• Head-to-head comparison with licensed bivalent mRNA-based comparator vaccine confirms competitive immune responses at lower doses and favorable tolerability profile
  • Monovalent mRNA vaccine candidate, CV0601, encoding Omicron BA.4-5 variant and bivalent candidate, CV0701, encoding Omicron BA.4-5 variant as well as the original SARS-CoV-2 virus, successfully boosted antibody titers and were generally well tolerated across all tested dose levels

TÜBINGEN, Germany / BOSTON, MA, USA I January 5, 2024 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 positive interim data from the ongoing Phase 2 study assessing monovalent and bivalent modified vaccine candidates against COVID-19. Both vaccine candidates are being developed in collaboration with GSK. Selected data can be reviewed in the presentation associated with this press release.

Results from the formal interim analysis showed that both vaccine candidates using CureVac’s proprietary second-generation mRNA backbone produced meaningful immune responses and favorable reactogenicity profiles across all tested doses, including the lowest tested dose. All three of the dose levels tested were below those used in mRNA-based COVID-19 vaccines licensed in the U.S. and EU.

“These positive Phase 2 data continue to strongly validate the competitiveness of our proprie­tary mRNA-technology platform and second-generation mRNA backbone in comparison to a licensed mRNA-based vaccine,” said Dr. Myriam Mendila, Chief Development Officer of CureVac. “We are greatly encouraged by the strong immunogenicity results achieved for our COVID-19 mRNA vaccine candidates and are in advanced discussions with regulatory authorities to determine the best path forward for a pivotal Phase 3 study. With this, we advance our joint COVID-19 development program along with our joint flu vaccine program, which continues to progress steadily as well.”

The Phase 2 study assesses the safety and immunogenicity of different single booster doses of monovalent vaccine candidate CV0601, encoding the spike protein of the Omicron BA.4-5 variant and bivalent vaccine candidate CV0701, encoding the spike protein of the Omicron BA.4-5 variant and original SARS-CoV-2 virus. Safety and immunogenicity were assessed in comparison to a licensed bivalent mRNA-based COVID-19 comparator vaccine. While the monovalent candidate CV0601 was tested at a single medium dose level, the bivalent candidate CV0701 was tested at low, medium, and high dose levels. The study is being conducted in Australia and is fully enrolled with 427 healthy adults aged 18 and older equally randomized between dose groups.

Reactogenicity data cover all dose groups for both vaccine candidates. The vaccine candidates were shown to be generally well tolerated with a lower or similar proportion of participants reporting solicited adverse events when compared to comparator vaccine participants within seven days of dosing.

Interim immunogenicity data showed meaningful titers of neutralizing antibodies for both candidates at all dose levels. Titers of neutralizing antibodies matched or numerically exceeded the titers induced by the licensed comparator vaccine at all tested doses except for the low dose level of CV0701.

The monovalent candidate CV0601, which was tested at a medium dose level, elicited neutralizing antibody titers against the Omicron BA.4-5 variant on day 29 following the booster vaccination that were 5.0 times the pre-boosting titers, numerically exceeding the 3.6-fold ratio generated by the licensed comparator vaccine.

For the low, medium, and high dose levels tested for the bivalent candidate CV0701, neutralizing antibody titers against BA.4-5 on day 29 following the booster vaccination were 2.7-fold, 3.7-fold and 4.6-fold the titers before the booster, compared to a 3.6-fold ratio of post- to pre-booster titers for the comparator vaccine.

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.