T3011 / ImmVira Pharma, Shanghai Pharma - LARVOL DELTA

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

Clinical Study of T3011 Intravesical Instillation for Treatment of NMIBC Patients (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Fudan University

New P1 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

ImmVira’s oncolytic product MVR-T3011 IT Intratumoral Injection Receives FDA Fast Track Designation for HNSCC Treatment (PRNewswire) - "ImmVira has recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for oncolytic virus product MVR-T3011 IT (intratumoral injection) for the treatment of recurrent or metastatic head and neck squamous cell cancer with disease progression after platinum-based chemotherapy and at least one prior line of anti-PD1/PDL1 therapy....The Fast Track designation was sought based on the promising potential of MVR-T3011 IT to meet the unmet medical needs associated with HNSCC. Supporting evidence for this request was derived from Phase I/II trials conducted in both the United States and China, focusing on evaluating the efficacy, safety, and durability of response in patients with HNSCC."

Fast track designation • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Clinical Study of T3011 in Combination With Toripalimab and Regorafenib in Patients With Liver Metastases From Colorectal Cancer (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: China Medical University, China

New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

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 | Active, not recruiting | Sponsor: ImmVira Pharma Co. Ltd | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

T3011 in Combination With Cobimetinib in Patients With Advanced Melanoma (clinicaltrials.gov) - P2 | N=68 | Suspended | Sponsor: ImmVira Pharma Co. Ltd | Phase classification: P2a ➔ P2 | Trial completion date: Jan 2026 ➔ Jan 2027 | Not yet recruiting ➔ Suspended | Trial primary completion date: Dec 2025 ➔ Dec 2026

Combination therapy • Metastases • Phase classification • Trial completion date • Trial primary completion date • Trial suspension • Melanoma • Oncology • Solid Tumor • BRAF

A Clinical Study of T3011 in Subjects With Advanced Melanoma (clinicaltrials.gov) - P1/2 | N=42 | Recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Melanoma • Oncology • Solid Tumor

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 | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Oncology • Solid Tumor

A Clinical Study of T3011 in Subjects With Advanced Melanoma (clinicaltrials.gov) - P1/2 | N=42 | Not yet recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Metastases • New P1/2 trial • Melanoma • Oncology • Solid Tumor

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 | Not yet recruiting | Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Combination therapy • Metastases • New P1/2 trial • Oncology • Solid Tumor

A Clinical Study of Intraperitoneal T3011 Given as a Single Agent in Patients With Malignant Ascites Induced by Advanced Colorectal Cancer (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: West China Hospital

Metastases • New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Clinical Study of T3011 in Combination With Regorafenib in Patients With Advanced Colorectal Cancer (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: West China Hospital

Combination therapy • Metastases • New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

MVR-T3011 IV, Global First Intravenous Oncolytic Product, Successfully Concludes Phase I Clinical Study in the U.S. with Outstanding Safety Results (PRNewswire) - P1 | N=18 | "...ImmVira announced the successful completion of Phase I clinical study conducted on late-stage patients with various tumor types for our intravenous oncolytic product, MVR-T3011 IV, in the United States. This milestone was marked by the product's exceptional safety results and preliminary efficacy for certain indications...17 patients (17/18, 94.4%) experienced Treatment-Emergent Adverse Events (TEAEs), with 16 patients (16/18, 88.89%) reporting drug-related Treatment-Related Adverse Events (TRAEs)....Overall, MVR-T3011 IV showed great safety profile at Phase I clinical study. Currently, there are 12 evaluable patients. According to RECIST 1.1, patients with endometrial, appendiceal, and gallbladder cancer demonstrated a significant reduction in tumor burden. The maximum reduction exceeded 15% compared to the baseline."

P1 data • Trial status • Appendix Cancer • Biliary Cancer • Biliary Tract Cancer • Endometrial Cancer • Gallbladder Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Oncology • Solid Tumor • Uterine Cancer

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

T3011 in Combination With Cobimetinib in Patients With Advanced Melanoma (clinicaltrials.gov) - P2a | N=68 | Not yet recruiting | Sponsor: ImmVira Pharma Co. Ltd | Initiation date: Mar 2023 ➔ Jun 2023

Combination therapy • Metastases • Trial initiation date • Melanoma • Oncology • Solid Tumor • BRAF