PRESS RELEASE June 20, 2023 CureVac Doses First Patient in Phase 1 Study of Cancer Vaccine Candidate for Surgically Resected Glioblastoma Cancer vaccine candidate CVGBM utilizes single mRNA, encoding eight epitopes of tumor-associated antigens with demonstrated relevance in glioblastoma Study designed to evaluate safety and immunogenicity in patients with glioblastoma after surgical resection and radiotherapy First study to apply CureVac’s second-generation mRNA backbone in oncology TÜBINGEN, Germany / BOSTON, USA – June 20, 2023 CureVac N.V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced that it has dosed the first patient with its investigational cancer vaccine CVGBM in a Phase 1 study. CVGBM is based on CureVac’s proprietary second-generation mRNA backbone and features a single mRNA, encoding eight epitopes derived from known tumor-associated antigens with demonstrated relevance in glioblastoma. A first data readout is expected in the second half of 2024.
“We are excited to enter the execution phase of our cancer vaccine development strategy with a study that is designed to establish proof-of-principle for our advanced second-generation mRNA backbone in oncology,” said Dr. Myriam Mendila, Chief Development Officer of CureVac. “We will use the study data to evaluate the ability of our second-generation mRNA backbone to raise strong tumor-directed immune responses and provide a firm foundation to further advance our oncology pipeline based on our potent vaccine platform and an unparalleled framework for antigen discovery.”
The open-label study evaluates 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 will consist of two parts, a dose-escalation part (Part A) and a dose-expansion part (Part B). In the initiated Part A, patients will receive a total of seven intramuscular administrations of CVGBM at escalating doses in the range of 12 to 100 µg on days 1, 8, 15, 29, 43, 57, and 71. In patients without disease progression, vaccinations can continue beyond day 71 every 6 weeks up until one year after the first CVGBM vaccination, disease progression or undue toxicity.
About CVGBM CVGBM is CureVac’s first investigational cancer vaccine based on its proprietary second-generation mRNA backbone designed for improved mRNA translation and increased as well as extended protein expression. It encodes a single fusion protein comprising eight epitopes derived from tumor-associated antigens (TAA) with relevance in glioblastoma, including HLA class I epitopes presented on HLA A0201 and class II epitopes. The applied epitopes have been previously shown to induce immune responses in glioblastoma patients when administered as peptide vaccines with adjuvants. CVGBM applies unmodified mRNA and is formulated within lipid nanoparticles (LNPs). The Phase 1 proof-of-principle study of CVGBM is currently being conducted in Germany, Belgium and the Netherlands.
About CureVac CureVac (Nasdaq: CVAC) is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing, optimizing, and manufacturing this versatile biological molecule for medical purposes. The principle of CureVac’s proprietary technology is the use of optimized mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range of diseases. In July 2020, CureVac entered in a collaboration with GSK to jointly develop new products in prophylactic vaccines for infectious diseases based on CureVac’s second-generation mRNA technology. This collaboration was later extended to the development of second-generation COVID-19 vaccine candidates, and modified mRNA vaccine technologies. Based on its proprietary technology, CureVac has built a deep clinical pipeline across the areas of prophylactic vaccines, cancer therapies, antibody therapies, and the treatment of rare diseases. CureVac N.V. has its headquarters in Tübingen, Germany, and has more than 1,100 employees across its sites in Germany, the Netherlands, Belgium, Switzerland and the U.S. Further information can be found at www.curevac.com.
