Drugs / VG161
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04758897 | Apr 2021 → Mar 2022 | cancer | CNBG-Virogin Biotech (Shanghai) Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT04806464 | Mar 2021 → Mar 2022 overdue | liver cancer | CNBG-Virogin Biotech (Shanghai) Ltd. | Recruiting | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT06124001 | Nov 2023 → Dec 2025 | hepatocellular carcinoma | CNBG-Virogin Biotech (Shanghai) Ltd. | Unknown | No outcome recorded |
| Phase 1/2 | NCT06008925 | Nov 2022 → Dec 2025 | gastric cancer | CNBG-Virogin Biotech (Shanghai) Ltd. | Unknown | No outcome recorded |
| Phase 1/2 | NCT05162118 | Mar 2022 → Mar 2025 | malignant pancreatic neoplasm | Zhejiang University | Unknown | No outcome recorded |
| Phase 1/2 | NCT07505615 | Oct 2021 → Apr 2023 | non-invasive bladder urothelial carcinoma | Ding-Wei Ye | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT05223816 | Jan 2024 → Oct 2025 overdue | hepatocellular carcinoma, intrahepatic cholangiocarcinoma | Virogin Biotech Canada Ltd | Recruiting | No outcome recorded |
| Phase 2 | NCT06126510 | Jul 2023 → Jul 2025 overdue | sarcoma | CNBG-Virogin Biotech (Shanghai) Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06746480 | Mar 2022 → Sep 2025 overdue | intrahepatic cholangiocarcinoma | CNBG-Virogin Biotech (Shanghai) Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2025-03-19 | CNBG-Virogin Biotech (Shanghai) Ltd. | Results Virogin’s Oncolytic Virus VG161 Clinical Data Published in Nature: Ignites Hope for Advanced Liver Cancer Patients virogin.com ↗
Results demonstrated that VG161 not only exhibited excellent safety but also significantly extended patient survival. |
| 2024-09-06 | CNBG-Virogin Biotech (Shanghai) Ltd. | Regulatory Breaking News | Virogin’s First Oncolytic Virus VG161 Receives Breakthrough Therapy Designation in China virogin.com ↗
The breakthrough therapy designation (BTD) granted to VG161 by the CDE is based on a China clinical trial of monotherapy for advanced HCC. |
| 2024-04-15 | CNBG-Virogin Biotech (Shanghai) Ltd. | Results Virogin Biotech Oncolytic Virus VG161 Benefit in HCC Patients Featured at ASCO 2024 and Case Reports in Sarcoma Published in Oncology Letters virogin.com ↗
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. |
| 2023-07-13 | CNBG-Virogin Biotech (Shanghai) Ltd. | Regulatory VIROGIN Receives FDA Fast Track Designation for VG161, a Novel Therapy Candidate for the Treatment of Advanced Hepatocellular Carcinoma virogin.com ↗
Virogin Biotech announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of VG161 for patients with advanced unresectable Hepatocellular Carcinoma. |
| 2023-02-23 | CNBG-Virogin Biotech (Shanghai) Ltd. | Regulatory VG161 granted for FDA Orphan Drug Designation virogin.com ↗
After obtaining the orphan drug grant, VG161 will be able to receive clinical research guidance and support from the FDA. |
| 2022-12-20 | China National Biotec Group Company Limited | Results 晚期肝癌治疗新进展！溶瘤病毒药物VG161临床效果显著 cnbg.com.cn ↗
经研究者评估决定，该患者于近日接受了残余病灶的根治性切除，实现无瘤生存，表明了VG161单药治疗不仅有良好安全性，且具有肿瘤减期减级的重要作用。 |
| 2022-06-17 | CNBG-Virogin Biotech (Shanghai) Ltd. | Regulatory Virogin Biotech Receives IND Approvals from Chinese NMPA for VG201 and VG161 virogin.com ↗ |
All press releases naming this drug 7 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | VG161 | “Here we present the results of a multicentre phase 1 clinical trial evaluating VG161, an engineered oncolytic herpes simplex virus that expresses IL-12, IL-15, IL-15Rα and a...” PMID 40108464 ↗ Mar 20258“Intratumoral injection of VG161 on day 1 only or day 1 through 3, in combination of Nivolumab intravenous injection only, Once every 2 weeks, 3 mg/kg each time.” NCT05162118 ↗ “VG161:1.0×10\^8PFU/day, intratumoral injection administration for 3 consecutive days, 28 days as a cycle” NCT06126510 ↗ “VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 Injectable.” NCT04758897 ↗ “VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 Injectable.” NCT06746480 ↗ “VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 injection.” NCT06124001 ↗ “VG161” NCT06008925 ↗ |
| Route | Other | “Intratumoral injection only.” NCT04806464 ↗ |