NeoImmuneTech’s signboard
NeoImmuneTech’s signboard

NeoImmuneTech said Thursday that NT-I7 (efineptakin alfa) has received orphan drug designation (ODD) from the U.S. Food and Drug Administration for pancreatic cancer.

The FDA's orphan drug system is designed to facilitate the development and approval of drugs to treat rare diseases that affect 200,000 or fewer people in the United States. Drugs granted orphan drug designation receive tax credits for clinical development costs, reduced fees for reviewing applications, and exclusive marketing in the U.S. for seven years.

NT-I7 is a T cell amplifier that amplifies T cells in the body. NeoImmuneTech is conducting clinical trials to determine the therapeutic benefits of combining NT-I7 with immune checkpoint inhibitors in cancer patients.

Pancreatic cancer is one of the most incurable cancers, accounting for about 140,000 deaths annually in the United States and Europe. It is also known as a cancer that is difficult to detect in the early stages due to its lack of specific symptoms, and the five-year relative survival rate for advanced pancreatic cancer is only 3 percent.

"NT-I7 has finally achieved remarkable results in pancreatic cancer, one of the most difficult cancers that existing immuno-oncology drugs have failed to overcome," a NeoImmuneTech official said. "In addition to pancreatic cancer, we are continuously confirming the therapeutic effects of NT-I7 in other cancers, such as glioblastoma and colorectal cancer, looking forward to benefiting patients who need a treatment alternative."

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