Oncorena receives regulatory approval in France and Portugal to initiate the Oncorella-1 clinical study

2026-03-04

Oncorena is pleased to announce that French and Portuguese regulatory authorities have granted approval to expand the Company’s Phase I/II clinical study, Oncorella-1 (NCT05287945; ONC001-CL-001), to France and Portugal.

Oncorella-1 is an open-label, single-arm study evaluating the safety, tolerability, and anti-tumor activity of Oncorena’s drug candidate ONC175 (orellanine) in patients with metastatic clear-cell or papillary renal cell carcinoma who are dependent on chronic dialysis.

The study is currently ongoing at Karolinska University Hospital (Stockholm, Sweden) and The University of Texas MD Anderson Cancer Center (Houston, Texas, USA). The expansion to France and Portugal marks an important step in increasing access to the study for a patient population with significant unmet medical need.

Börje Haraldsson, CEO and Co-founder of Oncorena, comments:

“Regulatory approvals in France and Portugal represent an important milestone for Oncorena and, most importantly, for patients with metastatic renal cell carcinoma who depend on chronic dialysis and have very limited treatment options. By expanding Oncorella-1 to additional European countries, we aim to improve patient access to the study and accelerate the generation of clinical data for ONC175 as a potential new treatment option for this underserved population.”

For more information, please contact
Börje Haraldsson, M.D., Ph.D., CEO, and CSO Oncorena AB
E-mail: borje.haraldsson@oncorena.com
Phone: +46 70 267 9544

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About ONC175
ONC175 is an investigational drug product under development that contains synthetically produced orellanine as active ingredient. Orellanine is highly specific to the kidney and induces irreversible renal failure. It is clinically well-known that orellanine does not affect organs other than the kidneys.
In pioneering preclinical studies ONC175 demonstrated a powerful and highly organ-specific mode of action capable of eradicating human metastatic renal cancer cells. The primary goal is to develop ONC175 as a potential curative treatment of metastatic renal cell carcinoma in patients with no remaining kidney function, i.e., patients on dialysis.

About kidney cancer
Approximately 400,000 patients are diagnosed with kidney cancer globally every year according to the WHO. The disease can often be cured by surgery if detected early, but the prognosis is less favorable if there are metastases. Today, the disease is treated with various types of targeted and immuno-active drugs, that seldom are curative. There is therefore a great and urgent unmet medical need for new, effective and safe drugs.

About Oncorena
Oncorena AB is a Swedish pharmaceutical company headquartered in Lund. The company develops a new potential breakthrough treatment for patients with metastatic renal cancer. The treatment is based on research led by professor Börje Haraldsson at the University of Gothenburg, Sweden. The project was initially developed with support from Vinnova, Sweden’s Innovation Agency, GU Ventures at the University of Gothenburg and private business angels. Today Oncorena is financed by the investment companies HealthCap, Linc AB and Fåhraeus Startup and Growth AB. For more information, please visit Oncorena’s website at www.oncorena.com