NeoImmuneTech (NIT), along with its parent company Genexine, has signed an agreement with Roche to perform a Phase Ib/IIa immuno-oncology trial evaluating HyLeukin-7 (IL-7-hyFc) in combination with Tecentriq (atezolizumab) to treat advanced high-risk skin cancers.
The proposed multi-centre open-label trial will cover three cancer types, including melanoma, Merkel cell carcinoma and cutaneous squamous cell carcinoma.
The trial will be led by NIT and the Immune Oncology Network (ION), and will aim to investigate safety and anti-tumour activity of HyLeukin-7 in combination with Tecentriq in around 70 patients with anti-PD-(L)1 naïve or refractory high-risk skin cancers.
The trial is expected to begin by the second half of this year and will be conducted across the US and possibly additional countries.
Fred Hutchinson Cancer Research Center Immune Oncology Network director Martin Cheever said: “HyLeukin-7 has shown in multiple studies to substantially increase the total body complement of T cells with little toxicity.
“HyLeukin-7 is designed to be effective when used in concert with a variety of different immunotherapy regimens, including the combination with anti-PD-(L)1 that is being tested in this trial.”
HyLeukin-7 is a T cell amplifier, featuring a covalently linked homodimer of engineered Interleukin-7 (IL-7) molecule, biologically fused with the proprietary long-acting platform hyFc.
The solution is currently under development as an ‘IO enabling’ therapy to harness T cell immunity in combination with other cancer treatments, especially with anti-PD-(L)1 agents or chemo/radiotherapy.
Tecentriq (atezolizumab), a registered product of Roche Group member Genentech, is a PD-L1 checkpoint inhibitor.