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CureVac’s lead mRNA program flunks a critical PhIIb study, raising questions for high-profile biotech unicorns

Ingmar Hoerr

CureVac’s leading mRNA program CV9104, a prostate cancer vaccine, has failed a critical Phase IIb study. And that stinging setback for the most advanced clinical study in the field will raise fresh questions about a complex new technology that has attracted billions of dollars in investment cash.

The German biotech reported that not only did CV9104 fail the primary endpoint on improving overall survival, there was also no improvement on progression-free survival over a placebo.

CureVac’s cancer vaccine is a 6-mRNA concoction aimed at whipping up an immune system attack by encoding for 6 antigens over expressed in prostate cancer.

The German biotech – run by CEO Ingmar Hoerr – has raised $360 million for its work, primarily backed by German billionaire Dietmar Hopp along with additional funding from Bill Gates’ foundation, both intrigued by the revolutionary potential of instructing cells to produce therapeutics.

The most prominent company in the messenger RNA space is Moderna, a Boston-based biotech which has raised $1.9 billion and just this week detailed a full pipeline of 5 clinical-stage therapies and another 7 preclinical projects. Moderna CEO Stephane Bancel is also working on a cancer vaccine with Merck, but he’s already sought to distinguish their approach to an individually tailored therapy with the shared-antigen approach that CureVac has.

I asked Bancel about the CureVac setback, and he responded:

“Cancer vaccines continues to be a high risk endeavor, which is why we partnered with Merck, a leader in immuno-oncology.”

Whether that kind of distinction will help Moderna avoid getting dinged by CureVac’s failure, though, has yet to be seen. Moderna has come under repeated attack by STAT’s Damian Garde, who has focused on questions regarding the technology and Moderna’s cautious approach in tackling vaccines first, with a leading effort on pandemic flu. But that’s the long game that Bancel is determined to play as he lines up his own first round of data on those programs deemed most likely to succeed.

The latest failure at CureVac also follows a wave of clinical flops for cancer vaccines in general, which proved far too weak to direct a significant immune system attack on cancer. That first-wave failure was followed by checkpoint inhibitors, which effectively take the brake off the immune system, as well as personalized vaccines that seek out the individual antigens that will make the most compelling difference for patients. But that is also still very early in the development process.

CureVac’s next step will likely focus on a combo approach, matching their mRNA tech with checkpoints, chemo and so on, which is already part of the plan.


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RAPS Regulatory Convergence 2017