Market Overview

Ichor Medical Systems Announces Utilization of Its Investigational TriGrid Delivery System in a Clinical Trial Evaluating GX-188E Vaccine Combined with a Checkpoint Inhibitor for Treatment of Cervical Cancer


Ichor Medical Systems, Inc. (Ichor) announced today that its
investigational TriGrid® Delivery System (TriGrid)
is being utilized in a Phase 1b/2 clinical trial to administer GX-188E,
an investigational therapeutic HPV DNA vaccine developed by Genexine,
Inc., in patients with human papilloma virus (HPV)-induced advanced
non-resectable cervical cancer, in combination with an anti-PD-1 therapy

Cervical cancer is the fourth most common cancer affecting women
worldwide and is almost always caused by infection with HPV.
Preventative vaccines for cervical cancer are ineffective in women who
are already infected with HPV, and despite advances in screening and HPV
vaccination, a significant number of women develop advanced disease.
Although chemotherapy is the standard first-line treatment for advanced
cervical cancer, the prognosis remains poor and effective second line
options are still needed.

Ichor's patented TriGrid Delivery System uses electroporation to open
pathways into cells to facilitate entry of a DNA vaccine into its
intracellular site of action. The TriGrid has been utilized in >25 clinical
, including randomized comparative studies demonstrating that
administration of DNA vaccines with the TriGrid device significantly
enhanced immune responses to the vaccines compared to conventional
injection. A Phase 1 study using the TriGrid to deliver GX-188E in
patients with high grade cervical intraepithelial neoplasia (CIN), a
precancerous stage of cervical cancer, showed promising results with
GX-188E demonstrating the ability to induce a tumor-specific immune
response with evidence of lesion clearance (Nat
Commun. 2014 Oct 30; 5: 5317

Immuno-oncology is a rapidly evolving field of medicine designed to
improve the ability of a patient's immune system to detect and destroy
tumors. The study has been initiated in Korea with plans to enroll up to
46 patients and was recently announced by Genexine.

Robert Bernard, Ichor Founder and CEO, stated, "Ichor's TriGrid Delivery
System is a platform technology used by an increasing number of Ichor
partners for clinical delivery of their DNA vaccines where T-cell
generation is a critical aspect of the prescribed immunotherapy. We are
pleased through our Genexine partnership to expand TriGrid's use into
additional areas of immuno-oncology around the world."

About Ichor Medical Systems, Inc.

Ichor Medical Systems' investigational TriGrid® Delivery
System is the first integrated and fully automated device for
electroporation-mediated nucleic acid administration in humans. Ichor, a
privately-held biotech company based in San Diego, CA, is collaborating
with partners to provide its enabling TriGrid platform as a means for
delivery of nucleic acid-based drugs and vaccines in disease indications
such as cancer, hepatitis B virus (HBV) infection, human papillomavirus
(HPV) infection, and human immunodeficiency virus (HIV) infection, as
well as for multiple biodefense agents. The TriGrid platform is also
being developed for nucleic acid-based antibody delivery as a rapid
countermeasure in the event of an infectious disease outbreak or
biological weapons attack. Visit

▶ About GX-188E:

GX-188E, currently being developed in Phase 2 clinical trials, is an HPV
therapeutic DNA vaccine for cervical intraepithelial neoplasia (CIN) and
HPV-induced cancers caused by persistent infection by high-risk HPV
types, 16/18. A Phase 1 study demonstrated that GX-188E, a rationally
designed HPV DNA vaccine to target HPV antigens preferentially on
dendritic cells, elicited significant E6/E7 specific IFN-γ-producing
T-cell responses in all CIN3 patients when administered intramuscularly
by electroporation. Seven out of nine patients had complete regression
of their CIN3 lesions, viral clearance, and exhibited enhanced
antigen-specific polyfunctional CD8 T-cell responses within 36 weeks of
follow-up. These results were published in October 2014 in Nature

▶ About Genexine:

Genexine, Inc., listed on KOSDAQ (095700) since 2009, is a leading
biotherapeutics company focused on immuno-oncology and orphan disease.
Genexine has robust pipelines in clinical and pre-clinical stages based
on long-acting Fc fusion technology and therapeutic DNA technology. In
the clinical stage, Genexine has GX-H9 (long-acting human growth
hormone, hGH-hyFc) for both adult and pediatric growth hormone
deficiencies, currently in multinational phase 2 trials. GX-188E
therapeutic DNA vaccine for HPV-associated diseases is in Phase 2 in
Europe and Korea for Cervical Intraepithelial Neoplasia 2/3, and has
initiated a Phase 1b/2 trial in cervical cancer with GX-188E in
combination with KEYTRUDA, an anti-PD-1 therapy marketed by Merck & Co.,
Inc., Kenilworth, NJ, USA. Founded in 1999, Genexine has over 150
employees, and half of them are scientists with MSc, or Ph.D. Genexine
is located in Pangyo Techno Valley near Seoul, Korea with a branch
office in New York.

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