23-Mar-2021 - CureVac AG

CureVac Expands CVnCoV COVID-19 Vaccine Candidate Clinical Trial Analyses

Impact of new SARS-CoV-2 variants supports specification of select strains for anticipated case-driven interim analysis in pivotal Phase 2b/3 study

CureVac N.V. announced plans to expand and further specify the protocols of its ongoing late-stage clinical trials with CVnCoV, its COVID-19 vaccine candidate.

CVnCoV efficacy is currently being evaluated in the pivotal HERALD Phase 2b/3 trial in Europe and Latin America. Rapid distribution of new virus variants in the countries where the study is conducted supports the need for further analysis specification for the anticipated case-driven interim analysis. This will allow to determine efficacy of the vaccine candidate for select variants. The company has ongoing discussions with the European Medicines Agency (EMA) to potentially include an amendment related to select virus strains in the study.

For its Phase 2a dose-confirmation trial in older adults in Peru and Panama, CureVac has submitted a protocol amendment to include a secondary objective for vaccine efficacy. The study initially aimed to evaluate safety, reactogenicity and immunogenicity of CVnCoV in adults. Expanded trial analysis is expected to allow for collection of relevant efficacy data which includes the important group of approximately 270 participants above the age of 60, treated with 12µg of CVnCoV.

“Our goal is to offer the public and especially the vulnerable older age groups the best possible protection against the virus and its variants with our vaccine candidate“, said Ulrike Gnad-Vogt, Interim Chief Development Officer of CureVac. “The additional efficacy analysis in Phase 2a is intended to leverage the data we can collect from older adults, and will represent important complementary data to the statistically relevant efficacy data from our HERALD trial. At the same time we need to make sure that our efficacy data are meaningful in view of the emergence of new virus variants. We are therefore aiming to specify what type of virus we are dealing with in the HERALD trial.”

CureVac expects data readouts from both clinical trials in the second quarter 2021. It also reaffirms its intention to file for formal marketing authorization within the second quarter 2021.

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