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Genexine Presents Phase 2 Interim Data of GX-H9 at JSPE
Genexine Inc. (KOSDAQ: 095700), an innovative biotechnology company, today announced that Dr. Michael Keyoung, CEO of Genexine, presented multinational Phase 2 interim data of GX-H9 for both pediatric and adult growth hormone deficiency (GHD) clinical trials during the 50th Annual Meeting of the Japanese Society for Pediatric Endocrinology (JSPE) in Tokyo on Nov 19th.
In pediatric GHD study, PK, PD, and safety data from up to 3 months of GX-H9 in the Phase 2 trial was presented. Based on the current results, GX-H9 demonstrated it was safe and well tolerated in pediatric GHD patients and the adverse events were comparable to those found in daily growth hormone control. Also, GX-H9 showed the potential for both weekly and twice-monthly treatment regimen. A full data from AGHD trial will be obtained by end of this year and interim data from PGHD trial will be available in 1H, 2017.
GX-H9, being co-developed with Handok under a strategic partnership, is a next-generation, long-acting recombinant human growth hormone (rhGH) consisting with Genexine’s proprietary hybrid Fc (hyFc) platform technology for pediatric and adult GHD patients. US FDA Office of Orphan Products Development (OOPD) has granted GX-H9 as an orphan drug designation for the treatment of growth hormone deficiency on Nov 9th.
▶About JSPE 2016
Founded in 1967, the Japanese Society for Pediatric Endocrinology (JSPE) has been leading the field of pediatric endocrinology and pediatric diabetes in Japan. JSPE has over 1,300 clinicians and researchers, who have specialized in pediatric endocrinology and diabetes. JSPE has established clinical practice guidelines for the most of the endocrinological disorders. Moreover, JSPE members have achieved substantial contributions to elucidating the mechanisms of a variety of endocrinological disorders utilizing cutting-edge techniques for molecular analyses such as next generation sequencing.
Genexine, Inc., listed on KOSDAQ (095700) since 2009, 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 recombinant human growth hormone, rhGH-hyFc) for both adult and pediatric GHD, currently in multinational phase II trials. 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.