NeoImmuneTech Receives Authorization to Proceed from the FDA for IND Application to Evaluate Hyleukin-7 in Combination with a PD-L1 Inhibitor in Advanced High-Risk Skin Cancers
NeoImmuneTech, Inc., an immunotherapy drug development company focused on advanced cancer treatments, and Genexine, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to evaluate the combination of Hyleukin-7 (IL-7-hyFc) and atezolizumab (Tecentriq®) in patients with high-risk skin cancers.
The phase 1b/2a clinical study will be led by NeoImmuneTech and the Immune Oncology Network (ION), a network of clinical research investigators from leading cancer centers and universities in North America that conducts multicenter trial of high priority immunotherapy agents. The purpose of this study is to evaluate the safety and preliminary anti-tumor activity of Hyleukin-7 in combination with Tecentriq in approximately 80 patients with anti-PD-(L)1 naïve or relapsed/refractory high-risk skin cancers. The planned multi-center open-label trial will be conducted in the US. ION is headquartered at the Fred Hutchinson Cancer Research Center in Seattle Washington.
Martin A. “Mac” Cheever, M.D., Director of ION and the National Cancer Institute’s Cancer Immunotherapy Trials Network had stated, “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.”
“Patients with high-risk skin cancers have very poor prognosis and limited treatment options,” NgocDiep Le, M.D.,Ph.D., NeoImmuneTech Chief Medical Officer added. “Although anti-PD-1/PD-L1, including Tecentriq, can induce remarkable responses in a subset of patients with skin cancers, PD-(L)1 blockade fails to induce complete responses in most patients, especially those with low tumor infiltrating lymphocytes. Based on the mechanism of action of Hyleukin-7, we believe that combining Hyleukin-7 with a checkpoint inhibitor, such as Tecentriq, would increase the frequency and/or depth of responses to PD-1/PD-L1 inhibition.”
Brian Gastman, M.D., the Principal Investigator of this trial, a surgeon and otolaryngologist of Cleveland Clinic, a member of ION, also said, “With the exciting advances in checkpoint inhibitor-based immunotherapy, we are at an inflection point to identify the next generation of cancer treatments to enhance both survival outcome and quality of life for our patients. Hyleukin-7 has all of the aspects of a therapy that should work to enhance current immunotherapies especially in the various high-risk skin cancer patient populations. I am personally excited to witness this class of drug entering the clinical trial phase as the pre-clinical results have been so promising and the need for an additional novel immunotherapy class of drugs has never been so pressing."
Hyleukin-7 TM (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 to increase both the number and functionality of T cells. Hyleukin-7 could play a pivotal role in reconstituting and reinvigoratiing T cell immunity in the treatment of patients with cancer and lymphopenia, as well as providing unique opportunities for immuno-oncology (IO) combination strategies. Hyleukin-7 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, Inc. (Genexine) are collaborating for clinical trials in advanced solid tumors, glioblastoma, etc. in the US and Korea.
NeoImmuneTech, a clinical-stage US biotech company founded in 2014, is focused on leading the development efforts for its flagship immunotherapy product, Hyleukin-7, mainly in the U.S. 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-7, aiming at developing not only the first-in-class treatment of lymphopenia but also a breakthrough cancer immunotherapy. www.neoimmunetech.com
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