancer cells all the time. This is just lies in our nature, but then we have an immune system that helps us to protect us from cancer, and now the question is how to support our immune system. And then you already said we know that exercise, not only cardiac cardiac training, but also muscle training is hugely important. We know that nutrition has a big effect, and and so we know many things, and we should do this before we get cancer, but it will not prevent us from getting cancer. We can do other things that will help us to get cancer earlier, which is not good for smoking and drinking too much alcohol and so on. But I strongly believe that we will not be free of cancer. So my recommendation is to accept that, and no one has done anything wrong. It's just how it is. Every potentially every fifth patient has a cancer predisposition. And if you know that, you need to be more careful. So you should to do surveillance much earlier, you should to take much more care about you and your health. Um, and in order to not get it so early, but to know that you can potentially get it and then detect it early. So the early detection is crucial. And there are new technologies coming, hopefully soon, not only from the imaging side, but also from blood-based tests, in order to detect it, and then hopefully we get more targeted treatment earlier. I don't know if this answers your question, but no one has done anything wrong. It's just how it is, unfortunately. And children get cancer and they have not done anything wrong.

Speaker 00: 38:34

Yeah, that's what I always think. Babies get cancer, they haven't used cell phones, they haven't drank alcohol or anything, and I think that gives some peace. I mean, we all want control. We all want to feel like we're doing something, especially, you know, in that time if you're waiting for your vaccine to be made, or there's downtime where there isn't really anything you can do. But best thing I always feel like, and you touched on it, is is to build up your immune system and make it as strong as possible by what you put in your body and what you do, and then it is what it is, you know.

Speaker 01: 39:03

You know, Rebecca, you know, and that I think is something that's really important for the future. We can actually build prophylactic vaccines so we can teach the immune system to recognize potential tumor mutations before the tumor occurs. And this is a big field for the future. And Tikava has the technology, we can already do that. To fund a trial for a prophylactic approach is impossible because we will potentially see the effect in 30, 40, 50 years. So I I strongly believe that the peptide, and now I have to say that because I'm really convinced about it, the peptide approach is a very, very safe approach. We create, we synthesize these peptides, we inject them in the skin, and these contain the mutations of the tumor, and then we are able to induce a T cell response. And T cells are good guys, they go only after the mutation, and if there's no mutation, they don't do any harm. And when I treated the first patient more than 13 years ago, the immunologist, you met him, our hero here in Tübingen, Hans-Georg Ramensy, I asked him, What can I do wrong when I put peptides in the skin? He said, Nothing. In the worst case, it's not doing anything. But if someone falls on the street, a lot of dirt gets in the skin and nothing happens. So don't worry. And so the peptides, compared to any other technology, have the huge advantage that they are 100% safe and they are very, very potent. So I personally, of course, I'm doing it, but I'm really a big believer in in peptides because they help us to induce an immune response. And the immune response is persisting over quite some time, and we can only do good and we are not doing harm. So this is why I'm so convinced that it will help us to build a prophylactic vaccine in the future.

Speaker 00: 40:50

And that's just the most incredible thing to think about that you would have a vaccine that would prevent you from getting cancer, especially in my case, which I've shared that I have such a strong wish with having a Lynch syndrome. There are so many risks that I have for getting cancer. And just, you know, people with a Broca mutation or other mutations with a strong family history could take a vaccine and it would do no harm, but maybe prevent them from ever having cancer is just an incredible thing to think about for the future. It's so much hope there.

Speaker 01: 41:20

I want you to be on my journey now, Rebecca. Well, yay! This is now another chapter. And I think from one patient and an individual approach to the clinical trial to treat the most severe disease, to go over to diseases that colorectal cancer, breast cancer, prostate cancer, with the aim to build a prophylactic vaccine that can help us to fight the disease in the future for your children, your grandchildren. I think this is what drives us. And so, yeah, this is why we cannot sleep until we have achieved this goal.

Speaker 00: 41:54

That's why you're everyone's hero. I mean, you you believe in this so much, and yeah, I mean you've you've saved so many lives. You saved my life. It's amazing. So grateful.

