The first phase 2 study with SCO-101 in combination with chemotherapy: Scandion Oncology has previously announced that all necessary permissions to initiate the clinical phase 2 study with SCO-101 in patients with chemotherapy resistant colorectal cancer were obtained late 2019. In addition, we have signed contracts with Herlev Hospital in Copenhagen and TFS International who will be our Clinical Research Organization (CRO) for the study. When the first three patients have been treated at Herlev Hospital, the Department of Oncology, then University Hospital in Aalborg, Denmark, will join the study. When we reach the second part of the study (see below) we will include additional Danish Oncology Departments in order to ensure a fast and smooth recruitment.
According to the approved clinical protocol, we enroll metastatic colorectal cancer patients who, after an initial response to the chemotherapy combination FOLFIRI, have developed resistance to this treatment as evidenced by regrowth of the cancer (relapse). The study consists of two parts. The first part is a dose-escalation study with a fixed dose of FOLFIRI plus increasing doses of SCO-101 aiming to define the maximal tolerable dose (MTD) of SCO-101 in combination with FOLFIRI. We expect to finalize this first part of the study by Q2, 2020. The second part of the study has the primary goal to determine patient benefit from the combination treatment. We expect to have this second part finalized late Q4, 2020 and a final report issued Q1, 2021.
We have agreed with the clinical investigators that we will follow normal practice in communication about clinical drug studies. This means that there will be a first press release when the first patient has been treated for 8 weeks where a new evaluation of the cancer disease will be performed. The primary end-points are safety, toxicity and efficacy. The trial is being registered at ClinTrials.gov.
Preparing for the next phase 2 study: We have started to design the protocol and associated documents on our second clinical phase 2 trial. In this second trial we will enroll patients with metastatic pancreatic cancer who are scheduled to receive first line standard treatment with taxane containing chemotherapy. The plan is to randomize the patients between standard chemotherapy versus standard chemotherapy combined with SCO-101. The main goal of this study is to investigate if we can delay the appearance of drug resistant relapse. We see this study as a stepping stone towards moving SCO-101 treatment forward to adjuvant or neo-adjuvant treatment of cancer where the aim of combining standard chemotherapy with SCO-101 is to cure the patients from their cancer disease. Since taxanes are widely used in oncology, this second study will also open the possibility to test SCO-101 in combination with taxanes in other cancer forms, e.g. breast cancer, lung cancer etc. We expect to file the documents to the Danish Medicines Agency and Ethical Committee in Q2, 2020. This study has been discussed with our clinical partners who have expressed significant interest in the study. Pancreatic cancer patients have a very poor prognosis due to development of drug resistance, so SCO-101 could represent a game changer for the future treatment of this disease.
Biomarkers as a handle to identify patients that will benefit from SCO-101: In parallel to performing the clinical trials, Scandion Oncology is developing predictive biomarkers. These biomarkers will initially be used to perform a post-treatment association analysis where we compare biomarker levels with clinical benefit from the treatment. Secondly, when validated, the biomarkers can be used in subsequent studies as one of the inclusion criteria. Thus, we expect in the future to be able only to recruit patients who will benefit from SCO-101 combined with the standard treatment.
Scandion Oncology is now at a very important time point regarding its drug development. In 2020 we will have the very first Proof of Concept clinical data on the efficacy of SCO-101 to block/circumvent cancer drug resistance. At present there are no other registered drugs to be used to target drug resistance mechanisms. With positive data from our clinical phase 2 studies, 2020/2021 will be the time where Scandion Oncology together with partners could advance SCO-101 towards treatment of drug resistance cancer and thereby save or prolong life of millions of future cancer patients.
We are now looking forward to issuing the first press release describing the results from the clinical phase 2 study.
For further information regarding Scandion Oncology, please contact:
Nils Brünner, CEO
Phone: +45 26 14 47 08
Scandion Oncology A/S is a biotechnology company addressing and tackling one of the greatest challenges in modern oncology – the effective treatment of drug resistant cancers which has developed resistance to a previously prescribed cancer-fighting drug. In preclinical in vitro-studies SCO-101 restores chemotherapy sensitivity in resistant cancer cells. Moreover, in animal studies, the company’s leading candidate drug, SCO-101, significantly enhances the efficacy of certain standard cancer treatments when given in combination. Scandion Oncology is now initiating clinical phase II trials with its lead compound, SCO-101 in patients with drug resistant cancer. Scandion Oncology was listed on Spotlight Stock Market, Sweden in November 2018.