On July 10, 2024 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported an update on the on-going OPTIMIZE-1 clinical Phase 2 trial with the company’s lead asset, mitazalimab (Press release, Alligator Bioscience, JUL 10, 2024, View Source [SID1234644766]). All patients in the 450 µg/kg back-fill cohort have been enrolled.
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The additional cohort was enrolled in order to provide further dose characterization following advice from the FDA, to ensure mitazalimab Phase 3 readiness.
"We are pleased to see the recruitment completed in a very swift manner, a testament to the committed work by the Alligator team and the great engagement of the study investigators and their research staff involved in the OPTIMIZE-1 trial", said Søren Bregenholt, CEO of Alligator Bioscience. "We are committed to bringing mitazalimab to patients as soon as possible, and this back-fill cohort is an important step to complete the dose-characterization and ensure mitazalimab’s Phase 3-readiness in accordance with the guidance from FDA."
OPTIMIZE-1, an open-label, single-arm, multicenter, Phase 1b/2 study, assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX in 1st line pancreatic cancer. On June 26, the 18-month follow-up analysis was reported, demonstrating robust data with substantial survival benefits compared to standard of care chemotherapy.
About pancreatic cancer
Pancreatic cancer is the 12th largest cancer by number of patients. It is expected to become the second leading cause of cancer death in the western world by 2030. There are about 200,000 annual cases in the U.S. and the EU, with very poor prognosis: five-year survival is about 10% and median survival about 6 months. For 80% of patients, the only option is chemotherapy that offers only marginal benefit. FOLFIRINOX is expected to be the preferred first line regimen in the U.S. and the EU for patients with good performance status.