|Andrea Pfeifer, CEO of AC Immune--image courtesy of AC Immune|
Based: Lausanne, Switzerland
CEO: Andrea Pfeifer
Clinical Focus: Alzheimer's
The Scoop: The drug development field for Alzheimer's is littered with the graves of high-profile failures. Billions of dollars have been spent--some would say wasted--on drugs like bapineuzumab, semagacestat and others. Eli Lilly ($LLY) is relying on secondary analysis to keep hope alive in solanezumab, another Phase III disaster. And yet AC Immune has been advancing a set of experimental Alzheimer's antibodies that manage to stir tremendous excitement about the company's potential.
One reason for the stir is AC Immune's major league partner, Genentech, which earlier this year announced a groundbreaking study that will test AC Immune's crenezumab in a new study which will enroll a pre-Alzheimer's population, bringing the drug to people before toxic proteins do their destructive work. And soon after that study was announced, with significant support from NIH, Genentech in-licensed AC Immune's second program, a preclinical anti-tau antibody that looked promising in rodent studies. AC Immune also has a small molecule program in place as it pioneers a new immunology approach that has implications that go far beyond Alzheimer's.
What Makes it Fierce?
AC Immune has been the beneficiary of a major turn in direction in treating Alzheimer's. While a Phase II study of crenezumab is once again testing the amyloid beta theory--that reducing levels of amyloid beta in the brains of patients can treat the disease--it's the shift to high-risk populations that is grabbing the attention of investigators in the field now. Months ago the NIH and Genentech agreed to finance a $100 million study of crenezumab, the first-ever test to see if a treatment could prevent the disease from occurring.
"We need to go early into the disease," insists AC Immune CEO Andrea Pfeifer. But pioneering a new treatment in a disease like Alzheimer's, where there's no conclusive evidence of what spurs the disease or how to treat it, is a devilishly complex task.
"Honestly, nobody knows where the limit is," says Pfeifer about drawing lines around populations that can benefit from this early-stage approach. "We're all speculating. There's no way to say yes, that's too late or too early. We simply don't know. Scientifically, though, it makes sense to stop the pathological process while the brain is still working, not after 70% of the neurons are dead."
AC Immune has grown from its 6 original staffers to 50. And it's done it in a typically Swiss fashion, which means keeping two years' worth of operating capital in the bank as it expands its research focus.
"We keep a Swiss attitude," says Pfeifer. "We always have good financing. We would not like to have a situation where we were forced, because of a lack of money, to make decisions. Other than that, because of the two platforms, we are in an extremely positive situation."
Genentech has played a big part in the biotech's financial stability. In June, the Roche ($RHHBY) subsidiary signed on to partner on AC's anti-tau antibody program with a package of incentives worth up to $418 million. As an independent group, Genentech signed on with AC Immune in 2006 with a $300 million deal. And the biotech followed up with a research pact in 2009.
One of the reasons Genentech was so excited about the AC Immune work was the specificity of the antibody they had. Better specificity allows for more precisely targeting mis-folded proteins, which in turn allows for higher dosing while limiting safety risks. The key now is finding the right dosage that works and then proving efficacy and safety in the clinic.
AC Immune recently added a Parkinson's program to the R&D work on its plate. New programs add to the prospect of new partnerships, which in turn could either trigger an acquisition or perhaps an IPO under the right circumstances.
Investors: AC Immune has raised a total of 64 million Swiss francs over the years. But the company has never disclosed its investor group.