The biopharma CureVac (Nasdaq:CVAC) and its partner GSK (NYSE:GSK) have announced positive extended preliminary data from two Phase 1 mRNA vaccine trials, one involving COVID-19 and another seasonal flu.
The company says the positive data support the next stage of clinical testing for modified mRNA COVID-19 and flu vaccines in 2023.
CureVac, which struggled to gain traction for its first-generation mRNA COVID-19 vaccine, is using a second-generation mRNA backbone for its latest mRNA COVID-19 and flu vaccines.
In early January, CurVac announced positive preliminary data from the Phase 1 clinical programs in COVID-19 and seasonal flu.
In a CureVac call with analysts, Umer Raffat, senior managing director at Evercore, stated that the data released then were “half-baked,” adding that a lot of more data from the ongoing Phase 1 study was forthcoming.
“This is a Phase 1 with small numbers, but I think the data clearly show the improved reactogenicity profile of our modified candidate compared to our former candidates,” responded CureVac’s head of clinical development Ulrike Gnad-Vogt.
CureVac’s CV0501 COVID-19 vaccine candidate encodes the prefusion stabilized full-length spike protein of the SARS-CoV-2 omicron BA.1 variant, which emerged in late 2021. The vaccine yielded a high ratio of neutralizing antibodies in adults 65 and older.
Its seasonal flu vaccine candidate was safe and well tolerated in the Phase 1 study, eliciting 2.3 times higher antibody titers than a licensed vaccine comparator in an older adult population.
The number of people achieving seroconversion was 89.7% for the Flu-SV-mRNA and 56.2% for a licensed flu vaccine.
The monovalent flu vaccine candidate encoded for the hemagglutinin protein from the A/Wisconsin/588/2019 (H1N1)pdm09-like virus.
Future versions of the flu vaccine candidate will target four influenza strains recommended by the WHO.
The CV0501 COVID-19 program administered 12, 25 and 50 μg doses to 10 subjects per dose group.
The company did not disclose the dose levels used for its Flu-SV-mRNA vaccine, administered in individuals aged 60 to 80.
The ongoing Phase 1 studies for CV0501 and Flu-SV-mRNA are being conducted in the U.S., Australia and the Philippines.
The company entered into a collaboration with GSK in 2020.
CureVac shares continue to trade around one-tenth of the level of 2021 highs. On February 5, 2021, for instance, its shares hit $120.43. In 2020, the company then anticipated winning approval for its first-generation vaccine candidate in 2021.
In July 2022, CureVac filed a lawsuit in the German Regional Court in Düsseldorf against the fellow mRNA vaccine company BioNTech (Nasdaq:BNTX), asking for compensation for infringing CureVac’s patents.
Filed Under: Infectious Disease
