US-based NeoImmuneTech (NIT) has received the US Food and Drug Administration (FDA) approval to initiate a Phase I/Ib clinical trial of Hyleukin-7 at the Center for Cancer Research, National Cancer Institute.

The trial will investigate the compound’s ability to boost immune reconstitution and vaccine responses in elderly cancer patients after chemotherapy.

Elderly cancer survivors are known to be vulnerable to vaccine-preventable diseases and have poor anti-vaccine-specific immune responses, requiring the prevention of communicable diseases.

Interleukin-7 (IL-7) is believed to be involved in immune reconstitution and enhancement in elderly patients following chemotherapy.

Hyleukin-7 is a long-acting human IL-7 and the trial is designed to assess its ability to enhance specific immune responses to certain vaccines in elderly cancer survivors.

NeoImmuneTech executive vice-president and chief medical officer NgocDiep Le said: “Through an in-depth analysis of Hyleukin-7’s function on specific T-cell subsets, both in quantitative and qualitative aspects in this clinical trial, we will be able to assess the potential of using Hyleukin-7 in combination with various vaccines in infectious disease and oncology.”

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Hyleukin-7 has been designed as a T-cell growth factor that comprises a covalently linked homodimer of engineered IL-7, biologically fused with the company’s long-acting hyFc platform.

According to NeoImmuneTech, the compound increases and bolsters persistent T-cell immunity in people with cancer and lymphopenia, in turn facilitating immuno-oncology (IO) combinations.

Findings from a Phase I trial in healthy subjects and various ongoing dose-escalation trials in cancer patients demonstrated a well-tolerated safety profile and dose-dependent rise in CD4+ and CD8+ T lymphocyte counts with Hyleukin-7.

The company is performing additional proof-of-concept studies of the compound as an IO-enabling therapy in combination with other cancer therapeutics.