LUND, SE / ACCESS Newswire / September 8, 2025 / Alligator Bioscience (Nasdaq Stockholm:ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, today announces that an investigator-initiated randomized Phase 2/3 clinical trial will evaluate mitazalimab in combination with FOLFOX chemotherapy in previously treated biliary tract cancer.
The trial will investigate mitazalimab's potential in an additional tumor type with significant unmet medical need and could have a meaningful impact for the patients concerned. It will be led by Prof. Cindy Neuzillet and Dr. Matthieu Delaye of Institut Curie, with Unicancer as the study sponsor. It is expected to enroll its first patient in the second quarter of 2026, with the initial part of the study enrolling a total of 112 patients across 30 sites in France.
"We are very pleased by the launch of this new project investigating mitazalimab, sponsored by Unicancer GI group (UCGI) and supported by PRODIGE intergroup. This support by academic network of recognized experts underscores the scientific and clinical relevance of targeting CD40 in biliary tract cancer and the broader interest in mitazalimab's therapeutic potential beyond pancreatic cancer," comments Søren Bregenholt, CEO at Alligator Bioscience . "We are proud to support this effort by the Unicancer group and look forward to seeing the study advance under the leadership of Prof. Neuzillet and Dr. Delaye. This trial provides an opportunity for patients with a tumor type which represents a significant unmet medical need to benefit from mitazalimab."
"The CROCOBIL study will investigate if the combination of mitazalimab with FOLFOX could overcome resistance to first-line chemo-immunotherapy in advanced biliary tract cancer and achieve better results than chemotherapy alone. To this end, our study will generate data on efficacy and tolerance of the combination, and will be supported by extensive ancillary work, " comments Prof. Cindy Neuzillet of Institut Curie , Principal Investigator of the trial. "The study has received the support of the PRODIGE French intergroup for clinical research in GI cancers. We are looking forward to moving forward to the next steps to start patient enrollment."
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 8 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.
About Unicancer
Unicancer is the only French hospital network that is 100% dedicated to the fight against cancer and the only national hospital federation that specializes in cancer. It brings together the 18 French Cancer Control Centers (CLCC) - private non-profit institutions - as well as two affiliated members.
A major player in research, Unicancer is the leading academic promoter of clinical trials in oncology in Europe, with more than 120 active studies (national and international), including 50 in recruitment, promoted by its R&D department. In addition, there are more than 600 trials promoted by the CLCCs.
A pioneer in the exploitation of health data, Unicancer has launched since 2014, via its data and partnerships department, five real-life data programs, including ESME (109,000 patients), CANTO (+13,000 patients), and OncoDataHub (ODH) (+60,000 patients). Each year, more than 600,000 patients benefit from the latest scientific, therapeutic, and organizational advances in cancer, driven by an agile model combining excellence, humanism, solidarity, and innovation.
www.unicancer.fr
Attachments
Grant awarded to investigator-initiated Phase 2/3 trial with mitazalimab in biliary tract cancer
SOURCE: Alligator Bioscience
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/biotechnology/grant-awarded-to-investigator-initiated-phase-2%2f3-trial-with-mitazalimab-in-biliary-t-1069956
