Alligator Bioscience said that the investigational new drug application for its CD40 targeting antibody mitazalimab has been approved by the US Food and Drug Administration (FDA).
The IND approval enables the Swedish biotech company to begin clinical trials for mitazalimab in the US.
According to Alligator Bioscience, a new benchmark data was recently published which showed that mitazalimab has the potential to be best-in-class in the CD40 field. The comparison showed the potent immune-activating properties and anti-tumor effects of the CD40 targeting antibody.
Per Norlén – CEO of Alligator Bioscience said: “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.
“Our key focus right now is to complete the submission of the CTA for start of OPTIMIZE-1 in the EU.”
Previously, mitazalimab delivered positive clinical data from a phase 1 study carried out by Janssen Biotech by showing a manageable safety profile along with early signs of efficacy.