T cell boosting therapy expands into oncology

By Maggie Lynch

- Last updated on GMT

(Image: Getty/Design Cells)
(Image: Getty/Design Cells)

Related tags Oncology Immuno-oncology T cell receptor T cells

US FDA grants orphan drug designation for Hyleukin-7, an immuno-oncology agent that boosts T cell production and functionality, for the treatment of ICL.

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.

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