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ImmVira Announces First Patient Dosed in a Multi-Regional Phase II Clinical Trial Evaluating MVR-T3011 Oncolytic Immunotherapy in Patients with BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

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ImmVira Announces First Patient Dosed in a Multi-Regional Phase II Clinical Trial Evaluating MVR-T3011 Oncolytic Immunotherapy in Patients with BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)
Business

Business

ImmVira Announces First Patient Dosed in a Multi-Regional Phase II Clinical Trial Evaluating MVR-T3011 Oncolytic Immunotherapy in Patients with BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

2025-06-10 20:00 Last Updated At:20:15

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. https://www.immviragroup.com/

Media Contacts:
Investor Relationship: ir@immviragroup.com 

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. https://www.immviragroup.com/

Media Contacts:
Investor Relationship: ir@immviragroup.com 

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

ImmVira Announces First Patient Dosed in a Multi-Regional Phase II Clinical Trial Evaluating MVR-T3011 Oncolytic Immunotherapy in Patients with BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

ImmVira Announces First Patient Dosed in a Multi-Regional Phase II Clinical Trial Evaluating MVR-T3011 Oncolytic Immunotherapy in Patients with BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

APIA, Samoa, Dec. 31, 2025 /PRNewswire/ -- Phemex, a user-first crypto exchange, has introduced a structured reward initiative for the newly listed LIT and MAGMA trading pairs. Running from December 31, 2025, to January 7, 2026, the program features a total allocation of 30,000 USDT designed to support liquidity and market engagement within its derivatives ecosystem.

The initiative highlights two infrastructure approaches in the DeFi sector. Lighter (LIT) is an order-book DEX infrastructure focused on institutional-grade capital efficiency and low-latency execution. Magma Finance (MAGMA) is an AMM DEX built for MOVE-based blockchains, utilizing a liquidity incentive engine designed to align the interests of traders, governance participants, and liquidity providers.

To ensure balanced participation, Phemex has partitioned the 30,000 USDT allocation into two categories:

Reward Mechanism Details:

  • Engagement-Based Pool (10,000 USDT): Dedicated to general interaction tasks, including social referrals and daily trading milestones. This pool is intended to broaden the user base for these emerging protocols.
  • Volume-Driven Competition (20,000 USDT): A competitive track focused on futures trading volume for LIT and MAGMA. Rewards are distributed based on ranking performance, with the top three participants eligible for a significant portion of the pool, including a maximum individual reward of 4,000 USDT.

By integrating these specialized protocols, Phemex continues to diversify its high-performance trading environment, providing users with exposure to the latest developments in order-book and MOVE-based AMM technologies.

About Phemex
Founded in 2019, Phemex is a user-first crypto exchange trusted by over 10 million traders worldwide. The platform offers spot and derivatives trading, copy trading, and wealth management products designed to prioritize user experience, transparency, and innovation. With a forward-thinking approach and a commitment to user empowerment, Phemex delivers reliable tools, inclusive access, and evolving opportunities for traders at every level to grow and succeed.

For more information, please visit: https://phemex.com/ 

 

APIA, Samoa, Dec. 31, 2025 /PRNewswire/ -- Phemex, a user-first crypto exchange, has introduced a structured reward initiative for the newly listed LIT and MAGMA trading pairs. Running from December 31, 2025, to January 7, 2026, the program features a total allocation of 30,000 USDT designed to support liquidity and market engagement within its derivatives ecosystem.

The initiative highlights two infrastructure approaches in the DeFi sector. Lighter (LIT) is an order-book DEX infrastructure focused on institutional-grade capital efficiency and low-latency execution. Magma Finance (MAGMA) is an AMM DEX built for MOVE-based blockchains, utilizing a liquidity incentive engine designed to align the interests of traders, governance participants, and liquidity providers.

To ensure balanced participation, Phemex has partitioned the 30,000 USDT allocation into two categories:

Reward Mechanism Details:

  • Engagement-Based Pool (10,000 USDT): Dedicated to general interaction tasks, including social referrals and daily trading milestones. This pool is intended to broaden the user base for these emerging protocols.
  • Volume-Driven Competition (20,000 USDT): A competitive track focused on futures trading volume for LIT and MAGMA. Rewards are distributed based on ranking performance, with the top three participants eligible for a significant portion of the pool, including a maximum individual reward of 4,000 USDT.

By integrating these specialized protocols, Phemex continues to diversify its high-performance trading environment, providing users with exposure to the latest developments in order-book and MOVE-based AMM technologies.

About Phemex
Founded in 2019, Phemex is a user-first crypto exchange trusted by over 10 million traders worldwide. The platform offers spot and derivatives trading, copy trading, and wealth management products designed to prioritize user experience, transparency, and innovation. With a forward-thinking approach and a commitment to user empowerment, Phemex delivers reliable tools, inclusive access, and evolving opportunities for traders at every level to grow and succeed.

For more information, please visit: https://phemex.com/ 

 

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

Phemex Launches 30,000 USDT Incentive Program for LIT and MAGMA Trading Pairs

Phemex Launches 30,000 USDT Incentive Program for LIT and MAGMA Trading Pairs

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