Policy & Regulation
Alligator Bioscience announces FDA's approval for CD40-targeting antibody mitazalimab for pancreatic cancer
4 December 2020 -

Biotechnology company Alligator Bioscience (Nasdaq Stockholm: ATORX) reported on Friday the receipt of approval from the the US Food and Drug Administration (FDA) for for the IND (Investigational new Drug) for the CD40 targeting antibody mitazalimab.

Following the IND approval by the US FDA, the company will now start clinical trials in the USA. The new benchmark data showed 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.

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.

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. The key focus is to complete the submission of the CTA for start of OPTIMIZE-1 in the EU, added CEO Per Norlén.