A Phase II Clinical Study to Evaluate the Tolerability, Safety, and Preliminary Efficacy of Intravesical Administration of Herpes Virus T3011 Injection in Participants With BCG-unresponsive High Risk Non-muscle-invasive Bladder Cancer

This is a single-arm, open-label, multicenter, phase II clinical study to evaluate the tolerability, safety, and preliminary efficacy of intravesical administration of Herpes Virus T3011 Injection in participants with BCG-unresponsive high risk non-muscle-invasive bladder cancer (NMIBC) .

Start Date30 May 2025

Sponsor / Collaborator

Shenzhen Yinuowei Medical Technology Co., Ltd.

NCT05756556

/ SuspendedPhase 2

A Phase 2a, Open-label Study of T3011 in Combination With Cobimetinib in Patients With Advanced Melanoma

This study will evaluate the efficacy and safety of T3011 in combination with Cobimetinib in patients with advanced melanoma.

Start Date30 Jun 2024

Sponsor / Collaborator

Shenzhen Yinuowei Medical Technology Co., Ltd.

NCT06283303

/ Not yet recruitingPhase 1IIT

A Clinical Study to Evaluate the Safety and Efficacy of Herpes Virus T3011 Injection in Combination With Toripalimab and Regorafenib in Patients With Liver Metastases From Colorectal Cancer

This is a phase I, open-label clinical study of T3011 in combination with Toraplizumab and Regorafenib in patients with liver metastases from colorectal cancer.

Start Date02 Apr 2024

Sponsor / Collaborator

China Medical University

[+1]

100 Clinical Results associated with MVR-T3011

100 Translational Medicine associated with MVR-T3011

100 Patents (Medical) associated with MVR-T3011

Literatures (Medical) associated with MVR-T3011

01 Jun 2025·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Discovery of dual CDK4/6 and BRD4 inhibitor as apoptosis and autophagy inducers against NSCLC in vitro and in vivo

Article

Author: Luo, Zhongwen ; Zheng, Long ; Ma, Liangliang ; Zou, Meiting ; Zhang, Yonglei ; Kong, Lingyi ; Zheng, Yiwei ; Jiang, Yuhan ; Wang, Xiaobing

Target of cyclin dependent kinase (CDK) by inhibitors has demonstrated promising potential as a therapeutic agent for cancer. However, the efficacy of monotherapy on tumors is limited and there is an urgent need for combination therapy with other inhibitors. It has been reported that restoring bromodomain-containing protein 4 (BRD4) resensitivity to tumor cells by inhibiting CDK4/6 is a potential therapeutic strategy. In this study, we present the design and optimization of dual CDK4/6 and BRD4 inhibitors, among which B15 exhibited potent and selective inhibition of both targets in vitro, and significant antiproliferative effects in non-small cell lung cancer (NSCLC) cells. Importantly, it also showed good pharmacokinetic properties in rats, meanwhile, B15 effectively inhibited tumor growth in vivo (TGI = 85.3 %) without causing significant toxicity. Overall, our results introduce a promising strategy of dual CDK4/6 and BRD4 inhibitors for the treatment of NSCLC.

01 Dec 2024·BIOORGANIC CHEMISTRY

Eco-conscious synthesis of novel 1,2,4-triazolo[1,5-a]pyrimidine derivatives as potent Anti-microbial agent and comparative study of cell viability and cytotoxicity in HEK-293 cell line utilizing Indian gooseberry (Phyllanthus emblica) fruit extract

Article

Author: Bhatt, Bhaktiben R. ; Bhatt, Bhaktiben R ; Bhatt, Vaibhav D ; Bhatt, Vaibhav D. ; Dixit, Bharat C ; Pandey, Kamalkishor ; Dixit, Bharat C. ; Patel, Tarosh ; Halpani, Chandani ; Modi, Anupama

