On January 18, 2022 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported an update on the on-going OPTIMIZE-1 clinical Phase Ib/II trial with the company’s lead asset, mitazalimab (Press release, Alligator Bioscience, JAN 18, 2022, View Source [SID1234605513]). All patients in the 450 µg/kg cohort have been dosed and there have been no adverse effects related to study medication has been reported. Dosing of the 900 µg/kg cohort has been initiated. The Phase 1b part of the study is expected to be completed during Q1 2022.
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OPTIMIZE-1, an open-label, multi-center phase Ib/II study is assessing the safety and efficacy of mitazalimab in combination with chemotherapy, mFOLFIRINOX, in patients with metastatic pancreatic ductal adenocarcinoma. First patient was dosed in Q3 2021 (press release). The study is designed to take full advantage of mitazalimab efficacy and tolerability profile administering higher and more frequent doses than competing molecules. This increases the likelihood of demonstrating clinical benefit to patients as a potential first-line treatment for metastatic pancreatic cancer in combination with mFOLFIRINOX. Patient recruitment is ongoing in sites France and Belgium. The study aims to enrol 67 patients with metastatic pancreatic cancer.
"I am happy to report that we continue to make great progress with our OPTIMIZE-1 trial," comments Søren Bregenholt, CEO of Alligator Bioscience. "We look forward to keeping the market regularly updated as the project advances."
The safety readout for OPTIMIZE-1 is expected to be announced in Q1 2022, with the interim readout in Q4 2022.