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) .

开始日期2025-05-30

申办/合作机构

深圳市亦诺微医药科技有限公司

NCT05756556

/ Suspended临床2期

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.

开始日期2024-06-30

申办/合作机构

深圳市亦诺微医药科技有限公司

NCT06283303

/ Not yet recruiting临床1期IIT

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.

开始日期2024-04-02

申办/合作机构

中国医科大学

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100 项与 T3011疱疹病毒相关的临床结果

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100 项与 T3011疱疹病毒相关的转化医学

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100 项与 T3011疱疹病毒相关的专利（医药）

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项与 T3011疱疹病毒相关的文献（医药）

2025-06-01·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

作者: Luo, Zhongwen ; Zheng, Long ; Ma, Liangliang ; Zou, Meiting ; Zhang, Yonglei ; Zheng, Yiwei ; Kong, Lingyi ; 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.

2024-12-01·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

作者: 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.

2024-11-01·DRUG DEVELOPMENT RESEARCH

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

Article

作者: 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.

项与 T3011疱疹病毒相关的新闻（医药）

2025-06-10

·PRNewswire

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)

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. Media Contacts: Investor Relationship： [email protected] SOURCE ImmVira WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

免疫疗法临床结果临床2期ASCO会议临床1期

2025-02-04

·医药观澜

加速审评！25款癌症新药获FDA快速通道资格，来自恒瑞、信达、科伦博泰等

▎药明康德内容团队编辑近年来，获得美国FDA特殊资格认定的中国创新药数量呈逐年增长趋势，尤其在快速通道资格上。据公开资料统计，2024年，由中国公司开发的新药获得了超过30项FDA快速通道资格（Fast Track Designation），相比2023年增长1.5倍之多。这些新药又以癌症新药居多，有至少25款抗肿瘤新药获得了近30项快速通道资格，适应症涵盖胃癌、肺癌、甲状腺癌、乳腺癌、多发性骨髓瘤等一系列疾病。快速通道资格是FDA推出的一项特殊认定，其目的是在使药物更早地获得批准，以治疗严重疾病或满足未竟医疗需求，造福病患。本文将分享25款于2024年获得快速通道资格的癌症新药基本信息，看看它们都有望惠及哪些患者？