Scandion Oncology (Scandion) announced updated positive interim results from Part 3 - the last part of the ongoing CORIST Phase IIa trial. Optimized dosing schedules were explored and caused the expected changes in exposure to SCO-101 and the chemotherapy. A novel potential biomarker - the UGT1A1 genotype - was positively associated to longer progression free survival (PFS) and overall survival (OS).

The promising safety and efficacy results were observed in heavily pretreated patients, showcasing the potential of SCO-101 to enhance treatment outcome. The updated Part 3 interim data confirm the rationale for the optimized dosing schedule in terms of pharmacokinetic data, biomarker potential, early signs of efficacy and interim OS data. Early signs of efficacy have been reported in terms of long Progression Free Survival (PFS), Clinical Benefit Rate and partial tumor responses in two patients.

In alignment with the Part 2 data, a low Bilirubin Index (BI) was also in Part 3 found to be clearly associated to increased PFS and improved OS with 6 of 9 patients still alive in the "low BI" group. The UGT1A1 genotype was investigated and patients with UGT1A1 wildtype had both longer PFS and OS than patients with mutated UGT1A1. Noteworthy, in the UGT1A1 wildtype patients the current mPFS is 7.04 months and the mOS is 13.74 months.

These interim data are very promising, and final data are expected in second half 2024. The optimized dosing schedules resulted in the expected changes in PK and data demonstrated a slight decrease (app. 20%) in the maximum peak value (Cmax) of the active chemotherapy (SN-38) and an increase in the maximum peak value of SCO-101.

The overall exposure to SN-38 and SCO-101 remained largely unchanged compared to CORIST Part 1. Additionally, SCO-101 caused a clear increase in the plasma levels of SN-38, caused a 5-fold shift in the ratio between active SN-38 and inactive SN-38 and an increase in unconjugated bilirubin. This is in full alignment with the PK data from CORIST Part 1. The updated data is planned to be further explored by increasing the irinotecan component of FOLFIRI in a 4-days schedule with 250 mg SCO-101 to establish the MTD in this schedule and to define the Recommended Phase 2 Dose (RP2D) for the subsequent randomized Phase IIb study. The topline data for mPFS included censored patients and was reported to 4.6 months.

Un-censoring changed the mPFS to a final value of 3.8 months for the 21 evaluable patients.