{"id":25242,"date":"2025-06-10T21:34:33","date_gmt":"2025-06-10T14:34:33","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=25242"},"modified":"2025-06-10T21:34:33","modified_gmt":"2025-06-10T14:34:33","slug":"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-c","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=25242","title":{"rendered":"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)"},"content":{"rendered":"\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

SUZHOU, China<\/span><\/span>, June 10, 2025<\/span><\/span> \/PRNewswire\/ —\u00a0ImmVira, 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.<\/p>\n

\n

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<\/span><\/p>\n<\/div>\n

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\u00d7109<\/sup> PFU dose cohort. Updated results from the expanded cohort of 16 evaluable patients with papillary diseases (as of April 30, 2025<\/span>, the data cutoff date) maintained robust efficacy, with a sustained Kaplan-Meier (K-M) estimated 3-month recurrence-free survival (RFS) of over 80%.<\/p>\n

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<\/span> and China<\/span> for evaluation of the clinical efficacy parameters including CRR, event-free survival rate and RFS rate. Meanwhile, safety and pharmacokinetic data will be evaluated.<\/p>\n

“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<\/span>. “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<\/span> to further explore the potential of this drug in NMIBC patients.”<\/p>\n

Lead study investigator and the Director of Clinical and Translational Research in Urologic Oncology at Rutgers Cancer Center, Dr. Vignesh Packiam<\/span>, 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\u00a0the early-phase antitumor efficacy.”<\/p>\n

About MVR-T3011 <\/b><\/p>\n

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-\u03b3 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<\/i> and in vivo<\/i> data have been presented internationally and the drug has, to-date, been evaluated in\u00a0over 200\u00a0Phase I\/II patients.<\/p>\n

About ImmVira<\/b><\/p>\n

ImmVira is a global leading clinical-stage biotechnology company leveraging differentiated expertise in biologics technology<\/span>, dedicated to the discovery, research, and development of novel biological products.\u00a0ImmVira 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<\/span> in patients to address the full spectrum of bladder cancer types. https:\/\/www.immviragroup.com\/<\/a><\/p>\n

Media Contacts:
<\/b>Investor Relationship\uff1a ir@immviragroup.com<\/a>\u00a0<\/span><\/p>\n

<\/div>","protected":false},"excerpt":{"rendered":"

<\/p>\n\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

SUZHOU, China<\/span><\/span>, June 10, 2025<\/span><\/span> \/PRNewswire\/ —\u00a0ImmVira, 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.<\/p>\n

\n

\"\"<\/a>
<\/span><\/p>\n<\/div>\n

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\u00d7109<\/sup> PFU dose cohort. Updated results from the expanded cohort of 16 evaluable patients with papillary diseases (as of April 30, 2025<\/span>, the data cutoff date) maintained robust efficacy, with a sustained Kaplan-Meier (K-M) estimated 3-month recurrence-free survival (RFS) of over 80%.<\/p>\n

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<\/span> and China<\/span> for evaluation of the clinical efficacy parameters including CRR, event-free survival rate and RFS rate. Meanwhile, safety and pharmacokinetic data will be evaluated.<\/p>\n

“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<\/span>. “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<\/span> to further explore the potential of this drug in NMIBC patients.”<\/p>\n

Lead study investigator and the Director of Clinical and Translational Research in Urologic Oncology at Rutgers Cancer Center, Dr. Vignesh Packiam<\/span>, 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\u00a0the early-phase antitumor efficacy.”<\/p>\n

About MVR-T3011 <\/b><\/p>\n

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-\u03b3 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<\/i> and in vivo<\/i> data have been presented internationally and the drug has, to-date, been evaluated in\u00a0over 200\u00a0Phase I\/II patients.<\/p>\n

About ImmVira<\/b><\/p>\n

ImmVira is a global leading clinical-stage biotechnology company leveraging differentiated expertise in biologics technology<\/span>, dedicated to the discovery, research, and development of novel biological products.\u00a0ImmVira 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<\/span> in patients to address the full spectrum of bladder cancer types. https:\/\/www.immviragroup.com\/<\/a><\/p>\n

Media Contacts:
<\/b>Investor Relationship\uff1a ir@immviragroup.com<\/a>\u00a0<\/span><\/p>\n

<\/div>\n

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