Update! Make a note for the date in last sentence! GSK has partnered in this! Good enough for GSK! I guess good enough for me? Hehehe
$CureVac (CVAC.US)$
CureVac Advances Cancer Vaccine Candidate CVGBM to Part B of Phase 1 Study
in Patients with Resected Glioblastoma
·First patient administered in dose-confirmation Part B of Phase 1 study with mRNA-based, multiepitope cancer vaccine candidate CVGBM
·Part B expected to include up to 20 patients to generate extended data on safety, tolerability, and immunogenicity of CVGBM
TÜBINGEN, Germany/BOSTON, USA – August 15, 2024 – CureVac N.V. Today announced the start of the dose-confirmation Part B of its “After successful completion of the dose-escalation part A of this clinical study with CVGBM, 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,” said Dr. Myriam Mendila, Chief Scientific Officer of CureVac. “Importantly, the review by the Data Safety Monitoring Board confirmed there have been no dose-limiting toxicities to date in Part A with the four doses tested, and have enabled us to move forward to this next part of the study.”
The open-label study is evaluating the safety and tolerability of CVGBM in patients with newly diagnosed and surgically resected MGMT-unmethylated glioblastoma or astrocytoma with a molecular signature of glioblastoma. CVGBM is administered as a monotherapy after surgical resection and completion of radiotherapy with or without chemotherapy. The study consists of two parts, a dose-escalation part (Part A) and a dose-expansion part (Part B). Part A has successfully been completed and involved 16 patients, testing doses in the range of 12 to 100 µg. A review of the safety data from Part A by the Data Safety Monitoring Board (DSMB) confirmed no dose-limiting toxicities. A 100 µg dose was recommended for Part B of the study.
Initial data on the dose-escalation Part A will be presented in an oral presentation at the European Society for Medical Oncology Congress (ESMO) on September 13, 2024.
CureVac Advances Cancer Vaccine Candidate CVGBM to Part B of Phase 1 Study
in Patients with Resected Glioblastoma
·First patient administered in dose-confirmation Part B of Phase 1 study with mRNA-based, multiepitope cancer vaccine candidate CVGBM
·Part B expected to include up to 20 patients to generate extended data on safety, tolerability, and immunogenicity of CVGBM
TÜBINGEN, Germany/BOSTON, USA – August 15, 2024 – CureVac N.V. Today announced the start of the dose-confirmation Part B of its “After successful completion of the dose-escalation part A of this clinical study with CVGBM, 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,” said Dr. Myriam Mendila, Chief Scientific Officer of CureVac. “Importantly, the review by the Data Safety Monitoring Board confirmed there have been no dose-limiting toxicities to date in Part A with the four doses tested, and have enabled us to move forward to this next part of the study.”
The open-label study is evaluating the safety and tolerability of CVGBM in patients with newly diagnosed and surgically resected MGMT-unmethylated glioblastoma or astrocytoma with a molecular signature of glioblastoma. CVGBM is administered as a monotherapy after surgical resection and completion of radiotherapy with or without chemotherapy. The study consists of two parts, a dose-escalation part (Part A) and a dose-expansion part (Part B). Part A has successfully been completed and involved 16 patients, testing doses in the range of 12 to 100 µg. A review of the safety data from Part A by the Data Safety Monitoring Board (DSMB) confirmed no dose-limiting toxicities. A 100 µg dose was recommended for Part B of the study.
Initial data on the dose-escalation Part A will be presented in an oral presentation at the European Society for Medical Oncology Congress (ESMO) on September 13, 2024.
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