June 1, 2018 — ROCKVILLE, Md.– (BUSINESS WIRE)–NeoImmuneTech, Inc. (NeoImmuneTech), an immunotherapy drug development company focused on advanced cancer treatments, announced today the initiation of its first U.S. clinical trial. The trial, studying Hyleukin-7TM, an immunotherapeutic agent for cancer patients being co-developed by NeoImmuneTech and Genexine, Inc. (Genexine), will be conducted under agreement with the Adult Brain Tumor Consortium (ABTC) in the U.S. and 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 Hyleukin-7TM’s effect on lymphocyte counts in patients with brain cancer following radiation. In addition, the safety and efficacy of different doses of this new agent will be explored. The study will enroll up to 75 patients.
“It is the first time that NeoImmuneTech’s Hyleukin-7TM has cleared the U.S. IND for clinical trials and is an important milestone for our global clinical development. We plan to continue expanding Hyleukin-7TM’s target indications and to initiate several additional research collaborations to study it in combination with global immuno-oncology products”, said NeoImmuneTech’s Chief Executive Officer, Se Hwan Yang, Ph.D.
The U.S. Food and Drug Administration (FDA) accepted NeoImmuneTech’s Investigational New Drug (IND) application on March 16, 2018. The study was recently approved by the NCI’s Cancer Therapy Evaluation Program (CTEP) allowing for a Phase 1 and Pilot study of Hyleukin-7TM (Registered code name: NT-I7) in brain cancer patients.
Glioblastoma, also known as glioblastoma multiforme (GBM), is the most common and most malignant type of primary brain tumor. Its standard therapy is 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 cell counts, especially T cells. Recent data suggest that poor survival rates are associated with very low T cell counts.
Hyleukin-7TM (IL-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, 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.
NeoImmuneTech, a Genexine related company founded in 2014, is focused on leading the development efforts for its flagship immunotherapy product, Hyleukin-7TM, in the US and EU. Based in Rockville, Maryland, NeoImmuneTech 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. NeoImmuneTech 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.