Affiris AG is an Austrian biotechnology company headquartered in Vienna, Austria, focused on developing novel immunotherapies for neurodegenerative diseases, particularly Parkinson's disease and related synucleinopathies. The company's proprietary SafePep技术 platform enables the development of therapeutic vaccines that target disease-specific protein aggregates, with lead programs targeting alpha-synuclein and tau pathology[1].
Affiris takes a unique approach by targeting post-translationally modified forms of alpha-synuclein, particularly phosphorylation at Ser129 (pSer129), which is a pathological hallmark of Lewy bodies and glial cytoplasmic inclusions in Parkinson's disease and related disorders[2].
| Attribute | Details |
|---|---|
| Headquarters | Vienna, Austria |
| Founded | 2006 |
| Technology Platform | SafePep (therapeutic vaccine) |
| Focus | Neurodegenerative disease immunotherapies |
| Stage | Clinical-stage |
PD01A is Affiris's lead clinical program, a therapeutic vaccine targeting phosphorylated alpha-synuclein (pSer129)[3].
| Attribute | Details |
|---|---|
| Target | Phosphorylated alpha-synuclein at Ser129 (pSer129) |
| Mechanism | Active immunization to generate anti-pSer129 antibodies |
| Indication | Parkinson's disease |
| Phase | Phase 1 completed, Phase 2 planning |
| Delivery | Subcutaneous injection |
PD01A works by stimulating the immune system to produce antibodies that specifically recognize and bind to alpha-synuclein that has been phosphorylated at Ser129. This post-translational modification is highly enriched in pathological inclusions in Parkinson's disease, Dementia with Lewy Bodies, and Multiple System Atrophy.
Key features:
Phase 1 Study (NCT01882191):
Phosphorylation at Ser129 is particularly relevant as a therapeutic target because:
PD03A is Affiris's second alpha-synuclein vaccine program, also targeting phosphorylated alpha-synuclein but using a different antigenic design.
| Attribute | Details |
|---|---|
| Target | Alpha-synuclein (phosphorylated forms) |
| Mechanism | Active immunization |
| Indication | Parkinson's disease, Multiple System Atrophy |
| Phase | Phase 1 planned |
PD03A was developed as a backup candidate with potentially improved immunogenic properties. The program remains in early development stages.
Affiris's SafePep technology platform enables the design of therapeutic vaccines that specifically target disease-associated protein conformations while minimizing immune responses against normal proteins.
Platform advantages:
| Company | Drug | Mechanism | Phase |
|---|---|---|---|
| Affiris | PD01A | Anti-pSer129 vaccine | Phase 1/2 |
| Prothena | Prasinezumab | Anti-α-syn mAb | Phase 2 |
| Vaxxinity | UB-312 | Anti-α-syn vaccine | Phase 2 |
| AC Immune | ACI-35 | Anti-pTau vaccine | Phase 2 |
| Roche | Ricobendazole | α-syn aggregation inhibitor | Phase 1 |
Alpha-synuclein aggregation is central to Parkinson's disease pathogenesis. The protein undergoes nucleation-dependent polymerization from native monomers to toxic oligomers and fibrils that form Lewy bodies.
Therapeutic rationale:
Active vaccination (therapeutic vaccines) offers several potential advantages over passive immunotherapy (monoclonal antibodies):