Mitazalimab is a monoclonal antibody that targets CD40, a protein that is expressed on the surface of many types of cancer cells. CD40 signaling is thought to play a role in tumor growth and metastasis. Mitazalimab works by blocking CD40 signaling, which can lead to tumor cell death.
The FDA has granted orphan drug designation to mitazalimab for the treatment of pancreatic cancer. Orphan drug designation is a special status granted to drugs that are intended to treat rare diseases. It provides a number of benefits to drug developers, including tax credits, grants, and extended market exclusivity. Mitazalimab is currently being investigated in a phase 2 clinical trial in patients with metastatic pancreatic cancer. The trial is evaluating the safety and efficacy of mitazalimab in combination with modified FOLFIRINOX, a standard chemotherapy regimen for pancreatic cancer.
If mitazalimab is ultimately approved for the treatment of pancreatic cancer, it could provide a new treatment option for patients with this deadly disease.