Vancouver, BC Canada, September 6 2024

The first-in-class oncolytic virus developed by Virogin Biotech Co., Ltd. (“Virogin Biotech”), and exclusively licensed to CNBG-Virogin (Shanghai) Co., Ltd. (“CNBG-Virogin “) for clinical development and commercialization in the China region, was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). It has officially been included in the list of breakthrough therapies for the treatment of patients with advanced hepatocellular carcinoma (HCC) who have failed standard therapies, marking VG161 as the first oncolytic virus product in this disease area to receive BTD from the CDE.

VG161 is a Herpes Simplex Virus type 1 (HSV-1) based novel oncolytic virus enhanced for anti-tumor immunity. It is the world’s first investigational oncolytic virus product to enter clinical trials, carrying four exogenous immune-regulating genes: IL12, IL15/15Rα (IL15 and its receptor subunit α), and a PD-L1 blocking peptide (PDL1B).

Previously, Virogin Biotech licensed the China rights of VG161 to CNBG-Virogin. Both companies share research data, with CNBG-Virogin holding exclusive rights in China, while Virogin Biotech, as the original developer, retains overseas rights to VG161. Virogin has also initiated multiple global clinical trials outside of China. Those trials are mainly focusing on evaluating the safety and efficacy of VG161 for treating advanced hepatocellular carcinoma (HCC), advanced intrahepatic cholangiocarcinoma, advanced bone and soft tissue sarcoma, and advanced gastric cancer.

The breakthrough therapy designation (BTD) granted to VG161 by the CDE is based on a China clinical trial of monotherapy for advanced HCC. Clinical data demonstrated that VG161 monotherapy provided significant clinical benefits to patients with advanced HCC, with a notably prolonged overall survival (OS) compared to the control group and a favorable safety profile. While the study included all advanced HCC patients who had failed standard treatments, the overall OS, objective response rate (ORR), and disease control rate (DCR) were comparable to previously approved second-line therapies for liver cancer. Notably, for patients who had received immune checkpoint inhibitors for more than three months, VG161 showed a significantly longer median overall survival compared to other second-line treatments reported in the literature.

It is worth mentioning that in June 2023, Virogin Biotech announced that the FDA granted VG161 Fast Track designation for the treatment of advanced HCC patients who had failed standard therapies. The FDA indicated in its response that VG161 could delay tumor progression or improve survival in patients with unresectable advanced HCC who had progressed on or were intolerant to currently available first- or second-line therapies. With the BTD recognition, VG161’s clinical research, evaluation, and market approval process are expected to accelerate, potentially offering a new treatment option for patients with advanced hepatocellular carcinoma (HCC) in China sooner.

Additionally, Virogin Biotech and CNBG-Virogin are exploring combination therapies with VG161, aiming to improve survival rates and quality of life for more cancer patients. The rapid advancements in science and technology are driving innovation in the oncolytic virus industry. Virogin Biotech is committed to accelerating its exploration of oncolytic virus therapies. The company aims to address unmet clinical needs and bring new hope and opportunities to many cancer patients. We also thank the dedicated efforts and outstanding contributions of the clinical team Professor Liang, Dr. Shen at the First Affiliated Hospital of Zhejiang University School of Medicine, and the patients participating in the trial.

About Virogin Biotech:

Founded in 2015 in Canada, Virogin Biotech is one of the few clinical-stage biotech companies worldwide with both next-generation oncolytic virus and mRNA technology platforms. Currently, three products are undergoing clinical trials in China and the U.S. VG161, the company’s first-generation oncolytic virus product, has received Fast Track and Orphan Drug designations from the FDA. VG161 targets the unmet clinical needs of hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC), with significant potential market value. Virogin’s HSV-1 oncolytic virus platform employs a proprietary transcription-translation dual-regulation viral backbone, significantly enhancing the virus’s oncolytic activity while ensuring safety. It also carries multiple synergistic exogenous genes and can be administered through intratumoral or intravenous injection.

Virogin Biotech has developed a prime-boost strategy by combining oncolytic viruses and mRNA vaccines. The mRNA vaccine creates a systemic anti-tumor immune response in a non-immunosuppressive environment, while the intratumoral oncolytic virus disrupts the immunosuppressive tumor environment, enabling the established systemic anti-tumor immune response to work more effectively. The oncolytic virus further enhances immune response by lysing tumor cells and exposing more tumor neoantigens that are presented by innate immune cells to T-cells for lasting anti-tumor immunity. This approach fully utilizes the complementary advantages of oncolytic viruses and mRNA vaccines, seeking systemic and synergistic activation of anti-tumor immunity.

About Breakthrough Therapy Drugs:

Breakthrough therapy drugs refer to innovative or improved drugs designed to treat or prevent life-threatening diseases or conditions that severely impact quality of life, for which no effective treatment currently exists, or that show significant clinical advantages over existing therapies based on sufficient evidence. The Breakthrough Therapy Designation (BTD) policy is aimed at accelerating the development and market approval process of drugs that demonstrate substantial clinical benefits. Since its implementation in 2020, this policy has played a key role in facilitating the rapid introduction of innovative drugs to the market, addressing urgent clinical needs.

The Center for Drug Evaluation (CDE) designates breakthrough therapies by focusing on drugs with superior clinical data, differentiated clinical targets, and highly promising therapies. This selection process has garnered significant attention within the pharmaceutical industry as it helps identify valuable new drug projects with precise entry points into the market.