GSK and CureVac Advance Second-Generation mRNA COVID-19 Vaccine CV2CoV into Clinical Trials

GSK, which was late to the COVID-19 vaccine development race, hopes to secure a share through various collaborations. The latest focus is on CureVac's improved vaccine CV2CoV, which has just entered clinical trials.

After the first attempt by CureVac failed, the company launched its second-generation mRNA vaccine CV2CoV, which has now entered Phase I clinical trials. In preclinical trials on monkeys, the vaccine triggered an immune response similar to that of natural infection.

"The Phase I trial of CV2CoV will provide foundational clinical data for subsequent development to flexibly address different COVID-19 variants and a range of other diseases, as well as explore potential combination vaccine scenarios," CureVac stated.

Currently, the study is recruiting more than 200 adults in the United States to determine the dosage, with initial data expected to be released in the second half of this year.

According to preliminary data previously released by CureVac on its first-generation mRNA candidate vaccine, the efficacy of the first-generation product in preventing COVID-19 was only 48%. In contrast, real-world data from the UK shows that the effectiveness of the Pfizer/BioNTech COVID vaccine can reach 93%.

After the data was released, CureVac's stock price fell by more than 50%, dropping to less than $46. CureVac made a quick decision to abandon the first-generation mRNA candidate vaccine and focus on a second attempt in collaboration with GSK.

For CureVac, this is a chance to make amends, as it has staked much of its credibility on vaccine development and its collaboration with GSK — in February last year, GSK committed to helping produce 100 million doses of the vaccine, but by October, the clinical trial had failed, leaving the small German pharmaceutical company in urgent need of proving itself.

On the contrary, for GSK, even if the progress of CV2CoV lags behind that of its peers such as Pfizer, the situation is not urgent. This is because the partnership with CureVac is just one of the different "baskets" in which it places its eggs.

GSK is also collaborating with Sanofi, South Korea’s SK Bioscience, and Canada’s Medicago on vaccine development. Among these partnerships, the collaboration with Sanofi is the most advanced, with their jointly developed COVID-19 vaccine having entered the EMA rolling review in February 2022 and currently undergoing Phase III clinical trials.

Nearly two years ago, GSK signed an agreement with CureVac for the latter's mRNA technology. As part of the deal, GSK paid more than 270 million euros upfront, which included 150 million euros in equity, to acquire five mRNA vaccines and monoclonal antibodies. Notably, the initial deal did not include a COVID vaccine. Additionally, GSK and CureVac are also collaborating on the development of a flu vaccine.

Last week, the FDA announced the suspension of the previously approved COVID therapy sotrovimab, developed by GSK and Vir Biotechnology, due to its reduced efficacy against the omicron subvariant BA.2. The two companies stated they are preparing a "data package" to support sotrovimab's effectiveness against the subvariant BA.2.

For the second-generation mRNA vaccine developed in collaboration with CureVac, GSK stated: "The second-generation vaccine, developed based on preclinical data, shows an immunogenicity 10 times higher than the first generation. These data will support us in developing low-dose monovalent and multivalent vaccines to address emerging COVID-19 variants."

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