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First Patient Administered Part B Dose, Confirmation of Phase 1 Study with mCVGBM-Based Multi-Epitope Cancer Vaccine Candidate
Part B is expected to include up to 20 patients to generate broad knowledge about the safety, tolerability, and immunogenicity of CVGBM.
TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / August 15, 2024 / CureVac N. V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company introducing a new generation of transformative medicines based on messenger ribonucleic acid ( “mRNA”), announced the initiation of dose confirmation for Part B of its ongoing Phase 1 study in patients with resected glioblastoma. CVGBM is CureVac’s first investigational cancer vaccine based on its proprietary second-generation mRNA structure. It encodes a unique fusion protein comprising 8 epitopes with demonstrated immunogenicity. in glioblastoma.
“Following the successful final touch of Part A of the dose escalation of this clinical study with CVGBM, Part B of the dose escalation is to verify that we have chosen the appropriate dose based on protection and immunogenicity for further studies in patients with glioblastoma,” said Dr. Myriam Mendila, chief scientific officer of CureVac. “Importantly, the review by the Data Safety Monitoring Board has shown that there have been no dose-limiting toxicities in Part A with the 4 doses tested so far, and has allowed us to move on to the next component of the review. “
The open-label study evaluates the protection and tolerability of GBVC in patients with newly diagnosed and surgically resected MGMT glioblastoma or unmethylated astrocytoma with a glioblastoma molecular signature. GBVC is given as monotreatment after surgical resection and final touch of radiation treatment with or without chemotherapy. The study is comprised of two components, a dose escalation component (Part A) and a dose expansion component (Part B). Part A was carried out effectively and involved 16 patients, testing doses between 12 and one hundred μg. A review of Part A protection data through the Data Safety Monitoring Board (DSMB) did not confirm any dose-limiting toxicity. A dose of one hundred μg was for Part B of the study.
The first insights into dose escalation, A, will be presented in an oral presentation at the European Society for Medical Oncology (ESMO) Congress on 13 September 2024.
You can find out more at clinictrials. gov (NCT05938387).
For more information, please see the Company’s reports and filings with the United States Securities and Exchange Commission (SEC). You can download those documents by visiting EDGAR at the SEC at www. sec. gov.
SOURCE: CureVac