Company Introduction
Company introduction
Genexine, Inc.
CEO
Young Chul Sung, Ph.D
Location
700 Daewangpangyo-ro, Korea
Bio Park Bldg. B, Bundang-gu,
Seongnam-si, Gyeonggi-do
463-400, South Korea
Homepage
http://genexine.com
30
Genexine, Inc. is a leading biotechnology company
specializing in immunotherapeutics, based on its
strong immunology expertise and R&D capabilities.
Founded in 1999, Genexine consists of about hundred employees, half
of which are scientists with MSc or PhD. Genexine is located in Korea
Bio Park, Pangyo Techno Valley near Seoul, Korea.
Platform Technology
1) hyFc
‌ technology – next generation half-life extension
technology
Genexine creatively invented hybrid Fc fusion half-life extension
technology that enables long-acting protein therapeutics with well-
balanced benefit of efficacy, safety, convenience, cost-efficiency as well
as substantially low risk of immunogenicity.
2) therapeutic DNA vaccine technology for infectious diseases
and cancer
Through long history of DNA vaccine R&D, Genexine has
accumulated extensive technology and know-how of therapeutic
DNA vaccines against viruses such as HPV, HBV, TB, etc. DNA vaccine
induces robust antigen-specific immune response against infected
cells or cancer.
Based on proprietary innovative platform technology, Genexine
has developed various products in preclinical and clinical-stages.
Genexine’s major clinical pipelines are GX-H9 (long-acting hGH-
hyFc) in Phase II in EU and Korea and GX-188E (therapeutic HPV
DNA vaccine) in Phase II in EU and Korea. In pre-clinical stage,
Genexine has GX-P2 (PD-L1-hyFc as a PD-1 agonist) for autoimmune
diseases, GX-I7 (IL-7-hyFc), GX-F7 (long-acting Factor VII-hyFc), etc.
R&D Pipeline
1) GX-H9 (Long-acting hGH-hyFc): Long-acting human growth hormone (hGH) genetically fused
with Genexine’s proprietary hybrid Fc (hyFc) platform. The first in human trial has been completed
in EU and currently a multinational AGHD patient phase 2 clinical study is being conducted in EU
and Korea. In phase I clinical trial, no SAEs and ADA formation were reported, and dose-dependent
PK and PD (IGF-1 level) profiles were demonstrated. GX-H9 is targeting pediatric and adult growth
hormone deficiency patients with weekly and semi-monthly administration and being co-developed
with Handok Pharmaceuticals.
2) GX-188E (HPV therapeutic DNA vaccine): HPV therapeutic DNA vaccine for Cervical
Intraepithelial Neoplasia (CIN) / Cervical Dysplasia in Phase II clinical trial. GX-188E has the
potential to induce complete regression from high grade Cervical Intraepithelial Neoplasia caused
by high-risk types of HPV16/18 infection. In Phase I clinical trial, Genexine demonstrated that
electroporation(Ichor Medical Systems)-enhanced immunization with a rationally designed HPV
DNA vaccine (GX-188E), preferentially targeting HPV antigens to dendritic cells, elicits a significant
E6/E7-specific IFN-γ-producing T-cell response in all nine cervical intraepithelial neoplasia 3 (CIN3)
patients. Seven out of nine patients displayed complete regression of their CIN3 lesions and viral
clearance and exhibited an enhanced polyfunctional antigen-specific CD8 T-cell response within 36
weeks of follow up. These results were recently published in Nature Communications (Kim et al.,
Nature Comm., 2014; 5,5317).
3) GX-P2 (PD-L1-hyFc as a PD-1 agonist): GX-P2 is PD-L1-hyFc as a PD-1 agonist, which is
a first-in-class drug candidate in preclinical stage for autoimmune diseases. It is based on our
innovative long-acting hyFc technology (next generation Fc fusion technology). GX-P2 is designed
to induce T-cell tolerance by targeting PD-1 and/or B7.1 and able to regulate uncontrolled T-cell
activation or proliferation in autoimmune diseases. We confirmed animal PoC in inflammatory
bowel disease (IBD) and published the results in Gut journal (Song et al., Gut, 2015; 64(2):260-
271).
31