AFFiRiS

About AFFiRiS

Founded in November 2003 by Dr. Walter Schmidt and Dr. Frank Mattner, AFFiRiS AG is a clinical-stage biotechnology company located in Vienna, Austria, that is focused on developing immunotherapies for chronic diseases. The founders, both with a background in scientific research and biotech entrepreneurship, established the company with the vision of using the body's immune system to fight the root causes of neurodegenerative diseases, moving beyond simple symptom management. Schmidt, for instance, previously co-founded InterCell AG, leveraging his experience in developing a peptide-based vaccine technology.

The core of the company's work is its proprietary and patented AFFITOME® technology platform. This technology is used to develop Specific Active Immunotherapies (SAIT), which are designed to stimulate the patient's immune system to produce antibodies against the specific harmful proteins that drive the progression of chronic illnesses. The process involves identifying key protein sequences (epitopes) and then creating synthetic mimics called AFFITOPEs®. These are administered via subcutaneous injection, prompting a targeted and long-lasting immune response. This approach is intended to allow for less frequent dosing, such as quarterly or twice-yearly.

AFFiRiS operates in the biopharmaceutical market, specifically targeting unmet medical needs in neurodegenerative and cardiometabolic diseases. Its business model revolves around the research and development of its immunotherapy candidates, with a strategy that includes forming strategic partnerships and licensing agreements with larger pharmaceutical companies to fund and advance its clinical pipeline. A notable milestone was the 2021 asset purchase agreement with AC Immune, which acquired AFFiRiS's portfolio of therapies targeting alpha-synuclein for neurodegenerative diseases in an all-stock transaction valued at $58.7 million. Another key deal was a 2021 licensing agreement with Frontier Biotechnologies to develop and commercialize an immunotherapy for hypercholesterolemia in Greater China, which included an upfront payment, milestone eligibility, and royalties.

The company's product pipeline has included candidates for a range of diseases such as Parkinson's Disease, multiple system atrophy (MSA), dementia with Lewy bodies (DLB), Huntington's disease, and hypercholesterolemia. Its lead candidate for Parkinson's, AFFITOPE® PD01, has completed Phase 1 trials, demonstrating it was well-tolerated and induced a durable immune response. This work has attracted support from organizations like The Michael J. Fox Foundation, which provided a $1.5 million grant for a Phase 1 trial. Following the sale of its alpha-synuclein programs, AFFiRiS has shifted its focus to developing its candidates for cardiovascular diseases and Huntington's disease through partnerships.