— ROCKVILLE, Md. – April 25, 2019 – Genexine, Inc. (Genexine) and NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, today announced that the first patient has been dosed in a combination regimen trial to investigate the safety and efficacy of Hyleukin-7TM, their T cell amplifier, in combination with Merck’s anti PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with refractory or relapsed triple-negative breast cancer (TNBC).
In June 2018, this study was selected as a grantee of ‘Joint R&D Program’ supported by Korea Drug Development Fund (KDDF) and recently received authorization to proceed from The Korean Ministry of Food and Drug Safety (MFDS) to initiate this Phase 1b/2 study. The clinical trial is currently under recruitment in about ten clinical sites in Korea including Samsung Medical Center.
TNBC consists 15~20% of breasts cancer patients, with a high incidence rate among young women. Its unmet medical needs are very high due to the absence of a targeted therapy and the comparably short survival period after relapse.
“This combination regimen trial of Hyleukin-7 and KEYTRUDA is very meaningful, in that it attempts to treat advanced or metastatic TNBC patients who respond poorly to standard-of-care treatments.” said Jung Won Woo, Ph.D., Senior Vice President, Head of Clinical Division of Genexine. “We believe Hyleukin-7 could deliver improvements for patients non-responsive to immunotherapy regimens by treating lymphopenia, which is commonly observed in TNBC patients, as well as amplifying tumor-infiltrating lymphocytes (TILs) that may enhance anti-tumor response.”
NIT, Genexine and Pohang University of Science and Technology (POSTECH) researchers have recently announced a new anti-tumor mode of action of Hyleukin-7 at the American Association for Cancer Research (AACR) Annual Meeting 2019. Hyleukin-7 treatment conferred anti-cancer activity by inducing an immune-favorable tumor microenvironment (TME) in animal models, where Hyleukin-7 drastically increased the ratio of killer T cells to immune-suppressive cells (such as regulatory T cells and myeloid-derived suppressor cells).
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. Genexine and NIT have been also actively conducting and planning multiple proof-of-concept clinical trials to develop Hyleukin-7, a T cell amplifier as an immune-oncology (IO)-enabling drug in combination with other cancer therapeutics such as immune checkpoint inhibitors and chemo/radiotherapies.
Additional information on the trial can be found on www.clinicaltrials.gov using the identifier NCT03752723.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.
Hyleukin-7TM (rhIL-7-hyFc, GX-I7, NT-I7), an immuno-oncology agent, is a homeostatic 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 Genexine, Inc.
Genexine, Inc., listed on KOSDAQ (095700) since 2009, is a leading biotherapeutics company focused on immuno-oncology and orphan disease. Genexine has a robust pipeline of products in the clinical stage, e.g. Hyleukin-7TM, HyTropin (GX-H9), Papitrol (GX-188E), etc. based on long-acting Fc fusion technology and therapeutic DNA vaccine technology. Genexine has completed multinational phase II trials and is preparing to apply IND of US Phase III trial for HyTropin (long-acting human growth hormone, hGH-hyFc). Papitrol, a therapeutic DNA vaccine for HPV-associated diseases, is under Phase II in Europe and Korea for Cervical Intraepithelial Neoplasia (CIN) II/III. Founded in 1999, Genexine has over 140 employees, and half of them are scientists with MSc, or Ph.D. Genexine is located in Pangyo Techno Valley near Seoul, Korea. www.genexine.com
About NeoImmuneTech, Inc.
NeoImmuneTech (NIT) is developing T cell-focused 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, 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.
Shai Biran, Ph.D.