AC Immune, a Swiss-based biopharmaceutical company, has entered into a worldwide exclusive license agreement and research collaboration with Janssen Pharmaceuticals to develop and commercialize therapeutic anti-Tau vaccines for the treatment of Alzheimer's disease and potentially other tauopathies.
Janssen R&D, an affiliate of Janssen Pharmaceuticals, will further develop the lead therapeutic vaccine, ACI-35, that currently is in a phase Ib clinical trial in Alzheimer's patients. ACI-35 is an active therapeutic vaccine stimulating the patient's immune system to produce a polyclonal antibody response against phosphorylated Tau protein.
AC Immune will receive an upfront payment and is eligible to receive research, development and commercialization milestone payments potentially totaling up to $509 million for Alzheimer´s and a potential second indication outside of Alzheimer’s. Additionally, the company is eligible to receive tiered royalties on net sales for any approved products resulting from the collaboration.
AC Immune and Janssen will co-develop ACI-35 through phase Ib completion. As of phase II and onward, Janssen will assume responsibility for the clinical development, manufacturing and commercialization of ACI-35. Additionally, the two companies have entered a three year joint research collaboration to further characterize and develop novel vaccine therapies for the treatment of tauopathies.
Prof. Andrea Pfeifer, CEO of AC Immune, said, "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."
"ACI-35 is the first therapeutic vaccine in clinical development that targets misfolded phospho-Tau protein that is associated with Alzheimer's disease. It is important to note that this vaccine approach offers the potential to treat Alzheimer's patients earlier and in broad populations and has an exciting future aptitude to treat other rarer tauopathy indications," said Dr. Andreas Muhs, chief scientific officer of AC Immune.