T3011

Intravesical T3011 demonstrates a promising anti-tumor efficacy and an excellent safety profile in patients with high risk BCG-failure NMIBC.

P1, N=20, Recruiting, Fudan University

P1/2, N=42, Active, not recruiting, ImmVira Pharma Co. Ltd | Recruiting --> Active, not recruiting

P1, N=8, Not yet recruiting, China Medical University, China

P2, N=68, Suspended, 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

P1/2, N=42, Recruiting, Shanghai Pharmaceuticals Holding Co., Ltd | Not yet recruiting --> Recruiting

P1/2, N=68, Recruiting, Shanghai Pharmaceuticals Holding Co., Ltd | Not yet recruiting --> Recruiting

P1/2, N=42, Not yet recruiting, Shanghai Pharmaceuticals Holding Co., Ltd

P1/2, N=68, Not yet recruiting, Shanghai Pharmaceuticals Holding Co., Ltd

P1, N=10, Recruiting, West China Hospital

P1, N=15, Recruiting, West China Hospital

P1/2, N=64, Recruiting, ImmVira Pharma Co. Ltd | Trial completion date: Aug 2030 --> Oct 2025 | Trial primary completion date: Jul 2030 --> Oct 2023

P2a, N=68, Not yet recruiting, ImmVira Pharma Co. Ltd | Initiation date: Mar 2023 --> Jun 2023

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.

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.

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.

The in vivo efficacy studies demonstrated that IT and IP administration of T7011, rather than MVR-T3011 virus which lacks CD19, specifically promoted CD19 CAR-T anti-solid tumor activities in both immunodeficient and immunocompetent mice. The new-generation of HSV oncolytic virus T7011 expressing the targetable CD19 antigen on tumor surface enables the CD19 CAR-T for solid tumor cell treatment as a combination therapy. The new-generation of HSV oncolytic virus T7011 expressing the targetable CD19 antigen on tumor surface enables the CD19 CAR-T for solid tumor cell treatment as a combination therapy. In addition, T7011 also carries multi-immunomodulators further to enhance antitumor efficacy by reinvigorating the infiltrated CAR-T cells and reversing the immunosuppressive TME. T7011 is expected to be a promising combinational therapy with CD19-specific CAR-T cells enabling effective cell therapy against multiple solid tumors.

P2a, N=68, Not yet recruiting, ImmVira Pharma Co. Ltd

P1/2, N=64, Recruiting, ImmVira Pharma Co. Ltd | Trial completion date: Oct 2024 --> Aug 2030 | Trial primary completion date: Oct 2022 --> Jul 2030