J&J unit, happy with AC Immune Alzheimer's work, moves 1 of 2 shots to next step

As the pharma world chatters about the merits of the amyloid theory in Alzheimer’s disease, Johnson & Johnson is taking things in another direction. The healthcare giant’s pharmaceutical unit Janssen has picked a tau vaccine from its collaboration with neurodegenerative-focused biotech AC Immune to advance into further development.

That means that another shot in development by the pair, JACI-35.054, will not move forward. The two vaccines had been tested head-to-head and ultimately, the candidate called ACI-35.030 was the winner, a spokesperson for AC Immune confirmed to Fierce Biotech. 

The decision comes as AC Immune presents interim phase 1b/2a data at the Clinical Trials on Alzheimer’s Disease (CTAD) conference showing that ACI-35.030 led to strong and durable induction of antibodies that target tau. The vaccine is designed to reduce the spread of the protein called tau, which misfolds and tangles up in the brains of patients with Alzheimer’s.

AC Immune CEO Andrea Pfeifer, M.D., called the advancement “a significant step for this collaboration.” She noted that early clinical testing has shown ACI-35.030 was well tolerated. The average age of the trial participants was 65, meaning the vaccine could become a treatment and preventive measure against Alzheimer’s.

While details are slim, the advancement means a completely new study for ACI-35.030 beyond the ongoing phase 1b/2a. The spokesperson could not provide additional details, only that AC Immune will no longer be responsible for material development costs.

Under the original terms of the 2014 agreement, AC Immune and Janssen would work together through phase 1b, with Janssen taking the reins for phase 2 and beyond, including manufacturing and commercialization.

At CTAD, AC Immune compared ACI-35.030 to the protein conjugate vaccine JACI-35.054. That shot is being tested in a parallel phase 1b/2 study.

AC Immune will have three vaccines in phase 2 testing in 2023 and is working on other therapeutics and diagnostics for neurodegenerative diseases as well. The company also has partnerships with Eli Lilly and Roche’s Genentech unit.

A number of leading Alzheimer’s drug developers are presenting at CTAD, including Eisai, which on Tuesday evening provided additional data on its phase 3, Biogen-partnered amyloid monoclonal antibody lecanemab. The Japanese pharma detailed two deaths that have made headlines over the past few months and also performed analysis of quality of life and caregiver data to make the case for the therapy.

Both Lilly and Genentech are scheduled to present Wednesday, with many industry watchers awaiting more details on the Roche unit’s failed phase 3 study for gantenerumab.

Editor's Note: This story was updated at 12:07 p.m. ET on Nov. 30, 2022, to include information on the discontinuation of JACI-35.054.