（不完全统计，按企业官宣时间排序）图片来源：123RF 易慕峰生物：IMC002 作用机制：靶向CLDN18.2的CAR-T细胞疗法适应症：胃癌 2024年12月7日，易慕峰生物宣布IMC002已获得FDA授予的快速通道资格，用于治疗不可切除的局部晚期、复发或转移性CLDN 18.2阳性胃癌患者。IMC002是一款纳米抗体靶向CLDN18.2的自体CAR-T细胞治疗产品，旨在突破实体瘤细胞治疗的挑战。该产品目前正针对胰腺癌、胃癌等实体瘤开展注册1期临床研究。蓝纳成/东诚药业：177Lu-LNC1004 作用机制：靶向FAP的放射性体内治疗药物适应症：甲状腺癌 2024年10月30日，东诚药业宣布下属公司蓝纳成在研产品177Lu - LNC1004注射液获得FDA授予的快速通道资格，用于治疗接受过一种及以上酪氨酸激酶抑制剂的转移性碘-131难治性分化型甲状腺癌患者。177Lu - LNC1004注射液是一种靶向FAP的放射性体内治疗药物，该产品目前已启动针对实体瘤的1期临床试验。同宜医药：CBP-1008 作用机制：靶向FRα和TRPV6受体的双配体偶联药物适应症：铂耐药卵巢透明细胞癌 2024年10月15日，同宜医药宣布其开发的注射用CBP-1008获得FDA授予快速通道资格，用于治疗铂耐药卵巢透明细胞癌。CBP-1008是一款双配体偶联药物，能够同时靶向肿瘤细胞膜上表达的FRα和TRPV6受体。目前该产品针对卵巢癌的适应症已获得疗效验证。信达生物：IBI363 作用机制：PD-1/IL-2α-bias双特异性抗体融合蛋白适应症：黑色素瘤（脉络膜黑色素瘤除外） 2024年9月4日，信达生物宣布其自主研发的PD-1/IL-2α-bias双特异性抗体融合蛋白IBI363获得FDA授予的快速通道资格，适应症为既往接受过至少一线含PD-1/L1检查点抑制剂系统性治疗后进展的局部晚期或转移性黑色素瘤（脉络膜黑色素瘤除外）。IBI363目前正处于国际1/2期临床研究阶段，针对各种晚期恶性肿瘤。百济神州：BGB-16673 作用机制：靶向BTK的CDAC 适应症：CLL/SLL 2024年8月27日，百济神州宣布FDA授予BGB-16673快速通道资格，用于治疗既往接受过至少两线治疗（包括BTK抑制剂和BCL2抑制剂）的复发/难治性慢性淋巴细胞白血病或小淋巴细胞淋巴瘤（CLL/SLL）成年患者。BGB-16673是一种口服靶向BTK的嵌合式降解激活化合物（CDAC），旨在诱导野生型BTK和多种突变型BTK的降解。该疗法目前正处于临床1/2期开发阶段。原启生物：Ori-CAR-017 作用机制：CAR-T细胞疗法适应症：多发性骨髓瘤 2024年7月15日，原启生物宣布FDA已授予其CAR-T细胞疗法Ori-CAR-017快速通道资格，用于治疗复发/难治性多发性骨髓瘤。OriCAR-017是一种针对GPRC5D靶点的CAR-T细胞疗法，正在针对多发性骨髓瘤开展临床1/2试验。该疗法在抗体亲和力、抗原结合活性与持久性、抗肿瘤疗效以及安全性方面均表现良好，针对多发性骨髓瘤的1期临床数据显示其总缓解率达到100%。迈威生物：9MW2821 作用机制：靶向Nectin-4的ADC 适应症：三阴性乳腺癌、食管鳞癌、宫颈癌 2024年7月12日，迈威生物宣布其研发的9MW2821获FDA授予快速通道资格，用于治疗局部晚期或转移性Nectin-4阳性三阴性乳腺癌。9MW2821为定点偶联抗体偶联药物（ADC），由具有内吞促进特性的人源化靶向Nectin-4单抗与单甲基澳瑞他汀E（MMAE）进行连接而成。本次是该产品在2024年第三次获得获FDA授予快速通道资格，此前于2024年2月和5月，该产品先后获FDA授予快速通道资格，分别用于治疗晚期、复发或转移性食管鳞癌；既往接受过含铂化疗方案治疗失败的复发或转移性宫颈癌。目前9MW2821针对宫颈癌等多个适应症已经进入3期临床阶段。思康睿奇：3HP-2827 作用机制：FGFR2抑制剂适应症：胆管癌 2024年7月3日，思康睿奇宣布其FGFR2抑制剂3HP-2827获得FDA授予快速通道资格，用于治疗含有FGFR2突变的胆管癌患者。3HP-2827能够高特异性的抑制FGFR2磷酸化，从而抑制FGFR2信号传导通路，进而发挥抗肿瘤作用。该产品已分别获批在中、美开展临床试验，拟单药或联合化疗和/或免疫药物治疗FGFR2异常的肿瘤患者。辐联科技：225Ac-FL-020 作用机制：靶向PSMA的放射性核素药物偶联物（RDC）适应症：前列腺癌 2024年7月3日，辐联科技宣布其PSMA靶向放射性核素药物偶联物225Ac-FL-020已获得FDA授予快速通道资格，用于治疗转移性去势抵抗性前列腺癌。