Oncorena initiates Phase I-II clinical trial with orellanine in patients with advanced kidney cancer at Karolinska University Hospital in Sweden

LUND, Sweden, February 1, 2022 /PRNewswire/ — Oncorena today announced the initiation of the Phase I-II clinical trial of the first-in-class compound orellanine in patients with advanced kidney cancer on dialysis. The company is dedicated to developing a unique and potential breakthrough therapy for advanced kidney cancer.

The drug candidate orellanine, which has a unique mode of action, is being developed for organ-specific chemotherapy with curative potential for patients with advanced kidney cancer undergoing dialysis due to renal failure . Preclinical evidence shows that orellanine specifically exerts potent anti-tumor effects on metastatic kidney cancer in different preclinical models.

The phase I-II clinical study will include up to 40 patients and may include patients from other European countries. The clinical trial is being conducted in collaboration with the Center for Clinical Cancer Studies at Karolinska University Hospital in Stockholm, Sweden. As patients are dependent on dialysis, hemodialysis is provided in collaboration with a team from the dialysis unit of Karolinska Hospital. The study is coordinated with a clinical research organization specializing in clinical trials in oncology.

“There is a great medical need for improved treatment options in patients with advanced kidney cancer on dialysis. We look forward to the important phase of clinical development in this therapeutic area. We hope that the results of our clinical study will be of great benefit to patients in the future,” said Lars Grundemar, President and CEO of Oncorena.

This release discusses experimental uses of an agent under development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any experimental use of such a product will successfully complete clinical development or obtain approval from health authorities.

For more information, please contact

Lars Grundemar, MD, Ph.D., Chief Executive Officer, Oncorena AB

Email: [email protected]

Telephone +46 (0)76 209 5518

About the Phase I-II clinical trial

In 2021, the Swedish Medical Products Agency approved Oncorena’s first clinical trial of orellanine in patients with advanced kidney cancer on dialysis. The Phase I-II clinical trial of orellanine is enrolling patients with advanced kidney cancer who are already on dialysis due to kidney failure. The study is being conducted at the Center for Clinical Cancer Studies at Karolinska University Hospital in Stockholm, Swedenand will study the safety, tolerability, pharmacokinetics and evidence of anti-tumor effects in treatment with a synthetic form of orellanine.

About orellanine

Orellanine, which has a new and unique mode of action, is being developed for organ-specific chemotherapy with curative potential for patients with advanced kidney cancer on dialysis. Orellanine is found in the mushrooms of Cortinaire family, these are sometimes accidentally picked and eaten because they are mistaken for funnel-shaped chanterelles. The clinical effects of orellanine are well documented and are completely limited to the kidneys. Orellanine is expected to have a positive effect on the two most common forms of kidney cancer: clear cell and papillary kidney cancer. About 90% of kidney cancer patients are affected by these types of cancer.

About Kidney Cancer

Approximately 400,000 patients are affected by kidney cancer worldwide according to the WHO. The disease can often be cured by surgery if detected in time, but unfortunately the diagnosis is often made when the tumor has already spread to other organs. The prognosis is then much less favorable and some groups have a median survival of less than two years. Today, the disease is treated with various types of targeted and immunoactive drugs, often with serious side effects, and standard chemotherapy drugs have limited effect. There is therefore a high 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 is developing a potential breakthrough new treatment for patients with advanced kidney cancer. The treatment is based on research at the University of Gothenburg, Sweden, led by Professors Börje Haraldsson and Jenny Nyström. The project was initially developed with the support of Vinnova, Sweden Innovation Agency, GU Ventures at the University of Gothenburg and private business angels. Today, Oncorena is mainly funded by investment companies HealthCap, Linc AB, Fåhraeus Startup and Growth AB, as well as biotech company AQILION AB. For more information, please visit the Oncorena website at www.oncorena.com

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SOURCEOncorena AB

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