May 22, 2024. Guangzhou Sinogen (HuaJin) Pharmaceutical announced that its proprietary bacterial oncolytic product, SalMet-Vec^®, has been granted a fast track designation (FTD) by the US Food and Drug Administration (FDA) for the treatment of patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma (HSNCC) who have received at least two prior lines of therapy, including immune checkpoint inhibitors. Previously, SalMet-Vec^® has been granted FTD by FDA for the treatment of metastatic osteosarcoma patients.

In the on-going Phase I dose escalation trials carried out in the United States, Mainland China, and Taiwan Province of China, the oncolytic bacteria (SalMet-Vec^®) has demonstrated favorable safety profiles with few adverse events (AEs) in the enrolled patients. Even at the first low-dose cohort, SalMet-Vec^® already displayed favorable efficacy in some HSNCC patients who have failed to respond to second-line treatment, and a significant progression-free survival (PFS) was observed. Guangzhou Sinogen has initiated the patient recruitment for the Phase II clinical trial for the indication of advanced head and neck squamous carcinoma in April 2024.

Dr. Allan Zhao, Chairman of Sinogen Pharmaceutical, indicated: “This is another fast track designation from the US FDA, gaining the recognition of the potential therapeutic benefit of SalMet-Vec^® in the treatment of unmet oncology needs.  SalMet-Vec^® is expected to provide the treatment option for the patients with recurrent or metastatic head and neck squamous cell carcinoma. We will work closely with clinical researchers and regulatory authorities to explore the potential benefit of SalMet-Vec^® for the treatment of other types of malignancies”.

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 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 HNSCC

Head and neck squamous cell carcinoma (HNSCC) is a group of malignancies comprising tumors in various head and neck regions, including but not limited to oral cavity, pharynx, and larynx. HNSCC is the seventh most common cancer in the world, with an estimated 890,000 new cases (roughly 4.5% of all cancer diagnoses) and 450,000 deaths every year (roughly 4.6% of global cancer deaths) (Barsouk et al., 2023). Approximately 50% of the patients with HNSCC will experience recurrence, with a high probability of recurrence occurring within 2 years of the intitial treatment. Recurrent and metastatic (R/M) head and neck squamous carcinoma (HNSCC) has a poor prognosis, and the current standard first-line treatment regimen for platinum-sensitive patients is chemotherapy in combination with cetuximab, with an OS of only 10 months. For recurrent metastatic head and neck squamous carcinoma, there is no standard treatment regimen for such patients after failing to respond standard second-line therapy; and the prognosis is even worse, with the majority of clinical studies reporting a progression-free survival (PFS) of about 3 months and an overall survival (OS) of about 6 months. Thus, there is an urgent clinical need to provide effective treatment options for these patients to improve their treatment outcomes and extend patients’ survival.

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.