“The Potential of Personalized Cancer Vaccines, Starting with Brain Cancer”

“The Potential of Personalized Cancer Vaccines, Starting with Brain Cancer” (Saskia Biskup, MD, PhD) [#141] 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. You need the transcriptome, the proteome, the spatial information, metabolomic information, metabolites, and the microbiome.

” – Saskia Biskup “I would rather combine strategies than pretend that there's a magic bullet. We have one platform technology, which is the neoantigen platform, but it can be easily combined.” – 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. I believe that everyone should have access to a fully personalized anti-cancer vaccine during their lifetime.

” – Saskia Biskup 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?

“The Potential of Personalized Cancer Vaccines, Starting with Brai

ial 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?

“The Potential of Personalized Cancer Vaccines, Starting with Brain Cancer” (Saskia Biskup, MD, PhD) [#141] Compared to traditional treatments like surgery, chemotherapy, and targeted therapies, a personalized vaccine potentially offers several advantages: ●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.

“The Potential of Personalized Cancer Vaccines, Starting with Brain Cancer” (Saskia Biskup, MD, Ph

iew 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.

“The Potential of Personalized Cancer Vaccines, Starting with Brain Cancer” (Saskia Biskup, MD, PhD) [#141] ●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 (Willy Hoos) [#29] ○"Cancer Vaccines” (Lisa Butterfield) [#50] ○“Unlock the Potential of Your Immune System” (Simo Arredouani, PhD) [#135] ○“A Unique Personalized Killer T-cell Treatment for Glioblastoma" (Wayne Carter, DVM, PhD) [#110] ○“A Novel Immunotherapy Approach for 'Cold' Cancers” (Gary Onik, MD) [#86] ○“Growing Your White Blood Cells to Treat Your Cancer” (Matthew Dons) [#79] ●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.

“The Potential of Personalized Cancer Vaccines, Starting with Brain Cancer” (Saskia Biskup, MD, PhD) [#141] 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).

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.

“The Potential of Personalized Cancer Vaccines, Starting with Brain Cancer” (Saskia Biskup, MD, PhD) [#141] ●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 (Willy Hoos) [#29] ○"Cancer Vaccines” (Lisa Butterfield) [#50] ○“Unlock the Potential of Your Immune System” (Simo Arredouani, PhD) [#135] ○“A Unique Personalized Killer T-cell Treatment for Glioblastoma" (Wayne Carter, DVM, PhD) [#110] ○“A Novel Immunotherapy Approach for 'Cold' Cancers” (Gary Onik, MD) [#86] ○“Growing Your White Blood Cells to Treat Your Cancer” (Matthew Dons) [#79] ●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.

“The Potential of Personalized Cancer Vaccines, Starting with Brain Cancer” (Saskia Biskup, MD, PhD) [#141] 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.

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 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.

“The Potential of Personalized Cancer Vaccines, Starting with Brain Cancer” (Saskia Biskup, MD, PhD) [#141] 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.