ImmVira Announces First Patient Dosed in a Multi-Regional Phase II Clinical Trial Evaluating MVR-T3011 Oncolytic Immunotherapy in Patients with BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

SUZHOU, China, June 10, 2025 /PRNewswire/ -- ImmVira, a global leading clinical-stage biotechnology company focused on the development of next-generation novel oncolytic immunotherapy for treatment of cancer, announced that the first patient diagnosed with NMIBC has been dosed in a multi-regional Phase II clinical trial evaluating its lead product candidate, MVR-T3011.

At the 2024 European Society for Medical Oncology (ESMO) Annual Meeting, ImmVira reported MVR-T3011's preliminary efficacy data in high-risk BCG-failed NMIBC patients, demonstrating an encouraging complete response rate (CRR) of over 80% at the 2×109 PFU dose cohort. Updated results from the expanded cohort of 16 evaluable patients with papillary diseases (as of April 30, 2025, the data cutoff date) maintained robust efficacy, with a sustained Kaplan-Meier (K-M) estimated 3-month recurrence-free survival (RFS) of over 80%.

Based on discussions with and approval by the U.S. FDA, the primary objectives of this Phase II study are to further confirm the recommended phase II dose (RP2D) of intra-vesically administered MVR-T3011, and based on which, assess the anti-tumor efficacy of MVR-T3011 in patients with BCG-unresponsive NMIBC. ImmVira plans to enroll eligible patients at 15-20 cancer centers in the United States and China for evaluation of the clinical efficacy parameters including CRR, event-free survival rate and RFS rate. Meanwhile, safety and pharmacokinetic data will be evaluated.

"The initiation of this multi-country Phase II study marks a major milestone for ImmVira," said ImmVira co-founder, CEO and chairwoman, Dr. Grace Guoying Zhou. "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."

Lead study investigator and the Director of Clinical and Translational Research in Urologic Oncology at Rutgers Cancer Center, Dr. Vignesh Packiam, added, "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."

About MVR-T3011

MVR-T3011 is a novel oncolytic immunotherapy combining a proprietary replication competent oncolytic virus backbone with payload expression of PD-1 Ab and IL-12. Upon delivery, locally produced IL-12 induces IFN-γ production, enhances oncolytic activity of NK cells and cytotoxic T lymphocytes, promotes anti-angiogenesis and inhibits tumor growth. Simultaneously, the PD-1 antibody acts as an immune checkpoint inhibitor to augment T-cell tumor-killing activity. Extensive and peer-reviewed in vitro and in vivo data have been presented internationally and the drug has, to-date, been evaluated in over 200 Phase I/II patients.

About ImmVira

ImmVira is a global leading clinical-stage biotechnology company leveraging differentiated expertise in biologics technology, dedicated to the discovery, research, and development of novel biological products. ImmVira strategically encompass the development of potentially best-in-class novel oncolytic immunotherapy and innovative engineered exosome candidates With a target to become a global leader in bladder cancer treatment, ImmVira has prioritized this indication as strategic breakthrough based on clinically validated potential of its lead oncolytic immunotherapy candidate MVR-T3011, and spearheaded clinical trials in both the U.S. and China in patients to address the full spectrum of bladder cancer types.

Media Contacts:
Investor Relationship：