245 words (source – 6% match) vs. 386 words (mine – 4% match)
In the European Union, Orphan designation is granted to therapies intended to treat or use for a rare disease or rare condition affecting no more than 5 in every 10,000 people. Once granted this status, drug developers receive benefits such as fee reductions, protocol assistance, and a period of market exclusivity. According to reporting from Pharmaceutical Technology, the European Medicines Agency (EMA) recently granted Orphan status to mitazalimab, a potential therapy intended for pancreatic cancer. It has also been granted Orphan Drug designation in the United States.
Developed by Alligator Biosciences, mitazalimab is described as:
an agonistic—or stimulatory—antibody that targets CD40, a receptor on the dendritic cells of the immune system, which are 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.
Orphan status was granted following interim trial results from the Phase 2 OPTIMIZE-1 study, which is still ongoing. In the interim data, mitazalimab showed efficacy in improving how the tumor responded to treatment. It had an objective response rate of 44% in the full patient cohort (57 people) with a 57% response rate by June 2023. Additionally, the treatment was sustained/durable over 8.7 months. More data should be available later this year.
Understanding Pancreatic Cancer
The pancreas is an organ in your digestive system. It releases digestive enzymes, as well as hormones to aid in blood pressure management. Pancreatic cancer forms in the pancreas and has multiple subtypes depending on where, exactly, it forms. Although pancreatic cancer accounts for just 3% of all cancers in the United States, it accounts for 7% of cancer-related death. The problem with pancreatic cancer is that it often eludes screening measures. As such, it is often undiagnosed until later stages. While there are available treatments, they tend to be minimally effective. The current 5-year survival rate for pancreatic cancer is 12%.
Symptoms associated with this cancer may include:
- Unintentional weight loss
- Newly onset diabetes or diabetes that is suddenly poorly managed
- Upper abdominal and/or middle back pain
- Jaundice (yellowing of the skin, eyes, and mucous membranes)
- Dark urine and pale, greasy stools
- Nausea and vomiting
- Blood clots
- Indigestion
- Extremely itchy skin
