On April 26, 2019 Genexine, Inc. (Genexine) and NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, reported that the first patient has been dosed in a combination regimen trial to investigate the safety and efficacy of Hyleukin-7, 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) (Press release, Genexine, APR 26, 2019, View Source [SID1234535421]).

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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) (Free AACR Whitepaper) 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.

About Hyleukin-7

Hyleukin-7 (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.