• COVID-19 Phase 2 clinical trial fully enrolled
    • Study compares mono- and bivalent vaccine candidates against licensed comparator COVID-19 vaccine
  • First participant dosed in seasonal flu Phase 2 part of combined Phase 1/2 study
    • Study compares a potentially differentiated, multivalent vaccine candidate with broad antigen coverage against licensed comparator vaccine

TÜBINGEN, Germany; BOSTON, MA, USA I November 1, 2023 I 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 solid progress in its clinical vaccine development programs in COVID-19 and seasonal flu, conducted in collaboration with GSK.

“Through the successful execution of Phase 1 and 2 studies, together with our partner GSK, we are on track to move our most advanced COVID-19 and seasonal flu programs forward into the later stages of clinical development,” said Dr. Myriam Mendila, Chief Development Officer of CureVac. “The impact of mRNA technology continues to transform healthcare. As a company at the forefront of continuing mRNA innovation, we are excited to move potentially disruptive vaccine candidates toward the market.”

In the joint COVID-19 development program, recruitment of the ongoing Phase 2 study was completed at 427 randomized participants after the first participant was dosed in August 2023. The study assesses the safety and immunogenicity of different single booster doses of two modified mRNA COVID-19 vaccine candidates: the monovalent candidate, CV0601, encoding the spike protein of the omicron BA.4-5 variant and the bivalent candidate, CV0701, encoding the spike protein of the omicron BA.4-5 variant as well as the original SARS-CoV-2 strain. Vaccine candidates are compared to a licensed or authorized bivalent COVID-19 comparator vaccine. Interim Phase 2 data are expected in early 2024.

In the joint seasonal flu development program, the first participant was dosed in the Phase 2 part of the combined Phase 1/2 study, following selection of a promising vaccine candidate based on positive Phase 1 interim data announced September 12, 2023. The potentially differentiated, multivalent candidate encodes antigens matched to all WHO-recommended flu strains. It was selected from the Phase 1 part of the study that compared a comprehensive series of multivalent, modified mRNA seasonal flu vaccine candidates with up to eight separate mRNA constructs per candidate. In Phase 2, the selected candidate will be tested in younger and older adults at different dose levels compared to age-appropriate licensed seasonal flu comparator vaccines. Data are expected in 2024.

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.