'No reason to slow down anything here': CureVac plans to march on with Covid-19 vaccine after pivotal failure
The day after CureVac revealed its mRNA vaccine failed a pivotal trial, crushing the company’s stock, a group of analysts tuned into the company call with variations of the same question: What’s next for CVnCoV?
CureVac’s shares $CVAC were down nearly 49% on Thursday morning, after announcing an interim vaccine efficacy of just 47% against Covid-19 disease of any severity. The company blamed its efficacy issues on emerging variants, arguing that the vaccine’s late entry left researchers in an “increasingly challenging variant-rich environment,” with 13 strains circulating, CEO Franz-Werner Haas said on a call with investors Thursday.
Out of 134 Covid cases assessed in the interim analysis, 124 were sequenced to identify the variant causing the infection, and only one case was due to the original SARS-CoV-2 virus that circulated the globe for much of 2020, Haas stressed.
The company also used the call to highlight preclinical data from CV2CoV, the second-generation vaccine it’s working on with GlaxoSmithKline. In animal studies, that candidate induced antibody levels 10 times higher than CVnCoV at peak level after six weeks.
Guggenheim’s Seamus Fernandez asked the question that likely floated to the top of everyone’s minds: “Can you just help us understand which program you’re more motivated to move forward with?”
Haas quickly responded that a reprioritization is not in the future.
“There is no reason to slow down anything here,” he said. “Not with regard to the building out of our manufacturing network, or to slow down the process with regards to CVnCoV. That’s the primary product candidate, close to the finish line.”
Although the study wasn’t statistically powered to read out efficacy data from separate subpopulations, interim chief development officer Ulrike Gnad-Vogt said on the call that trends suggest efficacy in younger populations, and in the most prevalent of the 13 strains detected in the study.
More than half of cases (57%) were caused by “variants of concern,” according to the company, while most others were caused by “less explored” variants like Lambda (C.37) first identified in Peru or B.1.621 first found in Colombia. Of the total 134 cases observed in the study, 119 were in people 60 years and younger, and 15 were in people over 60.
CureVac expects a final analysis in the next two to three weeks to confirm these age- and strain-related trends.
When analysts asked CureVac to break down the efficacy numbers for “variants of concern,” Gnad-Vogt responded: “It is premature to conclude about this today. We need to go for the final analysis to accrue sufficient cases to draw more statistically robust conclusions.”
If what CureVac’s saying is true, and variants vanquished what would have been an otherwise effective vaccine, the implication is that others are being similarly impacted, though we’ve seen little evidence of that.
A majority of the 124 cases CureVac sequenced were found to be caused by the Alpha strain, or B.1.1.7, which was first identified in the UK. However, Moderna and Pfizer have both said their vaccines work just fine against the B.1.1.7 variant, with Moderna releasing a study in January that showed no significant impact on neutralizing titers against that variant compared to prior ones.
Berenberg’s Zhiqiang Shu dug deeper into this theory, asking if CureVac will draw a conclusion on the vaccine’s efficacy against the Alpha strain in particular, and whether scientists could compare it side-to-side with other mRNA vaccines.
Gnad-Vogt gave a half-answer, responding: “We will continue to the final analysis, and that may allow us to get a better understanding, depending on the number of cases caused by the alpha strain, about the strain-specific efficacy. As I said already, as of today, a firm conclusion is not possible.”
When asked about the timeline of the company’s rolling submission with the EMA, Haas said: “It’s quite clear that we need to provide the data and the final analysis, before there is any estimation. Because what we can see in this changing environment … with all the different variants coming in… it’s quite hard to estimate.”