• Initial Phase 1 part started with multivalent modified mRNA influenza vaccine candidates
  • Candidates developed in collaboration with GSK within broad infectious disease vaccine program encode for antigens covering four WHO-recommended flu strains

TÜBINGEN, Germany / BOSTON, MA, USA I May 8, 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 that the first participant was dosed in the Phase 1 part of a combined Phase 1/2 study of multivalent, modified mRNA seasonal flu vaccine candidates, developed in collaboration with GSK. The tested multivalent vaccine candidates address all four WHO-recommended flu strains.

“Our clinically validated technology platform and second-generation mRNA backbone give us great confidence as we continue clinical development of novel vaccine candidates to address seasonal flu,” said Dr. Myriam Mendila, Chief Development Officer of CureVac. “There are still unmet needs as seasonal flu is ever-evolving and immune responses to current vaccines remain a challenge, particularly in older adults. The flexibility, speed and scalability of CureVac’s end-to-end mRNA capabilities position us well to develop and deliver seasonal flu vaccines together with GSK that combat dominant strains of the season as they emerge.”

The combined Phase 1/2 study will evaluate mRNA-based, modified, multivalent influenza vaccine candidates for safety, reactogenicity and immune responses. The first Phase 1 dose selection part is being conducted in the U.S. and Belgium and will feature a licensed flu comparator vaccine.

As previously reported, in CureVac and GSK’s ongoing Phase 1 trial in older and younger adults of a monovalent, modified mRNA seasonal flu vaccine candidate, preliminary data showed a favorable tolerability profile and no concerning safety signals. Preliminary immunogenicity data indicated strong hemagglutinin inhibition immune responses in line with a licensed flu comparator vaccine beginning at the lowest tested dose.

The CureVac-GSK infectious disease collaboration was first announced in July 2020 and focuses on the development of new products based on CureVac’s mRNA technology for different targets in the field of infectious diseases.

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 1,000 employees across its sites in Germany, the Netherlands, Belgium, Switzerland and the U.S. Further information can be found at www.curevac.com.