|
SUZHOU, China, Dec. 4, 2025 /PRNewswire/ -- On December 3, 2025 (local time in Arizona, USA), ImmVira Group ("ImmVira" or the "Company") announced a poster presentation at the 26th Annual Meeting of the Society of Urologic Oncology (SUO 2025). The presentation featured the latest interim clinical data (as of September 19, 2025) for its lead HSV-1 oncolytic virus product. MVR-T3011, in high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) patients.
The patients were enrolled and treated with intravesical MVR-T3011 at two dose levels: 2x109 PFU and 1x1010 PFU in this study. There were a total of 26 patients with papillary (16 patients at the dosage level of 2x109 PFU, 10 patients at the dosage level of 1x1010 PFU), and a total of 12 patients with carcinoma in situ (CIS) (7 patients at the dosage level of 2x109 PFU, 5 patients at the dosage level of 1x1010 PFU) enrolled in this trial. Data from the patients demonstrated a promising efficacy profile:
- Among 16 evaluable patients with BCG-unresponsive papillary who received MVR-T3011 at a dose of 2x109 PFU, the 3-month, 6-month, 9-month and 12-month recurrence-free survival (RFS) rates were 87.1%, 80.4%, 80.4% and 71.4%, respectively. Among 6 evaluable patients who received MVR-T3011 at a dose of 1x1010 PFU, 100% of patients remained recurrence free at Month 3 and Month 6.
- As of the same date, among 7 evaluable patients with BCG-unresponsive CIS (with or without Ta/T1) who received MVR-T3011 at doses of 2x109 PFU, the CR at any time, 3-month and 6-month CRR was 71.4%, and among 5 evaluable patients with BCG-unresponsive CIS (with or without Ta/T1) who received MVR-T3011 at doses of 1x1010 PFU, the CR at any time, 3-month and 6-month CRR was 100%.
Consistent with previous clinical findings, MVR-T3011 continued to demonstrate a favorable safety and tolerability profile in the latest study. Most treatment-emergent adverse events (TEAEs) were at Grades 1 or 2. Only five Grade 3 TEAEs were reported, two of which were treatment-related adverse events (TRAEs) and were consistent with reactions commonly associated with catheterization procedures. No Grade 3 or above TEAEs and no dose-limiting toxicities (DLT) occurred.
According to Frost & Sullivan, bladder cancer is one of the top 10 most common solid tumors globally by incidence and often requires prolonged treatment and surveillance spanning 5-10 years. NMIBC is a main type of bladder cancer, representing approximately 75% of all newly diagnosed bladder cancer cases. The current standard of care for high-risk NMIBC is Bacillus Calmette-Guerin (BCG). However, the availability of BCG is significantly limited by global supply shortages. In the U.S., BCG supply meets less than 30% of the total demand. These significant unmet medical needs highlight a clear opportunity for novel immunotherapies such as oncolytic viruses, which hold considerable potential as a new mechanism of action in this underserved market.
"We are highly encouraged by the interim efficacy data from the study, especially the high CR and RFS rate for both BCG-unresponsive CIS and papillary patients at 1x1010 PFU," said Dr. Grace Zhou, Chairwoman and CEO of ImmVira. "We have initiated a phase II trial for BCG-unresponsive high-risk NMIBC in the U.S. in June 2025 and are progressing a global multi-regional clinical trial (MRCT) inclusive of China. We believe MVR-T3011 could emerge as the new generation of therapy for patients with high-risk, BCG-unresponsive NMIBC."
About MVR-T3011
MVR-T3011, represents a breakthrough in HSV-1-based oncolytic immunotherapy. Its proprietary "3-in-1" design unites a replication-competent, tumor-lytic HSV-1 backbone with anti-PD-(L)1 antibody and IL-12, enabling it simultaneously to lyse tumor cells and stimulate innate and adaptive immunity. MVR-T3011 has demonstrated its adaptability and feasibility across multiple routes of administration including intratumoral, intracavitary and intravenous administrations. MVR-T3011 is the world's first HSV-1-based oncolytic immunotherapy that has completed a phase I trial via systemic intravenous dosing under the FDA regulatory regime.
