CureVac & GSK COVID-19 Vaccine Candidate Shows High Immunogenicity Against New Variants

CureVac N.V, a global biopharmaceutical company creating a novel class of revolutionary medicines based on messenger ribonucleic acid (mRNA), revealed jointly with its collaboration partner GSK, the first preclinical data in a rat model, demonstrated that its second-generation codeveloped COVID-19 vaccine candidate, CV2CoV, elicits significant levels of antigen production as well as high and dose-dependent immune responses in vaccinated animals according to the first preclinical data.

Second-Generation CureVac & GSK CV2CoV COVID-19 Vaccine Candidate Shows High Immunogenicity Against Virus Variants in Preclinical Study

The codeveloped CureVac-GSK COVID-19 vaccine nominee CV2CoV, is based on a novel mRNA backbone, which varies from CureVac’s first-generation vaccine candidate, CVnCoV, presently in a late-stage clinical study. Preclinical findings in rats inoculated with CV2CoV at doses ranging from 0.5 to 40g showed that robust immune responses were triggered quickly after the first dose.

Vaccinated animals’ serum also exhibited considerable cross-neutralization against variants initially found in Denmark (B.1.1.298), the United Kingdom (B.1.1.7), and South Africa (B.1.1.7) (B.1.351).

Dr. Igor Splawski, Chief Scientific Officer of CureVac said:

“mRNA technology has made tremendous progress since the clinical development of first-generation mRNA COVID-19 vaccine candidates started in early 2020. Spurred by the emergence of virus variants that have the potential to affect the efficacy of currently approved first-generation mRNA COVID-19 vaccines, CureVac and GSK aim to jointly develop second-generation vaccine candidates that offer improved immune responses and target emerging variants. Combined with lower doses, these second-generation vaccines could enable also broad protection against selected strains in a multivalent vaccine format.”

Roger Connor, president R&D GSK vaccines said:

”To successfully fight the COVID-19 pandemic in the long term, we will need different vaccines and we need to be able to respond effectively to emerging variants. We are pleased with these pre-clinical results as they show the potential of the next generation mRNA technology we are developing together with CureVac.”

About the Second-Gen CV2CoV Vaccine Candidate

CV2CoV is built on a novel mRNA backbone with targeted improvements to boost intracellular mRNA stability and translation, resulting in higher and prolonged protein expression. These advancements might lead to significant immune responses at low dosages, paving the way for the creation of multivalent vaccines to combat COVID-19 variants that are quickly spreading globally. The first CV2CoV clinical studies are planned to begin in the Q3 of 2021.

CV2CoV is being developed in conjunction with GlaxoSmithKline (GSK). The CureVac-GSK COVID-19 collaboration, announced in February 2021 extends the existing strategic mRNA technology codevelopment which began in July 2020. The collaboration will focus on second-generation vaccines and those that have the potential to treat multiple emerging variants in one vaccine using a multivalent or combination strategy.

About the CVnCoV Vaccine Candidate

In January 2020, CureVac began developing mRNA based COVID-19 vaccine candidates. CVnCoV, the first vaccine candidate chosen for clinical testing, is a non-chemically modified, optimised mRNA that encodes the full-length prefusion stabilized spike protein of the SARS-CoV-2 virus and is formulated in Lipid Nanoparticles (LNPs). CVnCoV clinical trials in phases 1 and 2a started in June and September 2020, respectively. CVnCoV was generally well tolerated across all doses tested according to the Phase 1 interim results released in November 2020, and elicited significant antibody responses as well as the first signs of T cell activation. The immunological response was equivalent to that of recovered COVID-19 patients, closely resembling that of a natural COVID-19 infection. CureVac launched the HERALD study, a pivotal Phase 2b/3 trial with a 12g dose of CVnCoV, in December 2020. CureVac started a rolling submission to the European Medicines Agency (EMA) for CVnCoV in February 2021.

About CureVac

CureVac is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing and optimizing the versatile biological molecule for medical purposes. The principle of CureVac’s proprietary technology is the use of non-chemically modified mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range of diseases. Based on its proprietary technology, the Company has built a deep clinical pipeline across the areas of prophylactic vaccines, cancer therapies, antibody therapies, and the treatment of rare diseases. CureVac had its initial public offering on the New York Nasdaq in August 2020. It is headquartered in Tübingen, Germany, and employs more than 600 people at its sites in Tübingen, Frankfurt, and Boston, USA.

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About GSK

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer.

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