Press Release

Hyleukin-7TM Selected as a Korea Drug Development Fund (KDDF) Project for Combination Trial with Merck’s KEYTRUDA®


July 18, 2018 — ROCKVILLE, Md.– (BUSINESS WIRE)–Genexine, a clinical stage biotechnology company developing innovative biologics, and its spin-off company in the US, NeoImmuneTech, Inc. (NIT), today announced that Hyleukin-7TM, their investigational T cell amplifier, has been selected for inclusion in the Korea Drug Development Fund (KDDF)’s new drug development project. With the support of a KDDF grant and NIT’s participation, Genexine will conduct a phase 1b/2 clinical trial to investigate the safety and efficacy of Hyleukin-7TM treatment in combination with Merck’s anti PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with triple-negative breast cancer.

“If successful, we believe this collaboration with Merck will give more clinical evidence for Hyleukin-7TM’s potential ability to reconstitute and reinvigorate the anti-tumor T cell immunity in TNBC patients, who tend to show relatively low response rates and poor survival for a checkpoint inhibitor treatment,” said Genexine’s SVP, Head of Development Division, Jungwon Woo, Ph.D. “This collaboration will allow us to progress quickly in the clinic as a part of robust examination of Hyleukin-7TM’s broad applicability.”

The purpose of the study is to evaluate the safety and anti-tumor activity of the combination agents in patients with triple negative breast cancer. The trial aims to study Hyleukin-7TM’s effect on the efficacy of KEYTRUDA® by enhanced antitumor T cell immunity and increased TIL (Tumor Infiltrated Lymphocytes) count.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.

About HyLeukin-7
Hyleukin-7TM (IL-7-hyFc, NT-I7) is a T cell amplifier, comprising 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, acting on increasing both the number and functionality of T cells. Hyleukin-7TM could play a pivotal role in reconstitution and reinvigoration of T cell immunity for treatment of cancer patients, providing unique opportunities for Immuno-oncology (IO) combination strategies. Hyleukin-7TM is being developed as an “IO enabling” therapy to harness T cell immunity in combination with many other cancer treatments, especially with anti-PD-(L)1 agents or chemo/radiotherapy. In a recent Phase I clinical trial in healthy volunteers, a single dose of Hyleukin-7TM was safe and well tolerated and substantially increased the absolute lymphocyte counts (ALC) as well as the number of CD4/CD8 T cells without an increase in the number of regulatory T cells. NeoImmuneTech and Genexine are collaborating in three Phase 1b/2a clinical trials in advanced solid tumors and glioblastoma in the US and Korea.

About Korea Drug Development Fund (KDDF)
Korea Drug Development Fund (KDDF), is a cross-ministry, full-cycle and government-initiated R & D business entity that supports new drug development beyond the boundaries of R & D. It was established by the Ministry of Science, ICT, and Future Planning, the Ministry of Trade, Industry, and Energy, and the Ministry of Health and Welfare to promote new drug development projects for global markets. Its aim is to have at least 10 new drugs developed and to advance the strategic investment platform for new drug R & D investment targeting global market.

About Genexine
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.

About NeoImmuneTech
NeoImmuneTech (NIT), a Genexine spin-off company founded in 2014, is focused on leading the development efforts for its flagship immunotherapy product, Hyleukin-7TM, in the U.S. and EU. Based in Rockville, Maryland, NIT has the core competency of global clinical and business development with a strong scientific focus and a broad network of global leading R&D organizations. NIT is currently conducting Phase 1b/2a clinical trials of Hyleukin-7TM, aiming at developing not only the first-in-class treatment of lymphopenia but also a breakthrough cancer immunotherapy.

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

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