Alligator Bioscience Announces mitazalimab OPTIMIZE-1 Trial Update: Successful Completion of Phase Ib, Phase II enrolling at 900 µg/kg

On March 23, 2022 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported an update on the ongoing OPTIMIZE-1 clinical Phase Ib/II trial in first-line metastatic pancreatic cancer with the company’s lead asset, mitazalimab (Press release, Alligator Bioscience, MAR 23, 2022, View Source [SID1234610658]). Safety evaluation of the second dose-escalation cohort (900 µg/kg of mitazalimab in combination with mFOLFIRINOX) has concluded, which marks the successful completion of the Phase Ib part of the study. The Data Review Committee has declared the 900 µg/kg mitazalimab dose to be safe and recommended that the dosing level should be continued for the Phase II study. Enrollment for the Phase II has begun and is ongoing at sites in Europe (NCT04888312).

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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’s design utilizes mitazalimab’s differentiated efficacy and tolerability profile, allowing administration of higher and more frequent doses. This increases the likelihood of demonstrating clinical benefit to patients as a potential first-line treatment for metastatic pancreatic cancer in combination with mFOLFIRINOX.

The interim efficacy readout for OPTIMIZE-1 is expected to be announced in Q4 2022.

"I am happy to report that mitazalimab is safe and tolerable at the highest dose tested in OPTIMIZE-1, especially in combination with chemotherapy like mFOLFIRINOX. This allows us to continue on to the Phase II of OPTIMIZE-1, dosing at 900 µg/kg," comments Søren Bregenholt, CEO of Alligator Bioscience. "We continue to enroll patients as projected and make great progress towards the efficacy read-out planned for later this year."