LUND, SWEDEN / ACCESS Newswire / July 1, 2025 / Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immunotherapies, today announced that new data from the ongoing OPTIMIZE-1 study, evaluating the CD40 agonist mitazalimab in combination with mFOLFIRINOX in metastatic pancreatic cancer, will be presented at the ESMO Gastrointestinal Cancers Congress 2025, taking place in Barcelona on 2-5 July.
The poster includes 24-month efficacy results and dose characterization data from OPTIMIZE-1 ( NCT04888312 ), a Phase 1b/2 trial in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). Patients receiving 900 µg/kg mitazalimab showed a median overall survival of 14.9 months and a median progression-free survival of 7.8 months, supporting a sustained clinical benefit. The survival rate at 24 months was 29.4%, triple that of chemotherapy alone.
A comparison between the 900 µg/kg and 450 µg/kg cohorts revealed a higher response rate for 900 µg/kg of 54.4% versus 22.7%. This indicates a dose-response relationship further supporting mitazalimab's contribution to the positive clinical response data observed in OPTIMIZE-1 , reinforcing the candidate's favorable safety profile and supporting 900 µg/kg as the recommended Phase 3 dose - a decision recently endorsed by the FDA.
Poster presentation details
Title: CD40 agonist mitazalimab + mFOLFIRINOX in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): 24-month follow up and dose characterization from the OPTIMIZE-1 study
Topic: Upper digestive - Biliary, ampullary and pancreatic cancer
Presentation number: 265P
Session: Poster display session 1 and coffee break
Date: Thursday, 3 July 2025
Time: 15:30-16:30 CEST
Location: Foyer
Presenter: Dr. Aurélien Lambert
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 1 July 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 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.
Attachments
Alligator to present 24-month OPTIMIZE-1 data at ESMO GI 2025
SOURCE: Alligator Bioscience
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/biotechnology/alligator-to-present-24-month-optimize-1-data-at-esmo-gi-2025-1044740
