These early-phase findings suggest that VG161 elicits meaningful immune activation in ICC and supports further investigation. By inducing both direct oncolysis and multilayered immune activation, VG161 shows clinical benefit in a heavily pretreated population and holds promise for integration with CPI-based regimens. Validation in larger trials is warranted.

2 months ago

Journal • PD(L)-1 Biomarker • IO biomarker

PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • IL15 (Interleukin 15)

5-fluorouracil • leucovorin calcium • VG161

9ms

Oncolytic virus VG161 in refractory hepatocellular carcinoma. (PubMed, Nature)

This provides a new avenue for treatment and advances the field of oncolytic virus-based immunotherapies. ClinicalTrials.gov registration: NCT04806464 .

9 months ago

Journal

IL15 (Interleukin 15)

VG161

1year

Clinical Study of VG161 in Subjects with Advanced Primary Liver Cancer (clinicaltrials.gov)

P1, N=44, Recruiting, CNBG-Virogin Biotech (Shanghai) Ltd. | Trial completion date: Dec 2022 --> Dec 2024

1 year ago

Trial completion date • Metastases

VG161

almost2years

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

almost 2 years ago

Phase classification • Trial completion date • Trial primary completion date • Combination therapy

MSI (Microsatellite instability) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)

MSI-H/dMMR • IDH1 mutation

Opdivo (nivolumab) • VG161

2years

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.

2 years ago

New P2 trial • Metastases

VG161

2years

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.

2 years ago

New P1/2 trial • Metastases

IL6 (Interleukin 6) • CD4 (CD4 Molecule) • NCAM1 (Neural cell adhesion molecule 1)

AiRuiKa (camrelizumab) • VG161

2years

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

2 years ago

Trial termination • Metastases

VG161

over2years

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.

over 2 years ago

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

over2years

P2a/2b, N=97, Recruiting, Virogin Biotech Canada Ltd | Not yet recruiting --> Recruiting | N=41 --> 97

over 2 years ago

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)

MSI-H/dMMR • IDH1 mutation

Opdivo (nivolumab) • VG161

over2years

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.

over 2 years ago

Journal • Oncolytic virus

CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • CD4 (CD4 Molecule)

IFNG expression

paclitaxel • VG161

3years

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.

3 years ago

Journal • Oncolytic virus • IO biomarker

CD34 (CD34 molecule)

gemcitabine • VG161

over3years

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.

over 3 years ago

Preclinical • Journal • Oncolytic virus

CD8 (cluster of differentiation 8)

VG161