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Genexine and NeoImmuneTech Announce Dosing of First Patient in the Combination Trial of Hyleukin-7™ with Merck’s KEYTRUDA® in Triple-Negative Breast Cancer

ROCKVILLE, Md.–(BUSINESS WIRE)–Genexine, Inc. (Genexine) and NeoImmuneTech,
(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-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).

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

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
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.

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-7™, 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,

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.

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.
+1 781-235-3060

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