Sinogen Pharmaceutical's oncolytic bacteria product SalMet-Vac® has obtained FDA Fast Track Designation
On January 23, 2024, The oncolytic bacteria injection SalMet-Vec® which is independently developed by Guangzhou Sinogen Pharmaceutical, was granted a fast track designation (FTD) by the US Food and Drug Administration (FDA) for the treatment of metastatic osteosarcoma patients who have received at least two treatments in the past. Obtaining this qualification will help accelerate the progress of clinical trials and market registration. Previously, SalMet-Vec® has been granted Orphan Drug Designation (ODD) by FDA for the treatment of osteosarcoma.
Dr. Allan Zijian Zhao, Chairman of Sinogen Pharmaceutical, stated, "This acquisition of the fast track designation from the US FDA marks recognition of the potential of the oncolytic bacteria SalMet-Vec® in the treatment of major diseases and unmet clinical needs. SalMet-Vec® is expected to become a better treatment option for patients with metastatic osteosarcoma. We will work closely with clinical researchers and regulatory authorities to explore more potential of SalMet-Vec® for the treatment of malignant tumors.”.
Sinogen Pharmaceutical is currently carrying out a phase I/IIa Multi-regional Clinical Trial (MRCT) of the oncolytic bacteria SalMet-Vec® in the United States, Taiwan and Mainland China, to explore the safety and effectiveness of its treatment of multiple solid tumors, including osteosarcoma.
About Fast Track Designation (FTD)
The FDA Fast Track Designation (FTD) aims to promote the development of new drugs that treat serious illnesses and address major unmet medical needs. It was initially included in the FDA Modernization Act and later revised as part of the FDA Safety and Innovation Act. This designation helps pharmaceutical companies to communicate and exchange research and development issues with the FDA in a more timely manner during the subsequent drug development review process. Pharmaceutical companies can also submit new drug research materials to the FDA in a rolling manner when submitting their marketing applications, which helps accelerate drug development and approval for market launch.
About Osteosarcoma
Osteosarcoma is a kind of malignant bone tumor commonly seen in adolescents under 20 years old. It has a high degree of malignancy (the incidence rate of malignant bone tumors in China is about 1.37/100000 people) and a poor survival prognosis (the mortality rate of malignant bone tumors in China is about 0.88/100000 people). At present, the treatment methods for osteosarcoma include surgical resection, radiotherapy, and chemotherapy. Although early diagnosis and timely treatment bring hope of survival to many patients, surgical radical surgery should consider removing limbs, which can reduce the quality of life of patients and have a longer lasting impact on the physical and mental health of young patients. Osteosarcoma is prone to lung metastasis in the early stages and is prone to recurrence during treatment. The use of chemotherapy drugs alone or in combination can lead to serious toxic side effects and rapid drug resistance. Therefore, finding more effective therapeutic drugs, especially in controlling lung metastasis of osteosarcoma, and improving the survival rate and quality of life of osteosarcoma patients, is currently one of the urgent challenges to be solved in the field of osteosarcoma.
About Sinogen Pharmaceutical
Sinogen Pharmaceuticals is a biopharmaceutical company jointly founded by four national high-level talents and experts, dedicated to the development of innovative biological anti-tumor drugs to meet the global demand for malignant tumor treatment market. Sinogen Pharmaceutical's independently developed oncolytic bacterial drug SalMet-Vec® is a first-in-class genetic engineering biological product that can accurately target and rapidly dissolve tumors. It 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 intellectual property rights and global rights of SalMet-Vec® which has obtained 6 IND clinical trial approvals from the US FDA, Taiwan TFDA and Mainland China NMPA. SalMet-Vec® has demonstrated good safety and significant clinical efficacy in the intravenous and intratumoral administration of broad-spectrum solid tumors such as liver cancer, lung cancer, sarcoma, and head and neck cancer. And it has obtained FDA's Orphan Drug Designation for the treatment of osteosarcoma, liver cancer, and small cell lung cancer, as well as Fast Track Designation for metastatic osteosarcoma.
