Scandion Oncology (SCOL) Study Result summary

CORIST part 2 results

• In 25 RAS wild-type patients treated with the part 1 dose, all had a CT scan after 8 weeks, as planned.

• The 7-day SCO-101 plus FOLFIRI schedule was feasible and safety was confirmed.

• Some tumor reductions were observed, but none reached the +30% threshold; no RECIST responses were seen at the planned 8-week assessment, so efficacy proof of concept was not reached.

• Some patients showed prolonged PFS and stable disease; safety, preliminary activity and pharmacokinetic evidence supported further study.

Study design and expansion

• CORIST is a phase II study with ORR by RECIST 1.1 as its primary endpoint; PFS and OS are secondary endpoints.

• The study added a 6-day SCO-101 plus FOLFIRI schedule, to be evaluated in patients with RAS wild-type and RAS-mutated mCRC.

• Part 3 will assess safety and tolerability in up to 36 patients, using up to six dose-escalation cohorts with a 3+3 design.

• Part 4 will assess preliminary activity in up to 24 patients receiving the optimal dose identified in part 3.

Planned updates

• Part 3 topline results were expected most likely in Q3 2023; a Q1 2023 update was planned on the completion timeline, subject to recruitment and toxicity.

• Part 3 results were to include the dose reached, safety, tolerability and any activity observed; an update on part 2 patients continuing treatment was also planned.

• Part 4 topline results were expected after all patients completed their first on-study CT scan at 8 weeks, potentially in H2 2023 or H1 2024; final study results were expected ~6 months later.