What AFFiRiS does

AFFiRiS AG is a Vienna-based, clinical-stage biopharmaceutical company founded in 2003 that develops Specific Active Immunotherapies (SAIT) against chronic diseases using its proprietary AFFITOME® technology platform. The platform generates short (~10 amino acid) peptide sequences (AFFITOPEs®) that mimic epitopes of self-proteins implicated in disease, such as alpha-synuclein in Parkinson's disease and Multiple System Atrophy, PCSK9 in hypercholesterolemia, and mutated huntingtin in Huntington's disease. When formulated with a carrier protein and adjuvant and administered subcutaneously, the candidates induce the patient's own long-lasting antibody response, with potential dosing as infrequent as once or twice per year. Human proof-of-concept has been demonstrated in both hypercholesterolemia (39% LDLc reduction in highest antibody responders with AT04A; 13.3% group mean reduction at week 70) and Parkinson's disease (51% reduction in CSF oligomeric alpha-synuclein at high-dose PD01A, published in The Lancet Neurology, June 2020).

The business model is asset-light and partnership-driven: AFFiRiS does not commercialize products directly. Revenue consists of licensing upfronts, milestone payments, and royalties tied to partners (e.g., Frontier Biotechnologies for AT04 in Greater China, AC Immune, which acquired the anti-alpha-synuclein portfolio for USD 58.7 million in stock plus USD 5 million cash in 2021) plus non-dilutive funding from The Michael J. Fox Foundation (USD 3.5 million), EU FP7 grants (SYMPATH €6 million, MULTISYN), and AWS. To date, the company has attracted roughly €165 million of cumulative capital, with approximately half sourced from license income and government grants, led by Santo Holding (Strüngmann family office) and MIG Funds.

Following the 2021 AC Immune divestiture and Frontier license, AFFiRiS has reorganized around a leaner pipeline — cardiovascular (AT04/AT06) and Huntington's (mAB C6-17) — and is pursuing additional partners to advance remaining assets, including a planned Phase 2 trial with PD01 in early Parkinson's disease following FDA pre-IND feedback. The principal customer segments are large pharmaceutical/biotech partners seeking differentiated active-immunotherapy candidates and grant-making institutions supporting neurodegenerative and cardiovascular research; ultimate end-beneficiaries are patients with Parkinson's disease, MSA, Huntington's disease, and hypercholesterolemia for whom current therapies are largely symptom-modifying or adherence-limited.

Name

AFFiRiS

Legal name

AFFiRiS AG

Website

https://affiris.com

Company type

Private

Founded year

2003

Operating status

Operating

Headcount range

11–50 employees

Short description

AFFiRiS is a Vienna-based clinical-stage biopharmaceutical company (founded 2003) that uses its proprietary AFFITOME® technology to develop Specific Active Immunotherapies (peptide vaccines) targeting chronic diseases including Parkinson's disease, hypercholesterolemia, and Huntington's disease, monetizing candidates via licensing deals with partners such as Frontier Biotechnologies and AC Immune.

Ownership category

akta.pro rank

Product category

Biopharmaceutical R&D

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical Preparation Manufacturing (325412), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

Immunology & Autoimmune Specialty Pharmaceuticals (HLAIACAB)

akta.pro secondary industries

Rare Immunology, Autoimmune & Autoinflammatory Therapies (HLAIAIAE), Cardiometabolic Pharmaceuticals (Cardiovascular/Diabetes/Obesity) (HLAIAAAE)

Keywords

• Peptide immunotherapy
• Active immunotherapy
• Neurodegenerative therapeutics
• PCSK9 vaccine
• Chronic disease vaccines

Headquarters

HQ city

Gerasdorf Bei Wien

HQ country

Austria

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations

Revenue model

1. Licensing and Partnership Agreements: As a clinical-stage company, AFFiRiS generates revenue through licensing its technology and drug candidates to larger pharmaceutical companies. This includes upfront payments, development and regulatory milestone payments, and tiered royalties on net sales. Examples: Frontier Biotechnologies deal for Greater China (upfront + milestones + royalties), AC Immune acquisition of anti-alpha-synuclein programs (stock valued at USD 58.7 million + USD 5 million cash).
2. Government Grants and Funding: Significant funding from EU Framework Programmes (SYMPATH Grant Agreement No. 602999, MULTISYN Grant Agreement No. 602646), The Michael J. Fox Foundation for Parkinson's Research, and Austrian government (AWS loan).

