Vancouver, Canada – Virogin Biotech, a clinical-stage biotech company is pleased to announce that their Investigational New Drug (IND) application for VG201 has been granted by the U.S. Food and Drug Administration (FDA), allowing Virogin to initiate a Phase I clinical trial of VG201.
VG201 is Virogin’s first product candidate built with Transcriptional and Translational Dual Regulated (TTDR) HSV-1 backbone and is the first oncolytic virus (OV), where viral replication is regulated with both transcriptional and translational dual mechanisms. Virogin TTDR viruses are uniquely engineered to enhance tumor-specific replication and payload expression without compromising safety. VG201 preclinical safety studies showed better safety than that reported in similar approved products. Since VG201 includes a CEA promoter for its replication, it is also potentially the first OV to use CEA serum level as a predictive biomarker for better efficacy. VG201 also encodes IL12 & IL15/IL15Ra as cytokine payloads to enhance both innate and adaptive anti-tumor activity. The value of this novel cytokine combination is supported by early clinical data from our first product candidate, VG161.
This Phase I study is being designed as a single arm, open label trial to evaluate the safety, tolerability, pharmacokinetics, and biologic effects of VG201 in patients with advanced solid tumors that have progressed after standard of care treatments. The study is planned to enroll up to 24 patients in the United States.
“The FDA’s acceptance of Virogin’s IND for the Phase I study for VG201, following our earlier announced IND acceptance for the Phase II study of VG161, is an important milestone in our pursuit of developing advanced treatments for cancer patients with the highest unmet need”, said Dr. Ronghua Zhao, Chief Medical Officer at Virogin Biotech. “We are encouraged by the FDA’s decision which was based on our preclinical data, bringing us one step closer to bring innovative treatments for patients with cancers.”
About Virogin Biotech
Virogin Biotech is a clinical stage biotech company developing next-generation immuno-oncolytic therapeutics to enhance the systemic antitumor immunity. With nearly 150 employees between Vancouver, BC and Shanghai, China, and led by a team with over 25 years of experience in fundamental research, translational and clinical development of immunotherapy & oncolytic virotherapy, Virogin is determined to be a global, best-in-class immuno-oncology company that creates impactful therapeutics for patients of the highest medical need. Earlier this week, Virogin announced the IND application for its lead oncolytic virus candidate, VG161, had been granted by the U.S. FDA, allowing the company to initiate a Phase II clinical trial. VG161 is an attenuated HSV type 1 oncolytic virus armed with multiple payloads of IL12, IL15/IL15Ra and a unique PD-L1 blocking peptide.
Virogin is developing two differentiated platforms that are highly complementary; an oncolytic HSV-1 platform armed with multiple therapeutic payloads and genomic regulation to increase oncolytic effect, and a discovery stage mRNA tumor vaccine platform with tumor vaccines to be used in combination with oncolytic virus to augment the anti-tumor effect.