Personalized Cancer Vaccines: Brain Cancer and Beyond
Featuring: Saskia Biskup, MD, PhD, Brad Power, Rhea Burjanroppa
In short
Saskia Biskup, MD, PhD, co-founder of CeGaT and Cecava in Germany, walks through how personalized cancer vaccines work — from sequencing your tumor's DNA to manufacturing a custom set of peptides that train your immune system to attack your specific cancer cells. The focus is on glioblastoma, an aggressive brain cancer with few good options, though the approach is being explored across other hard-to-treat cancers. She covers who might benefit, what the process involves, how much it costs, and what still needs to happen to make it more widely available.
- •You need recent tumor tissue and a blood sample to get started — ask your surgical team about preserving tissue at the time of biopsy or surgery, because older samples may not work.
- •The full process takes roughly 4–6 weeks for analysis and 3–4 months for manufacturing, so time matters; raise this option with your doctor early, not as a last resort.
- •Total costs can reach $60,000–$80,000 and are largely out of pocket today — ask about clinical trials through Cecava, which can reduce costs and may expand insurance coverage over time.
- •A strong immune system improves your chances of responding well; discuss with your doctor how prior chemotherapy or radiation may affect your eligibility before pursuing this path.
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Brad Power and Rhea Burjanroppa April 30, 2025 “The larger steps will come from the multiomics approach. We frequently see that genes are not everything. ” – Saskia Biskup “I would rather combine strategies than pretend that there's a magic bullet. ” – Saskia Biskup “My vision is that every person, even the healthy ones, are getting fully personalized, anti- cancer vaccines.
The reason why I believe this is so relevant is because we need to have immune responses before we get sick. I built a prophylactic cancer vaccine for my husband, Dirk, and myself. I tested the peptides. I noticed that I already have T-cell responses.
I see for many patients that they do not have a pre-existing T-cell response against their driver mutations, so that there must be a time where the immune system is failing, or maybe some patients do not build up these relevant immune responses.
Meeting Summary
Many cancers are aggressive and have few good treatment options, like pancreatic cancer and glioblastoma, which is an aggressive brain cancer. Getting a diagnosis of one of these cancers is devastating. They are often diagnosed very late, and are usually fatal. There are few good treatment options. Patients who are diagnosed with these cancers are confronted with difficult decisions that must be made urgently.
Immunotherapies provide lots of promise. But for glioblastoma, brain treatments must pass the blood-brain barrier. Immunotherapies have been very successful in blood cancers, but less so in solid tumors. Personalized cancer vaccines have promise across many cancers, and much research is being done.
Saskia Biskup, MD, PhD, co-founder and managing director at the Center for Genomics and Transcriptomics (CeGaT GmbH) in Tuebingen, Germany, is uniquely qualified to lead a discussion on the potential of personalized cancer vaccines, especially in brain cancer. She received her medical degree and her PhD at the University of Wuerzburg, Germany. She started her professional training in human genetics at the Technical University in Munich, Germany.
She co-founded CeGaT with her husband, Dirk, in 2009. CeGaT is a leader in genetics testing. Dirk and Saskia founded Cecava with the aim to launch a clinical trial for a personalized cancer vaccine for glioblastoma. Other clinical trials will follow. They are notable for connecting test results to your personalized care context. Why do you need to know about personalized cancer vaccines?
•Durable response : The vaccine can potentially induce T-cell responses that last for years, unlike shorter-term effects from some other treatments.
•Fewer side effects : Unlike chemotherapy, which damages healthy cells, the vaccine aims to stimulate the immune system to target cancer cells.
•Personalization: Unlike standard treatments, the vaccine is tailored to the individual patient's specific tumor mutations.
•New treatment options (especially for patients who have exhausted standard treatment options) How can a personalized cancer vaccine fight your cancer? Your immune system fights cancer through your white blood cells (T cells) that can recognize and target the unique mutations (neoantigens) specific to your cancer cells. You can identify your unique mutations by comparing the DNA from your normal cells and cancer cells, then design a personalized vaccine that helps T cells recognize and attack your cancer cells more effectively. The goal is to train the immune system to specifically target cancer cells while minimizing damage to healthy cells. Your personalized vaccine can be combined with other drugs (“adjuvants”) to enhance the immune response. The goal is to help your T cells build a strong, long-lasting response against your unique mutations. Are you a good candidate for a personalized cancer vaccine?
