On August 20, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported key highlights from its R&D event held on 19 August 2025 (Press release, Alligator Bioscience, AUG 20, 2025, View Source [SID1234655397]). The event featured presentations from Alligator’s management and scientific leadership, outlining Alligator’s clinical progress, upcoming milestones, and strategic outlook.
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Key takeaways from the event include:
Mitazalimab – Phase 3 readiness: Long-term follow-up data continue to demonstrate encouraging overall survival in metastatic pancreatic cancer, supporting the confirmed regulatory path and planned initiation of a Phase 3 trial.
Scientific insights: New translational biomarker data further expand and strengthen the rationale for mitazalimab in pancreatic cancer and other solid tumors, underscored by myeloid and T-cell activation and their correlation with improved clinical outcomes.
Trial completion and CMC status: The final, 30-month, data read-out from OPTIMIZE-1 is expected during Q3 2025. The trial will thereafter be finalized, with mitazalimab being provided to patients still on treatment, and sites with ongoing patients remain open under limited, risk-based monitoring; manufacturing of Phase 3 material has been successfully completed.
Investigator-initiated trials (IITs): Based on the significant investigator interest Alligator is engaged in a number of externally funded exploratory and Phase 2 clinical trials with mitazalimab across pancreatic, gastrointestinal and other solid tumors to expand mitazalimab’s future clinical use. Individual trials are expected to start during H2 2025 and the first half of 2026.
Pipeline updates: The HER2 antibody HLX22 (developed by Chinese Henlius) has entered a global Phase 3 trial in gastric cancers. Alligator expects to receive the next development milestone within 6–12 months, and estimates that its share of the future royalties will amount to SEK 150–400 million annually.
Strategic outlook: With a reduced burn-rate, Alligator is well positioned to advance mitazalimab into registrational trials together with a partner, and in parallel explore additional development options for the asset. Together mitazalimab and HLX22 represent a significant financial upside for Alligator. Other pipeline assets and technologies represent additional future development and income opportunities.