Oncoinvent (ONCIN) Study Result summary

Background and Study Design

• Final data from a phase I/II-A open-label trial evaluated RadspherinⓇ (RadSpay) in colorectal cancer patients with peritoneal metastases post-surgery and HIPEC, enrolling 47 patients across Norway and Sweden, with 36 dosed at 7 MBq.

• The study included dose escalation and expansion cohorts at sites in Oslo and Uppsala.

• Primary endpoints were dosing, safety, tolerability, and efficacy signals for intraperitoneal RadspherinⓇ.

• Peritoneal metastases in colorectal cancer present a major challenge, with limited options beyond surgery and HIPEC.

• Ongoing clinical development includes a phase 2 trial in ovarian cancer, recruiting in Europe and the US.

Efficacy Results

• At 18 months, 27.8% of colorectal cancer patients at 7 MBq experienced peritoneal recurrence, compared to ~50% in historical controls.

• In ovarian cancer (N=10), 7 MBq Radspherin led to a 10% overall recurrence rate at 18 months, versus ~40% in historical controls.

• 61.1% of colorectal patients had any recurrence at 18 months, but only 22.7% had peritoneum as the first site.

• Data confirm a sustained and meaningful effect, strengthening the case for RadspherinⓇ in both indications.

• Principal investigators noted outcomes exceeded expectations and highlighted clinical promise.

Safety and Tolerability

• RadspherinⓇ demonstrated a favorable safety profile across all dose levels (N=47), with no dose-limiting toxicities, deaths, or serious toxicity reported.

• Only two adverse events were possibly related to RadspherinⓇ, with no unexpected or high-frequency events.

• Absorbed doses to other organs were well below toxicity thresholds, and radioactivity was retained in the peritoneal cavity with minimal systemic exposure.

• Hospital staff exposure to radioactivity was very low, requiring no special precautions.

• Safety for hospital staff was confirmed, with no need for special precautions.