NeoImmuneTech, a Kosdaq-listed T-cell-based immunotherapy developer, said Monday that its pancreatic cancer drug, NT-I7 (efineptakin alfa), has received an orphan drug designation (ODD) from the U.S. FDA.

The FDA's ODD system is designed to facilitate the development and approval of drugs to treat rare diseases that affect less than 200,000 patients in the U.S.

Drugs granted ODD receive tax credits for clinical trials, reduced fees for reviewing applications, and other benefits throughout the drug's development, including seven years of exclusive marketing in the U.S.

NeoImmuneTech is conducting a phase 2a clinical trial of NT-I7 in 50 patients with pancreatic cancer in the U.S., with results expected this year.

Pancreatic cancer is one of the most incurable cancers, killing approximately 140,000 people annually in the U.S. and Europe. It is also known as a difficult cancer to detect in the early stages due to the lack of specific symptoms, showing only 3 percent of the five-year survival rate for advanced pancreatic cancer.

NT-I7, which is in clinical trials in a variety of cancers, is a T-cell amplifier that stimulates the body's T-cells.

Through several clinical trials, the company has confirmed that the combination of NT-I7 and immune checkpoint inhibitors can increase the therapeutic effectiveness of immunotherapy in cancer patients who are deficient in T cells.

"NT-I7 has finally achieved tangible results in pancreatic cancer, one of the most difficult cancers that existing immunotherapy has failed to overcome," a NeoImmuneTech official said. "We are continuing to confirm the therapeutic effects of NT-I7 in other cancers such as glioblastoma and colorectal cancer, and look forward to benefiting patients who are in dire need of treatment."