LUND, SE / ACCESS Newswire / August 20, 2025 / Alligator Bioscience (Nasdaq Stockholm:ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, provides key highlights from its R&D event held on 19 August 2025. The event featured presentations from Alligator's management and scientific leadership, outlining Alligator's clinical progress, upcoming milestones, and strategic outlook.
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.
A replay of the event is available through >>this link<< .
For further information, please contact:
Søren Bregenholt, CEO
E-mail: soren.bregenholt@alligatorbioscience.com
Phone: +46 (0) 46 540 82 00
The information was submitted for publication, through the agency of the contact person set out above, at 12:15 p.m. CEST on 20 August 2025.
About Alligator Bioscience
Alligator is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs focused on the CD40 receptor. This validated approach promotes priming of tumor-specific T cells and reversing the immunosuppressive nature of the tumor microenvironment, with significant potential benefits for cancer patients across multiple types of cancer. The Company's lead drug candidate mitazalimab is currently ready for Phase 3 development, and has previously presented unprecedented survival data at 24-months follow up in first-line metastatic pancreatic cancer patients in the Phase 2 trial OPTIMIZE-1.
Alligator is listed on Nasdaq Stockholm (ATORX) and headquartered in Lund, Sweden.
For more information, please visit alligatorbioscience.com .
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Alligator Bioscience provides highlights from R&D event 2025
SOURCE: Alligator Bioscience
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/biotechnology/alligator-bioscience-provides-highlights-from-randd-event-2025-1063202
