Genexine (KOSDAQ: 095700), an innovative biotechnology company focused on immuno-oncology, metabolic and orphan diseases, announced today that US FDA Office of Orphan Products Development (OOPD) has granted GX-H9 an orphan drug designation for the treatment of growth hormone deficiency.
GX-H9 is next-generation, long-acting recombinant human growth hormone (rhGH) consisting of recombinant growth hormone genetically fused to Genexine’s proprietary hybrid Fc (hyFc) platform, giving it extended half-life and potentially better safety profile. Compared to the current daily injection therapy, GX-H9 is being evaluated as weekly and twice-monthly dosing regimens to treat Growth Hormone Deficiency (GHD).
The US FDA’s Orphan Drug Designation is a program devised to advance the evaluation and expedite development of drugs and biologics which demonstrate significant promises for the diagnosis or treatment of rare diseases or life-threatening conditions affecting fewer than 200,000 people in United States. The designation provides the sponsor with development and commercial supports such as prioritized FDA review on clinical trials and approvals, credits on clinical trials, exemption from certain regulatory fees and 7 years of market exclusivity.
“We are thrilled to announce the first FDA Orphan designation of our pipeline. The Orphan Drug Designation for GX-H9 will enable us to move one step faster towards our goal of providing convenience to adults and kids suffering from GHD, especially in the largest GH market of the US,” stated Dr. Michael Keyoung, President and Chief Executive Officer of Genexine.
Genexine presented its multinational Phase 2 interim data from both pediatric and adult GHD trials at The European Society for Paediatric Endocrinology’s 55th Annual Meeting 2016 (ESPE) in September and will present at The 9th Biennial Asia Pacific Pediatric Endocrinology Society/50th Annual Japanese Society for Pediatric Endocrine Society Conference in Tokyo on November 19th. Genexine will obtain full data from AGHD trial by the end of this year and interim primary endpoint data from PGHD trial in 1H, 2017.
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 in strategic partnership with Handok. GX-188E therapeutic DNA vaccine for HPV-associated diseases is in Phase II in Europe and Korea for Cervical Intraepithelial Neoplasia II/III and plans to enter into Phase 1b/2a trial in cervical cancer with GX-188E in combination Keytruda (anti- PD-1 therapy) of Merck (also known as MSD) 1H of 2017. 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. Genexine has been listed on KOSDAQ (095700) since 2009.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161116005731/en/Business Wire
Last updated on: 16/11/2016
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