Scandion Oncology receives approval for initiating the CORIST part 2 trial
Scandion Oncology A/S, the Cancer Drug Resistance Company, today announced that the company has obtained approval from the Danish Medicines Agency and the Ethics Com-mittee in Denmark of the amendment of part 2 of the CORIST Phase II study. This means that the company can commence the inclusion of patients. To increase the recruitment rate, Scandion Oncology is expanding the number of sites in Denmark from 2 to 5 and will further add additional sites in the EU.
“With this approval, we can now commence part 2 of this seminal study. This next step in our journey will target a clear proof-of-concept to create clarity in order to make a difference for patients and create value for our shareholders. To accelerate the recruitment rate, we are opening additional sites and expect a read-out in Q2-Q3, 2022. We will communicate more about our plans and strategy at our upcoming Capital Markets Day on September 8,” said Bo Rode Hansen, President and CEO of Scandion Oncology.
On June 24, Scandion Oncology reported positive results from the dose-finding part 1 of the CORIST Phase II study. A well tolerated dose of SCO-101 in combination with the chemotherapy regimen FOLFIRI was determined and the treatment resulted in notable potentiation of FOLFIRI. Scandion Oncology also identified the oncogene RAS as a predictive biomarker, which led the company to making an amendment to the clinical protocol, optimizing the inclusion of patients and de-risking the study.
The design for part 2 of the study (the proof-of-concept arm) is a standard single arm Phase II study with the aim of assessing preliminary effect and further evaluating safety and tolerability of SCO-101 in combination with FOLFIRI. The primary efficacy objective is assessment of response (tumor reduction) and secondary objectives include assessment of Clinical benefit (The duration of Stable Disease, Progression Free Survival (PFS), Overall Survival (OS)) as well as biomarker assessment and correlation to treatment tolerability and outcome. Part 2 of the CORIST Phase II study will include up to 25 patients.
For further information regarding Scandion Oncology, please contact:
Bo Rode Hansen, President & CEO
Phone: +45 3810 2017
This information is information that Scandion Oncology A/S is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on September 6, 2021, at 8:30 CET
Scandion Oncology A/S is a clinical Phase II biotechnology company currently developing first-in-class, oral add-on drugs to existing market leading anti-cancer therapies. As add-on to standard anti-cancer therapies, it introduces an effective treatment approach for cancer, which is or has become resistant to cancer-fighting drugs, offering the potential for better response rates, longer survival and improved quality of life. The first-in-class lead candidate, SCO-101, is currently in clinical Phase II. The Company is targeting cancer drug resistance in various treatment modalities including chemotherapy, anti-hormonal therapy and immunotherapy. Scandion Oncology is listed on Nasdaq First North Growth Market Sweden. Ticker: SCOL.
Västra Hamnen Corporate Finance is the Company's certified advisor on Nasdaq First North Growth Market and can be reached at email@example.com or +46 (0) 40 200 250.