NeoImmuneTech’s Hyleukin-7 (rhIL-7-hyFc, NT-I7) was granted an orphan drug designation by the US Food and Drug Administration (FDA) for the treatment of idiopathic CD4+ lymphocytopenia (ICL). The drug candidate also received an orphan drug designation from the European Medicines Agency in 2017.
Additionally, the T cell amplifier is being investigated for the potential treatment of cancer, in combination with current oncology therapies.
ICL is a rare disease that causes patients without HIV or any immunodeficiency to have persistently low CD4+ T lymphocyte counts. Individuals with ICL are at a high risk for developing certain types of cancer and recurrent infections.
According to the company, Hyleukin-7 is designed to increase a patient’s T cells and is predicted to broaden T cell receptor diversity, which could bolster T cell responses.
The drug candidate amplifies T cell immunity in the treatment of patients with cancer and ICL, therefore providing treatment opportunities for immuno-oncology combination strategies, potentially alongside anti-PD-(L)1 agents or chemotherapy.
The orphan drug designation comes after a Phase I trial in healthy participants and multiple ongoing dose-escalation trials in cancer patients showed a well-tolerated safety profile and dose-dependent increases of CD4+ and CD8+ T lymphocyte counts.
According to NeoImmuneTech, Hyleukin-7 has the potential to amplify and prolong anti-tumor activity, which could extend survival for cancer patients. It is being studied in clinical trials for solid tumors and hematologic malignancies, in addition to its indication for ICL.