T3011 / ImmVira Pharma, Shanghai Pharma - LARVOL DELTA

Updated Phase II Study of MVR-T3011, an IL-12/Anti-PD-1 Armed Oncolytic HSV-1, in High-risk BCG-Unresponsive Papillary NMIBC (ESMO 2026) - No abstract available

P2 data • Bladder Cancer • Oncology • IL12A

Updated Phase II Study of MVR-T3011, an IL-12/Anti-PD-1 Armed Oncolytic HSV-1, in High-risk BCG-Unresponsive CIS NMIBC (ESMO 2026) - No abstract available

P2 data • Bladder Cancer • Oncology • IL12A

Intravesical MVR-T3011 in BCG-Naïve High-Risk NMIBC: A Phase II Trial of an IL-12/Anti-PD-1–Armed Oncolytic HSV-1 (ESMO 2026) - No abstract available

P2 data • Bladder Cancer • Oncology • IL12A

A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=64 | Recruiting | Sponsor: ImmVira Pharma Co. Ltd | Trial completion date: Aug 2030 ➔ Oct 2025 | Trial primary completion date: Jul 2030 ➔ Oct 2023

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR

A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=64 | Recruiting | Sponsor: ImmVira Pharma Co. Ltd | Trial completion date: Oct 2024 ➔ Aug 2030 | Trial primary completion date: Oct 2022 ➔ Jul 2030

Combination therapy • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR

Intravenous T3011 Given as a Single Agent and in Combination With Other Therapy in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=42 | Recruiting | Sponsor: ImmVira Pharma Co. Ltd | N=78 ➔ 42 | Trial completion date: Apr 2025 ➔ Aug 2025 | Trial primary completion date: Apr 2023 ➔ Mar 2025

Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

ImmVira Reports 100% Complete Response Rate at 9 Months in Bladder Carcinoma in Situ with MVR-T3011 at ASCO (Thailand Business News) - “ImmVira Group…announced that preliminary Phase IIa clinical data for MVR-T3011, its lead oncolytic immunotherapy candidate, was presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. As of the data cut-off on January 31, 2026, the optimized dose of MVR-T3011 achieved a 100% complete response rate (CRR) in BCG-unresponsive carcinoma in situ (CIS) and a durable 90% recurrence-free survival (RFS) in papillary (Ta/T1) tumors.”

P2a data • Bladder Cancer

Progress of phase II study of MVR-T3011, an IL-12/anti-PD-1 armed oncolytic HSV-1, in high-risk BCG-unresponsive CIS and papillary NMIBC. (ASCO 2026) - P1 | "MVR-T3011 is being evaluated as mono or combination therapy across multiple solid tumors. In this study, MVR-T3011 demonstrates suitability for intravesical administration, plus promising efficacy and a favorable safety profile. Durable complete responses were observed in CIS patients and encouraging 12-month RFS rates in papillary disease."

IO biomarker • P2 data • Bladder Cancer • Herpes Simplex • Infectious Disease • Nephrology • Renal Disease • IL12A

A Clinical Study of T3011 in Combination With PD-1/PD-L1 Inhibitors in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=68 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Trial completion date: May 2026 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Intravesical T3011, an IL-12/anti-PD-1 armed oncolytic HSV-1, in BCG-naïve high-risk NMIBC: A phase IIa trial. (ASCO-GU 2026) - "Oncolytic viruses and BCG both fall within the realm of immunotherapy, with the former possessing scientific attributes to potentially replace BCG in the future. With encouraging preliminary efficacy in papillary Ta/T1 disease, MVR-T3011 shows potential as an effective alternative therapy for BCG-naïve NMIBC, supported by its favorable safety profile."

IO biomarker • P2a data • Bladder Cancer • Genito-urinary Cancer • IL12A

ImmVira's Oncolytic Product MVR-T3011 Expanded to BCG-Naïve Bladder Cancer Patients for the First Time with Clinical Data Presented at the 2026 ASCO GU Conference (PRNewswire) - "In the study involving 18 BCG-naïve high-risk papillary Ta/T1 NMIBC patients treated with intravesical MVR-T3011 at two dose levels: 2x109 PFU (3 patients) and 1x1010 PFU (15 patients), preliminary data as of December 31, 2025, demonstrated encouraging efficacy and durability. Among the 14 evaluable patients, the 12-month recurrence-free-survival (RFS) rate was 100% (3/3) at the 2x109 PFU dose level. At the 1x1010 PFU dose level, the 3-month RFS rate was 100% (11/11). The 6-month and 9-month RFS rates were 75% (3/4) and 66.7% (2/3), respectively, but these data are preliminary, given the small patient numbers reaching those timepoints."

P2 data • Bladder Cancer

First-in-human phase 1/2a study of T3011, an oncolytic HSV expressing IL-12 and PD-1 antibody, administered via intratumoral (IT) injection as monotherapy in advanced solid tumors, including recurrent or metastatic HNSCC. (PubMed, BMC Med) - P1/2 | "T3011 shows a favorable safety profile, immune-modulating effects, and preliminary efficacy in patients with advanced solid tumors."

First-in-human • Journal • Monotherapy • P1/2 data • Head and Neck Cancer • Immune Modulation • Immunology • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8 • IL12A

Immvira Bioscience Inc. filed for an initial public offering on the Hong Kong Stock Exchange (HKEX), advancing its pipeline of oncolytic immunotherapies and engineered exosome therapies (flcube.com) - "The company’s lead asset, MVR-T3011, a novel HSV-1 based oncolytic virus expressing anti-PD-1 antibody and IL-12, is in Phase II trials for full-spectrum bladder cancer and third-line head and neck squamous cell carcinoma (HNSCC)."

