On September 9, 2024 CureVac N.V. (Nasdaq: CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), reported that the first clinical data from CureVac’s ongoing Phase 1 CVGBM cancer vaccine study in patients with resected glioblastoma will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (Barcelona, Spain, September 13-17, 2024). Clinical data will be presented as an oral presentation on Friday, September 13, along with a poster presentation of preclinical data supporting the program’s development.
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"Cancer vaccines have tremendous potential to improve the outcome of cancer patients and particularly, mRNA technologies offer innovative and promising platforms that could enable us to finally make cancer vaccines a reality in clinical practice," said Dr. Myriam Mendila, Chief Scientific Officer of CureVac. "We are assessing a breakthrough approach to cancer vaccines that uses our distinctive mRNA technology in one of the most aggressive forms of brain cancer and are very excited to share the first-in-human results of our mRNA technology platform in the GBLM trial in glioblastoma at ESMO (Free ESMO Whitepaper)."
The Phase 1 study includes a dose-escalation part (Part A) and dose-expansion part (Part B). Results for Part A will be covered in the oral presentation, with safety and tolerability as well as initial immunogenicity data provided for all evaluable patients at dose levels of 12-100 µg. A summary of treatment-emergent adverse events (TEAEs), which were mostly Grade 1-2 and yielded no dose-limiting toxicities as confirmed by a Data Safety Monitoring Board, will also be provided.
The Phase 1 study is evaluating the safety and tolerability of CVGBM in patients with newly diagnosed and surgically resected MGMT-promoter unmethylated glioblastoma or astrocytoma with a molecular signature of glioblastoma. CVGBM features a single unmodified mRNA encoding eight epitopes derived from known tumor-associated antigens, with demonstrated immunogenicity in glioblastoma. Enrollment began earlier this year for Part B of the study, which is expected to include up to an additional 20 patients at the recommended 100 µg dose.
Details on the presentations are below.
Abstract: 440O
Title: First in human study of the mRNA-based cancer vaccine CVGBM in patients with newly diagnosed and surgically resected MGMT-unmethylated glioblastoma (GBM): First results from the dose escalation phase
Session type: Proffered Paper
Date and Time: September 13, 14:00-14:10 CEST
Location: Pamplona Auditorium (Hall 3)
Speaker: Prof. Dr. Dr. Ghazaleh Tabatabai
Abstract: 22P
Title: Pre-clinical development of CVGBM: A therapeutic mRNA-based multiepitope vaccine for glioblastoma
Session type: Basic Science Poster
Date and Time: September 15, 09:00-17:00 CEST
Location: Hall 6
Speaker: Dr. Ronja I. Mülfarth