AFFiRiS AG, an Austrian biotech company, has been awarded $1.5 million (€1.1m) for a clinical study of AFFITOPE® PD01, a first-of-its-kind Parkinson´s disease (PD) vaccine.
AFFITOPE® PD01 targets and helps remove the alpha-synuclein protein, whose clumping is the pathological hallmark of PD.
Principal investigator Achim Schneeberger, chief medical officer at AFFiRiS AG, will head the Phase I study of the vaccine candidate.
Pre-clinical studies show that the PD01 vaccine stimulates the body´s immune system to produce antibodies that bind to the protein alpha-synuclein, clearing it from the brain and slowing disease progression.
Alpha-synuclein is the major component in the Lewy bodies that are found in the brains of people with Parkinson´s.
The funding has been awarded by the Michael J. Fox Foundation (MJFF), which believes there is compelling evidence that alpha-synuclein may play a role in both idiopathic and rarer genetic cases of PD.
AFFiRiS´s PD vaccine approach builds on the company´s experience developing an Alzheimer´s disease (AD) vaccine.
Two of its AD vaccine candidates have already passed Phase I safety and tolerability testing and one of these, AFFITOPE AD02, has moved forward into Phase II testing.
A third potential AD vaccine, AD03, is in the first stage of clinical testing.
“Both the AD and PD AFFITOPE® vaccine families are delivered by the proprietary AFFITOME® technology,” said Markus Mandler, PhD, head of the neurodegeneration team at AFFiRiS.
“Its safety has been validated during Phase I testing of our AD vaccines.
“More importantly, early efficacy signals in the AD02 vaccine support our development strategy, which proposes the early testing of several members of a vaccine family in humans, the most relevant setting.
“We are able to do this given the compelling safety profile of these vaccines. We call this concept clinical maturation.”
With this award, MJFF expands its research presence in Austria, with total awards of more than $2.5 million to Austrian research teams to date. In Innsbruck, a research team led by Werner Poewe, MD, is working to identify Parkinson´s biomarkers (including alpha-synuclein biomarkers) as one of 21 clinical sites of the Parkinson’s Progression Markers Initiative (PPMI), a landmark international study sponsored by MJFF.
Biomarkers are concrete ways to demonstrate that a candidate therapy is, or is not, impacting disease course in PD patients, as opposed to simply alleviating disease symptoms.
With biomarkers in hand, it will be possible to establish definitive endpoints for clinical trials of disease-modifying Parkinson´s treatments such as PD01.