AC Immune and Janssen Pharmaceuticals will work together to develop and commercialize therapeutic anti-Tau vaccines for the treatment of Alzheimer’s disease and potentially other tauopathies.
Janssen Research & Development, an affiliate of Janssen Pharmaceuticals, will further develop AC Immune’s lead therapeutic vaccine, ACI-35, which is currently in a Phase Ib. 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 disease and a potential second indication outside of Alzheimer´s disease. 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.
Two years ago, in January 2013, AC Immune discontinued development of ACI-91, a small molecule drug in development for advanced Alzheimers disease. The drug was in-licensed and had a different mode of action than in-house therapies under development. “We are disappointed at these Phase II clinical results, particularly in view of the convincing preclinical data and ACI-91’s long-standing safety record in other indications. As a small biotechnology company we have to make judicious use of our scientific and financial resources, and so will now focus on our own home-grown molecules with different modes-of-action from ACI-91. We remain convinced that our strategy to target both the Abeta and Tau proteins will lead to a breakthrough therapy for Alzheimer’s disease,” Andrea Pfeifer, CEO of AC Immune, said in a statement at the time.