US FDA approval to Alligator Bioscience for CD40-targeting antibody

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) may be a prerequisite to start out clinical trials within the USA.

Recently, new benchmark data was published showing that mitazalimab has the potential to be best-in-class within 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 carcinoma , OPTIMIZE-1, are going to be starting in Europe, the IND exposes for later expansion within the US. this is often essential for the longer term success of the product”, said Per Norlén, CEO of Alligator Bioscience.”, said Per Norlén, CEO of Alligator Bioscience. “Our key focus immediately is to finish the submission of the CTA for start of OPTIMIZE-1 within the EU”, he added.

The mitazalimab drug candidate has previously reported positive clinical data from a phase I clinical trial study performed by Janssen Biotech Inc., displaying a manageable safety profile also as early signs of efficacy.

About Janssen Biotech, Inc

Janssen Biotech, Inc., formerly  known as Centocor Biotech, Inc., It is a biotechnology company that was founded in 1979 in Philadelphia. The goal of Janssen Biotech is developing new diagnostic assays using monoclonal antibody technology.

#Janssen #JanssenBiotech #AlligatorBioscience