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German biotech CureVac N.V. (NASDAQ:CVAC) added ~29% on Friday, recording its biggest intraday gain ever after posting interim Phase 1 data for modified-mRNA-based COVID-19 and flu vaccine candidates the company co-develops with GSK (NYSE:GSK).
The company said that based on these preliminary results, the vaccine candidates would advance toward the next phase of clinical studies in 2023.
From the COVID-19 program, which tested second-generation mRNA backbone using modified mRNA, early results were available for the CV0501 vaccine candidate based on a group of up to 30 subjects.
According to the company, CV0501, which targets Omicron BA.1 variant, was well tolerated leading to relevant levels of neutralizing antibodies in younger adults even at the lowest tested dose. A mid-stage trial for monovalent and/or bivalent vaccine candidates is expected to start later in 2023.
The company also disclosed early results from a Phase 1 trial for the monovalent Flu-SV-mRNA vaccine, which comes under the the partners’ seasonal flu program.
Preliminary data for the candidate indicated no safety concerns across multiple doses, and Flu-SV-mRNA outperformed a licensed flu vaccine comparator in younger adults for the generation of a specific type of antibody.
In future clinical studies, the companies expect to target all four flu strains recommended by the WHO. And a Phase 1/2 study for multivalent vaccine candidates is scheduled to start around mid-2023.
In December, Seeking Alpha contributor Alberto Abaterusso expected the data readout to generate “some sort of rally” in CureVac (CVAC) shares. “Should this happen, it will have a short-term impact on the stock price,” the author added.