Speaker 01: 42:04

And I'm just happy that you have this conversation with me, and I will update you on the clinical trial. At the moment, we like I say, we are finalizing the IND. We have a very good partner, they are clinical research organization, and and they are potentially also doing the phase one with us, and then we work with two big university centers at the East Coast. Okay. But one once we go into phase two, uh, we will have many more recruiting centers to help us recruit patients. And with every patient we recruit, we will provide the vaccine locally in the US. And so this is also for me a dream becoming Drew that patients do not have to pay, they don't have to fly fly, they can stay with their families. And only that I don't get to know every patient, but this is just how it is.

Speaker 00: 42:51

Yeah. Oh my god. Well, yeah, I wish everyone could know you, but at least they can get to see you on this and and other platforms. When when you get that's the bigger trial, I know the smaller trial, I'm sure people will be fighting over the opportunity to be in there and you're recruiting patients. Please let me know if we can promote that or do anything. I'm always talking to people, obviously, who get diagnosed, and it's going to be a huge opportunity. You have a second clinic in Lithuania now as well, right? Besides the one in Germany. That's different at a clinical trial.

Speaker 01: 43:21

But yes, that's that's another option to get access, and it it's a great team there, and they are using the exact same technology. So that was basically the reason why we did this was that we got so many uh requests and also referrals from big centers that we could not handle. And so we have this option. Um, it's just for me to bridge the time. Even if you start a clinical trial, you will still have many more patients who would like to get enrolled and cannot get access. And we believe in the technology today, and we have to go through the many years until we have approval. So we know that on this way we cannot treat patients, and and if a patient can afford it and says, Look, you don't have to tell me my doctors uh recommended it, and you are not part of my team, and I just would like to to go this route together with you, then we offer this. And and interestingly enough, uh no one thinks about this. But if you look at the prices or if the on the cost for a medication that is approved, is so much more more compared to the cost that we have now. And if we so sometimes people say what you're doing is not right, and so if I have a patient who really understands what we are talking about and is making a decision and we are just supporting the patient, and this is data that we make available, I think this is important, and every patient contributed to the knowledge that allows us now to the clinical trial. But once we have approval, it will be much more expensive, and no one thinks about it. Some inhibitors, they have costs of more than 20,000 euro per month.

Speaker 00: 45:09

Yes. I saw that when I was doing the Key Truda, which is the inhibitor infusions during the early phase of my vaccine for GBM with you. I was doing that here in the US, and I would look at my bills and think, goodness, I had good insurance. I still would for sure hit my deductible every year. But you were right. I mean, in in two months, I would uh it would be more than all of the vaccine costs for you know, aside from traveling to Germany, it's insane how much how expensive the same with chemotherapy. I mean, every every dose is so much money. So it really, relative to that, the treatment in Germany isn't that expensive. It's just obviously that we have to pay for it out of pocket or crowdfund or you know, get a loan or sell your house or get rid of your retirement fund, which I did because I thought, you know what? I want to be here and alive and I don't care how long I have to work. This is going to be what I'm going to do. But yeah, it's it's for everyone to choose. But exactly, it's like you said, it's gonna be way more expensive once it's approved, which is ironic.

Speaker 01: 46:09

So, for example, for GBM, um, this is our first priority. The second priority is going to be a trial for patients with an IDH mutated brain cancer. Here, um, we would like to target the grade three, four, the more difficult ones, but we cannot afford the IDH inhibitor that is approved. So we have to go to the grade two in order to run the trial, so to add the vaccine to the IDH inhibitor, just because the approved IDH inhibitor is so hugely expensive that we cannot afford it in a trial. This is this is the situation, and that makes it also very difficult. Ideally, I would like to provide the vaccine to grade three and four because they have not so many options, but I would like to combine it with an IDH inhibitor. I have trouble to fund my peptide trial, let alone adding the inhibitor. So these are the difficulties that we are facing, and so I'm learning a lot more challenges. The science is one, so the disease, the science, but the approval process and the financing is so I think sometimes more complicated than the science. And now I'm really I'm really grateful, I have to say, that I found people supporting us, including you and others, helping us to go to this next step. I'm learning a lot every day. Um, this is a totally new world to me. We are just now like like you found us. We are now trying to find the right people in the US to help us to bring this into approval, to go to the next tumor entity and to help many more patients. And I'm I'm really humble and very grateful that I'm allowed to go this route and I'm very motivated to be now on this path.

