October 29, 2018 — ROCKVILLE, MD.– (BUSINESS WIRE)–NeoImmuneTech, Inc. (NeoImmuneTech), an immunotherapy drug development company focused on advanced cancer treatments, today announced the U.S. Food and Drug Administration (FDA) approved its Investigational New Drug (IND) application for a clinical trial for the treatment of newly diagnosed high grade glioma (HGG) patients with a combination of HYLEUKIN-7® and standard therapy. Hyleukin-7TM is an immunotherapeutic drug candidate designed to induce T cell proliferation and help the body fight serious disease.
“The new trial studies the effect of Hyleukin-7TM, an innovative immunotherapeutic agent, on lymphocyte counts and disease progression in patients with brain cancer following chemotherapy and radiation. Hyleukin-7TM is expected to increase the T cell count and provide clinical benefits to patients with brain cancer whose prognosis is poor with conventional therapy alone”, said Dr. NgocDiep Le, NeoImmuneTech’s Chief Medical Officer. “Many patients with high grade gliomas can have a severe reduction in immune cells that can be associated with reduced survival rate, making this treatment particulary relevant for HGG. The safety and efficacy of different doses of this new agent will be also explored.”
The study will enroll up to 46 patients and will be conducted in collaboration with the Washington University School of Medicine, led by principal investigator Dr. Jian Campian. Hyleukin-7TM is being co-developed by NeoImmuneTech and Genexine, Inc.
About High Grade Gliomas Tumors indicated by the World Health Organization (WHO) as grade 3 or grade 4 tumors tend to grow rapidly and spread faster than tumors of a lower grade. High grade gliomas indicate collectively the presence of grade 3 or 4 malignant tumors in brain tissue. Glioblastoma, also known as glioblastoma multiforme (GBM), is the most aggressive cancer that begins in the brain.
Standard therapy for HGGs includes both surgery and chemotherapy. The average survival rate is about 12 months, 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 inferior survival rate in patients with glioblastoma is associated with very low T cell counts.
Hyleukin-7TM (rhIL-7-hyFc, NT-I7), an immuno-oncology agent, is a T cell amplifier comprising a covalently linked homodimer of engineered Interleukin-7 (IL-7) molecule, biologically fused with the proprietary long-acting platform – hyFc℠. IL-7 is known to be a critical factor for T cells, acting on increasing both the number and functionality of T cells. Hyleukin-7TM could play a pivotal role in reconstitution and reinvigoration of T cell immunity for treatment of cancer patients and lymphopenia, providing unique opportunities for immuno-oncology (IO) combination strategies. Hyleukin-7TM is being developed as an “IO enabling” therapy to harness T cell immunity in combination with current cancer treatments such as anti-PD-(L)1 agents or chemo/radiotherapy. NeoImmuneTech and Genexine are collaborating in three Phase 1b/2a clinical trials in advanced solid tumors and glioblastoma in the US and Korea.
About NeoImmuneTech, Inc.
NeoImmuneTech (NIT), a Genexine related company founded in 2014, is focused on leading the development efforts for its flagship immunotherapy product, Hyleukin-7TM, in the U.S. and EU. Based in Rockville, Maryland, NIT has the core competency of global clinical and business development with a strong scientific focus and a broad network of global leading R&D organizations. NIT is currently conducting Phase 1b/2a clinical trials of Hyleukin-7TM, aiming at developing not only the first-in-class treatment of lymphopenia but also a breakthrough cancer immunotherapy. http://www.neoimmunetech.com/