•If you have a cancer with limited treatment options
•If your tumor has identifiable unique mutations (high “tumor mutational burden”)
•If your immune system is capable of mounting a strong response (which can depend on your overall health and prior treatments, e.g., chemotherapy and radiation)
•If you can afford the treatment
•If it can be combined with other treatments like checkpoint inhibitors or targeted therapies
•If you can get a comprehensive genetic analysis What do you need to do to access a personalized cancer vaccine?
•Exhaust standard treatment options
•Provide recent high quality tumor tissue and a blood sample : to identify unique mutations in your cancer cells through genome and transcriptome sequencing, mutation analysis, and review by an interdisciplinary tumor board).
•Have time: the complex analysis of multiple tests takes about 4-6 weeks, and the complex manufacturing process takes 3-4 months
•Be able to pay: the diagnosis costs $10,000 to $20,000 and the manufacturing, treatment, and monitoring costs up to $60,000.
•Be able to travel to the treatment center What are innovations that might expand access to personalized cancer vaccines?
•Run clinical trials to reduce costs, prove efficacy, and increase insurance coverage
•Get public funding and investor support
•Develop a phased approach to make the technology more scalable
•Create off-the-shelf peptide options for common cancer types
•Combine personalized vaccines with other treatment modalities, like checkpoint inhibitors or targeted therapies How can you learn more?
•See the meeting summary or video recordings:
•Personalized Cancer Vaccines
•• • • •
•Review the CeGaT website for diagnostics services and the Cecava website for the clinical trial.
•Contact Saskia Biskup at saskia.biskup@humangenetik-tuebingen.de The information and opinions expressed on this website or platform, or during discussions and presentations (both verbal and written) are not intended as health care recommendations or medical advice by Cancer Patient Lab, its principals, presenters, participants, or representatives for any medical treatment, product, or course of action. You should always consult a doctor about your specific situation before pursuing any health care program, treatment, product or other course of action that might affect your health. For the video, please see here. Meeting Notes KEYWORDS Personalized cancer vaccine, neoantigens, Glioblastoma, Tumor sequencing, Immune therapy, Clinical trial, Tumor mutational burden, Peptide vaccine, Immune response, Diagnostic pillar, Tumor board, Treatment cost, Multi-omics approach, Adjuvants, Patient accessibility. SPEAKERS Saskia Biskup (67%), Roger Royse (7%), Darren Rhea (7%), Chris Apfel (6%), Cindy Ness (5%), Elliot Davis (3%), Jason Binder (1%), Richard Anders (1%), Rick Bartram (1%), Karen Sachs (1%), Brad Power (<1%) SUMMARY Saskia Biskup, co-founder of CeGaT, discussed their personalized cancer vaccine for glioblastoma. The process involves genome sequencing of tumor tissue and normal tissue, isolating DNA and RNA, and identifying unique mutations (neoantigens). The vaccine, consisting of 20 peptides, costs $60,000 and includes 14 doses. Early detection and tr treatment is ideal, as is a multimodal (multiple therapies) approach. Success rates are challenging to quantify due to late-stage patient presentations. (This is often only available as a last ditch treatment.) The vaccine's efficacy is influenced by tumor mutational burden and the need for multiple tests (“multiomics”). Challenges include accessibility, affordability, and the need for clinical trials. OUTLINE Overview of Personalized Cancer Vaccines
•Saskia Biskup, MD, PhD, is co-founder and managing director of CeGaT, a leader in genetics testing.
•The diagnostic process ideally needs recent tumor tissue and blood sample collection and analysis for comparative sequencing.
•The process involves isolating DNA and RNA from tumor and blood samples, followed by whole exome and whole transcriptome sequencing.
•The analysis identifies unique mutations, driver mutations, and passenger mutations, and neoantigens.
•The manufacturing involves prioritizing the neoantigens and creating the unique combination of peptides (protein fragments). Success Rate
•The success rate is hard to measure in exact numbers due to the unique clinical situations of patients.
•A publication in Nature Communications showing evidence of longer overall survival in patients with immune responses.
•More clinical trials are needed. Funding is difficult.
•Accessibility is limited. Comparison with mRNA Vaccines
•The difference between CeGaT's neoantigen peptide vaccine and mRNA vaccines is the direct presentation of peptides in the skin compared to the more complex process of mRNA vaccines.
•The immune response of peptide vaccines may be longer.
•It is difficult to compare different modalities.
•CureVac's mRNA glioblastoma vaccine must overcome the heterogeneity of GBM. Accessibility and Affordability
•Jason Binder asked about the accessibility and affordability of CeGaT's treatment for glioblastoma patients in the US.
