Alligator Bioscience has received positive feedback from the FDA confirming the choice of 900 µg/kg mitazalimab for the planned Phase III study in metastatic pancreatic cancer (mPDAC). The announcement is an important milestone for the development of the CD40 agonist.
– We are very pleased with the FDA's prompt and constructive response. This is an important step forward as we complete our Phase III program for mitazalimab in one of the most aggressive and undertreated cancers. We are currently in active dialogues to secure the right partner to take mitazalimab further into Phase III, comments the CEO Soren Bregenholt.
