AC Immune announced it has “remarkable,” “unprecedented” results on an Alzheimer’s vaccine. You’re just not allowed to see the data.
On Thursday, the J&J-partnered Swiss biotech said that its vaccine had generated “high” levels of antibodies against tau, a tangled protein commonly implicated in Alzheimer’s, in every patient in their Phase I/II trial for the neurodegenerative disease. The stock $ACIU instantly doubled in pre-market trading, rising from $7.30 to $14.70, and briefly making AC Immune once again a $1 billion company.
There were two caveats, though. For one, the study was tiny by Alzheimer’s standards: just 32 patients across two dose cohorts.
And, perhaps more notably, the data release was surprisingly devoid of data. Although AC Immune said that they increased antibody levels to “potentially therapeutic levels” in 100% of patients, they didn’t define what they believed to be the potential therapeutic level — whether that was a 5% increase or a 90% increase. And they didn’t say what the average or median increase was across the study.
In a field that’s seen nearly every Phase III study fail, no matter how positive biomarkers were in early trials, the announcement earned derision from some investors on Twitter. The stock cooled down to $10 once trading opened.
New rule: if your CEO quote references “remarkable data” in your press release, you must actually have data (i.e. numbers) in your press release. $ACIU
— Brad Loncar (@bradloncar) February 11, 2021
Notably, the release comes after another Alzheimer’s biotech has surged dramatically off of sunny press releases. Cassava Sciences, an Austin biotech that sold for less than $3 a share 6 months ago, now trades just under $50 after releasing non-statistically significant data from open label trials that CEO Remi Barbier said they “could not be more pleased with.” The stock has caught on with retail investors, including the WallStreetBets subreddit made famous by the GameStop phenomenon.
AC Immune CEO Andrea Pfeifer similarly praised their non-disclosed data as “remarkable” and “unprecedented.” By contrast, after Eli Lilly announced results last month from an Alzheimer’s study that enrolled over 200 patients and included a detailed breakdown of statistically significant data on both cognitive decline and brain biomarkers, CSO Dan Skrovonsky called it “tantalizing, but debatable.”
In an email, an AC Immune spokesperson said they wouldn’t release the data, but that high titers of anti-tau antibody were critical, as it can be difficult to get older patients to generate a strong immune response to a vaccine.
“We now have evidence that ACI-35.030 is able to reach the levels of antibody that were therapeutic in preclinical models, in 100% of patients, with no safety issues,” he said. “This result warrants advancing the program into phase 2/3.”
The release is particularly notable given AC Immune’s recent history. After the wreckage of the amyloid hypothesis, biotech and pharma have increasingly turned to target tau as a potential path to slowing Alzheimer’s patients’ decline. That shift has landed AC Immune big-money collaborations with Eli Lilly, Genentech and J&J.
Yet the company has recently seen how difficult it can be to translate early data. The company’s stock collapsed in September after Genentech announced their co-developed tau-clearing antibody failed to improve cognitive performance on three different metrics, despite Phase I results that the companies evidently deemed promising enough. (AC Immune has yet to announce whether the drug cleared tau in the study.)
AC Immune was also dealt a small blow at the end of the last month, when Eli Lilly announced in their Q4 they would stop developing for Alzheimer’s a molecule they had licensed from the biotech. The AC Immune spokesperson said development will continue in other tauopathies, a group of rare neurodegenerative conditions.