•The process, including sequencing, clinical data collection, and interdisciplinary tumor board recommendations, is complex and expensive. Treatment Protocol and Patient Experience
•The typical protocol for patients includes three pillars of personalized medicine: diagnostic, interdisciplinary tumor board, and treatment.
•Immune system monitoring is important. Multi-omics Approach and Future Directions
•A multiomics approach, including single-cell transcriptome sequencing with spatial resolution, is important.
•Using off-the-shelf peptides is challenging. Adjuvants and Side Effects
•The adjuvants used in CeGaT's vaccine are GM-CSF and imiquimod to enh enhance the immune response.
•There is a potential for allergic reactions and monitoring the skin for side effects is important. Collaboration and Data Sharing
•To move the field forward, there is a need for collaboration between different groups and countries in personalized medicine.
Full transcript
Roger Royse Welcome to this week's webinar of the Cancer Patient Lab. This week we have Saskia Biskup. She's an MD, PhD, and co-founder and managing director of CeGaT in Germany. If any of you have ever thought about a personalized cancer vaccine, CeGaT is probably one of the first names that has ever come up, so she is uniquely qualified to lead this discussion about personalized cancer vaccines.
She received a medical degree and PhD at the University of Wurzburg, Germany, and she did her training in human genetics at Technical University in Munich, and co-founded CeGaT with her husband in 2009. CeGaT is a leader in genetics testing, and they have recently launched a clinical trial for a personalized cancer vaccine for glioblastoma. Saskia Biskup I'm a geneticist, that's my background. I'm a medical doctor, but specialized in genetics.
When a patient approaches us, the first thing we do is to try to understand the clinical situation of each individual patient. For example, if a patient approaches us with glioblastoma, which is a very malignant brain cancer, we hear about the clinical history and then we ask when the surgery took place, or the biopsy, because for our diagnostic step, we need tumor tissue, and it's crucial to have the most recent tumor tissue.
For some patients, a biopsy is a while ago. But especially when you design personalized treatments, you need to have very recent tissue. Then we get a blood sample from each patient, because what we are doing in the end is a comparative sequencing. We compare the normal genome of each patient with the tumor genome. Then, most importantly, we need the informed consent of a patient and coverage of costs.
From a technical perspective, we isolate the DNA from the leukocytes from the blood and from the tumor, and also we isolate the RNA from the tumor. Then we use a very comprehensive sequencing approach, which we call whole exome and whole transcriptome. ” Because every human carries mutations. We are different in about 3 to 4 million positions in our genome. But what we need to understand is what is unique to the tumor.
We need to understand what is driving the tumor to grow and the mutations. These are the ones t that we are interested in. We have two different groups of mutations. One group we classify as “driver mutations” – they are driving the growth of the tumor – and the other class we call “passenger mutations” – they are riding on the surface of tumor cells. They are presented through HLA. We try to find out the number of what we call “neoantigens”.
The mutations that are unique to the tumor are presented through HLA, because these mutations can theoretically be recognized by T cells, and these are the cells that we are interested in when we are talking about the immune system and about personalized immunotherapy. Our approach of sequencing the tumor genome in comparison to blood, identifying the neoantigens, is what we do in a very first step, which usually takes about four weeks.
How do we define the list of neoantigens that is unique for each individual patient? This is the recipe that we can use in order to manufacture a personalized vaccine. How do we prioritize these neoantigens? If you think about the number of a mutation load in a tumor, you have large differences. For example, if you take a malignant melanoma or a lung cancer from a smoker, you have hundreds and thousands of mutations.
If you, for example, take a brain cancer sample from a child, you have a very small number of mutations, and then you have a very large spectrum. The number that we use in order to define the tumor mutational burden is called “TMB”. This is the number of mutations per megabase, per 1 million positions in the tumor genome. Depending on this number, we have a larger or a smaller set of in the end, neoantigens.
The neoantigen is defined as being unique as presented through HLA. We need to know the likelihood that this mutation is on the surface of the tumor and can therefore be used for a personalized immunotherapy strategy. Here, lots of algorithms are used. They are either published and developed in house. Then we have a large database of immune data.
Once we do a personalized vaccine in a patient, we can after a certain time, usually about three months after the first vaccine, measure the T cell response that is specific towards a neoantigen. Here we also have a large database. Using databases, using different algorithms, we can come up with a list of neoantigens that we prioritize for each individual patient.
Here we also filed several patents, because it's not only about the list of neoantigens, but it's also about the knowledge you need to have on the solubility of peptides, on the likelihood they all go in solution.
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