Simsen Diagnostics’ technology to measure patient-specific tumor DNA in blood used in Oncorena’s Phase I-II clinical trial 

Gothenburg 2022-12-06

Simsen Diagnostics AB and Oncorena AB have entered into an agreement, where Simsen Diagnostics will measure circulating tumor DNA in Oncorena’s clinical phase I-II kidney cancer study. Simsen Diagnostics will design individualized tests that follow a unique mutation signature in each patient. The method is up to ten times more sensitive than conventional techniques for measuring tumor DNA in blood, which contributes to better monitoring of the treatment effect.

Oncorena is developing a potentially breakthrough treatment for patients with advanced kidney cancer. The drug candidate orellanine, which has a unique mechanism of action, is being developed for organ-specific chemotherapy with potential curative benefits for patients with advanced kidney cancer undergoing dialysis due to kidney failure. The drug candidate’s potential will now also be evaluated by measuring changes in the level of circulating tumor DNA in the patient’s blood. Recruitment of patients is ongoing and currently patients from Sweden, Denmark, Finland, Norway and Germany can participate in the study. The Phase I-II study will include up to 40 patients and will initially test Simsen Diagnostics’ method on a small number of patients. To reach the highest sensitivity, the test that measures tumor DNA in the blood is individualized. In short, the test is based on tumor tissue from the patient, which is examined using a less sensitive method. Based on the results, 15-30 different changes in the tumor are selected and a test is developed that only follows these, but with much higher sensitivity and in the blood instead of the tissue.

 “Personalized tests are much more sensitive and specific compared to alternative methods of measuring tumor burden in blood. This creates a better test and makes it possible to follow tumor changes over time. The result can be very useful in drug development”

Gustav Johansson – CEO Simsen Diagnostics

The FDA has described that they have recommended measurement of circulating tumor DNA in early drug development. Simsen Diagnostics’ assessment is that in the future there may be a possibility that even patients in health care are followed with a personalized test. Already today, many patients’ DNA is sequenced with broad methods and with the help of these results it would be possible to create patient-specific tests, which could lead to earlier detection of relapses and new ways of guiding treatment.

About Simsen Diagnostics

Simsen Diagnostics develops ultra-sensitive and easy-to-use technologies for reading DNA sequences. The company currently has customers in the pharmaceutical industry, where they provide a service for measuring cancer DNA in blood samples in clinical studies. The technology has a wide range of applications outside the field of cancer. The company is based at Sahlgrenska Science Park in Gothenburg and is founded on innovation from Anders Ståhlberg’s group at Sahlgrenska Academy. For more information visit Simsen Diagnostics website www.simsendiagnostics.com

About Oncorena

Oncorena AB is a Swedish pharmaceutical company headquartered in Lund. The company is developing a new and potentially groundbreaking treatment for patients with advanced kidney cancer based on research at the University of Gothenburg led by Professors Börje Haraldsson and Jenny Nyström. The project was initially developed with support from Sweden’s innovation agency Vinnova, GU Ventures at the University of Gothenburg and private business angels. Today, Oncorena is mainly financed by the investment companies HealthCap, Linc AB, Fåhraeus Startup and Growth AB, and the biotech company AQILION AB. For more information, visit the Oncorena website www.oncorena.com

Simsen Diagnostics will measure patient-specific tumor DNA in blood in Oncorena’s Phase I-II clinical trial  [1] 

Simsen Diagnostics AB and Oncorena AB have entered into an agreement whereby Simsen Diagnostics will be commissioned to measure circulating tumor DNA in Oncorena’s Phase I-II renal cancer clinical trial. Simsen Diagnostics will design customized tests that follow a unique mutation signature in each patient. The method is up to ten times more sensitive than conventional techniques to measure tumor DNA in blood, which contributes to better monitoring of treatment efficacy.

