Oncorena

About Oncorena

Oncorena AB is a Swedish clinical-stage pharmaceutical company focused on developing a novel treatment for metastatic renal cancer. Founded in 2011 in Gothenburg, the company is built upon the pioneering research of Professor Börje Haraldsson and his team at the University of Gothenburg. Their work identified the powerful and kidney-specific anti-tumor properties of orellanine, a toxin found in the Cortinarius family of mushrooms. This discovery led to the establishment of Oncorena by Börje Haraldsson, Jenny Nyström, Ulf Nilsson, and Lisa Buvall, with initial support from GU Ventures, Vinnova, and private investors. Professor Haraldsson, a world leader in renal research with prior experience at Novartis, now serves as the company's CEO, guiding its clinical development.

The company's core asset is ONC175, a synthetically produced version of orellanine. This drug candidate operates through a unique mode of action, selectively targeting and killing kidney cancer cells, including those that have metastasized. Preclinical studies have shown that ONC175 can eliminate over 90% of viable tumor mass in animal models without causing off-target toxicity. The business model centers on the clinical development and eventual commercialization of ONC175. Oncorena's strategy has attracted significant investment from major European life science venture capital firms, including HealthCap, Linc AB, Fåhraeus Startup and Growth AB, and AQILION AB, to fund its progression through clinical trials.

Oncorena is targeting a significant unmet medical need, as metastatic kidney cancer has a poor prognosis and affects hundreds of thousands of patients globally. The initial patient population for ONC175 consists of individuals with metastatic renal cancer who are already on dialysis due to chronic kidney disease. This approach provides a high benefit-risk ratio, as these patients have no remaining kidney function to lose but are in urgent need of effective therapies. In September 2023, the company announced the successful treatment of the first patient in its Phase I/II clinical trial, named Oncorella-1, at Karolinska University Hospital in Sweden. Subsequently, in March 2025, Oncorena received FDA approval to expand this trial to the US, with plans to enroll up to 75 patients across sites including the MD Anderson Cancer Center. The study is designed to evaluate the safety, tolerability, and anti-tumor efficacy of ONC175, with completion expected around August 2025.