Clinical Programs
While cecava’s platform technology has the potential to benefit patients with various solid and liquid tumors, cecava’s current Clinical Programs are dedicated to brain tumors, with a focused commitment to improving patient outcomes while maintaining quality of life.
Pipeline
Glioblastoma Multiforme (GBM) Program
Glioblastoma multiforme (GBM) is the most common and malignant primary brain tumor and accounts for about 3-5 new cases per 100,000 inhabitants every year. More than 12,000 new glioblastoma cases are diagnosed each year in the US and more than 15,000 cases in Europe. According to the latest WHO classification (2021), GBM is characterized as a high-grade astrocytic glioma with unmutated isocitrate dehydrogenase (IDH1/2) genes. It is a vast growing tumor diffusely infiltrating the surrounding healthy brain tissue and, therefore, difficult to treat. The current standard of care includes surgical resection followed by adjuvant radiochemotherapy and chemotherapy, sometimes combined with Tumor Treating Fields and/or targeted therapies. Despite this multimodal therapy, progression is inevitable, and overall survival remains poor. The 5-year survival rate for GBM is 6.9%, and the median overall survival is about 15 months. Although great efforts have been made in recent decades to develop new, more effective therapies for GBM, the standard treatment has remained virtually unchanged for 17 years. Due to the limited efficacy of this standard of care, participation in clinical trials is often encouraged both in the newly diagnosed or recurrent setting.
In 2024, cecava’s co-founder Saskia Biskup (MD, PhD) published in Nature Communications (Latzer et al. (2024)), the results of 173 GBM patients who were vaccinated with personalized neoepitope peptide vaccines in her doctor’s office in the setting of individual treatment attempts. The vaccines were well tolerated, with mainly mild and transient side effects. The median overall survival (mOS) of the whole cohort was 31.9 months (95% CI: 25.0–36.5), which compares favorably with the mOS achieved with the current standard of care (about 15 months) or the mOS of a cohort with matched historical controls (22.7 months). For 97 of 173 patients, the vaccine-induced immune responses were further investigated. 90% of these (87/97) showed T-cell responses against one or more vaccinated neoepitopes. Importantly, those patients who developed immune responses against multiple vaccinated neoepitopes experienced significantly prolonged survival (n= 77; mOS= 53 months) compared to patients with no or a low number of vaccine-induced responses (n=20; mOS= 27 months; p = 0.03).
Based on these encouraging results, cecava is currently setting up a Phase 1/2 clinical trial for the treatment of newly diagnosed GBM patients. In this trial, patients will receive standard care and personalized neoepitope peptide vaccines derived from their individual tumor mutations. The applied immunizations will follow the dosing and vaccination regimen that has proven efficacious in previous individual treatment attempts. The overall trial design is further guided by cecava’s advisory board, which contains globally recognized clinical neuro-oncology experts from the US and Europe. Following supportive feedback from competent authorities (US FDA and German Paul-Ehrlich-Institute), cecava is currently preparing the clinical trial documents (i.e., Investigational New Drug (IND) application) to be submitted to the FDA for approval of the study.
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