Antimicrobial resistance (AMR) is a pressing global health challenge that necessitates the search for novel antimicrobial agents and synthetic methodologies. This study investigates the synthesis and antimicrobial efficacy of 25 novel 1,2,4-triazolo[1,5-a]pyrimidine derivatives, catalyzed by Amla (Phyllanthus emblica) fruit juice, which is rich in organic acids and polyphenolic compounds, thus serving as an environmentally sustainable catalyst, in adherence to green chemistry principles. The synthesis is achieved through a one-pot, solvent-free process that yields high quantities of the desired compounds in significantly less time compared to traditional methods. Comprehensive antimicrobial evaluation was conducted against a range of clinically relevant microorganisms, including Chromobacterium violaceum, Klebsiella pneumoniae, Escherichia coli, Staphylococcus aureus, Bacillus subtilis, Candida albicans, Cryptococcus neoformans and Aspergillus niger. Concurrently, cytotoxic assays were performed on HEK-293 cells, to assess safety profiles, revealing that compounds B-1, B-6, B-7, B-14 and B-15 exhibited potent antimicrobial activity while maintaining low cytotoxicity and high cell viability. These findings underscore the therapeutic potential of the synthesized compounds in combatting infectious diseases and addressing the challenges posed by AMR, highlighting the critical importance of dose optimization in therapeutic applications. This study combats contagious diseases, mitigates AMR challenges and contributes significantly to the field of antimicrobial drug discovery, emphasizing the need for sustainable synthetic strategies that align with future pharmaceutical endeavors. Our research not only advances the understanding of these novel compounds but also supports ongoing efforts to develop safe and effective therapies against resistant pathogens.

01 Nov 2024·DRUG DEVELOPMENT RESEARCH

Discovery of Novel SIRT3 Inhibitors for the Cancer Differentiation Therapy by Structural Modification

Article

Author: Xu, Guangzhao ; Li, Fahui ; Li, Honggang ; Du, Yanmei ; Zhang, Lihui ; Zhang, Lei ; Zhang, Daopeng

ABSTRACT:

Inhibition of SIRT3 triggered differentiation of multiple myeloma (MM) cells. In discovery of potent SIRT3 inhibitors for cancer differentiation therapy, structural modification was performed on the previously developed lead compound S27. A total of 49 compounds divided into two series were designed and synthesized. In the enzyme inhibitory assay, several molecules (A7, A13, B15, and B26) exhibited potent SIRT3 inhibitory activity and selectivity. Significantly, representative compounds, especially A7, promoted differentiation of MM cells from cancer phenotype to normal cells, accompanied by increased expression of antigen CD49e, human immunoglobulin light chain λ‐IgLG and κ‐IgLG. Additionally, molecule A7 reversed growth factor IL‐6 induced MM cell proliferation, improved the antiproliferative activity of Ixazomib and increased the apoptotic rate of MM cells treated with Ixazomib. Collectively, potent SIRT3 inhibitors with MM cell differentiation potency were developed for the cancer therapy used alone or in combination.

News (Medical) associated with MVR-T3011

15 Sep 2024

·www.prnewswire.com

ESMO 2024 - ImmVira Unveils Clinical Results of Intravesical MVR-T3011 for High-Risk BCG-Failure NMIBC Patients

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. SOURCE ImmVira WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Clinical Result

15 Mar 2024

·www.prnewswire.com

ImmVira's oncolytic product MVR-T3011 IT Intratumoral Injection Receives FDA Fast Track Designation for HNSCC Treatment

SHENZHEN, China, March 15, 2024 /PRNewswire/ -- ImmVira has recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for oncolytic virus product MVR-T3011 IT (intratumoral injection) for the treatment of recurrent or metastatic head and neck squamous cell cancer with disease progression after platinum-based chemotherapy and at least one prior line of anti-PD1/PDL1 therapy. Fast track designation is intended to facilitate the development and expedite the review of drugs targeting serious conditions with unmet medical needs. The Fast Track designation was sought based on the promising potential of MVR-T3011 IT to meet the unmet medical needs associated with HNSCC. Supporting evidence for this request was derived from Phase I/II trials conducted in both the United States and China, focusing on evaluating the efficacy, safety, and durability of response in patients with HNSCC. HNSCC has become a growing public health concern, with increases in incidence rates as of 2023 statistics. Approximately 32% of patients face recurrence after curative therapy, and 3-10% present with metastatic disease at the time of diagnosis, emphasizing the aggressive nature and severity of this cancer. While immune checkpoint inhibitors such as PD-1/PD-L1 blockers have transformed HNSCC treatment, their benefits are confined to a modest 15-20% of patients. This treatment gap underscores the critical need for innovative therapies. Clinical data indicates that MVR-T3011 IT demonstrated the potential to overcome immunosuppression, and delivered favorable outcomes in terms of tumor shrinkage and control in patients who failed ICI treatments. "Attaining Fast Track designation from the FDA marks a pivotal milestone and underscores MVR-T3011 IT's capacity to address the substantial unmet needs of HNSCC patients," said Grace Guoying Zhou, Chairwoman and CEO of ImmVira. "We are encouraged by the FDA's decision as it reflects the need for FDA approved and widely available treatments for these patients. This designation will allow us to work closely with the FDA to quickly advance MVR-T3011 IT, to make a meaningful difference for patients who require new treatment options." About MVR-T3011 MVR-T3011, ImmVira's proprietary 3-in-1 oHSV, is a novel genetic engineered oHSV which aims to achieve the most favorable profile of attenuated HSV-1 with replication potency in tumor cells and highly restricted replication in normal cells. Its incorporation of two latest and well-validated exogenous genes, PD-1 antibody and IL-12, further enhances 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. SOURCE ImmVira

