T3011 / ImmVira Pharma, Shanghai Pharma - LARVOL DELTA

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

Updated results from an ongoing phase 1/2a study of T3011, an oncolytic HSV expressing IL-12 and PD-1 antibody, administered via IT injection as monotherapy or combined with pembrolizumab in advanced solid tumors. (ASCO 2023) - P1/2 | "Both T3011 IT monotherapy and combination therapy with pembrolizumab were safe and tolerable. The efficacy of T3011 in immune-resistant melanoma was encouraging. Our data suggest T3011 may modify the tumor microenvironment and overcome immune resistance."

Metastases • Monotherapy • P1/2 data • Fatigue • Immune Modulation • Melanoma • Musculoskeletal Pain • Oncology • Pain • Solid Tumor • CD8 • IFNG • IL12A

Intravenous (IV) infusion of T3011, an oncolytic HSV expressing IL-12 and PD-1 antibody, as monotherapy in advanced solid tumors: Preliminary results from an ongoing phase 1/2a study. (ASCO 2023) - P1/2 | "IV T3011 monotherapy was well tolerated and safe at the first 3 dose levels, highly unlikely to be transmissible. Preliminary efficacy was encouraging. Our results also suggest T3011 IV treatment could stimulate anti-tumor immunity in the tumor microenvironment."

Metastases • Monotherapy • P1/2 data • Oncology • Solid Tumor • IL12A

A 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. (ASCO 2023) - P1/2 | "The safety profile and clinical compliance of T3011 IT therapy are excellent. T3011 injected locally will not spread to blood, urine and saliva, regional shedding doesn't raise the possibility of transmission to the local and systemic environment. The encouraging anti-tumor activity of T3011 monotherapy in advanced HNSCC pts supports further evaluation in phase II studies."

Metastases • Monotherapy • P1/2 data • Anemia • Breast Cancer • Head and Neck Cancer • Hematological Disorders • Herpes Simplex • Infectious Disease • Influenza • Melanoma • Oncology • Renal Disease • Respiratory Diseases • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • IL12A

A phase I/IIa study to assess the safety, tolerability, PK, and PD of T3011, a genetically modified oncolytic virus (OVs) administered intravenously (IV) in patients with advanced solid tumors. (ASCO 2023) - P1/2 | "1 pt with colorectal cancer who experienced irinotecan-based chemotherapy, anti-VEGF and radiotherapy in Cohort 1 had a long-term SD for over 4 months... T3011 IV is safe and well tolerated, and unlikely to spread to close contacts. Preliminary efficacy is encouraging. T3011 DNA in blood is in a dose-dependent manner with additive effect from repeated doses supporting continued recruitment of pts to higher dose cohorts."

Clinical • Metastases • Oncolytic virus • P1/2 data • Anemia • Colorectal Cancer • Constipation • Dermatology • Dyslipidemia • Gastroenterology • Gastrointestinal Cancer • Gastrointestinal Disorder • Hematological Disorders • Hypertriglyceridemia • Immunology • Oncology • Pain • Pulmonary Disease • Solid Tumor • Urticaria • IL12A

ImmVira presented latest encouraging clinical results of two proprietary products at ASCO 2023 (PRNewswire) - P1/2a | N=74 | NCT05598268 | Sponsor: ImmVira Pharma Co. Ltd | "MVR-T3011 IV, global first intravenous oHSV product, showed assuring safety profile: As of December 16, 2022, a total of 15 patients (including 12 patients who received single ascending dose and 3 patients who received multiple ascending dose) received MVR-T3011 IV monotherapy with different dosages (1x106 PFU~3x108 PFU)....Among these patients, three had Grade 3 treatment emergent adverse events ('TEAE') in the Common Criteria for the Evaluation of Adverse Events ('CTCAE') (hypertriglyceridemia, dyspnea, lymphopenia), only one case of Grade 3 TRAE (lymphopenia) was reported, and no≥ Grade 4 adverse event ('AE') was reported. No drug-related Serious Adverse Event ('SAE') or DLT occurred; maximum tolerated dose ('MTD') was not reached. Trial results showed that, MVR-T3011 IV is safe, well-tolerated, and unlikely to spread to close contacts."

P1/2 data • Oncology • Solid Tumor

ImmVira presented latest encouraging clinical results of two proprietary products at ASCO 2023 (PRNewswire) - P1/2a | N=64 | NCT04370587 | Sponsor: ImmVira Pharma Co. Ltd | "Phase I/IIa study of MVR-T3011 IT administered via intratumoral injection in the U.S. as monotherapy and combination therapy combined with Pembrolizumab: As of January 17, 2023, among 29 patients who received MVR-T3011 IT monotherapy or in combination with pembrolizumab, most frequent TRAEs were pyrexia, and no additional safety signals were observed in combination therapy. 12 advanced melanoma patients failing prior PD-1 or PD-1/CTLA-4 combination treatment received MVR-T3011 IT monotherapy. The confirmed ORR and DCR were 25.0% and 33.3%, respectively. 6 patients (including 5 with melanoma and 1 with mesothelioma) were re-challenged with MVR-T3011 IT combined with pembrolizumab after progression on monotherapy, among which 1 patient achieved PR after 4 months and ongoing PR had lasted for more than 8 months as of the data cutoff date."

P1/2 data • Lung Cancer • Melanoma • Mesothelioma • Oncology • Skin Cancer • Solid Tumor • Thoracic Cancer