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.
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SOURCE ImmVira
