Genexine Enters into Clinical Research Collaboration with MSD

SEONGNAM, South Korea–(BUSINESS WIRE)– Genexine
(KOSDAQ:095700), a clinical stage biotechnology company developing
innovative biologics, today announced that it has entered into a
clinical research collaboration with Merck
& Co., Inc. (NYSE:MRK), Kenilworth, NJ, USA (known as MSD
outside the US and Canada), for the assessment of Genexine’s GX-188E,
HPV therapeutic DNA vaccine, in combination with MSD’s anti-PD-1
therapy, Keytruda® (pembrolizumab), for the treatment of patients with
HPV-induced cancers.

Under the terms of the agreement between Genexine and MSD, through a
subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Genexine will
conduct a Phase 1b/2a clinical trial to access safety and efficacy of
the combination therapy, and MSD will provide clinical supplies of
Keytruda and offer support to the study. The agreement also includes
provision for potential expansion to include Phase III registration
studies in the same indication. Additional details were not disclosed.

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 purpose of the study is to investigate which combination
modalities of treatment will work best in patients with advanced
HPV-induced cervical cancer. An objective response rate (ORR) of 12.5%
was observed in a Keytruda clinical trial in patients with advanced
cervical squamous cell cancer. Genexine expects that Keytruda is well
suited to complement its HPV therapeutic DNA vaccine and that the
combination with GX-188E can increase those response rates.

Gleaning from the trial in CIN, the Phase 1b/2a cancer study is
scheduled to begin in the first half of 2017 with plans to enroll up to
40 patients. GX-188E induces T cells specific to E6/E7 protein
originated from HPV type 16 and 18 and preclinical results for the
combination therapy show the potential that the induced disease-specific
T cells will work synergistically with anti-PD1 Ab. The combination
trial with Keytruda and GX-188E will test to replicate animal POC in
human to increase T cell specific immunotherapy.

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

About GX-188E

GX-188E,
currently being developed in Phase 2 clinical trials, is a 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 I 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
Communications.

About Genexine

Genexine,
Inc. is a leading biotherapeutics company focused on immuno-oncology
and metabolic/autoimmune diseases. 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 II trials after the completion of an EU Phase I
study. GX-188E therapeutic DNA vaccine for HPV-associated diseases is in
Phase II in Europe and Korea. GX-I7 is a long-acting Interleukin-7
(IL-7-hyFc) currently developed as a treatment of cancer and infectious
diseases. Founded in 1999, Genexine consists of about 140 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.
Genexine has been listed on KOSDAQ (095700) since 2009.

View source version on businesswire.com: http://www.businesswire.com/news/home/20161116005667/en/