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

AFFiRiS develops Specific Active Immunotherapies (SAIT) — peptide-based drug candidates built on its proprietary AFFITOME® technology — that stimulate the patient's immune system to produce antibodies against pathogenic proteins. Its pipeline targets chronic diseases including Parkinson's disease, Multiple System Atrophy, Huntington's disease, and hypercholesterolemia, with candidates such as AFFITOPE® PD01A, PD03A, AT04A, AT04, AT06A, and mAB C6-17. The company monetizes these candidates primarily through licensing and partnership agreements with larger pharmaceutical companies rather than direct commercialization.

Product overview

AFFiRiS is a clinical-stage biopharmaceutical company developing Specific Active Immunotherapies (SAIT) based on its proprietary AFFITOME® technology platform. The company is led by AFFITOPE® PD01A for Parkinson's disease, with additional candidates including AFFITOPE® PD03A for MSA/Parkinson's, AFFITOPE® AT04A/AT04 and AT06A for hypercholesterolemia targeting PCSK9, and mAB C6-17 monoclonal antibody for Huntington's disease. The AFFITOME technology creates peptide-based immunotherapies that stimulate the body to produce antibodies against disease-related proteins.

Differentiator

Problem solved

Functional benefit

Products and services

• AFFITOME® Technology Platform Proprietary patented technology platform that develops amino acid sequences (AFFITOPEs®) mimicking disease-related protein epitopes for use in Specific Active Immunotherapy (SAIT); forms the basis for AFFiRiS' pipeline. Licensed to and utilized by pharmaceutical partners for development and commercialization.
• Specific Active Immunotherapy (SAIT) Treatment modality that stimulates the body's immune system to produce antibodies against pathogenic proteins, administered via subcutaneous injection with infrequent dosing (once or twice yearly) to target chronic diseases.
• AFFITOPE® PD01A Alpha-synuclein (aSyn)-mimicking peptide-based active immunotherapy for treatment of early-stage Parkinson's disease patients; lead candidate demonstrating Phase 1 safety and immunogenicity with 51% reduction in CSF oligomeric aSyn.
• AFFITOPE® PD03A Alpha-synuclein-targeting immunotherapy candidate for Parkinson's disease and Multiple System Atrophy (MSA); showed dose-dependent immune response in Phase 1 studies.
• AFFITOPE® AT04A PCSK9-targeting active immunotherapy for hypercholesterolemia; demonstrated up to 39% LDLc reduction in highest antibody responders in Phase 1 trials; licensed to Frontier Biotechnologies for Greater China.
• AFFITOPE® AT06A PCSK9-targeting active immunotherapy candidate for cardiovascular disease/hypercholesterolemia; showed robust, long-lasting IgG antibody response in Phase 1 studies.
• AFFITOPE® AT04 Potential first-in-class investigational active immunotherapy targeting PCSK9 for hypercholesterolemia treatment; licensed to Frontier Biotechnologies for the Greater China region (mainland China, Hong Kong, Macau, Taiwan).
• mAB C6-17 Monoclonal antibody targeting mutated huntingtin (mtHTT) protein for Huntington's disease treatment; preclinical studies showed reduced mtHTT levels in peripheral organs and CNS with improved motor performance.

Quantifiable outcome

• 39% LDLc reduction in highest antibody responders with AT04A treatment
• +4 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Six partnerships are on record, tiered core and supporting.

