Alligator Bioscience Announces IND Approval for CD40 Targeting Antibody Mitazalimab
Alligator Bioscience | December 07, 2020
Alligator Bioscience declares an affirmed IND (Investigational new Drug) for the CD40 targeting antibody mitazalimab. IND endorsement by the US Food and Drug Administration (FDA) is an essential to begin clinical preliminaries in the USA. As of late, new benchmark information was distributed indicating that mitazalimab can possibly be top tier 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 recently reported positive clinical information from a Phase I study performed by Janssen Biotech Inc., showing a manageable safety profile just as early signs of efficacy.