Scandion Oncology (Scandion) announced positive topline results from the ongoing Part 3 of the CORIST phase IIa colorectal cancer trial with Scandion's lead compound SCO-101. A preliminary analysis of the study data shows tumor reduction supporting combination with chemotherapy, substantially increased Progression Free Survival, high Clinical Benefit Rate and consistent safety and tolerability. The results confirm previous data reported in Part 1 and 2 of the trial and support continued clinical development of SCO-101.

Preparations for a planned CORIST next step is ongoing. The CORIST Part 3 trial evaluates Scandion's lead compound SCO-101 as a combination treatment with FOLFIRI chemotherapy in 25 patients with metastatic colorectal cancer (mCRC) and previously demonstrated resistance to FOLFIRI. The 25 enrolled patients were heavily pretreated and no other active treatment options were available.

Part 3 of the trial is designed to provide an optimized dose and schedule for SCO-101 and chemotherapy to ensure maximum effect in patients with mCRC. Partial Responses (PR) In one of the trial cohorts, one of the six total patients had a PR, i.e. tumor reduction of more than 30%, which is considered an important measurement of the effect of cancer treatments. This cohort utilized a four-day dosing schedule.

This response support the concept of combining SCO-101 with chemotherapy. In the entire trial (which included 21 evaluable patients divided into four cohorts) tumor reductions were observed in a substantial number of patients. Progression Free Survival (PFS) In CORIST Part 3, a long PFS was observed and the median PFS was 4.6 months.

In CORIST Part 2, the median PFS was 2.0 months and historical data has been reported in the range of 1.7-1.8 months. In one cohort in CORIST Part 3 the median PFS was as high as 5.0 months. Clinical Benefit Rate (CBR) Amongst the 21 evaluable patients in CORIST Part 3, there was a high CBR observed.

In the cohort where the MTD was established, it saw a CBR of 100% after eight weeks. Overall, the CBR was 76% at week eight. The overall CBR observed in CORIST Part 3 exceeds the CBR in CORIST Part 2 of 46%.

Historical controls where CBR was evaluated after 6 weeks have been reported to be 11-16%. The PR, long PFS and high CBR seen in CORIST Part 3 suggests that the tested dosing regiments will also lead to improvements in Overall Survival (OS), which will be evaluated when the trial is concluded. Patients in CORIST Part 2 had median OS of 10.4 months while historical data for placebo or best supportive care have been reported in the range of 5-7 months.

Maximum Tolerated Dose (MTD) CORIST Part 3 was designed to establish the optimal dosing schedule and MTD for SCO-101 in combination with FOLFIRI. The trial's four dosing schedules aimed at optimizing the drug exposure in patients to enhance the effect of the treatment were based on learnings from CORIST Part 1 and 2. The MTD of SCO-101 was established at 150mg administered in a six-day schedule. This mirrors the maximum dose in CORIST Part 2; however, in Part 3 the chemotherapy was given earlier and in a different concentration, with 5FU, a part of FOLFIRI, increased to 100% as compared to 50% in Part 2. CORIST Part 3 also confirmed the findings from CORIST Part 2 of unconjugated bilirubin as a potential biomarker for patients most likely to benefit from treatment with SCO-101.

Overall, the treatment was safe and well tolerated. Scandion will conduct a thorough analysis of the complete dataset from CORIST Part 3 once the trial has concluded, and based on this analysis, determine next steps in clinical development.