Last update 12 Dec 2024

Recombinant Human IL12/15-PDL1B Herpes simplex type I oncolytic virus(Vero cell)(Virogin)

Last update 12 Dec 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Oncolytic virus

Synonyms

Recombinant Human IL12/15-PDL1B Herpes Simplex Type I Oncolytic Virus, recombinant human IL12/15-PDL1B HSV-1 oncolytic virus Injection, 重组人IL12/15-PDL1B单纯疱疹I型溶瘤病毒

+ [3]

Target

IL-12R x IL-15Rα x PDL1

Mechanism

IL-12R stimulants(Interleukin-12 receptor stimulants), IL-15Rα agonists(Interleukin-15 receptor subunit alpha agonists), PDL1 inhibitors(Programmed death-ligand 1 inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersSkin and Musculoskeletal Diseases+ [1]

Active Indication

Intrahepatic CholangiocarcinomaOsteosarcomaSoft Tissue Sarcoma+ [9]

Inactive Indication-

Originator Organization

Virogin Biotech Ltd.Startup

Active Organization

CNBG-Virogin Biotech (Shanghai) Ltd.

Virogin Biotech Ltd.Startup

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

RegulationFast Track (US), Breakthrough Therapy (CN), Orphan Drug (US)

Clinical Trials associated with Recombinant Human IL12/15-PDL1B Herpes simplex type I oncolytic virus(Vero cell)(Virogin)

NCT05223816 / RecruitingPhase 2

An Open-Label, Multiple-Center, Phase IIa/IIb Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of VG161 as Monotherapy and in Combination With Nivolumab for Treatment of Patients With Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma

Safety Run-in Cohort (cohort 1):
10 patients will be treated with IT injection of VG161 in the cohort 1 at dose level of 1.0x10E8 PFU x 3 days.
Monotherapy Cohorts (Cohort 2 and 3) Cohort 2 (HCC) This part is a single-agent, single one-dose level and single-arm design. Approximately 39 subjects will be enrolled in the study to receive VG161. In the first stage, 21 subjects will be enrolled. If there is only 1 or fewer subjects has been observed with objective response and no more than 12 (<13) subjects have PFS longer than 3 months, the trial will be stopped. Otherwise, this study will continue to enter the second stage, and 18 additional subjects will be added, and the total number of trial subjects will reach 39.
Cohort 3 (ICC) This part is a single-agent, single one-dose level and single-arm design. The trial will be carried out in two periods. In the first period, a total of 20 subjects will be enrolled. If there is only 1 or fewer response case in the 20 subjects, the trial will be stopped to investigate the efficacy of the IP, otherwise, subjects will continue to enter the second period, and 13 additional subjects will be added, and the total number of trial cases will reach 33.
Cohort 4 (ICC and HCC) Combination with Nivolumab Combination cohort and subjects will receive VG161 at the same schedule as the monotherapy cohorts and 240 mg of intravenous Nivolumab on days 8 and 15 of each treatment cycle. The Nivolumab dose can be changed to 480 mg every 4 weeks after cycle one based on investigator's discretion.

Start Date24 Jan 2024

Sponsor / Collaborator

Virogin Biotech Ltd.Startup

CTR20233149 / RecruitingPhase 1/2

VG161联合卡瑞利珠单抗治疗晚期原发性肝细胞癌患者的开放的Ib/IIa 期临床试验

[Translation] An open phase Ib/IIa clinical trial of VG161 combined with camrelizumab in patients with advanced primary hepatocellular carcinoma

Ib期主要目的：评价VG161连续多次肿瘤内注射给药联合卡瑞利珠单抗治疗晚期原发性肝细胞癌患者的安全性和耐受性，探索联合治疗最适合的II期推荐剂量（RP2D）。次要目的： 1）初步评价VG161联合卡瑞利珠单抗治疗晚期原发性肝细胞癌患者的抗肿瘤活性；2）监测药效学相关的免疫学指标变化； 3）评价I型单纯疱疹病毒抗体滴度水平对VG161安全性、有效性的影响。IIa期主要目的：评价VG161连续多次肿瘤内注射给药联合卡瑞利珠单抗治疗晚期原发性肝细胞癌患者的有效性，主要观察指标是客观缓解率（ORR）。次要目的：1）评价联合治疗有效性的次要观察指标，包括疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）、缓解持续时间（DOR）；2）监测药效学相关的免疫学指标变化；3）进一步评价 VG161联合卡瑞利珠单抗治疗的安全性。4）评价I型单纯疱疹病毒抗体滴度水平对VG161安全性、有效性的影响

