Press Release

NeoImmuneTech, Genexine, SNUH and POSTECH researchers Announce Presentations at the American Association for Cancer Research (AACR) Annual Meeting 2019


— Data presented includes results from preclinical studies and clinical trials with the T cell amplifier Hyleukin-7™ —

April 03, 2019 — ROCKVILLE, Md.--(BUSINESS WIRE)--NeoImmuneTech, Inc. (NIT), a T cell-based therapeutics company, today announced the presentation of new research at the AACR Annual Meeting, being held March 29 - April 3, 2019 in Atlanta, GA. Study results regarding Hyleukin-7™ (Interleukin-7-hyFc), developed jointly with Korean affiliate company Genexine, Inc. (Genexine), will be presented in two posters.

Presentation Details:
Title: CT045. Hyleukin-7, a long-acting interleukin-7, increased absolute lymphocyte counts after subcutaneous and intramuscular administration in healthy subjects
Date: April 1, 2019

This poster details Hyleukin-7’s safety profile and T cell boosting effects from the first-in-human study in healthy subjects. Hyleukin-7 administration was well-tolerated, exhibited dose-dependent increases in T cells, and significantly increased killer and memory T cells, which are crucial for effective anti-tumor response. Additionally, the poster reports that dose escalation of Hyleukin-7 in multiple ongoing clinical trials in cancer patients has shown similar safety profiles to the first-in-human study, and also demonstrated dose-dependent increases of killer T cells. The study was led by professor Howard Lee of Seoul National University Hospital (SNUH).

Title: 4991. Hyleukin-7, the Fc-fused interleukin-7, generates anti-tumor activity by modulating both adaptive and innate immune cells in the tumor microenvironment
Date: April 3, 2019

Data shown here focuses on the anti-cancer mechanism of Hyleukin-7 from preclinical studies. Hyleukin-7 affected the immune cells not only in the peripheral blood but also in the tumor microenvironment (TME). This study, led by professor Seung-Woo Lee of Pohang University of Science and Technology (POSTECH), Korea, demonstrated that administration of Hyleukin-7 in an animal cancer model significantly increased the quantity of killer T cells. Most importantly, within the TME killer T cells drastically increased while regulatory T cells and myeloid lineage cells (immune suppressor cells) such as myeloid-derived suppressor cells (MDSC) substantially decreased, resulting in significant anti-tumor activity.

"This research is the first to demonstrate that a long-acting IL-7 effectively modulates the TME, significantly amplifying anti-tumor T cells and reducing immune-suppressive cells such as MDSCs in the tumor," said professor Seung-Woo Lee. "These data allow us to envision Hyleukin-7 as a potential next-generation cancer immunotherapy with a differentiated function."

“Having recently raised $92 million in Series D funding round, we aim to use the funds to continue confirming the anti-tumor effects and mode of action of Hyleukin-7 through multiple monotherapy and combination therapy clinical trials in various tumor types,” added Se Hwan Yang, Ph.D., Chief Executive Officer of NIT.

NIT and Genexine are currently conducting dose-escalation studies to identify an optimal Hyleukin-7 dosing regimen in advanced solid tumors and brain cancer (glioblastoma) patients. NIT and Genexine are also collaborating with global pharmaceutical companies to combine Hyleukin-7 with anti-PD-1/anti-PD-L1 therapies in clinical trials in high-risk skin cancers and triple-negative breast cancer patients in the United States and Korea, respectively.

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-based therapeutics designed to prime, enhance and extend the activity of current and future cancer therapies. Our lead product, Hyleukin-7™, a T cell growth factor, amplifies and reinvigorates persistent 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.
NIT is a U.S.-based company developing Hyleukin-7 for the U.S. and EU markets in collaboration with Korean-based Genexine.

MacDougall Biomedical Communications
Shai Biran, Ph.D., +1 781-235-3060