Speaker 00: 47:48

Oh my gosh. Well, we are so grateful for you. I mean, I've been hoping this would happen for almost seven years. And, you know, we have a family mutation. So I have such a personal, personal vested interest in this, obviously, doing this podcast because I have such a huge heart for all these families with glioblastoma, as I know do you. And so we're all so grateful for you. So grateful and that you're willing to do this. And, you know, being a medical doctor, a geneticist, I can't imagine how hard this is on your heart doing this every day with people and and then trying to learn this whole curve of the financial and the investors and the insurance and the clinical trials and phases and to keep going. So thank you for continuing to persevere.

Speaker 01: 48:31

Thank you, Rebecca. I can tell you one thing which is interesting. When when I wanted to found Seaget together with Stirk, many people said, Don't do this. You're going to lose everything, and this is going to be the biggest ittity thing to do. So don't do it. And so now, whenever someone comes to me and says, Don't do it, or what you're doing is wrong, it's the biggest motivation. All these enemies and people who think that this is something really not good to do, I think, no, I see it in a different way. And the more people that think you are not doing the right thing, the more it motivates us to exactly do this. This is what we learned from the past.

unknown: 49:09

I love that.

Speaker 00: 49:10

I'll show you. That's wonderful. I love it. I'm so excited. I'm so, so, so happy to hear this. Wow. That was one of the most exciting conversations I have ever had, certainly on this podcast, and one of the most exciting moments I've had in the last eight years to hear what Dr. Saskia Biscup had to say. I to know that CKV is real, that the treatment is coming to the US, that there is a clinical trial starting in the U.S. early in 2026 for newly diagnosed patients unmethylated. It's just blowing my mind. I am so grateful. I'm so excited. I know so many of you have been waiting for this moment. It's going to be a process. It I know from experience with people in my life who've tried to move treatment through the FDA process and it's set up for good reason for our safety. I understand that, but it is a slow process. It is an arduous process. First, show no harm, small group of people, then enroll a larger group of people in the next phase. There are it's going to be years. None of us wants to hear that, but that's the way it goes. But it's starting, it's going to roll out this year. And in the meantime, if you're like, I need this now, I need to have access to this treatment now. That's what Dr. Saskia Viskop was saying. The clinic is available in Germany. It is harder. There are restrictions. You have to do your own financing, crowdfunding. That's what I did. I depleted my IRA. If this is something you firmly believe in, talk to your neuro oncologist. Make sure you have a good team and they can reach out. You can reach out. She is there. She's doing the best that she can. Her team is doing the best they can to help people. This is Dr. Saskia Biscup's life's mission. I've witnessed it for many years with my own eyes. And I don't know how we are so lucky to have her on this earth at the same time we are living, but we are. And I'm so excited. I am so excited for all of you. I'm excited for me. I hope none of my family ever has to face this. But if they do, I know there is hope. I'm always trying to share hope. And I am here for you. I am going to put a transcript on this one. I haven't been doing that yet. I'm still kind of learning all the ways to do a podcast, as I'm sure you know, uh, because I'm doing it all myself. But I'm going to put the transcript because it's a lot of information to digest and you might need to go back and look at it more and more. The other thing I'm going to try to do, no promises, is to edit the video for this and put captions on and put it over on YouTube. If I do, I will definitely put that on social media. It's just a little bit of a difficult process for me, but I'm sitting there thinking, okay, Dr. Saskia Biscup is doing, she is a geneticist, a medical doctor, and now she's doing like this whole FDA process. I'm sure I can figure out how to edit a video. I'm gonna work on that. I really am. Teenage kids for the win, I hope. So I am really, really hoping this is as helpful to you as I think it will be. If there are more questions you have, I know I didn't tackle every question that I got on social media. I did my best, send them to me. You can always email Dr. Saskia Biscup as well, and her team will get back to you as soon as they can. You can read the article that was published in Nature. I have links to everything on my website. You can always reach out to me. I love you guys. I am going to keep working on getting all the information to you as soon as I can. And I'm rooting for all of you.