[Translation]

The main purpose of Phase Ib is to evaluate the safety and tolerability of VG161 combined with carrelizumab in the treatment of patients with advanced primary hepatocellular carcinoma, and to explore the most suitable Phase II recommended dose (RP2D) for combined treatment. Secondary objectives: 1) Preliminary evaluation of the anti-tumor activity of VG161 combined with carrelizumab in the treatment of patients with advanced primary hepatocellular carcinoma; 2) Monitor changes in immunological indicators related to pharmacodynamics; 3) Evaluate the impact of herpes simplex virus type I antibody titer on the safety and efficacy of VG161. The main purpose of Phase IIa is to evaluate the effectiveness of VG161 combined with carrelizumab in the treatment of patients with advanced primary hepatocellular carcinoma, with the primary observation index being the objective response rate (ORR). Secondary objectives: 1) Evaluate secondary observation indicators of the effectiveness of combined treatment, including disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and duration of response (DOR); 2) Monitor changes in immunological indicators related to pharmacodynamics; 3) Further evaluate the safety of VG161 combined with carrelizumab. 4) Evaluate the impact of herpes simplex virus type I antibody titer on the safety and efficacy of VG161

Start Date04 Dec 2023

Sponsor / Collaborator

CNBG-Virogin Biotech (Shanghai) Ltd.

NCT06124001 / Not yet recruitingPhase 1/2

An Open-label Phase Ib/IIa Clinical Trial of VG161 Combined With Camrelizumab in the Treatment of Advanced Primary Hepatocellular Carcinoma

VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 injection.This study will be conducted in combination with camrelizumab in patients with advanced advanced primary hepatocellular carcinoma who have received at least one first-line treatment regimen. This is an open-label study divided into two parts.
Part 1: This part is an escalating dose trial to explore the safety of the combination and determine the recommended safe dose of the combination.
Part 2: This part is an extension trial to investigate the preliminary efficacy of the combination at a safe dose.

Start Date30 Nov 2023

Sponsor / Collaborator

CNBG-Virogin Biotech (Shanghai) Ltd.

100 Clinical Results associated with Recombinant Human IL12/15-PDL1B Herpes simplex type I oncolytic virus(Vero cell)(Virogin)

100 Translational Medicine associated with Recombinant Human IL12/15-PDL1B Herpes simplex type I oncolytic virus(Vero cell)(Virogin)

100 Patents (Medical) associated with Recombinant Human IL12/15-PDL1B Herpes simplex type I oncolytic virus(Vero cell)(Virogin)

Literatures (Medical) associated with Recombinant Human IL12/15-PDL1B Herpes simplex type I oncolytic virus(Vero cell)(Virogin)

01 May 2023·Journal of medical virology

Combination of novel oncolytic herpesvirus with paclitaxel as an efficient strategy for breast cancer therapy

Article

Author: Jia, Weiguo ; Shen, Yinan ; Deng, Xinyue ; Zhao, Bin ; Zhang, Chaomei ; Ding, Jun ; Dai, Zhijun ; Leng, Qi ; Xue, Dixuan ; WeiyangLou ; Zhao, Ronghua ; Yi, Ming ; Dong, Chenfang ; Zhong, Guansheng

Abstract:

Background:

New strategies are needed to improve the treatment of patients with breast cancer (BC). Oncolytic virotherapy is a promising new tool for cancer treatment but still has a limited overall durable antitumor response. A novel replicable recombinant oncolytic herpes simplex virus type 1 called VG161 has been developed and has demonstrated antitumor effects in several cancers. Here, we explored the efficacy and the antitumor immune response of VG161 cotreatment with paclitaxel (PTX) which as a novel oncolytic viral immunotherapy for BC.

Methods:

The antitumor effect of VG161 and PTX was confirmed in a BC xenograft mouse model. The immunostimulatory pathways were tested by RNA‐seq and the remodeling of tumor microenvironment was detected by Flow cytometry analysis or Immunohistochemistry. Pulmonary lesions were analyzed by the EMT6‐Luc BC model.

