Oncoinvent (ONCIN) Aktiespararna Digital temakväll - Life Science summary

Radspherin and treatment approach

• Radspherin uses radium-224 on calcium carbonate microparticles, injected into the abdominal cavity after surgery to target residual peritoneal cancer while limiting systemic exposure.

• Microparticles remain in the cavity; the 3.6-day half-life releases 75% of radioactivity in the first week, with meaningful activity for 2–3 weeks after treatment.

• Alpha particles travel ~0.1 mm, or 2–10 cell diameters; the short range is intended to kill nearby cancer cells while sparing underlying organs.

• Initial development is focused on ovarian cancer; the mechanism may apply to other cancers affecting the peritoneum, including colorectal and gastric cancer.

Clinical progress and safety

• Phase I ovarian cancer data showed recurrence in 30% of 10 patients versus a literature expectation of 55%–60% at 2 years; only one recurrence was peritoneal, a positive but small-trial signal.

• In the colorectal trial, the speaker described 18-month peritoneal recurrence results as encouraging; together, the two early trials supported advancing ovarian cancer development.

• Across the first 68 patients in the phase I program, there were no dose-limiting toxicities; three serious adverse events were considered possibly related, with one involving a catheter falling out.

• A randomized phase II ovarian cancer trial has enrolled about two-thirds of its more than 100-patient target; a safety interim review of 70–80 patients was planned before Christmas 2026.

• An efficacy interim analysis is planned for April 2027, near expected full recruitment; a second interim analysis is expected nine months later. If results are good, phase III could start as early as 2027, targeting submission in 2030.

Market opportunity and competitive positioning

• Ovarian cancer patients often relapse in the peritoneum after surgery; 85% relapse was cited. FDA Fast Track designation supports the focus on local control of this high-need disease.

• Payer research indicated potential U.S. pricing comparable to Lutathera, with treatment pricing estimated at ~$200,000; ovarian cancer alone in the U.S. and EU top five was described as having blockbuster potential.

• Colorectal cancer peak sales potential was estimated at $650 million in the U.S. and EU five; across indications and geographies, peak sales potential was estimated at $3–4 billion if development succeeds.

• The speaker described limited competition in peritoneal metastases and positioned local microparticle delivery as less complex than systemic radioligands; claimed target hit rate was up to 85%, versus typically less than 1% for other radioligands.

• The phase III plan is to broaden eligibility to all patients with complete resection, beyond the narrower phase II group; the goal is a broader label and faster recruitment.