- Continued technology platform validation with extended preliminary data from older adults in ongoing Phase 1 studies in COVID-19 and flu
- COVID-19: monovalent modified mRNA construct CV0501 successfully boosted antibody titers against BA.1 and ancestral variants in adults age ≥65
- Flu: monovalent modified mRNA construct Flu-SV-mRNA elicited antibodies approximately 2.3 times those of licensed vaccine comparator in adults aged 60-80
- Reaffirming plan to advance modified mRNA COVID-19 and flu candidates to the next stages of clinical development in collaboration with GSK in 2023
TÜBINGEN, Germany; BOSTON, MA, USA I January 30, 2023 I CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced positive extended preliminary data from ongoing Phase 1 clinical programs in COVID-19 and seasonal flu conducted in collaboration with GSK. The newly reported data focus on older adult age groups in both indications. Detailed data can be reviewed in the associated presentation. The data further support the decision to advance updated versions of the modified mRNA COVID-19 and flu vaccine constructs to the next stage of clinical testing in 2023.
“The exciting preliminary data seen among older adults for our COVID-19 and flu programs significantly add to the validation of our technology platform into this highly relevant and at-risk population,” said Franz-Werner Haas, Chief Executive Officer of CureVac. “The strong immune responses we observed in both indications further support our commitment to advancing to the next stage of product development in 2023.”
Newly reported immunogenicity data from CV0501 in older adults (age ≥65) are based on the fully recruited dose groups of 12, 25 and 50µg, consisting of 10 subjects per dose. They show relevant titers of neutralizing antibodies beginning at the lowest tested dose. On day 29 at the 12µg dose level, CV0501 generated a ratio of post-boost to pre-boost serum neutralizing titers against BA.1 of 13.3.
While CV0501 encodes the Omicron BA.1 variant, a Phase 2 clinical study, expected to start later in 2023, will assess monovalent and/or bivalent vaccine candidates designed to target clinically relevant variants.
Seasonal Flu Program
A single dose of Flu-SV-mRNA (dose level undisclosed) was assessed for safety and reactogenicity in older adults (age 60-80) and was observed to be safe and well tolerated with no grade 3 adverse events in the 32 subjects who were administered the mRNA construct. Immunogenicity of Flu-SV-mRNA was assessed in parallel with a licensed seasonal flu vaccine comparator. Adjusted geometric mean hemagglutinin inhibition antibody titers elicited by Flu-SV-mRNA in older adults were approximately 2.3 times those elicited by the licensed vaccine comparator. In the same age group, the percentage of subjects achieving seroconversion 1) was 89.7% for Flu-SV-mRNA and 56.2% for the licensed flu vaccine comparator.
The vaccine candidate for future clinical development is expected to target all four flu virus strains currently recommended by the WHO for influenza vaccines. A Phase 1/2 study for multivalent vaccine candidates is expected to start around mid-2023.
Previously discussed preliminary results in younger adults for the COVID-19 and flu programs can be reviewed via the conference call and webcast materials archived on January 6, 2023, on the Events section on the CureVac homepage.
The CureVac/GSK infectious disease collaboration was first announced in July 2020. It focuses on the development of new products based on CureVac’s mRNA technology for different targets in the field of infectious diseases. The collaboration was extended in February 2021 to also include jointly developed vaccine candidates for COVID-19. In 2022, the companies broadened their development strategy to test modified mRNA in addition to unmodified mRNA.
 Defined as the percentage of participants who either have a HI pre-dose antibody titer < 1:10 and a post-dose titer ≥ 1:40 or a pre-dose HI antibody titer ≥ 1:10 and at least a 4-fold increase in post-dose titer.
CV0501 is the first COVID-19 vaccine candidate applying chemically modified mRNA from the COVID-19 vaccine program developed in collaboration with GSK. It is based on CureVac’s advanced second-generation mRNA backbone. CV0501 encodes the prefusion stabilized full-length spike protein of the SARS-CoV-2 Omicron variant BA.1 and is formulated with lipid nanoparticles (LNPs). As for all vaccine candidates applying the second-generation mRNA backbone, CV0501 was designed with specifically optimized non-coding regions aiming to deliver improved mRNA translation for increased and extended protein expression compared to the first-generation mRNA backbone. The ongoing Phase 1 dose-escalation study is assessing the safety, reactogenicity and immunogenicity of CV0501 as a booster vaccination in the dose range of 12 to a potential maximum of 200µg in the predefined age groups of 18-64 years and ≥65 years. It is expected to also test additional cohorts at a 3 and 6µg dose level. The study is being conducted in the U.S., Australia, and the Philippines and is expected to enroll up to 180 healthy participants. Data provided in this press release represent preliminary data prior to database lock. Neutralizing antibodies were evaluated using a pseudo-typed neutralization assay.
FLU-SV-mRNA is the first flu vaccine candidate applying modified mRNA from the infectious disease mRNA vaccine program developed in collaboration with GSK. It is based on CureVac’s advanced second-generation mRNA backbone. The monovalent candidate encodes for the hemagglutinin (HA) protein from the A/Wisconsin/588/2019 (H1N1)pdm09-like virus based on the recommendations of the World Health Organization (WHO) for the Northern Hemisphere 2021-22 season. The ongoing Phase 1 dose-escalation study is assessing the safety, reactogenicity and immunogenicity of the monovalent candidate as a booster vaccination in up to five dose levels in the range of 2 to 54µg in the predefined age groups of 18-45 years and 60-80 years. It includes a licensed flu vaccine as an active comparator. The study is being conducted in Canada, Spain and Belgium and is fully enrolled with 198 healthy participants. The extended data provided in this press release represent cleaned data prior to database lock.
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.