Lund, Sweden – 8 September 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.”