After completing a successful phase I partnership with TFS International (TFS), Araclon Biotech decided to continue the partnership advancing their Alzheimer’s disease (AD) vaccine ABvac40 into phase II.  The placebo-controlled phase II trial will be carried out at 21 clinical investigational sites across Europe over the next two years.

ABvac40 is an active immunotherapy that uses the C-terminal fragment of the amyloid-beta 40 peptide as an immunogen.  This is a different approach to other AD vaccines, because the immunogen peptide of ABvac40 (Aβx-40) seems to be more relevant to the development of the disease than other peptides targeted by other vaccines. 

In the phase I study, the vaccine demonstrated a good safety and tolerability profile and produced an immune response in a high percentage of patients. In the phase II for ABvac40, of the 120 participants, some will have amnestic mild cognitive impairment (MCI) and some will have very mild AD, in order to evaluate the efficacy and safety at early stages of the disease, both at the cognitive and molecular levels.

This study was approved by the Spanish Agency of Medicinal Products and Medicinal Devices earlier this year.

“After establishing such a strong partnership with Araclon during the phase I program, we are very pleased to have been chosen to collaborate in the phase II of  this exciting and innovative new approach to the management of Alzheimer´s Disease through ABvac40 vaccine.  One of our core values at TFS is ‘It’s All About Trust,’ and we are delighted that Araclon had the confidence to put their trust in TFS to take ABvac40 into phase II.” said Ed Tumaian, vice president of Clinical Development at TFS