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VG161
i
Other names: VG161, oncolytic herpes virus VG161, oncolytic HSV-1 virus VG161, Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection, recombinant human IL12/15-PDL1B Oncolytic HSV-1 (Vero Cell)
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Company:
CNBG-Virogin Biotech, ViroGin Biotech
Drug class:
PD-L1 inhibitor, IL-15R stimulant, IL-12 stimulant
Related drugs:
2ms
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 (clinicaltrials.gov)
P2, N=97, Recruiting, Virogin Biotech Canada Ltd | Phase classification: P2a/2b --> P2 | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Oct 2025
Phase classification • Trial completion date • Trial primary completion date • Combination therapy
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MSI (Microsatellite instability) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
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MSI-H/dMMR • IDH1 mutation
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Opdivo (nivolumab) • VG161
6ms
Clinical Study of VG161 in the Treatment of Advanced Bone and Soft Tissue Sarcoma (clinicaltrials.gov)
P2, N=40, Recruiting, CNBG-Virogin Biotech (Shanghai) Ltd.
New P2 trial • Metastases
|
VG161
6ms
Clinical Study of VG161 Combined With Camrelizumab in Patients With Advanced Primary Hepatocellular Carcinoma (clinicaltrials.gov)
P1/2, N=36, Not yet recruiting, CNBG-Virogin Biotech (Shanghai) Ltd.
New P1/2 trial • Metastases
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IL6 (Interleukin 6) • CD4 (CD4 Molecule) • NCAM1 (Neural cell adhesion molecule 1)
|
AiRuiKa (camrelizumab) • VG161
8ms
A first-in-human study of VG161 in participants with advanced malignant tumours that have not responded to conventional therapies. (ACTRN12620000244909)
P1, N=36, Terminated, Virogin Biotech Australia Pty. Ltd. | Recruiting --> Terminated
Trial termination • Metastases
|
VG161
8ms
Clinical Study of VG161 Combined With Nivolumab Injection in Patients With Advanced Metastatic Gastric Cancer (clinicaltrials.gov)
P1/2, N=43, Recruiting, CNBG-Virogin Biotech (Shanghai) Ltd.
New P1/2 trial • Metastases
|
PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • IL6 (Interleukin 6) • NCAM1 (Neural cell adhesion molecule 1)
|
Opdivo (nivolumab) • VG161
9ms
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 (clinicaltrials.gov)
P2a/2b, N=97, Recruiting, Virogin Biotech Canada Ltd | Not yet recruiting --> Recruiting | N=41 --> 97
Enrollment open • Enrollment change • Combination therapy
|
PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule) • CD69 (CD69 Molecule) • NCAM1 (Neural cell adhesion molecule 1) • IL15 (Interleukin 15)
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MSI-H/dMMR • IDH1 mutation
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Opdivo (nivolumab) • VG161
12ms
Combination of novel oncolytic herpesvirus with paclitaxel as an efficient strategy for breast cancer therapy. (PubMed, J Med Virol)
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.
Journal • Oncolytic virus
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CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • CD4 (CD4 Molecule)
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IFNG expression
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paclitaxel • VG161
over1year
Pre-Existing HSV-1 Immunity Enhances Anticancer Efficacy of a Novel Immune-Stimulating Oncolytic Virus. (PubMed, Viruses)
Moreover, VG161 efficacy in HLA-matched CD34+ humanized intrahepatic cholangiocarcinoma (ICC) patient-derived xenograft (PDX) models was also tested in multicycle treatment and was compared to standard chemotherapy for this type of cancer (gemcitabine). In conclusion, the anticancer efficacy of VG161 can be enhanced by pre-immunization with HSV-1 and multicycle administration when the virus is given intratumorally, indicating that pre-existing antiviral immunity might enhance OV-induced antitumor immunity. Our results suggest potential clinical benefits of HSV-1-based OV therapy in HSV-1-seropositive patients and multicycle administration of VG161 for long-term maintenance treatment.
Journal • Oncolytic virus • IO biomarker
|
CD34 (CD34 molecule)
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gemcitabine • VG161
over1year
VG161 activates systemic anti-tumor immunity in pancreatic cancer models as a novel oncolytic herpesvirus expressing multiple immunomodulatory transgenes. (PubMed, J Med Virol)
In conclusion, VG161 can systematically activate acquired and innate immunity in pancreatic models, as well as improve the tumor immune microenvironment, indicative of strong anti-tumor potential. The more robusting anti-tumor outcome for VG161 monotherapy or in combination with other therapies on pancreatic cancer is worth of being explored in further clinical trials.
