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Genexine innovative assets in clinical phase 2 Trial (Pd No. : 3079053)

(Updated : Feb/13/2017)
product information
Model Nm GX-H9/GX-188E
HS CODE 300220
M.O.Q
Ceritification
Keywords GX-H9,GX-188E,hyFc,Therapeutic DNA vaccine, Human Growth Hormone
Seller ID genexine1
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[Company Introduction]


Genexine, Inc. (KOSDAQ, 095700) is a leading biotechnology company specialized in long acting Fc fusion protein drugs based on its proprietary hyFc platform technology and immunotherapeutic vaccines

 

Genexine is developing proprietary pre- and clinical stages biologics targeting cancer, orphan diseases and autoimmune disorders. In clinical stages, Genexine has long acting (weekly or longer) GX-H9 (hGH-hyFc) for both adult and pediatric hGH deficiencies in phase II in EU and Korea after completion of EU Phase I, GX-E2 (EPO-hyFc) for chronic kidney disease induced Anemia in Phase II in Korea (partnered with Fosun for China) and GX-188E (therapeutic DNA vaccine) for high grade Cervical Intraepithelial Neoplasia currently in two separate Phase II trials in EU and Korea and also phase I study in the US for combination treatment with immune adjuvant in cervical cancer under preparation.

 

Founded in 1999, Genexine consists of about 130 employees, half of which are scientists with MSc or PhD. Genexine is located in Pangyo Techno Valley near Seoul, Korea.

 


 [Technology Description]

 

GX-188E


1. Description


 HPV therapeutic DNA vaccine for high-grade Cervical Intraepithelial Neoplasia (CIN2/3) in Phase II clinical trial. GX-188E has a potential to induce complete regression of high grade Cervical Intraepithelial Neoplasia caused by persistent infection with high-risk HPV types, 16/18.

  Phase I clinical trial demonstrated that GX-188E, a rationally designed HPV DNA vaccine to target preferentially HPV antigens to dendritic cells, elicited significant E6/E7specific IFN-γ-producing T-cell responses in all nine cervical intraepithelial neoplasia 3 (CIN3) patients when administered intramuscularly by electroporation. Seven out of nine patients displayed complete regression of their CIN3 lesions and viral clearance and exhibited enhanced poly-functional antigen-specific CD8 T-cell responses within 36 weeks of follow up.


2. Clinical trials/clinical strategy

-Phase II in Korea for CIN3 (interim data available)

-Phase II in EU for CIN2/3 (on going)


3. Key publications

-Nature Communications. 2014; 5,5317, (Kim et al.)

 

4. IP rights

 Worldwide Patents registered

 

 

GX-H9 (hGH-hyFc)

 

1. Description


  Long-acting human growth hormone (hGH) genetically fused with Genexine’s proprietary hybrid Fc (hyFc) platform for growth hormone deficiency. Phase I trial completed in the Netherlands and currently two multinational Phase II clinical studies being conducted, for both AGHD and PGHD in EU/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 deficiencies with weekly and twice monthly administration and being co-developed with Handok Pharmaceuticals.

 

2. Clinical trials/clinical strategy

-Phase I in EU completed in 2Q/2014.

-Phase II in EU/KR ongoing for AGHD

-Phase II in EU/KR ongoing PGHD

 

3. Partners

Handok (Korea), Tasly (China)

 

4. IP rights

Worldwide Patent registered






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Company Information

company information
Contact Person Jin J. Lim
Company Genexine Co., Ltd.
Address
Homepage www.genexine.com , http://seller.buykorea.org/genexine--1068953
Tel 02-3482-3877 Fax 02-3482-3878
Biz. Type Est. Year
Employees Annual Export USD 0~1 mn
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