Synthetic Biologics Inc (NYSE: SYN) has revealed that its Phase II dose-escalation trial has been publicized. The study was on VCN-01 oncolytic adenovirus for severe solid tumors. Furthermore, the data is now in the Journal for Immunotherapy of Cancer. Findings indicate that the compound is safe with good clinical and biological activity.
According to the General Director at the European division of Synthetics Biologics, Manel Cascallo, these results indicate that VCN-01 can be safely administered intravenously in ≥3.3×1012vp/patient doses.
What researchers learned from the study
He adds that administering the drug resulted in exposure to the virus in the replication inside the tumor. It also caused possible remodeling of the tumor’s matrix to cause inflammation. Moreover, these findings helped the company confirm the mode of action for VCN-01. It also used them to structure its Phase II study, which will test the drug’s efficacy on pancreatic adenocarcinoma. This study will begin later in the year.
For the Phase I study, researchers administered only one VCN-01 dose on its own for solid tumor patients. When it came to patients with metastatic or local pancreatic adenocarcinoma, they used SoC chemotherapy with a single dose of VCN-01.
There were few side effects with VCN-01
Researchers realized that the compound was safe and well-tolerated among the study participants. They noted a few side effects, including elevated liver transaminases, symptoms of flu, and pyrexia.
The adverse effects were reversible and dose-dependent. They were also similar to the other impacts that experts have noted with compounds that utilize adenovirus products. Furthermore, they discovered thrombocytopenia and neutropenia when administered with SoC chemotherapy. Researchers also had a volunteer suffer from fatal thrombocytopenia and enterocolitis.
The researchers found a general response rate of 50% in people with pancreatic adenocarcinoma. They also found viral genome from VCN-01 in 5 of 6 tumors after they carried out biopsies on the eighth day of the trial.
Synthetic Biologic intends to perform multiple clinical trials of VCN-01 worldwide. This includes a Phase II study where it administers an SoC chemotherapy with the compound. These goals align with the company’s vision to create therapies for indications that have unmet needs.
