Oncoinvent (ONCIN) 7th Targeted Radiopharmaceuticals Summit Europe presentation summary

Transforming cancer care through direct alpha therapy

• Focus on direct alpha therapy using 224Ra-labelled microparticles (RadspherinⓇ) for peritoneal carcinomatosis, especially ovarian and colorectal cancers.

• RadspherinⓇ delivers alpha-emitting radiation directly to the peritoneum, maximizing tumor exposure and minimizing systemic toxicity.

• The approach bypasses biological targeting, retaining the radioactive payload at the tumor site and reducing exposure to sensitive organs.

• RadspherinⓇ is in Phase 2 for ovarian cancer, with promising efficacy signals and a strong safety profile.

• High unmet need exists for local control of peritoneal metastases, with limited competition in this space.

Clinical development and results

• Phase 1/2a studies in ovarian and colorectal cancer show reduced peritoneal recurrence rates compared to historical controls.

• In ovarian cancer, 10% peritoneal recurrence at 24 months vs. ~55-60% in historical controls; recurrences mainly in lymph nodes.

• In colorectal cancer, 28% peritoneal recurrence at 18 months vs. 50% in historical controls.

• Both studies confirm strong safety: no dose-limiting toxicity, low systemic exposure, and minimal risk to hospital staff.

• Phase 2 ovarian cancer trial is enrolling, with interim and final results expected through 2028.

Product and manufacturing

• RadspherinⓇ combines 224Ra with CaCO3 microparticles, offering a depot effect with 75% of the dose delivered in the first week.

• Shelf life of 8 days enables centralized manufacturing and distribution.

• In-house GMP pilot plant produces ~200 doses annually, with plans for outsourcing and scale-up for Phase 3.

• Production process involves elution of 224Ra from a 228Th generator and labeling to CaCO3 microparticles.