Oncorena is developing a potentially groundbreaking treatment for patients with advanced kidney cancer. The drug candidate orellanin, which has a unique mechanism of action, is being developed for organ-specific chemotherapy with potential curative benefits for patients with advanced kidney cancer undergoing dialysis due to renal failure. The drug candidate will now be evaluated by measuring changes in the level of circulating tumor DNA in the patient’s blood. Patient recruitment is ongoing; currently, patients from Sweden, Denmark, Finland, Norway and Germany can participate in the study. The Phase I-II study will include up to 40 patients, and initially, Simsen Diagnostics’ approach will be tested on a small number of patients. To achieve the highest sensitivity, the test, which measures tumor DNA in the blood, will be individualized. In brief, the test is based on tumor tissue from the patient, which is examined using a less sensitive method. Based on the results, 15-30 different changes in the tumor are selected and a test is developed that only follows these changes, but with much higher sensitivity and in the blood instead of the tissue.

 “Personalized tests are much more sensitive and specific than alternative methods of measuring tumor burden in blood. It delivers patient specific results which allows us to track tumor change over time. The results can be beneficial in drug development,” says Gustav Johansson, CEO of Simsen Diagnostics.

The FDA has described that they recommended the measurement of circulating tumor DNA in early drug development. Simsen Diagnostics’ believes that in the future, there may be a possibility that also patients in healthcare are followed with a personalized test. Already today, many patients’ DNA is sequenced using broad methods. Using these results, it would be possible to create patient-specific tests, which could lead to earlier detection of relapses and guide treatment in new ways.

About Simsen Diagnostics

Simsen Diagnostics develops ultra-sensitive and easy-to-use technologies to read DNA sequences. The company currently has customers in the pharmaceutical industry, where it provides a service to measure cancer DNA in blood samples in clinical trials. The technology has a wide range of applications outside the cancer field. The company is based at the Sahlgrenska Science Park in Gothenburg and was founded on innovation from Anders Ståhlberg’s group at the Sahlgrenska Academy. For more information, visit the Simsen Diagnostics website www.simsendiagnostics.com

About Oncorena

Oncorena AB is a Swedish pharmaceutical company headquartered in Lund, Sweden. The company is developing new and potentially groundbreaking treatments for patients with advanced kidney cancer based on research at the University of Gothenburg led by Professors Börje Haraldsson and Jenny Nyström. The project was initially developed with support from the Swedish Innovation Agency Vinnova, GU Ventures at the University of Gothenburg and private business angels. Today, Oncorena is mainly funded by the investment companies HealthCap, Linc AB, Fåhraeus Startup and Growth AB, and the biotechnology company AQILION AB. For more information, please visit Oncorena’s website www.oncorena.com

Pontus Rehn

Chief Executive Officer (CEO)

Pontus Rehn has over 20 years of experience in commercial leadership roles in the medical device and IVD industries, including global and regional positions like VP Market Development, Chief Commercial Officer, and Director of Commercial Strategy. 

Lina Said

Laboratory and Quality Manager

Lina Said, a licensed Biomedical Scientist, brings 18 years of experience from Sahlgrenska University Hospital to her role as the Lab and Quality Manager at Simsen Diagnostics. Her primary focus is ensuring quality assurance and fostering an optimal work environment for the lab. 

My Vu

Lead Laboratory Technician

My Vu is currently doing a master’s degree in biotechnology and demonstrates expertise in laboratory procedures. Her previous experience includes analyzing COVID samples and conducting her bachelor’s thesis at Fraunhofer. My is analyzing all the samples that comes to the lab.  

Stefan Filges

Chief Technology Officer (CTO)

Stefan Filges, an accomplished bioinformatician with a Ph.D. in ultrasensitive sequencing, became part of Simsen Diagnostics in 2022. He played a crucial role as a co-author in the original publication of SiMSen-Seq, which was published in Nature Protocols. 

Camilla Hietanen

Head of Sales and Marketing

Camilla Hietanen holds an M.Sc. in Business Development from the Chalmers School of Entrepreneurship. Her academic background encompasses studies in Sports & Nutrition, and she brings prior experience from various Start-ups. Within Simsen Diagnostics, her primary focus lies in Sales and Marketing. 

Almost there

Sign up on our maillist to gain access to your article. You can at any time unsubscribe from the list.