Results:

In this report, we demonstrate that VG161 can significantly represses BC growth and elicit a robust antitumor immune response in a mouse model. The effect is amplified when combined with PTX treatment. The antitumor effect is associated with the infiltration of lymphoid cells, including CD4+ T cells, CD8+ T cells, and NK cells (expressing TNF and IFN‐γ), and myeloid cells, including macrophages, myeloid‐derived suppressor cells, and dendritic cell cells. Additionally, VG161 cotreatment with PTX showed a significant reduction in BC lung metastasis, which may result from the enhanced CD4+ and CD8+ T cell‐mediated responses.

Conclusions:

The combination of PTX and VG161 is effective for repressing BC growth by inducing proinflammatory changes in the tumor microenvironment and reducing BC pulmonary metastasis. These data will provide a new strategy and valuable insight for oncolytic virus therapy applications in primary solid or metastatic BC tumors.

01 Jan 2023·Journal of medical virology

VG161 activates systemic antitumor immunity in pancreatic cancer models as a novel oncolytic herpesvirus expressing multiple immunomodulatory transgenes

Article

Author: Sheng, Jianpeng ; Yang, Zifan ; Song, Wei ; Shen, Yinan ; Ding, Jun ; Zhao, Ronghua ; Guo, Sida ; Bai, Xueli ; Li, Yuwei ; Wang, Meng ; Pan, Xinping ; Lou, Yufeng ; Murad, Yanal ; Liang, Tingbo ; Wu, Zongsong ; Lin, Danni ; Zhang, Xiaozhen ; Wang, Zijun ; Jia, Weiguo

Abstract:

The VG161 represents the first recombinant oncolytic herpes simplex virus type 1 carrying multiple synergistic antitumor immuno‐modulating factors. Here, we report its antitumor mechanisms and thus provide firm theoretical foundation for the upcoming clinical application in pancreatic cancer. Generally, the VG161‐mediated antitumor outcomes were analyzed by a collaboration of techniques, namely the single‐cell sequencing, airflow‐assisted desorption electrospray ionization‐mass spectrometry imaging (AFADSI‐MSI) and nanostring techniques. In vitro, the efficacy of VG161 together with immune checkpoint inhibitors (ICIs) has been successfully shown to grant a long‐term antitumor effect by altering tumor immunity and remodeling tumor microenvironment (TME) metabolisms. Cellular functional pathways and cell subtypes detected from patient samples before and after the treatment had undergone distinctive changes including upregulated CD8+ T and natural killer cells. More importantly, significant antitumor signals have emerged since the administration of VG161 injection. In conclusion, VG161 can systematically activate acquired and innate immunity in pancreatic models, as well as improve the tumor immune microenvironment, indicative of strong antitumor potential. The more robusting antitumor outcome for VG161 monotherapy or in combination with other therapies on pancreatic cancer is worth of being explored in further clinical trials.

Oncology letters

Oncolytic virotherapy stimulates anti‑tumor immune response and demonstrates activity in advanced sarcoma: Report of two cases

Author: Singh, Manu ; Ding, Jun ; Qiu, Yeting ; Murad, Yanal ; Tan, Qian ; Qin, Aijun ; Jia, William Wei-Guo ; Zhao, Ronghua ; Kichenadasse, Ganessan

Sarcoma is derived from mesenchymal neoplasms and has numerous subtypes, accounting for 1% of all adult malignancies and 15% of childhood malignancies. The prognosis of metastatic or recurrent sarcoma remains poor. The current study presents two cases of sarcoma enrolled in a phase I dose escalation trial for solid tumor, who had previously failed all standard therapies. These patients were treated with VG161, an immune-stimulating herpes simplex virus type 1 oncolytic virus with payloads of IL-12, IL-15 and IL-15 receptor α unit, and a programmed cell death 1 (PD-1)/PD-1 ligand 1 blocking peptide. Both cases demonstrated stable disease as the best response, accompanied by a noteworthy prolongation of progression-free survival (11.8 months for chondrosarcoma and 11.9 months for soft tissue sarcoma, respectively) at a dose of 2.5×10⁸ PFU/cycle. In addition, the treatment led to the activation of anti-cancer immunity, as evident from cytokine, lymphocyte subset and related pathway analyses of peripheral blood and/or tumor biopsy samples. These promising results suggest that VG161 monotherapy holds promise as an effective treatment for sarcoma and warrants further investigation through clinical trials. The two reported patients were part of a phase I clinical trial conducted and registered on the Australian New Zealand Clinical Trials Registry in Australia (registration no. ACTRN12620000244909; registration date, 26 February, 2020).

