China’s oncology specialist Guangzhou Sinogen Pharmaceutical Co., Ltd. has announced receiving Orphan Drug Designation (ODD) from the US FDA for its SalMet-Vec in pancreatic cancer. This oncolytic bacteria drug has previously earned ODD statuses from the agency for osteosarcoma, hepatocellular carcinoma, and small cell lung cancer.
Drug Profile and Mechanism
SalMet-Vec is a genetically engineered oncolytic bacterium that carries specific methionine hydrolase through an attenuated Salmonella carrier. This mechanism deprives the necessary amino acids required for tumor growth, thereby killing the tumor and preventing its proliferation. The drug has demonstrated good safety and significant clinical efficacy in trials involving solid tumors such as liver cancer, lung cancer, sarcoma, and head and neck cancer, through both intravenous and intratumoral administration.
Clinical Approvals and Trials
SalMet-Vec has received clinical approvals in the US, Taiwan, and mainland China. These approvals are based on the drug’s promising safety and efficacy profiles in treating various solid tumors, highlighting its potential as a novel therapeutic option in oncology.
Significance of the Orphan Drug Designation
The Orphan Drug Designation for SalMet-Vec in pancreatic cancer underscores the potential of this innovative therapy to address significant unmet medical needs. This designation is expected to facilitate the development and regulatory review process, bringing the drug closer to market and potentially improving patient outcomes in pancreatic cancer.-Fineline Info & Tech
