ORLANDO, FL, USA I April 2, 2017 I Genexine Inc. (KOSDAQ: 095700) and Handok Inc. (KRX: 002390), co-developing next-generation, long-acting recombinant human growth hormone (rhGH), consisting Genexine’s proprietary hybrid Fc (hyFc) platform technology for pediatric and adult growth hormone deficiency (GHD) patients called GX-H9, today presented positive interim results from the ongoing phase 2 clinical trials of GX-H9 in pediatric growth hormone deficiency and full data from adult growth hormone deficiency (GHD) at the 99th Annual Meeting of the Endocrine Society for Pediatric Endocrinology (ENDO) on April 1st, 2017.
In multi-national, open label, randomized phase 2 pediatric growth hormone deficiency (GHD) trial, GX-H9 demonstrated annualized height velocities comparable to that of active comparator, daily recombinant human growth hormone (rhGH) at 3 months. This interim analysis was conducted with data obtained from 24 patients, which represents approximately 50% of the total enrollment in the trial completing three months out of the total six months of treatment. Key conclusions from the interim analysis include:
- mean annualized height velocities at 3 months were 10.7 cm and 15.3 cm for the two weekly doses of 0.8 mg/kg and 1.2mg/kg, respectively;
- twice-monthly dosing group receiving 2.4mg/kg, the mean annualized height velocity was 12.4 cm;
- mean annualized height velocities from three doses with weekly and twice monthly frequencies were comparable to active comparator, daily injections of Genotropin® with the mean annualized height velocity of 12.7cm;
- a dose-proportional increase in IGF-1 levels was observed following dosing of the three GX-H9 hormone doses in PGHD trial;
- both in pediatric and adult growth hormone deficiency (GHD) trials, GX-H9 was safe and well tolerated and the adverse events were comparable to those found in daily hGH treatment and dose-dependent PK/PD profiles were observed.
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 November 9th 2016. These GX-H9 trials have been funded partially by Korean Drug Development Fund (KDDF). Genexine and Handok are expecting full six-month efficacy results from PGHD trial in the 2nd half of 2017.
Genexine, Inc, listed on KOSDAQ (095700-KQ) since 2009, is a clinical stage biotherapeutics company focused on immuno-oncology,metabolic and autoimmune diseases. Genexine has robust R&D pipelines in clinical and pre-clinical stages based on long-acting Fc fusion technology and therapeutic DNA vaccine technology. In the clinical stage, Genexine has GX-H9 (long-acting human growth hormone, hGH-hyFc) co-developed with Handok 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. Currently Genexine is running over 9 clinical trials from Phase I to Phase IIb in Europe and Asia. In addition to Merck (MSD) collaboration, Genexine has strategic partnerships with leading Asian companies such as Shanghai Fosun Pharma, Tasly Pharma, Kalbe Pharma (largest healthcare Indonesian company), and Korean big Pharma companies such as Handok, Green Cross and Yuhan. 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. More information can be found at www.genexine.com
Handok (Chairman & CEO Young-Jin Kim), listed on KRX(002390) is a leading innovation-driven pharmaceutical/health-care company in Korea. Handok develops, manufactures and distributes healthcare solutions to improve the health and quality of human life. Handok has a core business focus on diabetes, cardiovascular, muscular skeletal, psychoneurotic disease, human vaccines, medical devices, diagnostics and consumer health. Handok, founded in 1954, grew as a joint venture with Hoechst/Aventis/Sanofi from 1964 to 2012. Handok has also established strategic collaborations in several areas with multiple multinational pharmaceutical companies. More information can be found at www.handok.co.kr
About ENDO 2017
ENDO 2017 is the world’s premier event for getting the latest updates in endocrine science and medicine. This is an annual meeting hosted by Endocrine Society which is 100-year-old global membership organization representing professionals from the intriguing field of endocrinology. This year Endocrine Society celebrates its Centennial and honors the profession with sessions highlighting the important advances in the history of endocrinology. More than 9,000 experts including medical doctors, scientists, researchers, and educators will participate for an educational experience and updates covering a broad array of topics about endocrinology.
The 99th Annual Meeting of Endocrine Society will be held at April 1st-4th, 2017 in Orlando.
About Korea Drug Development Fund (KDDF)
Established in September 2011, the Korea Drug Development Fund (KDDF), a consortium of three health-related Korean Ministries – the Ministry of Science, ICT, and Future Planning; the Ministry of Trade, Industry, and Energy; and the Ministry of Health and Welfare – is a government-initiated drug development program, which aims to transform Korea into a global leader for new drug development and to enhance national competitiveness in the global arena. More information can be found at www.kddf.org.