Scandion Oncology (Scandion), a biotech company developing first-in-class medicines aimed at treating cancer which is resistant to current treatment options, has as planned initiated part 3 of the CORIST phase II trial studying Scandion’s lead compound SCO-101 as a combination treatment in patients with metastatic colorectal cancer (mCRC). The first of up to 36 patients has been enrolled as the development of SCO-101 seamlessly continues with the momentum from the ongoing part 2 of the trial maintained.

CORIST part 3 expands the development program to best exploit SCO-101’s potential in mCRC, adding a new schedule for combining SCO-101 and chemotherapy (FOLFIRI), which will be evaluated in patients with both RAS wild-type and RAS mutated tumors. Part 2 of the trial only includes patients with RAS wild-type tumors.

The new optimized dosing schedule for CORIST part 3 is based on evidence about safety and pharmacokinetics gathered so far from part 2 of the trial. This schedule is expected to provide a potentially improved modality for combining SCO-101 and FOLFIRI.

“We are pleased to initiate part 3 of CORIST in accordance with our plans and communicated timeline. SCO-101 has potential to improve treatment options in mCRC and we are excited to continue the work to best harness this potential to the benefits of patients, health care professionals and Scandion”, says Johnny Stilou, acting Chief Executive Officer of Scandion.

New administration schedule

CORIST part 3 will evaluate the safety and tolerability of SCO-101 in combination with FOLFIRI when administered once daily on day 1 to day 6 and FOLFIRI administered on day 2 to day 4 of each treatment cycle. Based on pharmacokinetics and pharmacodynamics data this new schedule is expected to be better both in term of efficacy and tolerability.

CORIST part 3 is planned to include up to 36 patients, however the number of patients will vary according to the observed tolerance. Topline results from CORIST part 3 are currently expected in the third quarter of 2023, but timelines may change depending on number of patients enrolled.

Following completion of part 3, Scandion expects to expand the CORIST trial with a part 4. Here, up to 24 patients will be enrolled to assess the preliminary activity of SCO-101 in combination with FOLFIRI administered at the optimal dose found in part 3. After completion of part 4, the overall study results will be analyzed to choose the best schedule and the appropriate patient population for further development of SCO-101 in mCRC.

For further information please contact:

Mads Kronborg, Head of External Communication

Phone: +45 6051 4955

Email: ir@scandiononcology.com

The information was provided by the contact person above for publication on October 10, 2022, at 17.00 CET.

Scandion Oncology (Scandion), the Cancer Drug Resistance Company, discovers and develops first-in-class medicines aimed at treating cancer which is resistant to current treatment options. We are at the forefront of this field, developing novel medicines that address cancer’s resistance against treatment. Our aim is to make existing cancer treatments work better and longer, thereby potentially prolonging and improving the life of patients who would otherwise have a high risk of dying from their cancer.

Globally, close to 10 million patients die every year from cancer and approximately 90 percent of all cancer related deaths are related to cancer drug resistance. Our medicines could be relevant in several cancers and makes both our medical and commercial potential significant.

Scandion is based in Copenhagen and its lead candidate, SCO-101, is currently being studied in clinical phase I and II trials. The company 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 ca@vhcorp.se or +46 (0) 40 200 250.