maj 2, 2022
Ectin Research AB initiates collaboration with Simsen Diagnostics AB aiming to measure ctDNA (circulating tumor DNA) in patient samples
Ectin Research AB (”Ectin” or ”the Company”) today announces that it has entered into an agreement with Simsen Diagnostics AB to explore the possibility of measuring ctDNA (circulating tumor DNA) in patients during the clinical phase I part of the phase I / II study.
Ectin has previously announced that it plans to initiate its combined clinical phase I / II study of MFA-370 for the treatment of patients with metastatic urothelial bladder cancer. In the first part of the study (phase I) 10 patients will be treated with MFA-370, with an evaluation of safety and tolerability taking place after 6 weeks of treatment. If the results from the phase I study show that the treatment has an acceptable side-effect profile, phase II will be initiated provided that funding is obtained.
One of the exploratory efficacy measures planned for the clinical study will be measurements of ctDNA in patients’ blood. ctDNA can be analyzed in blood samples and is a measure of cancer cell death as this release very small amounts of ctDNA into the blood and other body fluids. ctDNA measurements can be used in several different applications – for example to analyze how effective a cancer treatment is, and to identify the recurrence of cancer and persistent cancer. Ectin now announces that it has entered into an agreement in which Simsen Diagnostics will handle the ctDNA analyses during the phase I part of the clinical phase I / II study, in order to exploratively try to identify whether the amount of ctDNA can be determined in patient samples, and whether there are signs that treatment with MFA-370 may have produced clinical effects. If the outcome is positive and the amount of ctDNA can be determined, or the results indicate that the treatment seems to correlate with a clinical effect, there is a possibility that the method can be used in future studies to monitor the treatment effect of MFA-370. In order to statistically ensure the clinical effect using ctDNA analyses, ctDNA studies will also need to be analyzed during the phase II part of the combined phase I / II study. This part of the study will focus on identifying the clinical effect of treatment with MFA-370 based on a number of different effect parameters and in a larger number of patients.
Analysis of the results of the ctDNA study from the phase I part of the clinical study is expected to take three months after the last patient has been treated, but the result will not determine whether the phase II part of the phase I / II study will be initiated, as the phase I part of the clinical study is designed and focused on safety and tolerability. The decision to initiate the phase II part could also be made before the ctDNA analyses have been fully analyzed and regardless of the results. However, the analysis results may determine the forms of any future ctDNA assays.
Ectin Research CEO, Anna Sjöblom-Hallén: ”We are very pleased to have entered into an agreement with Simsen Diagnostics for the research purpose of measuring ctDNA in patient samples during the phase I study. In the long run, this study may also allow for later development of companion diagnostics during treatment with MFA-370. Simsen Diagnostics is at the forefront of research using ultra-sensitive and easy-to-use DNA sequencing measurement methods, with the goal of improving our healthcare, and will therefore be an excellent partner for us moving forward.”
Simsen Diagnostics CEO, Gustav Johansson: ”By choosing Simsen Diagnostics to measure ctDNA, Ectin Research has a powerful biomarker to monitor the effectiveness of their treatment. Simsen Diagnostics’ groundbreaking technology enables you to create a personal test with incredibly high sensitivity and specificity based on the cancer’s unique fingerprint. We are delighted to work with Ectin Research and believe that this approach suits more innovative pharmaceutical companies.”