Alligator Biosciences IND For CD40-targeting Antibody Mitazalimab Gets US FDA Approval

Alligator Biosciences IND For CD40-targeting Antibody Mitazalimab Gets US FDA Approval

By, Admin 7 December 2020

Alligator Bioscience, a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, announced an approved IND for the CD40 targeting antibody mitazalimab. IND approval by the US Food and Drug Administration (FDA) is a prerequisite to start clinical trials in the USA.Recently, new benchmark data was published showing that mitazalimab has the potential to be best-in-class in the CD40 field. The comparison demonstrated the potent immune-activating properties and anti-tumor effects of mitazalimab."While the upcoming clinical phase Ib/II study in pancreatic cancer, OPTIMIZE-1, will be starting in Europe, the IND opens up for later expansion in the US. This is essential for the future success of the product", said Per Norlén, CEO of Alligator Bioscience.", said Per Norlén, CEO of Alligator Bioscience. "Our key focus right now is to complete the submission of the CTA for start of OPTIMIZE-1 in the EU", he added.The mitazalimab drug candidate has previously reported positive clinical data from a phase I study performed by Janssen Biotech Inc., displaying a manageable safety profile as well as early signs of efficacy.

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