Fast TrackImmunotherapyClinical Study

10 Nov 2023

·www.prnewswire.com

MVR-T3011 IV, Global First Intravenous Oncolytic Product, Successfully Concludes Phase I Clinical Study in the U.S. with Outstanding Safety Results

SHENZHEN, China, Nov. 9, 2023 /PRNewswire/ -- On November 9, 2023, ImmVira announced the successful completion of Phase I clinical study conducted on late-stage patients with various tumor types for our intravenous oncolytic product, MVR-T3011 IV, in the United States. This milestone was marked by the product's exceptional safety results and preliminary efficacy for certain indications. Concurrently, a series of comprehensive pharmacokinetics/pharmacodynamics (PK/PD) and immune responses research were also conducted, generating valuable firsthand data to guide the forthcoming Phase II clinical study. As of October 31, 2023, 17 patients (17/18, 94.4%) experienced Treatment-Emergent Adverse Events (TEAEs), with 16 patients (16/18, 88.89%) reporting drug-related Treatment-Related Adverse Events (TRAEs). Notably, all of these adverse events were of grade 1 or 2 severity, and no TRAEs of grade 3 or higher were observed. TEAEs with an incidence of over 20% included abdominal pain (4/18, 22.2%), urinary tract infection (5/18, 27.28%), nausea (6/18, 33.3%), hypokalaemia (4/18, 22.2%) and hypotension (6/18, 33.3%). 7 patients (7/18, 38.89%) experienced Serious Adverse Events (SAEs), none of which were drug-related. Overall, MVR-T3011 IV showed great safety profile at Phase I clinical study. Currently, there are 12 evaluable patients. According to RECIST 1.1, patients with endometrial, appendiceal, and gallbladder cancer demonstrated a significant reduction in tumor burden. The maximum reduction exceeded 15% compared to the baseline. Simultaneously, Company is conducting a series of clinical exploratory studies in China for multiple tumor types. By combining PK/PD data from Phase I clinical study in both the U.S. and China, our goal is to devise a development strategy for a registrational Phase II clinical study targeting real unmet clinical needs. Chairwoman and CEO Dr. Grace Guoying Zhou said that, "The development of intravenously administered oncolytic virus products has long been a challenging bottleneck. Oncolytic viruses must overcome numerous hurdles, such as neutralization by antibodies or the risk of cytokine storms, in order to effectively reach tumor sites with a sufficient number of viruses to achieve anti-tumor effects. With the successful Phase I clinical study results of MVR-T3011 IV, global first clinical-stage intravenous oHSV product, our company is now fully confident and committed to expediting clinical explorations in colorectal cancer, non-small cell lung cancer, and other indications, including combination treatments with immune checkpoint inhibitor or chemotherapy. Our goal is to bring the benefits of intravenous oncolytic virotherapy to cancer patients as swiftly as possible." About MVR-T3011 MVR-T3011, ImmVira's proprietary 3-in-1 oHSV, is a novel genetically engineered oHSV, which aims to achieve the most favorable profile of attenuated HSV-1 with replication potency in tumor cells and highly restricted replication in normal cells. Its incorporation of two latest and well-validated exogenous genes, PD-1 antibody and IL-12, further enhances 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. SOURCE ImmVira

