ImmVira, a clinical-stage biotechnology company, has announced the dosing of the first patient in a multi-regional Phase II clinical trial evaluating MVR-T3011, its lead oncolytic immunotherapy candidate for treating BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC). The milestone represents a significant advancement for patients with limited treatment options following BCG failure.
Promising Phase I Results Drive Phase II Advancement
At the 2024 European Society for Medical Oncology (ESMO) Annual Meeting, ImmVira reported encouraging preliminary efficacy data from its Phase I trial. The study demonstrated a complete response rate (CRR) of over 80% at the 2×10⁹ PFU dose cohort in high-risk BCG-failed NMIBC patients. Updated results from an expanded cohort of 16 evaluable patients with papillary diseases, as of April 30, 2025, maintained robust efficacy with a sustained Kaplan-Meier estimated 3-month recurrence-free survival (RFS) of over 80%.
FDA-Approved Phase II Study Design
Following discussions with and approval by the U.S. FDA, the Phase II study has two primary objectives: confirming the recommended phase II dose (RP2D) of intra-vesically administered MVR-T3011 and assessing its anti-tumor efficacy in patients with BCG-unresponsive NMIBC. The trial will enroll eligible patients at 15-20 cancer centers across the United States and China, evaluating clinical efficacy parameters including complete response rate, event-free survival rate, and recurrence-free survival rate, alongside safety and pharmacokinetic data.
"The initiation of this multi-country Phase II study marks a major milestone for ImmVira," said Dr. Grace Guoying Zhou, ImmVira co-founder, CEO and chairwoman. "We are delighted with the notable progress and results achieved in the Phase I clinical trial of MVR-T3011 for the treatment of NMIBC and are extremely excited about working with key thought leaders in the U.S. and China to further explore the potential of this drug in NMIBC patients."
Novel Mechanism of Action
MVR-T3011 represents a novel approach to cancer treatment, combining a proprietary replication-competent oncolytic virus backbone with payload expression of PD-1 antibody and IL-12. Upon delivery, locally produced IL-12 induces interferon-γ production, enhances oncolytic activity of natural killer cells and cytotoxic T lymphocytes, promotes anti-angiogenesis, and inhibits tumor growth. Simultaneously, the PD-1 antibody functions as an immune checkpoint inhibitor to augment T-cell tumor-killing activity.
Dr. Vignesh Packiam, lead study investigator and Director of Clinical and Translational Research in Urologic Oncology at Rutgers Cancer Center, emphasized the therapeutic potential: "MVR-T3011 represents a novel drug design and has the potential to address an unmet need in NMIBC. Integration of PD-1 Ab and IL-12 genes into the genome of this novel oncolytic immunotherapy can augment immune responses in the tumor microenvironment and prolong the early-phase antitumor efficacy."
Extensive Clinical Experience
The drug has been evaluated in over 200 Phase I/II patients to date, with extensive peer-reviewed in vitro and in vivo data presented internationally. ImmVira has strategically prioritized bladder cancer as a breakthrough indication based on the clinically validated potential of MVR-T3011, spearheading clinical trials in both the U.S. and China to address the full spectrum of bladder cancer types.
