ImmVira's Oncolytic Product MVR-T3011 Expanded to BCG-Naive Bladder Cancer Patients

Preliminary data shows promising efficacy and safety in first-time use for BCG-naive patients.

Published on Feb. 27, 2026

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ImmVira Group announced preliminary positive results from its clinical trial evaluating MVR-T3011, an oncolytic virus, in BCG-naive high-risk papillary Ta/T1 non-muscle-invasive bladder cancer (NMIBC) patients. The data were presented at the ASCO GU 2026 Conference in San Francisco. The study involving 18 BCG-naive patients demonstrated encouraging efficacy and durability, with a 12-month recurrence-free-survival rate of 100% at the 2x10^9 PFU dose level and a 3-month rate of 100% at the 1x10^10 PFU dose level. MVR-T3011 also maintained a favorable safety profile.

Why it matters

Bladder cancer is the 9th most prevalent cancer worldwide, with approximately 75% of cases classified as NMIBC. While Bacillus Calmette-Guerin (BCG) remains the current standard of care for high-risk NMIBC, global shortages have limited its availability. Oncolytic immunotherapy, like MVR-T3011, offers enhanced immune activation and potential durability as a promising alternative to BCG.

The details

In the study, 18 BCG-naive high-risk papillary Ta/T1 NMIBC patients were treated with intravesical MVR-T3011 at two dose levels: 2x10^9 PFU (3 patients) and 1x10^10 PFU (15 patients). Preliminary data as of December 31, 2025 showed that among the 14 evaluable patients, the 12-month recurrence-free-survival (RFS) rate was 100% at the 2x10^9 PFU dose level. At the 1x10^10 PFU dose, the 3-month RFS rate was 100%. The 6-month and 9-month RFS rates were 75% and 66.7% respectively, but these data are preliminary due to the small patient numbers. MVR-T3011 also maintained a favorable safety profile, with most treatment-emergent adverse events being Grades 1 or 2 and no treatment-related adverse events observed.

  • On February 26, 2026, the data were presented at the ASCO GU 2026 Conference in San Francisco, California.
  • The preliminary data is as of December 31, 2025.

The players

ImmVira Group

A clinical-stage biotechnology company dedicated to the discovery, development, manufacture and commercialization of novel oncolytic immunotherapies and engineered exosome therapies.

Dr. Grace Zhou

Chairwoman and CEO of ImmVira.

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What they’re saying

“We are highly encouraged by the preliminary efficacy and safety data from the study. MVR-T3011 shows its potential to serve as a reliable and widely accessible alternative to BCG, ultimately benefiting patients worldwide.”

— Dr. Grace Zhou, Chairwoman and CEO of ImmVira

The takeaway

As a global shortage of the standard-of-care BCG treatment for bladder cancer patients persists, ImmVira's oncolytic virus product MVR-T3011 has demonstrated promising early results as a potential new alternative therapy, offering both efficacy and a favorable safety profile for BCG-naive patients.