AFFiRiS Initiates Trial with Alpha-Synuclein-Targeting Parkinson Disease Vaccine

Austrian firm AFFiRis initiated what it claims is the first clinical trial to evaluate a disease-modifying therapeutic vaccine against Parkinson disease. Developed using the firm’s Affitome® technology, the peptide-based vaccine PD01A is designed to trigger an antibody response that targets the alpha-synuclein deposits in the brain implicated in Parkinson disease development and progression. The first-in-man study, carried out in Vienna, will evaluate the safety and tolerability of PD01A in 32 Parkinson disease patients.

Development of the vaccine has been supported by two grants from the Michael J. Fox Foundation (MJFF). In October last year AFFiRiS was awarded $1.5 million to fund continued development of the immunotherapeutic vaccine and take it into the clinic. The financial support in 2011 followed on from a $475,000 award made by MJFF in 2010 to support preclinical development of a Parkinson disease vaccine candidate.

AFFiRiS is exploiting its Affitome technology to develop therapeutic peptide vaccines against disorders including Alzheimer disease, atherosclerosis, and hypertension. The vaccine antigens are short peptides that function as B-cell epitopes designed to trigger an antibody immune response to the target protein. However, neither the target molecule nor fragments of it are used as the vaccine antigens. Instead, the Affitome technology results in the generation of a pool of antigen mimics comprising unrelated amino acid sequences, which can be fine-tuned to optimize their immunogenicity.

The firm’s lead Alzheimer disease vaccine is in Phase II clinical development, and two follow-on Alzheimer disease candidates are undergoing Phase I evaluation. The Alzheimer disease program was licensed exclusively to GlaxoSmithKline in 2008. Under terms of the potentially €430 million deal, AFFiRis received €22.5 million up front.