April 17, 2024. Guangzhou Sinogen Pharmaceutical announced that it has initiated a Phase II clinical trial of the oncolytic bacteria product, SalMet-Vec^®, for the treatment of advanced Head and Neck Squamous cell carcinoma (HNSCC) for the patients who have failed standard care therapies (including the second line). West China Hospital of Sichuan University is the lead organization of this clinical trial, and other hospitals will also participate in this Phase II clinical study.

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.

In the completed Phase I dose escalation studies carried out in the United States, the Chinese Mainland and Taiwan Province of China , the safety of monotherapy with oncolytic bacteria (SalMet-Vec^®)  was favorable, with few adverse events (AEs) in patients after intratumoral administration, and essentially same-day remission with symptomatic treatment, and with no DLT events. It is exciting to see that even the first low-dose group already demonstrated favorable efficacy in patients with head and neck squamous carcinoma after failing to respond second-line, and a significant of progression-free survival (PFS) was observed. Therefore, Guangzhou Sinogen  has decided to formally initiate the patient recruitment for the Phase II clinical trial for the indication of advanced head and neck squamous carcinoma.

About oncolytic bacteria SalMet-Vec^®

Guangzhou Sinogen Pharmaceutical owns the complete global intellectual property rights of oncolytic bacteria SalMet-Vec^®, which has gained 6 IND clinical trial approvals from FDA, TFDA and 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. Recently, SalMet-Vec^® has received FDA's Orphan Drug Designations for the treatment of osteosarcoma, liver cancer, and small cell lung cancer, and a Fast Track Designation for metastatic osteosarcoma.