Shenzhen-based ImmVira announced that it has administered the first patient dose in a global, multi-center Phase II clinical study for its intravenous oncolytic virus product, MVR-T3011. The study focuses on high-risk non-muscle-invasive bladder cancer (NMIBC) unresponsive to BCG therapy.
MVR-T3011 Mechanism
MVR-T3011 is a novel oncolytic immunotherapy based on a highly replicative oncolytic viral vector engineered to co-express PD-1 antibody and IL-12. Upon administration, it locally produces IL-12, inducing IFN-γ generation to enhance the oncolytic activity of natural killer (NK) cells and cytotoxic T lymphocytes (CTLs), while promoting anti-angiogenesis and inhibiting tumor growth. The PD-1 antibody acts as an immune checkpoint inhibitor, significantly boosting T-cell-mediated tumor killing.
Clinical Trial Results
Previous Phase I data showed that the 2×10⁹ PFU dose group achieved a complete response rate exceeding 80%, with a 3-month recurrence-free survival rate also surpassing 80%.
Phase II Trial Details
The Phase II trial will be conducted across 15–20 sites in China and the U.S. It aims to evaluate the drug’s efficacy, safety, and pharmacokinetics. This trial will help confirm the recommended Phase II dose and lay the groundwork for global registration.-Fineline Info & Tech
