On October 10, 2022 Scandion Oncology (Scandion), a biotech company developing first-in-class medicines aimed at treating cancer which is resistant to current treatment options, reported that it 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) (Press release, Scandion Oncology, OCT 10, 2022, View Source,c3645573 [SID1234621863]). 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.
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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.