About ImmVira
ImmVira is a global leading clinical-stage biotechnology company that is powered by proprietary biological engineering technology, and is dedicated to the discovery, development, manufacture and commercialization of novel oncolytic immunotherapies and engineered exosome therapies. We have strategically designed and built a risk-balanced product portfolio that comprised both potentially best-in-class oncolytic immunotherapy candidates for solid tumors and innovative engineered exosome assets for clinical application or direct commercialization. Driven by our strategic priority to become a global leader in the full spectrum of bladder cancer treatment development, we have adopted a rationalized, adaptive approach to advance oncolytic immunotherapy candidates with high clinical potential globally. In parallel, leveraging our deep expertise in biological engineering, we have pioneered development of engineered exosome candidates targeting chronic, hard-to-treat diseases as well as age-related conditions. These selected engineered exosome assets are being deliberately accelerated through strategic, differentiated regulatory pathways to enable expedited commercialization and generate sustainable cash flows that will fuel our broader drug development efforts.
SUZHOU, China, Dec. 4, 2025 /PRNewswire/ -- On December 3, 2025 (local time in Arizona, USA), ImmVira Group ("ImmVira" or the "Company") announced a poster presentation at the 26th Annual Meeting of the Society of Urologic Oncology (SUO 2025). The presentation featured the latest interim clinical data (as of September 19, 2025) for its lead HSV-1 oncolytic virus product. MVR-T3011, in high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) patients.
The patients were enrolled and treated with intravesical MVR-T3011 at two dose levels: 2x109 PFU and 1x1010 PFU in this study. There were a total of 26 patients with papillary (16 patients at the dosage level of 2x109 PFU, 10 patients at the dosage level of 1x1010 PFU), and a total of 12 patients with carcinoma in situ (CIS) (7 patients at the dosage level of 2x109 PFU, 5 patients at the dosage level of 1x1010 PFU) enrolled in this trial. Data from the patients demonstrated a promising efficacy profile:
- Among 16 evaluable patients with BCG-unresponsive papillary who received MVR-T3011 at a dose of 2x109 PFU, the 3-month, 6-month, 9-month and 12-month recurrence-free survival (RFS) rates were 87.1%, 80.4%, 80.4% and 71.4%, respectively. Among 6 evaluable patients who received MVR-T3011 at a dose of 1x1010 PFU, 100% of patients remained recurrence free at Month 3 and Month 6.
- As of the same date, among 7 evaluable patients with BCG-unresponsive CIS (with or without Ta/T1) who received MVR-T3011 at doses of 2x109 PFU, the CR at any time, 3-month and 6-month CRR was 71.4%, and among 5 evaluable patients with BCG-unresponsive CIS (with or without Ta/T1) who received MVR-T3011 at doses of 1x1010 PFU, the CR at any time, 3-month and 6-month CRR was 100%.
Consistent with previous clinical findings, MVR-T3011 continued to demonstrate a favorable safety and tolerability profile in the latest study. Most treatment-emergent adverse events (TEAEs) were at Grades 1 or 2. Only five Grade 3 TEAEs were reported, two of which were treatment-related adverse events (TRAEs) and were consistent with reactions commonly associated with catheterization procedures. No Grade 3 or above TEAEs and no dose-limiting toxicities (DLT) occurred.
According to Frost & Sullivan, bladder cancer is one of the top 10 most common solid tumors globally by incidence and often requires prolonged treatment and surveillance spanning 5-10 years. NMIBC is a main type of bladder cancer, representing approximately 75% of all newly diagnosed bladder cancer cases. The current standard of care for high-risk NMIBC is Bacillus Calmette-Guerin (BCG). However, the availability of BCG is significantly limited by global supply shortages. In the U.S., BCG supply meets less than 30% of the total demand. These significant unmet medical needs highlight a clear opportunity for novel immunotherapies such as oncolytic viruses, which hold considerable potential as a new mechanism of action in this underserved market.
"We are highly encouraged by the interim efficacy data from the study, especially the high CR and RFS rate for both BCG-unresponsive CIS and papillary patients at 1x1010 PFU," said Dr. Grace Zhou, Chairwoman and CEO of ImmVira. "We have initiated a phase II trial for BCG-unresponsive high-risk NMIBC in the U.S. in June 2025 and are progressing a global multi-regional clinical trial (MRCT) inclusive of China. We believe MVR-T3011 could emerge as the new generation of therapy for patients with high-risk, BCG-unresponsive NMIBC."
About MVR-T3011
MVR-T3011, represents a breakthrough in HSV-1-based oncolytic immunotherapy. Its proprietary "3-in-1" design unites a replication-competent, tumor-lytic HSV-1 backbone with anti-PD-(L)1 antibody and IL-12, enabling it simultaneously to lyse tumor cells and stimulate innate and adaptive immunity. MVR-T3011 has demonstrated its adaptability and feasibility across multiple routes of administration including intratumoral, intracavitary and intravenous administrations. MVR-T3011 is the world's first HSV-1-based oncolytic immunotherapy that has completed a phase I trial via systemic intravenous dosing under the FDA regulatory regime.
