Press release

Alligator Bioscience presents OPTIMIZE-1 biomarker data at ASCO 2025 Annual Meeting

Lund, Sweden, 23 May 2025 – Alligator Bioscience (Nasdaq Stockholm: ATORX) today announced the presentation of biomarker data from its OPTIMIZE-1 clinical trial at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

OPTIMIZE-1 is an ongoing Phase 1b/2 trial of mitazalimab in combination with mFOLFIRINOX in first-line metastatic pancreatic cancer (mPDAC). The trial has demonstrated strong clinical outcomes to date, including a ~30% survival rate at 24-months follow up.

Mitazalimab-induced biomarkers were associated with clinical benefit supporting a significant contribution of mitazalimab to clinical efficacy, including the intratumoral immune activation in responding patients. In addition, a fibrosis-related gene signature was identified as potentially predictive of improved overall survival, while ctKRAS clearance and molecular response were significantly associated with longer survival and outcomes.

These translational data strengthen the rationale for mitazalimab’s mode of action, showing that mitazalimab-induced immune activation and suppression of tumor-promoting genes contribute to the clinical benefits observed in OPTMIZE-1. With an observed median overall survival of 14.9 months and objective response rate of 54.4%, the results support further development of mitazalimab in mPDAC, including the planned randomized confirmatory trial.

Alligator’s participation at ASCO reflects its commitment to scientific exchange and business development. The meeting provides an important platform to highlight mitazalimab’s potential and engage in strategic partnering discussions.

Abstract information:

Title: Biomarkers associated with outcomes from OPTIMIZE-1: CD40 agonist mitazalimab with mFOLFIRINOX in patients with untreated metastatic pancreatic cancer
First Author: Philippe Cassier
Date and time: 2^nd June 2025, 1.30 p.m. - 4:30 p.m CDT.
Session Title: Developmental Therapeutics—Immunotherapy
Sub Track: Tissue-Based Biomarkers
Abstract Number: 2624
Poster Board Number: 271
Abstract link

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 in preparation 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.