After diving deep into the amyloid beta theory on Alzheimer's and coming up empty-handed--so far--Johnson & Johnson ($JNJ) is partnering with Switzerland's AC Immune on an early-stage therapeutic vaccine that targets tau tangles as a prime suspect in triggering the memory-wasting ailment.
J&J and the Swiss biotech put out the word on Sunday night, JP Morgan time, that the pharma giant has struck a deal to pick up the development of ACI-35, AC Immune's therapeutic vaccine that is designed to spur an antibody reaction against toxic clumps of phosphorylated tau protein. The program is currently in an early-stage Phase Ib study.
In exchange for the right to take over development of ACI-35 at Phase II, J&J's Janssen is handing over an unspecified upfront payment and committing itself to pay up to $509 million in milestones for a successful program. And the two companies also hammered out a 3-year deal to collaborate on the development of other tau vaccines.
|AC Immune CEO Andrea Pfeifer|
There's still no solid scientific consensus about what triggers Alzheimer's. The most popular theory is that toxic concentrations of amyloid beta, commonly found in the brains of patients, plays the primary role. AC Immune has been playing a big role in that field as well. But tau comes in as an oft-cited follow-up target. And AC Immune CEO Andrea Pfeifer has frequently said that any successful effort to develop a new drug for Alzheimer's will likely have to take the form of a cocktail that can target multiple triggers.
The Swiss biotech, though, has also experienced first-hand just how frustrating the field can be. Just last summer the company said that its drug crenezumab, partnered with Roche ($RHHBY), failed its coprimary endpoints in a midstage study. But like others in the field, investigators in the study pointed out that the drug appeared to perform better among patients with a milder form of the disease, raising the possibility that it could still work among a subset of patients.
J&J and Pfizer ($PFE) were prominent backers of bapineuzumab, one of the first big efforts in developing a drug that targets amyloid beta. But the drug failed in late-stage studies, along with Eli Lilly's ($LLY) solanezumab. But neither Lilly nor J&J were persuaded to back away from a field in neurosciences that has bedeviled drug developers for years with a 99% failure rate. Over that time, J&J's thinking on the subject has changed to embrace the multi-pronged approach to drug development.
"In Alzheimer's, nothing is known yet," J&J R&D chief Paul Stoffels told FierceBiotech in 2013. "Whether it's amyloid beta, whether it's tau, BACE inhibitors. Nothing is known yet. Maybe it will be combinations of all those. It is important for us to pursue different pathways."
"This is our third major collaboration with pharmaceutical partners involving the tau protein and underscores the strength of our technology platforms for targeting proteinopathies and our success in bringing to the clinic tau and Abeta therapies and diagnostics," noted AC Immune CEO Pfiefer, who's enjoyed significant financial support from German billionaire Dietmar Hopp.
- here's the release