Virogin Biotech Advances Global Clinical Development of Oncolytic Viruses with Multiple Approvals for VG161 and VG201

Recently, Vcanbio announced thatTwo Self-Developed Oncolytic Virus Products: VG161 and VG201Recently obtained multiple clinical approvals in China and the United States:

● Following the successful filing of the Phase II clinical trial in China, the FDA approved the IND application for conducting Phase II clinical trials in the United States on January 29, 2022;

● The IND application for the Phase I/II clinical trial of VG161 in combination with a PD-1 monoclonal antibody was recently accepted by the NMPA.

● On January 21, 2022, the FDA approved the IND application for VG201, and the IND application in China has also been accepted by the NMPA;

● The Phase I clinical trial of VG201 will be officially launched in both China and the United States in the first half of 2022.

As global clinical strategies continue to advance steadily, Virogin Biotech’s exceptional innovation and R&D capabilities have been fully demonstrated, further underscoring its strong proficiency in clinical translation and clinical development.

VG161 as ReproGene’s Synerlytic^TMAs the first product from this technology platform, it has successfully completed Phase I clinical trials in China and Australia. The product has not only demonstrated superior safety but also yielded encouraging preliminary efficacy results. The approval for the U.S. Phase II clinical trial, along with the acceptance by the Center for Drug Evaluation (CDE) of the Investigational New Drug application for the combination therapy Phase I/II clinical trial, will enable a more in-depth and comprehensive exploration of VG161’s clinical efficacy, laying a solid foundation for subsequent clinical studies and commercial launch.

VG201 is a first-in-class clinical oncolytic virus product based on the TTDR (Transcription and Translation Dual Regulation) mechanism. RevoGen’s proprietary TTDR viral backbone achieves tumor-specific oncolytic activity by regulating, rather than deleting, genes essential for viral replication. Preclinical data indicate that VG201 demonstrates an order-of-magnitude increase in oncolytic activity compared to attenuated oHSV backbones, and exhibits a superior safety profile relative to currently approved drugs in the same class. Furthermore, VG201 holds the potential to enable precision oncolytic virotherapy based on tumor biomarkers for the first time. VG201 also leverages Synerlytic^TMA technological platform engineered with multiple exogenous genes to synergistically activate innate and adaptive anti-tumor immunity.

Regarding the multiple clinical trial approvals for VG161 and VG201, Dr. Zhao Ronghua, Chief Medical Officer of Vcanbio, stated: “VG161 and VG201 are both core assets in Vcanbio’s product pipeline, demonstrating the advanced nature and innovativeness of the company’s core technologies from different perspectives. VG161 highlights the importance of synergistic immune activation, while VG201 marks the formal entry of a new generation of oncolytic viruses based on non-attenuated backbones into clinical research. I have high expectations for the clinical performance of VG161 and VG201 and will closely monitor the clinical implications arising from differences in viral backbones.”

Dr. Shahram Rahimian, Head of North American Clinical Studies and Senior Vice President of Clinical Research and Medical Affairs at Venn Group, stated, “Within just one week, the FDA successively approved our company’s Phase II clinical trial for VG161 and Phase I clinical trial for VG201 in the United States. This represents a significant milestone in our North American clinical development and marks a solid step forward in our commitment to putting ‘patients first.’ While greatly encouraged by this progress, our North American clinical team remains dedicated to advancing our efforts, striving to develop safe and highly effective innovative therapies for cancer patients with high unmet medical needs.”

VGene Biotechnology, a biopharmaceutical company dedicated to the R&D of innovative drugs, was founded in 2015 by a team of overseas Chinese scientists and established its clinical translation center in Shanghai Nanxiang Precision Medicine Industrial Park in 2018. As a global leader in the field of oncolytic virus R&D, VGene’s core technical team boasts over 25 years of experience in oncolytic virus development, including clinical expertise that facilitated the market approval of China’s first oncolytic virus. The company’s commercial leadership team possesses extensive experience and profound expertise in R&D strategy, clinical development advancement, and commercial operations. VGene’s oncolytic virus products leverage its proprietary Transcriptional and Translational Dual Regulation (TTDR) viral backbone, combined with its uniquely developed Synerlytic^TMBy expressing multiple synergistic immunomodulatory factors, the technology platform significantly enhances tumor-specific oncolytic activity and substantially improves the tumor microenvironment, thereby effectively activating systemic anti-tumor immunity. Adhering to the R&D philosophy of “synergistic immunity,” Virogin Biotech has expanded its strategic layout beyond its oncolytic virus technology platform to deeply invest in mRNA technology platforms, dedicated to the development of prophylactic and therapeutic cancer vaccines. By leveraging the complementary advantages of combining the oncolytic virus platform with the mRNA cancer vaccine platform, Virogin Biotech will continue to develop innovative, highly effective, and safe cancer immunotherapies.