Phase 1Clinical ResultImmunotherapyPhase 2

100 Deals associated with MVR-T3011

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-Muscle Invasive Bladder Neoplasms	Phase 2	United States	Shenzhen Yinuowei Medical Technology Co., Ltd.	30 May 2025
Melanoma, Cutaneous Malignant	Phase 2	United States	Shenzhen Yinuowei Medical Technology Co., Ltd.	30 Jun 2024
Uveal Melanoma	Phase 2	United States	Shenzhen Yinuowei Medical Technology Co., Ltd.	30 Jun 2024
Locally Advanced Melanoma	Phase 2	China	Shanghai Pharmaceuticals Holding Co., Ltd.	26 Jan 2024
Melanoma	Phase 2	China	Shenzhen Yinuowei Medical Technology Co., Ltd.	05 Jan 2024
Advanced cancer	Phase 2	China	Shenzhen Yinuowei Medical Technology Co., Ltd.	21 Feb 2022
Lung Cancer	Phase 2	China	Shenzhen Yinuowei Medical Technology Co., Ltd.	21 Feb 2022
Lymphoma	Phase 2	China	Shenzhen Yinuowei Medical Technology Co., Ltd.	21 Feb 2022
Malignant Pleural Mesothelioma	Phase 2	China	Shenzhen Yinuowei Medical Technology Co., Ltd.	21 Feb 2022
Colorectal Cancer	Phase 2	United States	Shenzhen Yinuowei Medical Technology Co., Ltd.	10 Aug 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06427291 (ESMO2024) Manual	Phase 1	Non-Muscle Invasive Bladder Neoplasms Second line	13	T3011 5x10^7 PFU	mlrgzjyeie(ermnohryto) = bbiwkyhkdp xksoconwtq (jhsqmvvlvl )	Positive	15 Sep 2024
NCT06427291 (ESMO2024) Manual	Phase 1	Non-Muscle Invasive Bladder Neoplasms Second line	13	T3011 5x10^8 PFU	mlrgzjyeie(ermnohryto) = kowgqbkdug xksoconwtq (jhsqmvvlvl )	Positive	15 Sep 2024
NCT04780217 (PRNewswire) Manual	Phase 1	Neoplasms	18	MVR-T3011	ronjlwbfre(jdxmgeotxe) = qjqsikiaoz imyjjstafc (ulwbiciuak ) View more	Positive	09 Nov 2023
NCT04780217 (ASCO 12023 \| ASCO 22023) Manual	Phase 1/2	HR-positive/HER2-low Solid Tumors	10	MVR-T3011	obldojecqt(rzxaokhfwf) = nuiscwmiui xhetnxlxtd (zeipjirhzb ) View more	Positive	31 May 2023
NCT05602792 (ASCO 12023 \| ASCO 22023) Manual	Phase 1/2	HR-positive/HER2-low Solid Tumors	90	T3011	leyczhprcb(gxnzgntyrw) = zytszrwebu gugambdoxg (zfiekgqpyf ) View more	Positive	26 May 2023
NCT04370587 (ASCO 12023 \| ASCO 22023) Manual	Phase 1/2	HR-positive/HER2-low Solid Tumors	29	T3011	zrresvsark(kciasppxld) = 3.4% (1/29) bwrcbbuoeq (thelctrybs ) View more	Positive	26 May 2023
NCT04370587 (ASCO 12023 \| ASCO 22023) Manual	Phase 1/2	HR-positive/HER2-low Solid Tumors	29	T3011+Pembrolizumab		Positive	26 May 2023
NCT05598268 (ASCO 12023 \| ASCO 22023) Manual	Phase 1/2	HR-positive/HER2-low Solid Tumors	15	T3011	twgsbpafdx(kphsxjnspz) = myhzihkoue lhvjzuaukd (rnkitfegrh ) View more	Positive	26 May 2023
NCT04370587 (ASCO 12021 \| ASCO 22021) Manual	Phase 1	Skin Neoplasms	8	T3011	rhwcychbwi(vzwjipsizb) = pain at injection site, leukopenia, anemia, hypocalcemia, nausea, fever, headache, dermatitis, and diaphoresis ssvxuhjxnx (joozxdodnh )	Positive	28 May 2021

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