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Alligator Announces Publication of OPTIMIZE-1 Biomarker Analysis in Cell Reports Medicine Supporting mitazalimab and mFOLFIRINOX in Metastatic Pancreatic Cancer
LUND, SE / ACCESS Newswire / October 8, 2025 / Alligator Bioscience (Nasdaq Stockholm: ATORX)(STO:ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, today announced the publication of a peer-reviewed ...
About this update from Alligator Bioscience Ab
[{"type":"text","content":"LUND, SE / ACCESS Newswire / October 8, 2025 / Alligator Bioscience (Nasdaq Stockholm: ATORX)(STO:ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, today announced the publication of a peer-reviewed article in Cell Reports Medicine, a Cell Press journal. The paper presents biomarkers associated with clinical efficacy endpoints from the Phase 1b/2 OPTIMIZE-1 trial evaluating Alligator's CD40 agonist mitazalimab in combination with mFOLFIRINOX chemotherapy in patients with untreated metastatic pancreatic ductal adenocarcinoma (mPDAC).","length":597,"tagName":"p"},{"type":"text","content":"The publication, titled "CD40 agonist mitazalimab with mFOLFIRINOX in untreated metastatic pancreatic cancer: biomarkers associated with outcomes from OPTIMIZE-1", provides mechanistic insights into determinants of clinical response and offers translational support for a planned randomized Phase 3 trial.","length":315,"tagName":"p"},{"type":"text","content":"Key findings from the publication include:","length":42,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Clinical efficacy: The OPTIMIZE-1 study met its primary endpoint, with a confirmed objective response rate of 42.1% in the Phase 2 cohort. Median duration of response was 12.6 months, progression-free survival 7.7 months, and overall survival 14.9 months. The survival rate at 24 months was 29.4%, triple that of chemotherapy alone.","length":332,"tagName":"p"}]},{"val":[{"type":"text","content":"Tumor gene signature linked to outcome: Baseline expression of a tumor-intrinsic fibrotic gene signature, directly linked to the mode of action of mitazalimab, was associated with improved overall survival.","length":206,"tagName":"p"}]},{"val":[{"type":"text","content":"Peripheral immune activation: Mitazalimab-induced increases in circulating activated immune cells correlated with better clinical outcomes.","length":139,"tagName":"p"}]},{"val":[{"type":"text","content":"Intratumoral immune activation: Patients with objective clinical responses displayed mitazalimab-induced immune activation supporting mitazalimab's contribution to clinical outcomes","length":185,"tagName":"p"}]},{"val":[{"type":"text","content":"Translational impact: strongly supports mitazalimabs contribution to the improved clinical ...