On December 28, 2020 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that it has submitted a CTA (Clinical Trial Authorization) application to the relevant regulatory authorities to start a Phase II efficacy study of its wholly-owned CD40 targeting antibody mitazalimab (Press release, Alligator Bioscience, DEC 28, 2020, View Source [SID1234573273]).

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The upcoming Phase II study OPTIMIZE-1 is an open-label, multi-center study assessing the clinical efficacy of mitazalimab in combination with chemotherapy (mFolfirinox) in patients with metastatic pancreatic cancer. The OPTIMIZE-1 study will be performed at several clinics in Europe and encompass up to a total of 66 patients. Inclusion of the first patient is planned during the first half of 2021 and will begin with a run-in period to determine the best dose for the combination with chemotherapy.

"The CTA submission is an important milestone for Alligator, as we are now entering clinical Phase II for the first time. With best-in-class benchmark data presented for mitazalimab during the autumn, I believe that OPTIMIZE-1 has great potential to deliver robust efficacy results in pancreatic cancer", said Per Norlén, CEO of Alligator Bioscience.

The mitazalimab drug candidate has previously reported positive clinical data from two Phase I studies, one performed by Alligator, one performed by Janssen Biotech Inc., displaying a manageable safety profile as well as early signs of efficacy.