A clinical trial of HyLeukin-7, an immunotherapeutic agent for cancer patients, which is being co-developed by NeoImmunTech Inc. (NIT) and Genexine Inc. (Genexine) will be conducted under agreement with the Adult Brain Tumor Consortium (ABTC) in the U.S. supported by the National Cancer Institute (NCI), as a joint study of the Cancer Immunotherapy Trials Network (CITN) for biomarker analysis. The purpose of this study is to determine how well HyLeukin-7 raises lymphocyte counts in patients with brain cancer following radiation. In addition, the effect and side effects of different doses of this new agent will be explored. There will be 12-75 patients taking apart in this study.
NIT announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application on March 16th and was recently approved by the NCI's Cancer Therapy Evaluation Program (CTEP) allowing for a Phase 1 and Pilot study of HyLeukin-7 (Registered code name: NT-I7), an innovative immuno-oncology drug, in brain cancer patients.
Glioblastoma, also known as glioblastoma multiforme (GBM), is the most aggressive cancer that begins in the brain which collectively is a condition that malignant tumors are present in brain tissue. Its standard therapy is surgery and chemotherapy. The average survival rate is about 12 months which is relatively shorter than other solid tumors. When glioblastoma patients are treated with standard radiation and chemotherapy, approximately 40% experience a severe reduction in their immune cells, especially T cells. Recent data suggest that the survival rate is associated with inferior survival in patients with glioblastoma and very low T cell counts.
HyLeukin-7 is an immuno-oncology agent comprised of an optimally engineered Interleukin-7 (IL-7) molecule based on Genexine’s proprietary long-acting protein platform technology, hybrid Fc (hyFc). IL-7 is required for human T-cell development and for maintaining and restoring homeostasis of mature T cells. IL-7 is the main homeostatic driver of T-cell numbers. Recent clinical trials in humans have demonstrated the potential of IL-7 to expand and protect loss of CD4 and CD8 T cells.
“It is the first time that NeoImmuneTech’s HyLeukin-7 has cleared the U.S. IND for trials in our pipeline and is an important milestone for global clinical development. We have plans to expand the target indications and will initiate several additional collaboration types of research with global immuno-oncology products”, said a NIT representative.