Mitazalimab Snags Orphan Drug Designation for Pancreatic Cancer

Although the 5-year survival rate for pancreatic cancer has slightly risen (from 11% to 12%), there is still much work to be done. Pancreatic cancer can be difficult to treat. Alligator Biosciences is working to overcome this, and improve patient care, through the development of their lead candidate mitazalimab, which the company describes as:

an agonistic—or stimulatory—antibody that targets CD40, a receptor on the dendritic cells of the immune system, which are the cells that detect enemies such as cancer cells. Mitazalimab’s activation of CD40 enables dendritic cells to stimulate the immune response’s weapons more effectively—in this case, T cells—allowing the immune system to selectively attack the cancer.

Recently, shares an article in OncLive, the company reported that the U.S. Food and Drug Administration granted Orphan Drug designation to mitazalimab. This designation is given to therapies intended to treat, prevent, or diagnose rare (affecting fewer than 200,000 people nationwide) conditions. As a benefit, Alligator Biosciences earns fee waivers, increased FDA assistance, tax credits, and up to seven years of market exclusivity if the drug is approved.

Studying Mitazalimab

Alligator Biosciences has been evaluating mitazalimab, in conjunction with modified FOLFIRINOX, within the Phase 2 OPTIMIZE-1 study. Interim data suggests that the drug is safe, effective, and well-tolerated. The data shows that this combination treatment led to a 90% disease control rate and 52% objective response rate, which refers to how many people had any response to treatment. Data that should be available later this year and/or in early 2024 will also include information on survival rates, progression-free survival, and disease control. 

The Basics of Pancreatic Cancer

  • What is it? Pancreatic cancer forms in your pancreas, an organ which plays a role in blood sugar management and digestion.
  • Are there different types? Yes! The main types include pancreatic adenocarcinoma (the most common form) and pancreatic neuroendocrine tumors (a rare form). 
  • What are the risk factors? Being obese, smoking tobacco, having a family history of pancreatic cancer, being older in age, and being male all increase your risk. 
  • Is there a cause? We don’t currently know the exact cause of pancreatic cancer. 
  • What are the symptoms? Symptoms may include newly onset or worsening diabetes, fatigue, blood clots, dark urine and pale stools, appetite loss, upper abdominal pain that radiates to the back, unintentional weight loss, bowel obstructions, and the yellowing of your skin and eyes. 
  • How is pancreatic cancer diagnosed? Your doctor may take multiple diagnostic approaches, including taking your medical history, performing a physical exam, and using PET or CT scans, MRIs, ultrasounds, biopsies, blood tests, and tumor marker tests.
  • Are there treatments? Treatment may include surgery, chemotherapy, radiation, targeted therapy, and supportive care.