On October 22, 2026 ImmVira Group ("ImmVira") reported that updated clinical data from three bladder cancer studies of its lead oncolytic immunotherapy candidate, MVR-T3011, will be presented at the 2026 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. These presentations covered three key patient populations: 1) BCG-unresponsive high-risk carcinoma in situ (CIS); 2) BCG-unresponsive high-risk papillary (Ta/T1) tumors; and 3) BCG-naïve papillary (Ta/T1) tumors. The updated data showed encouraging clinical activity across the three patient populations, highlighting MVR-T3011’s broad therapeutic potential in bladder cancer and underscoring ImmVira’s comprehensive and long-term strategic commitment to this clinical landscape.

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As of the August 31, 2026 data cutoff, the updated poster presentations highlight the following key efficacy results:

Updated Phase II Study of MVR-T3011 in High-risk BCG-Unresponsive CIS NMIBC (E-poster FPN: 4792eP; NCT06971614)

The study enrolled 20 patients. Among them, 19 were evaluable for efficacy, receiving intravesical MVR-T3011 at either a 2×109 PFU (9 patients) or a 1×1010 PFU (10 patients) dose.
The 1×1010 PFU cohort achieved 88.9% and 87.5% complete response rate (CRR) at 6 months and 9 months respectively. The anytime CRR for the 1×1010 PFU dose reached 90% (9/10). This demonstrated superior response rates compared to the 2×109 PFU cohort, which achieved a 66.7% (6/9) anytime CRR.
Updated Phase II Study of MVR-T3011 in High-risk BCG-Unresponsive Papillary NMIBC (E-poster FPN: 4793eP; NCT06971614)

This cohort included 17 evaluable patients treated with the 2×109 PFU dose of MVR-T3011.
Patients achieved a 12-month recurrence-free survival (RFS) rate of 75.1%. Notably, 6 patients (6/17, 35%) successfully completed the full 2-year treatment course and remained recurrence-free.
Intravesical MVR-T3011 in BCG-Naïve High-Risk Papillary NMIBC (E-poster FPN: 4790eP)

Evaluating the therapy in a frontline setting, 15 patients were enrolled with 14 patients were evaluable. Patients were treated at the 1×1010 PFU dose.
Early results showcased robust clinical activity, with patients achieving a 92.9% RFS rate at 3 months. The RFS rate remained strong at 78.6% at 6 months, and 69.8% at both 9 and 12 months.
Across all three evaluated patient cohorts, MVR-T3011 demonstrated an excellent tolerability profile consistent with earlier clinical findings. The therapy maintained a highly manageable safety record even at the optimized higher doses, with no Grade 4 or higher treatment-related adverse events reported.

"Following our earlier presentation at ASCO (Free ASCO Whitepaper) 2026, we are highly encouraged to see the continuing clinical momentum and explosive potential of MVR-T3011 across broader NMIBC indications at this year’s ESMO (Free ESMO Whitepaper) Congress," said Dr. Grace Zhou, Chairwoman and CEO of ImmVira. "These updated data further validate the therapy’s ability to provide a durable, highly effective, well-tolerated, and safe treatment option for bladder cancer patients. We remain fully committed to accelerating its clinical development to establish MVR-T3011 as an affordable, foundational novel treatment choice for bladder cancer patients worldwide, while actively expanding its clinical evaluation into late-stage muscle-invasive bladder cancer (MIBC) to offer a novel immunotherapy that enables bladder preservation and improves quality of life."

About MVR-T3011

MVR-T3011 represents a breakthrough in HSV-1-based oncolytic immunotherapy. Its proprietary "3-in-1" design unites a replication-competent, tumor-lytic HSV-1 backbone with anti-PD-(L)1 antibody and IL-12, enabling it simultaneously to lyse tumor cells and stimulate innate and adaptive immunity. MVR-T3011 has demonstrated its adaptability and feasibility across multiple routes of administration including intratumoral, intracavitary and intravenous administrations.

(Press release, Immvira, OCT 22, 2026, View Source [SID1234673680])