MVR-T3011

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： [email protected] SOURCE ImmVira WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SHENZHEN, China, Sept. 15, 2024 /PRNewswire/ -- ImmVira announced the latest clinical results for its lead oncolytic virus product, MVR-T3011, via intravesical administration in patients with high-risk BCG-failure non-muscle invasive bladder cancer (NMIBC). The results were published through poster presentation at the 2024 European Society for Medical Oncology (ESMO 2024). This Phase I, open-label, dose-escalation and expansion study was conducted in China to assess the safety and efficacy of MVR-T3011 administered intravesically in patients with high-risk BCG-failure NMIBC. The study enrolled a broader patient population, including those with high-grade Ta, T1, or CIS +/- Ta/T1 bladder cancer, regardless of the presence of CIS. This inclusive approach aims to target a wider range of patients, potentially accelerating future trial enrollment and expanding market opportunities. The treatment was delivered via intravesical instillation at three dose levels, with weekly induction course lasting 12 weeks, followed by bi-weekly maintenance course for up to one year. According to poster presented (cut-off as of June 27, 2024), among 14 evaluable patients, the overall 3-month complete response (CR) rate across all dose levels was 71.4% (10/14). At the 2×109 PFU dose level (expected RP2D), the CR rate reached an impressive 87.5% (7/8). The study showed a favorable safety profile, with no dose-limiting toxicities (DLTs) reported and no maximum tolerated dose (MTD) reached. Additionally, MVR-T3011 treatment simplifies clinical procedure by eliminating the need for bladder prewash by nature, further reducing patient discomfort. The instillation process is both quick and efficient. By September 15, 2024, the most recent data shows that 20 subjects have received MVR-T3011 treatment. At the RP2D dose level, the 3-month CR rate remained strong at 81.8% (9/11). Of the 9 patients who have reached the 6-month assessment, 8 have maintained CR, while 4 patients have reached the 9-month assessment and all remained in CR. We are continuing to gather additional data to support further analysis. "There is a significant unmet need for innovative treatments for bladder cancer," said Dr. Grace Zhou, Chairwoman and CEO of ImmVira. "We are highly encouraged by the preliminary safety and efficacy data from this Phase I study, especially the 3-month CR rate over 80%, along with durable responses at 6- and 9-month time points. With this early success, we are committed to accelerating clinical development of intravesical MVR-T3011 treatments for BCG-failure NMIBC patients and exploring its potential across other bladder cancer indications. Our goal is to provide a novel, effective, and well-tolerated treatment solution for patients." About MVR-T3011 MVR-T3011, ImmVira's proprietary 3-in-1 oHSV, is a novel genetic engineered oHSV with advanced backbone design aiming to achieve the most favorable profile of attenuated HSV-1 with replication potency in tumor cells and highly restricted replication in normal cells, supporting intratumoral, intravenous and intravesical administrations. Additionally, MVR-T3011 incorporated two latest and well-validated exogenous genes, PD-1 antibody and IL-12, to further enhance immune responses in the tumor microenvironment. About ImmVira ImmVira is a biotechnology company focused on developing and synthesizing biological vector delivery platform. The company has constructed a fully integrated OVPENS® (Open Vector+ Potent, Enabling, Novel & Safe) platform with solid science, technology and CMC know-how, and three derivative subplatforms including Oncolytic Virus, Cancer Vaccine and Biosynthetic Exosome, to support ongoing R&D, clinical studies and commercialization of best-in-class mono and combo therapies driven by clinical benefits in oncology and non-oncology fields. SOURCE ImmVira WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED