The Food and Drug Administration (FDA) has granted Orphan Drug designation to NT-I7 (efineptakin alfa; NeoImmuneTech) for the treatment of progressive multifocal leukoencephalopathy (PML). 

PML is a rare infection of the brain caused by the reactivation of John Cunningham virus (JCV) in immunocompromised patients. NT-I7 is a long-acting human interleukin-7 fusion protein that is believed to work by amplifying T cell development and improving immune function. “NT-I7 has demonstrated its ability to reverse immunosuppression by increasing T cell counts and functionality, paving a potential path to recovery for the currently underserved PML patient population,” said NgocDiep Le, MD, PhD, Executive Vice President and Chief Medical Officer of NeoImmuneTech.

In addition, NT-I7 is being investigated in solid tumors and as a vaccine adjuvant in multiple clinical trials. The Company also plans to evaluate NT-I7 in hematologic malignancies, additional solid tumors and other immunology-focused indications.

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The FDA’s Orphan Drug designation is granted to treatments for rare diseases that affect ≤200,000 individuals.

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