LUND, SE / ACCESS Newswire / September 22, 2025 / Alligator Bioscience (STO:ATORX)(Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, today announced final results from the OPTIMIZE-1 trial evaluating its lead asset, mitazalimab, in combination with mFOLFIRINOX chemotherapy in patients with previously untreated metastatic pancreatic cancer.
The OPTIMIZE-1 study has consistently demonstrated promising clinical activity throughout its course. The final read-out confirms that mitazalimab in combination with standard chemotherapy continues to deliver encouraging efficacy outcomes, with durable responses and survival rates that compare favorably to historical benchmarks.
These results further strengthen the rationale for advancing mitazalimab into a pivotal Phase 3 trial in metastatic pancreatic cancer.
After a median follow-up of 33 months, two patients remained on treatment and 8 in long-term survival follow up resulting in a 30-month overall survival (OS) rate of 21%. The final readout confirms data maturity, demonstrating both primary and secondary efficacy endpoints that compare favorably with historical controls. As previously reported, the objective response rate (ORR) was 54.4% (42.1% confirmed). The median duration of response was 12.6 months, with a median progression-free survival (PFS) of 7.8 months. Median OS reached 14.9 months, with OS rates of 58%, 37%, 26%, and 21% at 12, 18, 24, and 30 months, respectively-an unprecedented outcome in this hard-to-treat cancer. These results underscore a durable benefit, with a meaningful proportion of patients achieving long-term survival beyond two years.
"The final OPTIMIZE-1 results reinforce our belief that mitazalimab has the potential to become a transformative treatment option for patients with pancreatic cancer, a disease with very limited therapeutic advances in decades," said Søren Bregenholt, CEO at Alligator Bioscience . "OPTIMIZE-1 has now successfully fulfilled it purpose and will be winding down following these final results. Hence, the costs continue to decrease as clinical sites close, while we remain well prepared to initiate a confirmatory Phase 3 trial together with a partner. We look forward to bringing this important therapy one step closer to patients."
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 8:45 a.m. CEST on 22 September 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 announces final 30-month OPTIMIZE-1 results highlighting the potential of mitazalimab in metastatic pancreatic cancer
SOURCE: Alligator Bioscience
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https://www.accessnewswire.com/newsroom/en/biotechnology/alligator-announces-final-30-month-optimize-1-results-highlighting-the-potential-of-m-1076524
