ImmVira Presents Clinical Data from Three Bladder Cancer Studies at ESMO 2026

SUZHOU, China, Oct. 23, 2026 /PRNewswire/ — ImmVira Group ("ImmVira") today announced 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) 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.

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 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 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.

About ImmVira

ImmVira is a global, clinical-demand-driven biotechnology company dedicated to the discovery, development, manufacturing, and commercialization of novel oncolytic immunotherapies powered by its proprietary bioengineering platform. The company strategically builds a differentiated pipeline that balances breakthrough innovation with clinical feasibility, targeting major oncological indications including bladder cancer, intracranial tumors, and various refractory solid tumors.

Driven by the strategic vision to become a global leader in cancer immunotherapy—specifically across all lines of bladder cancer treatment—ImmVira adopts a rational and adaptive global R&D approach. Leveraging deep expertise in bioengineering modification, ImmVira integrates multiple mechanisms including genetic modification, tumor microenvironment remodeling, and targeted delivery. This enables the development of potential best-in-class oncolytic immunotherapies alongside robust combination strategies with immune checkpoint inhibitors, chemotherapy, and other targeted agents. Supported by fully integrated capabilities spanning target discovery, process development, commercial-scale GMP manufacturing, and global multi-center clinical filings, ImmVira is strategically accelerating the clinical translation and commercialization of its core pipeline to deliver transformative treatments to patients worldwide.