Crystal Genomics' immunotherapy gets orphan drug status from US regulator

Lee Han-soo  Published 2019.08.28  17:44  Updated 2019.08.28 22:40


Crystal Genomics' CG-745, a molecular immunotherapy for pancreatic cancer, has won orphan drug designation (ODD) from the U.S. Food and Drug Administration.

The drug candidate inhibits the function of the histone deacetylase (HDAC), an epigenetic protein, and weakens or destroys the cancer cell's command system. The company had gained the ODD from the Ministry of Food and Drug Safety, too.

The ODD is a system that helps facilitate the development and approval of therapeutic drugs for rare or life-threatening diseases. ODD drugs receive tax benefits, exemption of license application fees, and seven-year monopoly after obtaining authorization.

"CG-745 is undergoing a phase 2 clinical trial at Severance Hospital to evaluate its safety and efficacy in combination with Gemcitabine and Erlotinib to treat advanced or metastatic pancreatic cancer patients incapable of performing pancreatic cancer surgery," a company official said. "The company firmly believes that the treatment is a best-in-class drug candidate among all HDAC inhibitors being developed around the world in terms of efficacy and safety."

The official noted that the treatment had shown significant efficacy in phase 1 clinical trial with a response rate of 56 percent among various cancer patients. Crystal Genomics also expects an excellent response rate and efficacy in phase 2 clinical trials, he added.

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