Commercial • Bladder Cancer • Squamous Cell Carcinoma of Head and Neck

A Clinical Study of T3011 in Subjects With Advanced Melanoma (clinicaltrials.gov) - P1/2 | N=42 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Trial completion date: Sep 2025 ➔ Sep 2026 | Trial primary completion date: Sep 2025 ➔ Sep 2026

Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor

High Response in Bladder Cancer: Immvira Announced Its MVR-T3011 Latest Clinical Results in BCG-Unresponsive Bladder Cancer Patients at 2025 Annual Meeting of the Society of Urologic Oncology (PRNewswire) - "Among 16 evaluable patients with BCG-unresponsive papillary who received MVR-T3011 at a dose of 2x109 PFU, the 3-month, 6-month, 9-month and 12-month recurrence-free survival (RFS) rates were 87.1%, 80.4%, 80.4% and 71.4%, respectively. Among 6 evaluable patients who received MVR-T3011 at a dose of 1x1010 PFU, 100% of patients remained recurrence free at Month 3 and Month 6. As of the same date, among 7 evaluable patients with BCG-unresponsive CIS (with or without Ta/T1) who received MVR-T3011 at doses of 2x109 PFU, the CR at any time, 3-month and 6-month CRR was 71.4%..."

P1/2 data • Bladder Cancer

Intravesical T3011, an IL-12/Anti-PD-1 Armed Oncolytic HSV-1, in BCG-Unresponsive High-Risk NMIBC: A Phase I/IIa Trial (SUO 2025) - "With durable complete responses in CIS patients and encouraging 12-month RFS rates in Ta/T1 disease, MVR-T3011 shows potential as an effective bladder-sparing therapy for BCG-failure NMIBC, supported by its manageable safety profile."

IO biomarker • P1/2 data • Bladder Cancer • Gene Therapies • Genito-urinary Cancer • Herpes Simplex • Infectious Disease • Nephrology • Renal Disease • Solid Tumor • Xerostomia • IL12A

A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: ImmVira Pharma Co. Ltd | N=64 ➔ 30 | Trial completion date: Oct 2025 ➔ Jan 2027 | Trial primary completion date: Oct 2023 ➔ Sep 2026

Enrollment change • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR

A Clinical Study of T3011 Bladder Perfusion in Patients with High-risk Non-muscle-invasive Bladder Cancer (ChiCTR) - P=N/A | N=15 | Recruiting | Sponsor: Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center

New trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

A Study of T3011 in Patients With BCG-Unresponsive NMIBC or BCG-Exposed, Chemotherapy-Unresponsive NMIBC (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: ImmVira Pharma Co. Ltd | N=70 ➔ 160

Enrollment change • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

ImmVira Announces First Patient Dosed in a Multi-Regional Phase II Clinical Trial Evaluating MVR-T3011 Oncolytic Immunotherapy in Patients with BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) (PRNewswire) - "ImmVira...announced that the first patient diagnosed with NMIBC has been dosed in a multi-regional Phase II clinical trial evaluating its lead product candidate, MVR-T3011....ImmVira plans to enroll eligible patients at 15-20 cancer centers in the United States and China for evaluation of the clinical efficacy parameters including CRR, event-free survival rate and RFS rate."

Trial status • Bladder Cancer

A Study of T3011 in Patients With BCG-Unresponsive High Risk NMIBC (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: ImmVira Pharma Co. Ltd

New P2 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

A Clinical Study of T3011 in Subjects With Advanced Melanoma (clinicaltrials.gov) - P1/2 | N=42 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Trial primary completion date: Sep 2024 ➔ Sep 2025

Metastases • Trial primary completion date • Melanoma • Oncology • Solid Tumor

Preliminary results from a phase I study of T3011, an oncolytic HSV expressing IL-12 and anti-PD-1 antibody, for BCG-failure non-muscle-invasive bladder cancer (NMIBC) (ESMO 2024) - "Intravesical T3011 demonstrates a promising anti-tumor efficacy and an excellent safety profile in patients with high risk BCG-failure NMIBC."

P1 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • IFNG • IL12A

ESMO 2024 - ImmVira Unveils Clinical Results of Intravesical MVR-T3011 for High-Risk BCG-Failure NMIBC Patients (PRNewswire) - P1 | N=20 | NCT06427291 | "ImmVira announced the latest clinical results for its lead oncolytic virus product, MVR-T3011, via intravesical administration in patients with high-risk BCG-failure non-muscle invasive bladder cancer (NMIBC)....According to poster presented (cut-off as of June 27, 2024), among 14 evaluable patients, the overall 3-month complete response (CR) rate across all dose levels was 71.4% (10/14). At the 2×109 PFU dose level (expected RP2D), the CR rate reached an impressive 87.5% (7/8). The study showed a favorable safety profile, with no dose-limiting toxicities (DLTs) reported and no maximum tolerated dose (MTD) reached....By September 15, 2024, the most recent data shows that 20 subjects have received MVR-T3011 treatment. At the RP2D dose level, the 3-month CR rate remained strong at 81.8% (9/11)."

P1 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Intravenous infusion (IV) or intracavitary perfusion (IP) of T3011, an oncolytic HSV expressing IL-12 and PD-1 antibody: Analyses of two phase 1 studies. (ASCO 2024) - P1/2 | "IV T3011 monotherapy has a very manageable safety profile and some encouraging activity in advanced solid tumors. IP T3011 monotherapy is also well tolerated and demonstrates promising activity against malignant pleural effusion and ascites. Clinical trial information: NCT04780217."

P1 data • Colorectal Cancer • Gastrointestinal Cancer • Hematological Disorders • Leukopenia • Oncology • Respiratory Diseases • Solid Tumor • IFNG • IL12A