CureVac and GSK Report Promising Phase 2 COVID-19 Vaccine Results

CureVac, a biopharmaceutical firm specializing in mRNA technology, has reported encouraging interim results from its Phase 2 clinical trial for two COVID-19 vaccine candidates. The vaccines, CV0601 and CV0701, are designed to target the Omicron BA.4-5 variant and the original SARS-CoV-2 virus, respectively. The study, conducted in collaboration with GSK, aimed to evaluate the safety and immunogenicity of single booster doses of these vaccines compared to a licensed bivalent mRNA-based comparator vaccine.
The findings indicate that both candidates demonstrated significant immune responses and were well-tolerated across all tested dosages, which were notably lower than those used in currently licensed mRNA vaccines. Dr. Myriam Mendila, CureVac's Chief Development Officer, highlighted the competitive edge of their mRNA-technology platform and expressed optimism regarding the strong immunogenicity outcomes. She also mentioned ongoing discussions with regulatory bodies to chart the course for a pivotal Phase 3 study.
The Phase 2 study involved 427 healthy adults aged 18 and above, with equal distribution across different dosage groups. The reactogenicity data revealed that the vaccine candidates were generally well-tolerated, with a lower or comparable proportion of participants reporting solicited adverse events within a week of vaccination, compared to the comparator vaccine group.
The interim immunogenicity data showed that both vaccine candidates produced substantial levels of neutralizing antibodies at all tested dosages. Notably, the monovalent candidate CV0601, administered at a medium dosage, induced a 5.0-fold increase in neutralizing antibody titers against the Omicron BA.4-5 variant, surpassing the 3.6-fold ratio achieved by the licensed comparator vaccine. Similarly, the bivalent candidate CV0701 showed a 2.7 to 4.6-fold increase in antibody titers at varying dosages, which were comparable to the comparator vaccine's 3.6-fold ratio.
CureVac, listed on Nasdaq under the ticker CVAC, has over two decades of experience in mRNA technology. The company's proprietary approach involves using optimized mRNA to instruct the body to produce proteins that combat various diseases. In addition to the COVID-19 vaccine development, CureVac is also working on a joint flu vaccine program with GSK. The company has a robust clinical pipeline that includes prophylactic vaccines, cancer therapies, antibody therapies, and treatments for rare diseases, with headquarters in Tübingen, Germany, and over 1,100 employees worldwide.