ESMO 2024: ImmVira Presents Clinical Results of MVR-T3011 for High-Risk BCG-Failure NMIBC

ImmVira recently revealed the latest clinical outcomes for its leading oncolytic virus product, MVR-T3011, administered intravesically to patients with high-risk BCG-failure non-muscle invasive bladder cancer (NMIBC). These findings were shared via a poster presentation at the 2024 European Society for Medical Oncology (ESMO 2024) conference.

The Phase I study, conducted in China, was an open-label, dose-escalation and expansion trial designed to evaluate the safety and efficacy of MVR-T3011. The study targeted a broad range of patients, including those with high-grade Ta, T1, or CIS +/- Ta/T1 bladder cancer, irrespective of the presence of CIS. This inclusive patient selection aimed to expedite future trial enrollments and broaden market prospects. MVR-T3011 was administered through intravesical instillation at three different dose levels. The treatment schedule included a weekly induction course lasting 12 weeks, followed by a bi-weekly maintenance course for up to one year.

As of the June 27, 2024 cut-off, the results indicated that among 14 evaluable patients, the overall 3-month complete response (CR) rate across all dose levels was 71.4% (10 out of 14). Notably, at the 2×109 PFU dose level, which is the expected recommended Phase 2 dose (RP2D), the CR rate reached an impressive 87.5% (7 out of 8). The study also demonstrated a favorable safety profile, with no dose-limiting toxicities (DLTs) and no maximum tolerated dose (MTD) being reached. Additionally, MVR-T3011 treatment simplifies the clinical procedure by naturally eliminating the need for bladder prewash, thereby reducing patient discomfort. The instillation process is both quick and efficient.

By September 15, 2024, data showed that 20 subjects had received MVR-T3011 treatment. At the RP2D dose level, the 3-month CR rate remained strong at 81.8% (9 out of 11). Of the nine patients who reached the 6-month assessment, eight maintained CR, while all four patients who reached the 9-month assessment also remained in CR. Further data collection is ongoing to support additional analysis.

Dr. Grace Zhou, Chairwoman and CEO of ImmVira, emphasized the need for innovative bladder cancer treatments. She expressed enthusiasm for the preliminary safety and efficacy data from this Phase I study, highlighting the over 80% 3-month CR rate and the durable responses observed at 6- and 9-month time points. Dr. Zhou affirmed the company's commitment to accelerating the clinical development of MVR-T3011 for BCG-failure NMIBC patients and exploring its potential for other bladder cancer indications. The ultimate goal is to provide a novel, effective, and well-tolerated treatment solution for patients.

MVR-T3011 is ImmVira's proprietary 3-in-1 oncolytic herpes simplex virus (oHSV). It features an advanced genetic design aimed at achieving a favorable profile of attenuated HSV-1 with robust replication in tumor cells while limiting replication in normal cells. This supports multiple administration routes, including intratumoral, intravenous, and intravesical. MVR-T3011 also incorporates two validated exogenous genes, PD-1 antibody and IL-12, to enhance immune responses within the tumor microenvironment.

ImmVira is a biotechnology company dedicated to developing and synthesizing biological vector delivery platforms. The company has constructed the OVPENS® platform, which includes subplatforms for Oncolytic Virus, Cancer Vaccine, and Biosynthetic Exosome. These platforms support ongoing research and development, clinical studies, and commercialization of therapies designed to deliver clinical benefits in both oncology and non-oncology fields.