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Jacobio’s JAB-3312 received Orphan Drug Designation from U.S. FDA

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[Abstract]:

  On September 18, 2020, the United States Food and Drug Administration (U.S. FDA) granted Orphan Drug Designation to JAB-3312, an in-house developed innovated drug candidate, for the treatment of esophageal cancer, so as to provide support for the drug's global development for this indication.

  JAB-3312, which was granted Orphan Drug Designation by the U.S. FDA this time, is Jacobio's second small-molecule oral anti-tumor agent with global intellectual property rights and it was independently designed and developed by the company. This drug has received investigational new drug approval by both the U.S. FDA and Chinese NMPA in 2019. Currently, a phase I clinical trial has been initiated for this program in several sites based in the United States and China.

  JAB-3312 is a SHP2 protein tyrosine phosphatase inhibitor (PTPi) that may block the KRAS-MAPK signaling pathway. It can also relieve the tumor immunosuppressive microenvironment and enhance the efficacy of existing antitumor immunotherapies. Preclinical studies have shown that JAB-3312 can be used to treat a variety of solid tumors.

  In May 2020, Jacobio and AbbVie entered into a global strategic collaboration agreement for the development and commercialization of SHP2 inhibitors.