#China #Suzhou #Bladder Cancer #ImmVira #MVR-T3011

ImmVira Presents Clinical Data from Bladder Cancer Studies at ESMO 2026

ImmVira Group has unveiled promising clinical data from three essential bladder cancer studies, highlighting the efficacy of its lead oncolytic immunotherapy candidate, MVR-T3011. This presentation took place at the esteemed 2026 European Society for Medical Oncology (ESMO) Congress, where the findings indicated significant therapeutic potential across various patient demographics.

The three studies particularly focused on high-risk bladder cancer populations that are traditionally challenging to treat. The patient groups analyzed included those classified as BCG-unresponsive high-risk carcinoma in situ (CIS), BCG-unresponsive high-risk papillary tumors, and BCG-naïve papillary tumors. The results collectively underscore the broad applicability and effectiveness of MVR-T3011 in managing bladder cancer.

Study Highlights

As of the cutoff date of August 31, 2026, several key efficacy results were shared:

1. Phase II Study of MVR-T3011 in High-risk BCG-Unresponsive CIS (E-poster FPN 4792eP; NCT06971614)
- Twenty patients were enrolled, with 19 evaluable for the efficacy analysis. Participants received the treatment at either a dose of 2×10^9 PFU or 1×10^10 PFU.
- The cohort dosed at 1×10^10 PFU showed striking complete response rates (CRR) of 88.9% at six months and 87.5% at nine months, and an impressive overall CRR of 90% for the same cohort.
- The lower dose cohort (2×10^9 PFU) exhibited a CRR of only 66.7%, emphasizing the dose-dependent efficacy of the treatment.

2. Phase II Study of MVR-T3011 in BCG-Unresponsive Papillary NMIBC (E-poster FPN 4793eP; NCT06971614)
- This cohort involved 17 evaluable patients treated with the 2×10^9 PFU dosage.
- Patients achieved a 75.1% recurrence-free survival (RFS) rate at 12 months. Notably, among these, 35% (6 out of 17) successfully completed the full two-year treatment regimen without recurrence.

3. Intravesical MVR-T3011 in BCG-Naïve High-Risk Papillary NMIBC (E-poster FPN 4790eP)
- This study enrolled 15 patients, with 14 being evaluable. The treatment was administered at a dose of 1×10^10 PFU.
- Early data demonstrated robust clinical activity, reporting a RFS rate of 92.9% at three months, which remained strong at 78.6% at six months, and further decreased to 69.8% at both nine and twelve months.

Safety Profile

Across all three patient cohorts, MVR-T3011 maintained a commendable safety profile, consistent with previous findings. Despite the optimized higher doses, the treatment showcased a highly manageable safety record devoid of any severe treatment-related adverse events (Grade 4 or higher) reported.

ImmVira's Commitment

Dr. Grace Zhou, Chairwoman and CEO of ImmVira, expressed her encouragement about the ongoing clinical momentum and the promising potential of MVR-T3011 across more extensive non-muscle invasive bladder cancer (NMIBC) applications presented at ESMO 2026. She stated, "These updated data reinforce the therapy’s ability to deliver a durable, effective, and safe treatment option for bladder cancer patients. We are committed to accelerating the clinical development of MVR-T3011 and expanding its evaluation into late-stage muscle-invasive bladder cancer (MIBC) while seeking to provide an innovative immunotherapy that promotes bladder preservation and enhances life quality."

About MVR-T3011

MVR-T3011 is a groundbreaking oncolytic immunotherapy based on the HSV-1 virus. Its unique design integrates a replication-competent and tumor-lytic HSV-1 backbone with anti-PD-(L)1 antibodies and IL-12 to promote simultaneous tumor cell destruction and the stimulation of both innate and adaptive immunity. It is versatile for various administration routes including intratumoral, intracavitary, and intravenous pathways.

About ImmVira

ImmVira is a global biotechnology company committed to developing innovative oncolytic immunotherapies through a proprietary bioengineering platform. Their strategic pipeline is designed to address significant oncological challenges, such as bladder cancer and various refractory solid tumors, thereby affirming ImmVira's position as a leader in cancer immunotherapy.