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CMC Biologics and Genexine Announce Manufacturing Agreement for Genexine's Human Growth Hormone Drug, GX-H9
(source : CMC Biologics) URL - http://www.cmcbio.com/resource-center/news/cmc-biologics-and-genexine-announce-manufacturing-agreement-for-gx-h9
BOTHELL, Washington, U.S.A., and SEONGNAM, Republic of Korea, February 21, 2017 -
CMC ICOS Biologics, Inc. (“CMC Biologics”), a global leader in clinical and commercial manufacturing of therapeutic proteins, and Genexine, Inc. (KOSDAQ: 095700), an innovative biotechnology company focused on immuno-oncology, metabolic and orphan diseases, today announced that they have entered into a manufacturing agreement for the process transfer and cGMP manufacturing of Genexine’s GX-H9.
GX-H9, being co-developed with Handok under a strategic partnership, 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) in adult and pediatric patients. The US FDA Office of Orphan Products Development (OOPD) has granted GX-H9 orphan drug designation for the treatment of growth hormone deficiency.
“We have selected CMC Biologics as our manufacturing partner for GX-H9 because of their demonstrated technical expertise and the quality of their cGMP operations,” said Dr. Michael Keyoung, Genexine’s President & Chief Executive Officer. “The successful transfer and manufacture of GX-H9 is critical to meeting our clinical timelines as we advance our lead candidate towards a pivotal study and we believe that CMC can take us there.”
Human growth hormone (hGH) is a polypeptide hormone consisting of 121 amino acids. It is produced by the pituitary gland located in the lower part of the brain and promotes growth and development of human body. hGH plays a critical role in the human metabolic system, stimulating synthesis of proteins and the absorption of amino acids at the cellular level. hGH stimulates production of IGF-1 insulin-like growth factor 1 (IGF-1) in the liver, which has growth-stimulatory effects on variety of tissues including muscles and bone tissue. The level of hGH increases through childhood and adolescence. It is present at the most optimum level during the age of 15 years to 30 years but declines with age.
“As human growth hormone plays a critical role in the human metabolic system, GX-H9 will be critical for both children and adult with hormone defiency to receive this drug. We are very excited to be working with Genexine, to help these patients potentially live their lives as normal as possible after treatment,” said Gustavo Mahler, PhD, Global Chief Executive Officer & President of CMC Biologics.
The key function of hGH is growth and is responsible for increasing height. Thus in children and adolescents, deficiency of hGH or Growth Hormone Deficiency (GHD) can thus lead to dwarfism, delay in sexual maturity or growth delay. In adult, shortage in hGH can adversely affect the overall quality of life including reduction in social, mental and physical energy; reduction in muscle mass, increase in body fat, increase in cholesterol level, higher cardiovascular disease rates and lower bone density.