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Alligator Bioscience presents new data

Søren Bregenholt

Alligator Bioscience has announced positive 18-month follow-up data from the OPTIMIZE-1 Phase 2 study of the company’s lead asset mitazalimab in 1st line metastatic pancreatic cancer.

The open-label, multi-center study assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX, in previously untreated, chemotherapy naïve pancreatic cancer patients. The data demonstrated a near doubling of the 18-month survival rate to 36.2% in patients treated with mitazalimab in combination with mFOLFIRINOX, compared to 18.6% reported with FOLFIRINOX alone. The updated Median Overall Survival (mOS) was 14.9 months, up from 14.3 months at the time of first analysis, comparing favorably to the 11.1 months demonstrated by FOLFIRINOX and more recently by NALIRIFOX. Median follow-up duration for the updated analysis was 18.2 months, indicating the maturity of these outcomes. At the time of the analysis, a total of 17 (30%) patients were still alive, and of these 9 (16% overall) were still on treatment. The longest ongoing treatment duration was 24 months.

“These latest results from the OPTIMIZE-1 study of our lead asset provide a strong validation of the clear and sustained clinical benefit produced by mitazalimab when combined with mFOLFIRINOX in the treatment of first-line pancreatic cancer. In fact, mitazalimab increases your chance of being alive at the 18-month mark by 95 percent, compared to published FOLFIRINOX data,” says Søren Bregenholt, CEO of Alligator Bioscience. “These highly promising outcomes warrant continued clinical development of mitazalimab in a confirmatory setting and we are committed to bringing mitazalimab to pancreatic cancer patients as fast as possible.”


Phase 3 on track to start in first half of 2025

Alligator is continuing its preparations for the global Phase 3 registration study to evaluate mitazalimab in pancreatic cancer and the company remains on track to initiate the study in 2025. This follows Alligator’s discussions with the US Food and Drug Administration (FDA) which established a clear development and approval pathway for mitazalimab in pancreatic cancer.

In 2023, mitazalimab was granted orphan drug designation in pancreatic cancer by both the FDA and the European Medicines Agency (EMA).

Photo of Soren Bregenholt: Alligator