First tumor-targeted amino acid metabolism regulation therapy oncolytic bacteria biological product has been registered for initiation of Phase I clinical trial (intravenous administration).

Sinogen has registered in ClinicalTrials.gov to initiate the Phase I clinical trial for the oncolytic bacteria biological product SGN1 (SalMet-Vec^®) for the treatment of advanced malignant solid tumors (clinicaltrials.gov registration number: NCT05038150) on September 8, 2021;

The clinical trial is intended to assess the safety and tolerability followed by a dose expansion study to characterize safety, and preliminary efficacy of SGN1, a genetically modified strain of Salmonella enterica, serotype typhimurium (VNP20009-M) that expresses L-Methioninase, in participants with advanced malignant solid tumors.

The mechanism of action for SGN1 is based on the fact that most tumors are methionine dependent.  SGN1 is designed to be used as a live bacterial therapeutic product that can preferentially replicate and accumulate in tumors and starve them of essential amino acids by delivering L-methioninase to consume methionine in tumor tissues.

The treatment populations shall be patients presenting with histologically confirmed advanced and/or metastatic solid tumors that are refractory to standard curative therapy and for which no other conventional therapy exists. SGN1 will be administered through IV infusion.