CureVac hand-picks mRNA flu vaccine for GSK-partnered program but keeps data tucked away

CureVac has hand-picked the mRNA influenza vaccine that will advance into the phase 2 portion of a clinical trial, but the famously tight-lipped biotech is keeping the data to itself for now.

The candidate was chosen based on an interim analysis from the ongoing phase 1/2 study, where a “comprehensive series of flu vaccine candidates” is being tested, the German vaccine biotech announced in a short press release Tuesday.

CureVac said the candidate was the best performing of the group and provided broad antigen coverage against World Health Organization (WHO)-recommended flu strains. The shot will now move into the phase 2 portion, with dosing expected in the fourth quarter of the year in older adults aged 65 to 85 years.

The ability to fight off all WHO-recommended strains is key, as Moderna found out in February. The famed COVID-19 shot maker’s flu candidate—heralded as its next development wave to come as the pandemic market slides into the rear view—was less successful against two influenza B strains. The WHO recommends protection against the two A subtypes, H1N1 and H3N2, as well as the influenza B Victoria and Yamagata lineages be included in annual flu shots.

Moderna quickly revamped its candidate to boost efficacy against the B strains but has still been struggling to turn up the positive data that could define this next era of the company’s future.

While CureVac did not provide detailed data, the short update suggests the now phase 2 candidate at least met the WHO’s bar.

CureVac’s multivalent modified mRNA vaccines in the GSK-partnered program contain up to eight mRNA constructs per candidate. The phase 1 part of the trial included 270 healthy volunteers aged 18 to 50. There were no safety concerns at the interim analysis for any dose levels for the multivalent candidates, CureVac said. The shots were tested against an approved seasonal flu vaccine comparator. CureVac also plans additional midstage testing in younger adults.

“The power, flexibility and speed of our mRNA technology platform offers tremendous potential to overcome the current challenges associated with providing seasonally updated and highly effective influenza vaccines,” Chief Development Officer Myriam Mendila, M.D., said in today's release. 

GSK first signed the mRNA deal with CureVac in July 2020 in the first months of the global pandemic.

CureVac has previously rankled analysts with its tight-lipped approach to data. In January, the company caught flak for what analysts called a "half-baked" disclosure about the mRNA approach that had been selected to advance into the clinic for flu and COVID. The company's shares still moved on that news, rising 17% to $7.49.

As of market open Tuesday, CureVac was trading at $8.39, down just over 1% from the day before at close.