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NeoImmuneTech Announces that the FDA has Allowed the Center for Cancer Research, National Cancer Institute to Proceed with an Investigational New Drug Application to Initiate a Clinical Trial for Hyleukin-7™ with Vaccines in Elderly Cancer Survivors

— ROCKVILLE, Md. – May 24, 2019 – NeoImmuneTech, Inc. (NIT), a T cell-focused immunotherapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has allowed the Center for Cancer Research, National Cancer Institute to proceed with an Investigational New Drug application (IND) application for Hyleukin-7™, a long acting T cell amplifier, to begin a clinical trial aiming to enhance the immune reconstitution and vaccine responses in elderly cancer survivors following chemotherapy.


The study’s principal investigator, Ronald Gress, M.D., Chief, Experimental Transplantation & Immunology Branch, Center for Cancer Research, National Cancer Institute (NCI), National Institutes of Health commented. “Our previous study with IL-7 in humans showed restoration of polyclonality in T cell populations; the question now is whether the restored clonality has functional benefit in response to antigen challenge.”


Elderly cancer survivors are vulnerable to vaccine-preventable diseases and are known to have poor anti-vaccine-specific immune responses. Effective prevention of communicable diseases is important for cancer survivorship, especially in the elderly population. The cytokine Interleukin-7 (IL-7) may play a role in immune reconstitution and immune enhancement in various circumstances of immune insufficiency in older individuals following chemotherapy. This phase 1/1b study will test whether Hyleukin-7, a long acting human IL-7, can enhance specific immune responses to selected vaccines in older subjects following chemotherapy.


“As we continue to explore the potential of Hyleukin-7 in oncology and other therapeutic areas, including infectious disease, NIT and the world-renowned experts at the NCI are very encouraged by the strong scientific rationale supporting the combination of Hyleukin-7 with various vaccines to enhance immune responses,” said NgocDiep Le, M.D., Ph.D., NIT’s Executive VP and Chief Medical Officer. “Our mission at NIT is to develop innovative therapeutic options to ultimately improve the survival and quality of life for cancer patients. Through an in-depth analysis of Hyleukin-7’s function on specific T cell subsets, both in quantitative and qualitative aspects in this clinical trial, we will be able to assess the potential of using Hyleukin-7 in combination with various vaccines in Infectious Disease and Oncology.”


In the phase 1 trial in healthy subjects and multiple ongoing dose-escalation trials in cancer patients, Hyleukin-7 showed a well-tolerated safety profile and dose-dependent increases of CD4+ and CD8+ T lymphocyte counts. NIT has been also actively conducting and planning multiple proof-of-concept clinical trials to develop Hyleukin-7 as an immune-oncology (IO)-enabling drug in combination with other cancer therapeutics such as immune checkpoint inhibitors or chemo/radiotherapies.


About Hyleukin-7™

Hyleukin-7™ (rhIL-7-hyFc, NT-I7), an immuno-oncology agent, is a T cell growth factor composed of 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 homeostasis, acting to increase both the number and functionality of T cells. Hyleukin-7 amplifies and reinvigorates persistent T cell immunity in the treatment of patients with cancer and lymphopenia, thus 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 as well as next generation IO therapeutics. 


About NeoImmuneTech, Inc.  

NeoImmuneTech (NIT) is developing T cell-focused immunotherapeutics designed to prime, enhance and extend the activity of current and future cancer therapies. Our lead product, Hyleukin-7™, a T cell growth factor, has the potential to amplify and prolong anti-tumor activity, which is pivotal to extending survival of cancer patients. Hyleukin-7 is being studied in multiple clinical trials in solid tumors, and being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications. www.neoimmunetech.com

NIT is a U.S.-based company developing Hyleukin-7 for the U.S. and European markets in collaboration with Korean-based Genexine. 


Contacts

MacDougall

Shai Biran, Ph.D.

+1 781-235-3060

sbiran@macbiocom.com


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