Glioblastoma (GBM) is one of the deadliest cancers, stealing lives in as little as 15-17 months, with only 5% of patients surviving five years. Families watch their loved ones lose not just time, but also independence and quality of life, while treatments offer little more than borrowed months. At cecava, we’re fighting to change this with Individualized Peptide Cancer Therapy (INPECT) – a personalized immunotherapy that trains each patient’s immune system to hunt down and destroy every last tumor cell without harming healthy brain tissue. In real-world cases, this approach extended survival and preserved quality of life, offering hope where none existed. With your support, we can take the next step toward giving GBM patients a real chance at more life and a future beyond this devastating disease.
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Glioblastoma (GBM) is one of the most aggressive and deadly brain cancers, striking over 12,000 people every year in the United States. It grows fast, spreads deep into healthy brain tissue, and is nearly impossible to remove completely without destroying healthy tissue – even with surgery, radiation, and chemotherapy. Despite decades of research, the reality hasn’t changed for GBM patients: standard treatments can slow the disease, but they never stop it. Survival rates remain devastatingly low, and no truly effective new therapies have been approved in nearly 20 years.
At cecava, we believe GBM patients deserve better. That’s why we’ve developed a breakthrough approach called Individualized Peptide Cancer Therapy (INPECT) – a treatment designed to turn the body’s own immune system into a precision weapon against each patient’s unique tumor. Every glioblastoma is different at the genetic level, which is why “one-size-fits-all” therapies fail. Using advanced AI trained on proprietary data, we identify the most potent tumor-specific targets – called neoepitopes – for each individual. These targets exist only on cancer cells, not healthy ones.
With a personalized peptide therapy built from these neoepitopes, we “teach” the immune system to hunt and destroy tumor cells – even the ones hiding deep within the brain that surgery and chemotherapy leave behind. In a real-world study of 173 GBM patients published in Nature Communications, adding our therapy to standard treatment significantly extended survival compared to historical outcomes – and with minimal side effects, allowing patients to maintain their quality of life.
For patients facing a diagnosis that feels like a death sentence, we’re working to change the story – one personalized treatment at a time.
We’re preparing to launch our first Phase 1 clinical trial in the United States to bring our personalized immunotherapy for GBM closer to approval. Building on promising real-world results where – GBM patients treated with our therapy lived longer and maintained their quality of life (as published in Nature Communications) – this trial will confirm that our treatment is safe, triggers the expected immune response, and may replicate the survival benefits we’ve already seen.
To make this trial a reality, we are raising $450,000 to secure FDA approval for the study (IND application) – a critical milestone that will unlock additional funding and allow us to officially begin clinical development. These funds will support our engagement with the FDA, refinement of our manufacturing and clinical plans, and the preparation of all required documentation, including the full trial protocol, Investigator’s Brochure, and supporting scientific data.
An FDA-approved IND will not only allow us to treat our first trial patients but also pave the way to expand this therapy to other aggressive cancers. With the right support, we can take a major step toward transforming GBM care and offer real hope where few options exist today.
The $450,000 we’re raising will cover:
Expert guidance on FDA policies and requirements – $30,000
Planning, hosting, and analyzing a Type C scientific advice meeting with the FDA – $100,000
Drafting the Clinical Trial Protocol and Investigator’s Brochure – $80,000
Preparing all other IND documents, including details on how our therapy is made and all research to date – $200,000
Representation and final submission of our IND application – $20,000
Reviewing FDA feedback and making any final clarifications – $20,000
Over the past decade, hundreds of late-stage cancer patients, including those battling GBM, have received our personalized immunotherapy. The treatment has been well tolerated and shown promising improvements in survival across multiple tumor types. Powered by our patent-pending AI algorithms, we can pinpoint each patient’s most potent tumor-specific targets and create customized peptide-based therapies quickly and cost-effectively.
We’re now preparing our first Phase 1 clinical trial in GBM, working alongside world-class neuro-oncology experts and two leading U.S. cancer centers. To make this trial a reality, we need to raise $7.5 million to secure FDA approval, finalize key research and manufacturing partnerships, and launch the study. With our experienced team and strategic partners in place, we’re ready to bring this breakthrough therapy to patients who urgently need new hope – and, ultimately, to expand it to many other cancers.