News (Medical) associated with Recombinant Human IL12/15-PDL1B Herpes simplex type I oncolytic virus(Vero cell)(Virogin)

06 Sep 2024

·virogin.com

Breaking News | Virogin’s First Oncolytic Virus VG161 Receives Breakthrough Therapy Designation in China

About History Our Leadership Team Scientific Advisory Board Technology Oncolytic Virotherapy mRNA Platform saRNA Prime-Boost Approach Pipeline Clinical Trials Strategy & Milestones VG161 VG201 Publications Careers Investors Media History Our Leadership Team Scientific Advisory Board Oncolytic Virotherapy mRNA Platform saRNA Prime-Boost Approach saRNA Strategy & Milestones VG161 VG201 About History Our Leadership Team Scientific Advisory Board Technology Oncolytic Virotherapy mRNA Platform saRNA Prime-Boost Approach Pipeline Clinical Trials Strategy & Milestones VG161 VG201 Publications Careers Investors Media History Our Leadership Team Scientific Advisory Board Oncolytic Virotherapy mRNA Platform saRNA Prime-Boost Approach saRNA Strategy & Milestones VG161 VG201 About History Our Leadership Team Scientific Advisory Board Technology Oncolytic Virotherapy mRNA Platform saRNA Prime-Boost Approach Pipeline Clinical Trials Strategy & Milestones VG161 VG201 Publications Careers Investors Media History Our Leadership Team Scientific Advisory Board Oncolytic Virotherapy mRNA Platform saRNA Prime-Boost Approach saRNA Strategy & Milestones VG161 VG201 About History Our Leadership Team Scientific Advisory Board Technology Oncolytic Virotherapy mRNA Platform saRNA Prime-Boost Approach Pipeline Clinical Trials Strategy & Milestones VG161 VG201 Publications Careers Investors Media History Our Leadership Team Scientific Advisory Board Oncolytic Virotherapy mRNA Platform saRNA Prime-Boost Approach saRNA Strategy & Milestones VG161 VG201 September 6, 2024 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.

Fast TrackClinical StudyOrphan DrugVaccineBreakthrough Therapy

21 Aug 2024

·virogin.com

Virogin Secures Oral Presentation at ESMO 2024 with New Clinical Data on VG201

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.

Phase 1Fast TrackImmunotherapyOrphan DrugVaccine

15 Apr 2024

·virogin.com

Virogin Biotech Oncolytic Virus VG161 Benefit in HCC Patients Featured at ASCO 2024 and Case Reports in Sarcoma Published in Oncology Letters

