SHENZHEN,China,Sept. 15,2024 -- 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 presentationat 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.