Sinogen Pharmaceutical's oncolytic bacteria drug SalMet-Vec® has obtained the third Orphan Drug Designation (ODD) from FDA for the treatment of small cell lung cancer
On August 28, 2023 US time, the oncolytic bacteria drug SalMet-Vec® which is independently developed by Sinogen Pharmaceutical, has been granted Orphan Drug Designation (ODD) by the US Food and Drug Administration (FDA) for the treatment of small cell lung cancer (SCLC). This is the third Orphan Drug Designation obtained by SalMet-Vec®. Previously, Sinogen Pharmaceutical's ODD application for the use of SalMet-Vec® in the treatment of osteosarcoma and hepatocellular carcinoma has been granted by the FDA.
Dr. Allan Zijian Zhao, Chairman and CEO of Sinogen Pharmaceutical, said, “Small cell lung cancer is a malignant tumor with a high degree of malignancy and extremely limited treatment methods, resulting in a very short survival period. This Orphan Drug Designation of SalMet-Vec® granted by the FDA not only reflects the urgent clinical needs in treating small cell lung cancer, but also recognizes the potential of SalMet-Vec®. We will take this opportunity to quickly carry out the clinical development of SalMet-Vec® in small cell lung cancer.”
About Small Cell Lung Cancer
Lung cancer is the malignant tumor with the highest incidence rate and mortality rate in the world. Small cell lung cancer (SCLC) is a kind of neuroendocrine tumor in the lung. It is characterized by low differentiation, high malignancy degree and poor prognosis (about 250,000 new cases and more than 200,000 deaths every year in the world), accounting for about 15% of all lung cancer cases. Smoking is a high-risk factor for the development of small cell lung cancer, with only 2% of SCLC patients being non-smokers. At present, the treatment methods for SCLC mainly include surgery, radiotherapy, chemotherapy, and targeted therapy. However, SCLC patients are prone to drug resistance and recurrence, so the five-year survival rate is only about 20%, while patients with metastasis have a five-year survival rate of less than 5%. Therefore, finding more effective drugs that target tumors and simultaneously kill primary and metastatic lesions to improve the survival prognosis of SCLC patients is an important challenge in clinical treatment of SCLC.
About Orphan Disease
Orphan disease is a rare disease. The FDA's Office of Orphan Products Development grants orphan status to drugs intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. ODD is designed to provide drug developers with various benefits to support the development of novel drugs, including market exclusivity for seven years upon FDA approval, eligibility for a 25% federal tax credits for qualified clinical trials, waiver of marketing registration application fees, reduced annual product fees, clinical protocol assistance and qualification for expedited development programs.
About Oncolytic Bacteria Product SalMet-Vec®
Oncolytic bacteria product SalMet-Vec® is a first-in-class genetic engineering biological product that can accurately target and rapidly dissolve tumors. SalMet-Vec® carries specific methionine hydrolase through attenuated Salmonella carrier, depriving the necessary amino acids required for tumor growth, thus killing tumor and preventing tumor proliferation. It is an efficient and tumor-targeting product for broad-spectrum solid tumors. Sinogen Pharmaceutical owns the complete global intellectual property rights of SalMet-Vec®, and it has more than 50 invention patents worldwide and has been authorized for 20. At present, Sinogen Pharmaceutical has successfully obtained the new drug clinical trial application (IND) license from the US FDA and Taiwan TFDA, and is conducting phase I/IIa registered clinical trials of intravenous administration and intratumoral administration of SalMet-Vec® in multiple clinical trial centers in the US and Taiwan, China. The clinical trials recruited patients with liver cancer, osteosarcoma, lung cancer, head and neck cancer, prostate cancer, breast cancer, melanoma and other advanced malignant solid tumors. In order to accelerate its development and review process in the United States, the FDA has granted three Orphan Drug Designations to the oncolytic bacteria drug SalMet-Vec®.
