Synthetic Biologics' VCN-01 Shows Favorable Safety Profile, Clinical Activity In Early-Stage Cancer Study

Synthetic Biologics Inc SYN announced the peer-reviewed publication of the Phase 1 study investigating intravenous VCN-01 oncolytic adenovirus with or without standard-of-care (SoC) chemotherapy in advanced solid tumors. 

• The data, published in the Journal for ImmunoTherapy of Cancer, suggests that treatment with VCN-01 is feasible and has an acceptable safety profile, with encouraging biological and clinical activity. 
• In patients with pancreatic adenocarcinoma, overall response rates were 50% (Part 2) and 50% (Part 3). 
• VCN-01 viral genomes were detected in tumor tissue in five out of six biopsies (primary pancreatic tumor and liver metastases) on day eight. 
• A second peak of virus concentrations in plasma and increased serum hyaluronidase levels suggest replication after IV injection in all patients. 
• Higher peaks of hyaluronidase serum levels were associated with maximum tumor shrinkage, and increased levels of immune biomarkers were found in sera after VCN-01 administration. 
• Several markers of tumor inflammation were described in tumor biopsies indicating that VCN-01 promotes a change in the tumor immune environment.
• Synthetic Biologics anticipates starting a Phase 2 trial of intravenous VCN-01 combined with SoC chemotherapy as first-line therapy in newly diagnosed metastatic pancreatic adenocarcinoma patients in Q4 of 2022.
• The Company also plans to initiate a Phase 2/3 pivotal trial of intravitreal VCN-01 as an adjunct to chemotherapy or a potential rescue therapy in pediatric retinoblastoma patients in early 2023.
• Price Action: SYN shares are down 2.12% at $0.34 during the market session on the last check Tuesday.