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.”
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.