Aurealis Therapeutics

Aurealis Therapeutics is a clinical-stage synthetic biology company with dual headquarters in Switzerland and Finland, focused on developing cell and gene therapies for chronic wounds, cancer, and inflammatory diseases. Founded in 2010 by Dr. Thomas Wirth, who serves as the Chief Scientific Officer, the company leverages its expertise in drug development and cell and gene therapies, with deep roots in the research community of Kuopio, Finland. The management team includes CEO Juha Yrjänheikki and COO Laurent Décory. The company's business model is typical of a biotech firm, aiming to develop products through clinical trials and then partner, license, or sell them to larger pharmaceutical companies for commercialization. To date, Aurealis has raised a total of $22 million over six funding rounds from investors including Tesi, Business Finland, and Lynx Financial.

The company's core technology platform utilizes a non-pathogenic, food-grade lactic acid bacteria (Lactococcus cremoris) that is genetically engineered to function as millions of microscopic bioreactors directly at the disease site. These bacteria are designed to produce and release multiple human therapeutic proteins, such as growth factors and cytokines, to modulate the body's immune response and promote healing. This approach allows for the creation of multi-target therapies within a single product. The company's lead product candidate, AUP-16, is a topical treatment for chronic wounds like Diabetic Foot Ulcers (DFU). It delivers three human therapeutic proteins to reduce inflammation, promote the formation of new blood vessels, and encourage tissue growth. In a Phase 1 clinical study for DFUs, 83% of patients receiving the therapeutic dose achieved complete wound healing. The European Medicines Agency (EMA) has granted AUP-16 PRIME designation, providing enhanced regulatory support. Following successful Phase 1 trials, AUP-16 has advanced to Phase 2 clinical studies across multiple countries. Aurealis is also developing AUP-55, an oncology candidate targeting cancers such as ovarian and peritoneal carcinomatosis.

Aurealis Therapeutics operates in the advanced wound care and oncology markets, addressing significant unmet medical needs. The company collaborates with strategic partners, such as Xbiome, Lynx Financial, and Huahai Pharma in China, to advance its clinical trials and explore market entry. By focusing on diseases that are complex and multi-factorial, Aurealis aims to provide curative treatments that go beyond simply managing symptoms. The company outsources its manufacturing and laboratory operations but is considering establishing its own manufacturing facilities in Kuopio.

Keywords: cell therapy, gene therapy, synthetic biology, chronic wounds, diabetic foot ulcer, oncology, Lactococcus cremoris, AUP-16, therapeutic proteins, bioreactors, clinical-stage, biopharmaceutical, regenerative medicine, immunotherapy, inflammatory diseases, venous leg ulcer, pressure ulcer, ovarian cancer, peritoneal carcinomatosis, Thomas Wirth, Juha Yrjänheikki