For patients diagnosed with GBM, the most aggressive brain cancer, the reality is devastating. Current treatments – surgery, radiation, and chemotherapy – only extend life to about 15–17 months on average, and just 5% survive five years after diagnosis. Because GBM cells spread deep into healthy brain tissue, removing the tumor completely isn’t possible, and the disease almost always returns quickly. Beyond the physical toll, GBM often changes how patients think, feel, and act, leaving families to watch loved ones lose their independence and personality while struggling under the weight of round-the-clock care.
Our therapy is designed to change this story by using the body’s own immune system to seek and destroy tumor cells – down to the very last one. Using unique structures called neoepitopes, which are found only on tumor cells, we train and amplify immune cells to recognize these cancer markers as “foreign” and attack with pinpoint precision. Once activated, these immune cells infiltrate the brain, acting like a cellular scalpel that can eliminate cancer cells far more precisely than surgery or radiation, without damaging healthy tissue. Because our treatment targets only the tumor, it’s also well tolerated, preserving patients’ quality of life while fighting the cancer.
https://jitc.bmj.com/content/13/6/e011070
https://www.nature.com/articles/s41467-024-51315-8
https://www.mdpi.com/2076-393X/12/4/397
https://www.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2023.1271449/full
https://www.mdpi.com/2076-393X/10/11/1882
https://jitc.bmj.com/content/9/1/e001406
https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1382-1
Cecava has filed two patent families which are currently under review of patent offices in the US, EU, and China. Here we list the most recent US publication of each patent family:
https://worldwide.espacenet.com/patent/search?q=pn%3DUS2025046393A9
https://worldwide.espacenet.com/patent/search?q=pn%3DUS2025161421A1
After inventing the neoepitope vaccine technology, Saskia 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 a Doctor of Medicine and a PhD in genetics from the University of Würzburg.
Dirk actively drives the company’s strategic development, and founded and continues to lead several diagnostic testing companies.
In 2009, he co-founded the human diagnostics company CeGaT GmbH with his wife, Saskia Biskup (MD, PhD). CeGaT was among the first companies worldwide to leverage high-throughput sequencing to comprehensively identify genetic mutations causative for various diseases, including cancer. For this pioneering work, CeGaT received several awards, including the German Founders Award in the category of Best StartUp (2011) and the EU Innovation Award (2014). In 2013, Dirk and Saskia Biskup were honored as Germany’s Best Entrepreneurs by Ernst & Young. Today, CeGaT is fully owned by the founder family and ranks among the largest sequencing and genetic diagnostics labs in Europe.
Dirk also founded Cenata GmbH, a leader in non-invasive prenatal testing in Germany, and CAG GmbH (now Generatio GmbH), one of the country’s largest animal genetic testing laboratories. He currently also serves as managing director of the MVZ Tübingen GmbH, an outpatient clinic specializing in oncology and gastroenterology care.
Previously, Dirk held senior leadership roles at Bertelsmann AG, serving as Senior Director in the M&A department, where he contributed to numerous company acquisitions. He also served as CFO at Berryville Graphics, Bertelsmann’s largest U.S. printing facility, and as European CFO of AEG Electric Tools, overseeing its European subsidiaries and holding companies as managing director.
He holds a Master’s degree and a PhD in Business Administration from the University of Hamburg and the University of Bielefeld, respectively.
Dirk supports clinical development in all scientific and regulatory aspects. As leader of the bioinformatics team, he drives the advancement of cecava’s AI-based in silico pipeline for neoepitope identification and prioritization. He is also responsible for the qualification of suppliers and the GMP-compliant manufacturing of neoepitope peptide vaccines for cecava’s clinical trials.
Previously, Dirk served as Head of Clinical Trials at the Center for Human Genetics Tübingen, where he played a key role in developing and implementing the personalized neoepitope vaccine technology. He co-invented the proprietary neoepitope selection algorithm, which led to several patent applications. He also developed and implemented the workflow for peptide vaccine manufacture and discussed clinical trial strategies with regulatory authorities and clinical centers in the EU and US.
Earlier roles include Head of R&D and Head of Validation at CeGaT and Group Leader at the R&D department of Qiagen, where he contributed to developing numerous products for the life science and in vitro diagnostic market, including regulated NGS-based cancer diagnostics.
Dirk holds a Master’s degree and PhD in biology from the University of Cologne.
$50 donated by Randy Seale
$100 donated by Anonymous
$100 donated by Anonymous
