Lipum (LIPUM) Investing in Life Science 2025 summary

Clinical progress and data highlights

• Lead asset mitazalimab, a CD40 monoclonal antibody, is phase III ready for first-line metastatic pancreatic cancer.

• Combination with FOLFIRINOX chemotherapy more than tripled 24-month survival compared to chemotherapy alone, without significant added side effects.

• Phase II data showed some patients achieved full remission and many had extended survival beyond 18 and 24 months.

• Mechanistic studies confirmed a direct link between mitazalimab-induced immune activation and improved patient outcomes.

• At 30 months, 20% of patients remained alive, supporting readiness for phase III trials.

Regulatory and development status

• Phase III protocol and patient materials have been approved by both FDA and European authorities.

• Phase III will mirror phase II in patient population, endpoints, and treatment schedule.

• Investigator-initiated trials are ongoing, with a large randomized phase II study in France set to start in Q2 next year, funded by the French government.

Market potential and financial outlook

• Mitazalimab targets a market of 25,000 patients annually in the US and Europe, qualifying for blockbuster status.

• Expansion into other solid tumors is planned, leveraging the drug’s safety and mechanism.

• HLX22, a HER2 monoclonal antibody outlicensed in China, is in phase III for gastric cancer and could generate $15–40 million annually in the early 2030s.