About ImmVira
ImmVira is a global leading clinical-stage biotechnology company that is powered by proprietary biological engineering technology, and is dedicated to the discovery, development, manufacture and commercialization of novel oncolytic immunotherapies and engineered exosome therapies. We have strategically designed and built a risk-balanced product portfolio that comprised both potentially best-in-class oncolytic immunotherapy candidates for solid tumors and innovative engineered exosome assets for clinical application or direct commercialization. Driven by our strategic priority to become a global leader in the full spectrum of bladder cancer treatment development, we have adopted a rationalized, adaptive approach to advance oncolytic immunotherapy candidates with high clinical potential globally. In parallel, leveraging our deep expertise in biological engineering, we have pioneered development of engineered exosome candidates targeting chronic, hard-to-treat diseases as well as age-related conditions. These selected engineered exosome assets are being deliberately accelerated through strategic, differentiated regulatory pathways to enable expedited commercialization and generate sustainable cash flows that will fuel our broader drug development efforts.
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
High Response in Bladder Cancer: Immvira Announced Its MVR-T3011 Latest Clinical Results in BCG-Unresponsive Bladder Cancer Patients at 2025 Annual Meeting of the Society of Urologic Oncology
High Response in Bladder Cancer: Immvira Announced Its MVR-T3011 Latest Clinical Results in BCG-Unresponsive Bladder Cancer Patients at 2025 Annual Meeting of the Society of Urologic Oncology
High Response in Bladder Cancer: Immvira Announced Its MVR-T3011 Latest Clinical Results in BCG-Unresponsive Bladder Cancer Patients at 2025 Annual Meeting of the Society of Urologic Oncology
At Anker Day 2026, Anker Innovations marks its 15th anniversary by unveiling THUS™ - ANKER's first neural-net Compute-in-Memory AI audio chip - and a new generation of products across soundcore and eufy.
NEW YORK and Bellevue, Wash., May 22, 2026 /PRNewswire/ -- Anker Innovations is hosting Anker Day 2026: Where Ultimate Meets Possible, its annual brand event to showcase the newest product launches and technology break-throughs across its portfolio. Where Ultimate Meets Possible will bring together media, retail buyers and key influencers for an exclusive look at what's next in consumer electronics, spanning premium audio, home energy and the smart home appliances.
Where Ultimate Meets Possible will be held at STORIED in New York City, an invite-only experience featuring keynote presentations, hands-on product demonstrations and a deep dive into the company's latest innovations.
Anker Day 2026 debuted innovations across three brands: soundcore's Liberty 5 Pro and Pro Max — the first earbuds powered by Anker's new THUS™ AI chip — alongside VibeOS AI platform and Nebula SpaceFlow; Anker SOLIX's S2000, the world's longest-lasting 2kWh home backup power station; and eufy's EdgeAgent™, a local AI home security agent, plus new baby care products.
Started With Power
Anker was founded in 2011 and released its first product in the following year: a 4,500mAh ultra-slim power bank. It was a modest beginning, but behind it was an engineering conviction that would shape everything that followed. If technology is going to make a meaningful difference in people's lives, it has to be built to the highest possible standard.
2012 - The Beginning
Anker's first product: a 4,500mAh ultra-slim power bank - the start of a commitment to putting well-engineered, reliable power in people's hands.
2013 - PowerIQ™
Introduced PowerIQ™, enabling fast-charging compatibility across both iOS and Android - setting the standard for universal charging intelligence.
2018 - GaN from Aerospace
An early adopter of Gallium Nitride (GaN) from aerospace applications for consumer charging - delivering a 40% size reduction without sacrificing output.
2019 - World's Smallest 18W Charger
Delivered the world's smallest 18W charger at the time - proving that ultimate performance and ultra-compact form are not a trade-off.
2022 - GaNPrime™
Pioneered high-power multi-port chargers with dynamic power distribution - intelligently allocating power across multiple devices simultaneously.
2023 - 240W Wall Charger
Delivered the industry's highest-power 240W wall charger at the time - meeting the demands of the most power-hungry professional setups.
2024 - InstaCord™ & UltraDura™
In 2024, InstaCord™ became Anker's most advanced retractable‑cable technology and UltraDura™ achieved industry‑leading durability.