• Frontier Biotechnologies Inc.coreOEM/ Whitelabel/ Licensing Partner · 22 December 2021License agreement for AFFITOPE AT04 (active immunotherapy targeting PCSK9 for hypercholesterolemia) in Greater China. Frontier obtains exclusive rights to develop and commercialize; AFFiRiS receives upfront payment, development/regulatory milestones, and tiered royalties in upper single-digit range on net sales. Frontier responsible for all development costs in licensed territory. AFFiRiS retains all rights in rest of world.
• AC Immune SAcoreStrategic or Co-development Partner · 27 July 2021AC Immune acquired AFFiRiS' anti-alpha-synuclein programs targeting neurodegenerative diseases. All-stock acquisition valued at USD 58.7 million plus USD 5 million cash for 7.1 million shares of AC Immune common stock. Programs based on AFFiRiS' AFFITOME technology including active vaccine candidates targeting alpha-synuclein. This allows AFFiRiS to focus on PCSK9 and Huntington's programs.
• SYMPATH Consortium (EU FP7)coreStrategic or Co-development Partner · 1 March 2018EU Framework Programme 7 funded collaboration (Grant Agreement No. 602999) with 8 academic and industry partners to advance clinical development of aSyn-targeting vaccines PD01A and PD03A. €6 million grant funding. Includes biomarker identification research.
• MULTISYN Consortium (EU FP7)supportingStrategic or Co-development Partner · 1 March 2018EU Framework Programme 7 funded collaborative project (Grant Agreement No. 602646) supporting AFFiRiS' development activities.
• Medical University of ViennasupportingStrategic or Co-development Partner · 1 March 2018Clinical trial site for Phase 1 studies with AT04A and AT06A targeting PCSK9. Department of Clinical Pharmacology conducted first-in-human studies.
• Privatklinik Confraternitaet, ViennasupportingStrategic or Co-development Partner · 1 March 2018Clinical trial site for Phase 1 studies with PD01A in Parkinson's disease patients. Principal Investigator Dr. Dieter Volc led the studies.

Scale indicators8 records

Recent moves7 records

Expansion highlights5 records

Emerging players

• BioInvent International: Clinical-stage biotech developing immuno-oncology and antibody-based therapies. Smaller European biotech with similar scale and clinical-stage profile to AFFiRiS, though focused on oncology rather than chronic disease.

Direct peers

• Prothena Corporation: Clinical-stage biotech developing immunotherapies (both active and passive) targeting proteinopathies including alpha-synuclein for Parkinson's and amyloid for Alzheimer's. Closely comparable therapeutic area focus and modality mix for neurodegenerative diseases.
• Vaxxinity: Clinical-stage biotechnology company developing synthetic peptide vaccines for chronic diseases including PCSK9 for hypercholesterolemia and alpha-synuclein for Parkinson's. The most directly comparable active-immunotherapy peer given shared target indications and peptide-vaccine modality.
• Immatics: Clinical-stage biopharmaceutical company developing peptide-based immunotherapies (TCR-based and adoptive cell therapy) targeting solid tumors and chronic diseases. Comparable peptide-platform technology focus and immunotherapy modality, though primarily oncology-oriented.
• AC Immune: Swiss clinical-stage biopharmaceutical company developing immunotherapies for neurodegenerative diseases including active vaccines targeting alpha-synuclein (acquired AFFiRiS' anti-aSyn programs in 2021). Directly comparable as a peer active-immunotherapy developer in Parkinson's and related neurodegenerative indications.

Broad incumbents

• Novavax: Established vaccine biotechnology company developing recombinant nanoparticle vaccines against infectious diseases. While focused on infectious disease rather than chronic disease, it represents a comparable recombinant-protein vaccine platform peer at much larger scale.
• Regeneron (PCSK9 franchise): Global biopharmaceutical company co-marketing Praluent, the second major PCSK9 monoclonal antibody. Represents a key established competitor in AFFiRiS' lead remaining therapeutic area of hypercholesterolemia.
• BioNTech: German biotechnology company developing mRNA-based immunotherapies for cancer and infectious diseases with growing chronic-disease pipeline. MIG Verwaltungs AG (AFFiRiS Chairman Michael Motschmann's firm) holds a BioNTech supervisory board seat, indicating shared investor ecosystem. Broadly comparable as an immunotherapy platform company.
• CureVac: European clinical-stage biopharmaceutical company developing mRNA-based vaccines and immunotherapies. Comparable as a German/European vaccine technology peer at larger scale, though focused on mRNA rather than peptide-based active immunotherapy.
• Amgen (PCSK9 franchise): Global biopharmaceutical company that markets Repatha, the leading PCSK9 monoclonal antibody for hypercholesterolemia. Represents the dominant incumbent competitor AFFiRiS' AT04 vaccine would face in the PCSK9 cardiovascular market.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xtwitter.com/AFFiRiSAG
• LinkedInlinkedin.com/company/affiris-ag

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds4 records

Investors4 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about AFFiRiS