CSPC Pharmaceutical Group Limited (01093) said that humanized connexin 43 (Cx43) monoclonal antibody (ALMB-0168), a product candidate independently developed by its subsidiary AlaMab Therapeutics Inc., was granted rare paediatric disease designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. It represents another designation of ALMB-0168 in addition to the orphan-drug designation granted by the U.S. FDA in September 2019.
ALMB-0168 is a first-in-class humanized monoclonal antibody agonist for hemichannel Cx43 membrane protein. Through the activation of Cx43 protein to release tumour-inhibiting cytokines, ALMB-0168 has shown to effectively inhibit osteosarcoma and bone metastasis in pre-clinical in vitro and in vivo animal studies.
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