2025 - GaNPrime™ 2.0 • PowerIQ™ 5.0 • AnkerSense™ View • TurboBoost™
GaNPrime™ 2.0 (most advanced fast charging), PowerIQ™ 5.0 (smartest compatibility), AnkerSense™ View (intelligent display technology), and TurboBoost™ for ultra-fast power bank recharging. The pursuit never stops.
Fifteen years. Eight technology generations. Every breakthrough driven by one and only promise: seeking the ultimate innovation, not as an end in itself, but because technology built to its highest standard is how we put the possibilities people want in their lives within reach. Technology in service of people. That is what this pursuit has always meant.
Today's Milestone: Anker Thus™
For 80 years, chip design has followed the same logic established by John von Neumann in 1945: separate the processor from memory, and shuttle data between them one instruction at a time. For eight decades across mainframes, desktops, and data centers, this model worked. AI breaks that assumption. A neural network draws on millions of learned parameters all at once - and in a wearable device, moving that data between memory and processor consumes more than 90 percent of chip power, leaving almost nothing for actual computation.
THUS™ applies a different principle: embed computation directly inside NOR Flash memory cells, where the model already lives. The model parameters never have to move. The energy previously consumed by data movement is redirected entirely to computation.
The first THUS™ AI chip debuts in earbuds, delivering up to 150 times more AI computing power on the environmental noise cancellation task than Anker's previous-generation flagship earphones.
Clear Calls - the chip's first disclosed feature - runs a large neural network entirely on-device, anchored by eight MEMS microphones and two bone conduction sensors, for a significantly clear call in any environment. Additional AI-powered features including Signature Sound and Voice Control debuted at Anker Day.
"Every AI chip built until now stores the model on one side and does the computation on the other. To think, the device has to carry all those parameters across, many times per second, every single inference. THUS™ puts the computation where the model already lives. The model never has to move again."
- Steven Yang, Founder and CEO, Anker Innovations
THUS™ takes inspiration from "Thus have I heard", a Buddhist phrase that reflects direct transmission - knowledge conveyed as it was experienced, without distortion.
All performance figures are based on internal Anker lab tests. The 150× AI computing power figure applies specifically to the environmental noise cancellation task and reflects the architectural change from rule-based to neural-net AI processing. It is not a general performance claim and does not reflect a process node upgrade. The environmental noise cancellation workload referenced here runs as an on-device neural network model on the first THUS™ chip.
Anker soundcore Liberty 5 Pro: The First Product Powered by Anker Thus™
The soundcore Liberty 5 Pro and Liberty 5 Pro Max are the first two products to ship with the THUS™ chip. Their positioning is organized around three on-device intelligence layers the chip enables - understanding, adapting, and tuning - each representing a function earbuds could not credibly perform before neural-net AI became viable at this scale. Coming to the market soon.
15 Years, One Promise
From our first power bank to a proprietary AI chip in 2026 - the categories we build in keep expanding, and so does the scope of what technology can do for people's lives. Our promise has been one and only, seeking the ultimate innovation, with the conviction that technology built to its highest standard makes the possibilities people want in their lives the ones they can actually live. Fifteen years is long enough to know that trust is earned slowly. Fifteen years in. The pursuit continues.
About Anker Innovations
Anker Innovations is a global consumer technology company driven by ultimate innovation, creating products that help people power, create, connect, and live more freely. Founded in 2011, Anker Innovations serves more than 200 million consumers across 146 countries and regions. Learn more at anker.com.
DISCLAIMER
*Statements in this news release that are not statements of historical fact may include forward-looking statements regarding future events or the future financial performance of the company. We wish to caution you that such statements are just predictions and that actual events or results may differ materially. Forward-looking statements involve a number of risks and uncertainties surrounding competitive and industry conditions, market acceptance for the company's products, risks of litigation, technological changes, developing industry standards and other factors related to the company's businesses. The actions referred to in this press release are not an admission or acknowledgement of any claim or allegation. The Company reserves all of its rights.
** This press release is distributed by PR Newswire through automated distribution system, for which the client assumes full responsibility. **
15 Years of Seeking Ultimate Innovation: From Power Banks to Proprietary AI THUS™ Chip
15 Years of Seeking Ultimate Innovation: From Power Banks to Proprietary AI THUS™ Chip
15 Years of Seeking Ultimate Innovation: From Power Banks to Proprietary AI THUS™ Chip