Preclinical • Journal • Oncolytic virus
|
CD8 (cluster of differentiation 8)
|
VG161
2years
Clinical Study of VG161 in Combination With Nivolumab in Subjects With Advanced Pancreatic Cancer (clinicaltrials.gov)
P1/2, N=51, Recruiting, Zhejiang University | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy
|
CD19 (CD19 Molecule) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule) • NCAM1 (Neural cell adhesion molecule 1) • CA 19-9 (Cancer antigen 19-9)
|
Opdivo (nivolumab) • VG161
over2years
Clinical Study of VG161 in Combination With Nivolumab in Subjects With Advanced Pancreatic Cancer (clinicaltrials.gov)
P1/2, N=51, Not yet recruiting, Zhejiang University
New P1/2 trial • Combination therapy
|
CD19 (CD19 Molecule) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule) • NCAM1 (Neural cell adhesion molecule 1) • CA 19-9 (Cancer antigen 19-9)
|
Opdivo (nivolumab) • VG161
over2years
Newly Developed Oncolytic Herpes Simplex Viruses Expressing Multiple Immunomodulatory Transgenes Effectively Target AML Cells (ASH 2021)
Moreover, PD-L1 expression was highly increased in AML patient cells when cultured with VG161 as compared to VG160 (2.7-fold) and this was further enhanced when co-cultured with VG161 and PBMC. Thus, we have demonstrated that newly developed oHSVs engineered with several immunomodulatory transgenes effectively target primitive AML cells, suggesting a potential treatment strategy for AML.
PARP Biomarker • PD(L)-1 Biomarker • IO biomarker
|
PD-1 (Programmed cell death 1) • CASP3 (Caspase 3) • CASP8 (Caspase 8) • TNFRSF18 (TNF Receptor Superfamily Member 18)
|
PD-L1 expression • PD-L1 overexpression
|
VG161
3years
Clinical Study of VG161 in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov)
P1, N=18, Recruiting, CNBG-Virogin Biotech (Shanghai) Ltd. | Not yet recruiting --> Recruiting
Clinical • Enrollment open • IO biomarker
|
PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD4 (CD4 Molecule) • NECTIN2 (Nectin Cell Adhesion Molecule 2)
|
VG161
3years
Clinical Study of VG161 in Subjects With Advanced Primary Liver Cancer (clinicaltrials.gov)
P1, N=44, Recruiting, CNBG-Virogin Biotech (Shanghai) Ltd. | Not yet recruiting --> Recruiting
Clinical • Enrollment open
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • CD4 (CD4 Molecule)
|
VG161
3years
Clinical Study of VG161 in Subjects With Advanced Primary Liver Cancer (clinicaltrials.gov)
P1, N=44, Not yet recruiting, CNBG-Virogin Biotech (Shanghai) Ltd.
Clinical • New P1 trial
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • CD4 (CD4 Molecule)
|
VG161
3years
[VIRTUAL] Pre-existing HSV-1 Immunity enhances anti-cancer efficacy of a novel immune stimulating oncolytic virus - VG161 (AACR 2021)
When the tumor reached 100-150 mm3, animals were divided into 4 groups (10 mice/group): vehicle control, positive control (oxaliplatin 5 mg/kg and gemcitabine 100 mg/kg), and 2 groups treated with VG161 at high dose (7.75×106 PFU) or low dose (3.10×105 PFU). The median time for 3-fold increase of tumor size is 41.5 days (95%CI: 32-58) in the vehicle control, 74 days (95%CI: 51-undefined) in high dose group, and not reached in low dose group (p<0.01). Repeated treatment (2-3 cycles) increased the anti-cancer efficacy of VG161.The anti-cancer efficacy of VG161 can be enhanced by pre-immunization of HSV-1 or multicycle administration when the virus is given by IT, suggesting potential clinical benefits of HSV-1 based OV therapy in HSV sero-positive patients and multicycle administration of VG161 for long term maintenance treatment.
Clinical • Oncolytic virus
|
CD34 (CD34 molecule)
|
gemcitabine • oxaliplatin • VG161
3years
Clinical Study of VG161 in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov)
P1, N=18, Not yet recruiting, CNBG-Virogin Biotech (Shanghai) Ltd.
Clinical • New P1 trial • IO biomarker
|
PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD4 (CD4 Molecule) • NECTIN2 (Nectin Cell Adhesion Molecule 2)
|
VG161
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