In August 2024 CureVac announced the start of the dose-confirmation Part B in its ongoing Phase I study of CVGBM in patients with resected glioblastoma. CVBGM is CureVac’s first investigational cancer vaccine based on the proprietary second-generation mRNA backbone. The vaccine encodes a single fusion protein comprising eight epitopes with “demonstrated immunogenicity” in glioblastoma.
CureVac’s approach
CureVac states that the approach to mRNA-based cancer treatments “enhances antigenic properties of proteins”. A “special transport system” simulates viral infection, which “optimally addresses the immune system”. The therapeutic pipeline comprises “several” mRNA molecules encoding specific tumour-associated antigens. Furthermore, the approach attacks the cancer cells “directly” with RNA and modifies the tumour tissue environment for immune modulation.
The next step
The research involves an open-label study to evaluate the safety and tolerability of CVGBM in patients newly diagnosed and surgically resected MGMT-unmethylated glioblastoma or astrocytoma with a molecular signature of glioblastoma. It is administered as a monotherapy after surgical resection and completion of radiotherapy with or without chemotherapy.
After successful completion of a dose-escalation Part A, the vaccine candidate progresses to dose-expansion in Part B. In Part A 16 patients were involved to test doses between 12µg and 100µg. Safety data has been reviewed and confirmed no dose-limiting toxicities. A 100µg dose is recommended for Part B, which is expected to involve up to 20 patients.
Dr Myriam Mendila, Chief Scientific Officer of CureVac, is pleased with the “successful completion” of Part A.
“The dose expansion part B is important to confirm that we have selected the appropriate dose based on safety and immunogenicity for further studies in patients suffering from glioblastoma.”
Dr Mendila also highlighted the importance of the review by the Data Safety Monitoring Board, which confirmed no dose-limiting toxicities. This “enabled us to move forward to this next part of the study”.
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