Vancouver BC Canada, April 15, 2024 Virogin Biotech recently announced that their latest clinical trial results for advanced Hepatocellular Carcinoma (HCC) have been selected for poster presentation at the American Society of Clinical Oncology (ASCO) 2024. The trial features the innovative oncolytic virus VG161, which has demonstrated impressive survival benefit, in subgroup of patients with advanced Hepatocellular Carcinoma (HCC) who failed two or more prior lines of therapy. The poster presentation revealed clinical data for VG161 in patients with HCC who had previously failed at least 2 lines of prior treatments, including checkpoint inhibitors. The data showcased noteworthy clinical benefits of VG161 as a monotherapy, providing extended overall survival (OS) rates compared to the current treatment modalities in selected patient population. Remarkably, VG161 clinical benefit in heavily pretreated (third-line and beyond) patients matched or exceeded reported outcomes for second-line therapies, underscoring its potential as a superior treatment option with a good safety profile for selected liver cancer patients. The comprehensive clinical data will be displayed in a poster presentation during ASCO conference. Additionally this month, the clinical team and scientists at Virogin Biotech have reported two cases of advanced sarcoma patients, who got benefited from dosing with VG161, in Oncology Letters. Research Highlights: The recent publication has highlighted encouraging results from the use of VG161 (Virogin Oncolytic Virus Product) when administered intratumorally to two Australian patients with different subtypes of sarcoma. This innovative approach involves intralesional administration of an immunostimulatory oncolytic herpes simplex virus type 1, which is engineered to deliver interleukins (IL-12, IL-15) and their receptor (IL-15α) along with a programmed cell death protein 1 (PD-1)/PD-L1 inhibitor peptide. The clinical data presented shows VG161 has achieved substantial improvements in progression-free survival (PFS) for patients diagnosed with advanced chondrosarcoma and soft tissue sarcoma. In fact, the median PFS for patients with these diagnoses typically ranges around 4.7 and 4.1 months, respectively. However, with the administration of VG161, PFS has been extended to approximately one year—11.8 months for chondrosarcoma and over 11.9 months for soft tissue sarcoma. Further analyses of cytokine profiles, lymphocyte subpopulations, biomarkers in peripheral blood and tumor biopsies indicate VG161 activates the anti-tumor immune response. These findings suggest VG161 not only provides significant clinical benefits in terms of survival but also ignites immune system to fight cancer. About Oncology Letters: Oncology Letters is a respected journal that focuses on all aspects of clinical oncology, chemotherapeutics, cancer genes, carcinogenesis, metastasis, epidemiology, and virological studies in cancer. The journal aims to promptly publish high-quality original research and detailed case reports in these areas. About Virogin Biotech: Virogin Biotech is a clinical-stage immuno-oncology company, with a primary focus on innovative HSV-1 based oncolytic virus and mRNA-based (including self-amplifying RNA/saRNA) therapeutics to generate robust and durable anti-tumor immune response against solid tumors. Both platforms exhibit a high degree of complementarity via a mechanism of heterologous prime boost. Yet each platform has ‘plug-to-play’ features to independently develop novel therapies against cancer and other indications. Our oncolytic HSV-1 platform has three candidates in clinical trials, with our most advanced asset in Phase 2. Candidates from our mRNA platform have also completed preclinical proof of concept.

ASCOClinical ResultPhase 2Clinical StudyImmunotherapy

100 Deals associated with Recombinant Human IL12/15-PDL1B Herpes simplex type I oncolytic virus(Vero cell)(Virogin)

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Intrahepatic Cholangiocarcinoma	Phase 2	US	Virogin Biotech Ltd.Startup	24 Jan 2024
Advanced Hepatocellular Carcinoma	Phase 2	-	CNBG-Virogin Biotech (Shanghai) Ltd.	30 Nov 2023
Osteosarcoma	Phase 2	CN	CNBG-Virogin Biotech (Shanghai) Ltd.	27 Jul 2023
Soft Tissue Sarcoma	Phase 2	CN	CNBG-Virogin Biotech (Shanghai) Ltd.	27 Jul 2023
Metastatic gastric adenocarcinoma	Phase 2	CN	CNBG-Virogin Biotech (Shanghai) Ltd.	06 Mar 2023
Metastatic gastroesophageal adenocarcinoma	Phase 2	CN	CNBG-Virogin Biotech (Shanghai) Ltd.	06 Mar 2023
Metastatic Gastric Carcinoma	Phase 2	CN	CNBG-Virogin Biotech (Shanghai) Ltd.	17 Nov 2022
Bile Duct Neoplasms	Phase 2	CN	CNBG-Virogin Biotech (Shanghai) Ltd.	14 May 2022
Hepatocellular Carcinoma	Phase 2	-	Virogin Biotech Ltd.Startup	04 Feb 2022
Liver Cancer	Phase 1	CN	Virogin Biotech Ltd.Startup	23 Apr 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04806464 (ASCO2024) Manual	Phase 1	Hepatocellular Carcinoma Second line	44	VG161	-	Positive	24 May 2024
NCT04806464 (ASCO2024) Manual	Phase 1	Hepatocellular Carcinoma Second line	44	VG161 expressing IL12, IL15/IL15 receptor α unit, and PD-L1 blocking peptide	(yxfrharemx) = yxlimnzapz kgdhtvukzw (bvvpkpjubg ) View more	Positive	24 May 2024
NCT04806464 (694, SITC2022)	Phase 1	Primary Malignant Liver Neoplasm PD-L1 \| PD-1 \| CD69 ... View more	11	VG161	ayduqdjcfy(atorslhvmt) = oayqkndzug qakibrmuad (wagmdybwcn ) View more	Positive	07 Nov 2022

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Recombinant Human IL12/15-PDL1B Herpes simplex type I oncolytic virus(Vero cell)(Virogin)

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