VG-201

Vancouver BC Canada, August 14, 2024 Virogin Biotech, a clinical-stage biotechnology company specializing in next-generation oncolytic viruses and mRNA technologies, proudly announces that its latest research on VG201, an advanced non-attenuated HSV-1 oncolytic virus product based on transcription-translation dual regulation (TTDR), has been selected for an oral presentation at the prestigious 2024 European Society for Medical Oncology (ESMO) Conference. This year’s ESMO Congress will be held at the Fira Barcelona Gran Via in Barcelona, Spain, from September 13 to September 17, 2024. The presentation, titled “The updated report of phase I trial of VG2025, a non-attenuated HSV-1 oncolytic virus expressing IL-12 and IL-15/Rα payloads in patients with advanced solid tumors,” will unveil updated findings from VG201’s Phase I trial. VG201’s preliminary results were previously presented at the 2023 ASCO and ESMO Asia conferences. The updated data to be presented at ESMO 2024 will include outcomes from 23 patients treated with VG201, with treatment durations ranging from 1 to 12 months. The study population included 13 males and 10 females, with a median age of 51.5 years (ranging from 43 to 73 years). 30% of the patients had been resistant to PD(L)1 inhibitors, with over 65% having undergone at least three prior treatments. To date, 8 serious adverse events (SAEs) have been reported, none of which were related to VG201. Importantly, no treatment-related adverse events (TRAEs) led to drug reduction, treatment discontinuation, or death, and no viral shedding was observed in any samples. Among the 15 evaluable patients, there were 3 partial responses (PR), including one case each of intrahepatic cholangiocarcinoma (ICC), neuroendocrine carcinoma (NEC), and breast cancer, alongside 8 cases of stable disease (SD). Tumor reduction was also observed in non-injected lesions, further underscoring VG201’s clinical safety and encouraging anti-tumor efficacy. These findings support continued research into VG201’s potential across multiple solid tumor indications. VG201 received FDA IND approval in January 2022 (NCT05266612) and CDE IND approval in April 2022 (NCT05477849), initiating its Phase I clinical trials in China and the U.S. These trials are currently underway at the First Affiliated Hospital of Zhejiang University School of Medicine in China and at MD Anderson Cancer Center in the U.S. About ESMO: The European Society for Medical Oncology (ESMO) Congress is one of the most influential annual meetings in the field of oncology. ESMO brings together the latest advancements in oncology research and clinical practice, fostering collaboration between laboratories and clinics to advance cancer treatment. The goal of the congress is to unite researchers and clinicians in pursuit of better cancer treatments and more precise medical research for the benefit of patients worldwide. About Virogin: Founded in 2015 in Canada, Virogin is a clinical-stage biotechnology company with dual technology platforms in next-generation oncolytic viruses and mRNA therapies. Currently, the company has three products in clinical trials in both China and the United States. Its first-generation oncolytic virus product, VG161, has received FDA Fast Track and Orphan Drug Designation for its potential in addressing unmet clinical needs in hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC), offering significant market potential. Virogin’s proprietary HSV-1 oncolytic virus platform significantly enhances the oncolytic activity of the virus while maintaining safety, thanks to the unique transcription-translation dual regulation design. This platform also enables the delivery of multiple synergistic exogenous genes and allows for both intratumoral and intravenous administration. In addition to its oncolytic virus platform, Virogin has developed an mRNA technology platform with a proprietary delivery system that supports both traditional and self-amplifying mRNA (saRNA) drug development. The company’s optimized saRNA frameworks are being explored for various therapeutic applications, including several preclinical mRNA cancer vaccine candidates. Virogin is pioneering a combined oncolytic virus and mRNA vaccine therapy, known as the Prime-Boost approach, which leverages the complementary strengths of oncolytic viruses and mRNA vaccines to induce systemic antitumor immunity and overcome the immunosuppressive tumor microenvironment. This strategy enhances immune response by exposing more tumor antigens through oncolytic virus-mediated tumor cell lysis, offering a promising and synergistic approach to cancer immunotherapy. Virogin remains committed to developing innovative oncolytic virus therapies and mRNA-based cancer immunotherapies that enhance systemic antitumor immunity for patients in need.