该产品靶向载体FL-020运用了辐联科技专有的平台研发而成，能显著增强药物在肿瘤部位的摄取效率，同时确保快速的全身清除。目前该产品处于临床1期研发阶段。海创药业：HP518 作用机制：AR蛋白降解靶向嵌合体适应症：三阴乳腺癌 2024年6月30日，海创药业宣布其在研的蛋白降解靶向嵌合体（PROTAC）HP518片获得FDA授予快速通道资格，用于治疗AR阳性三阴乳腺癌。HP518片是一款高活性、高选择性的AR蛋白降解靶向嵌合体，能够降解AR和其突变体，阻断AR在三阴乳腺癌中的信号通路。映恩生物/BioNTech：DB-1311 作用机制：靶向跨膜糖蛋白B7-H3的ADC 适应症：前列腺癌 2024年6月24日，映恩生物和BioNTech宣布，FDA授予DB-1311（又名：BNT324）快速通道资格，用于治疗标准全身治疗期间或之后出现疾病进展的晚期/不可切除或转移性去势抵抗性前列腺癌患者。DB-1311是一种基于拓扑异构酶I抑制剂的靶向B7H3创新ADC分子，目前正在针对实体瘤适应症开展1/2期临床研究。信诺维：XNW-27011 作用机制：靶向Claudin18.2的ADC 适应症：胃癌 2024年6月14日，信诺维宣布其研发的靶向Claudin18.2的新一代ADC疗法XNW27011获得FDA授予快速通道资格，用于治疗胃癌。研究表明，XNW27011在Claudin18.2低表达和高表达的药理学模型及患者中均展现出了良好抗肿瘤活性，且安全性良好，整体安全性可控。信达生物：IBI343 作用机制：靶向CLDN18.2的ADC 适应症：胰腺导管腺癌 2024年6月13日，信达生物宣布其抗CLDN18.2抗体-依喜替康偶联药物IBI343获得FDA授予快速通道资格，拟定适应症为至少接受过一种系统性治疗的CLDN18.2表达阳性的晚期胰腺导管腺癌。IBI343拟开发适应症包括胃癌、胰腺癌、胆道癌、以及其他实体瘤等，其中针对胃/胃食管交界处腺癌的临床试验已进入3期阶段。中美瑞康：RAG-01 作用机制：小激活RNA（saRNA）适应症：非肌层浸润性膀胱癌 2024年5月21日，中美瑞康宣布其自主研发的saRNA药物RAG-01获得美国FDA授予快速通道资格，用于治疗卡介苗无应答的非肌层浸润性膀胱癌。RAG-01是一款特异性靶向激活肿瘤抑制基因p21的双链saRNA药物，其用于治疗非肌层浸润性膀胱癌已获得FDA的临床试验许可。恒瑞医药：SHR-A2102 作用机制：Nectin-4靶向ADC 适应症：晚期尿路上皮癌 2024年4月18日，恒瑞医药宣布其靶向Nectin-4的ADC注射用SHR-A2102获FDA授予快速通道资格，用于治疗晚期尿路上皮癌。SHR-A2102为一款靶向Nectin-4的ADC，其有效载荷是拓扑异构酶抑制剂（TOPi）。该产品针对晚期尿路上皮癌的临床研究已进展到3期阶段。先声再明：SIM0500 作用机制：GPRC5D-BCMA-CD3三特异性抗体适应症：多发性骨髓瘤 2024年4月9日，先声再明宣布其人源化GPRC5D-BCMA-CD3三特异性抗体SIM0500获得FDA授予的快速通道资格，用于既往接受过≥3线治疗，且对于已知可以提供临床获益的标准治疗耐药，或无法耐受的多发性骨髓瘤患者。值得一提的是，针对这款三抗产品，先声再明于2025年初已经与艾伯维（AbbVie）达成一项超10.5亿美元的授权合作。目前该产品正在中美两国进行临床1期研究。恒瑞医药：SHR-A1921 作用机制：靶向TROP-2的ADC 适应症：铂耐药复发上皮性卵巢癌、输卵管癌及原发性腹膜癌 2024年3月28日，恒瑞医药宣布注射用SHR-A1921获得FDA授予快速通道资格，用于治疗铂耐药复发上皮性卵巢癌、输卵管癌及原发性腹膜癌。SHR-A1921是一款靶向TROP2的ADC，可与表达TROP-2的肿瘤细胞特异性结合，经肿瘤细胞内吞后在溶酶体内水解释放小分子毒素。该产品针对卵巢上皮癌已进入3期临床阶段。亦诺微医药：MVR-T3011 作用机制：疱疹溶瘤病毒疗法适应症：头颈部鳞状细胞癌 2024年3月15日，亦诺微医药宣布其在研疱疹溶瘤病毒产品MVR-T3011 IT（瘤内注射）已获得FDA授予的快速通道资格，用于治疗既往铂类化疗和PD-1/L1疗法失败的复发或转移性头颈部鳞状细胞癌患者。MVR-T3011是一种三合一疱疹溶瘤病毒创新产品，该产品针对头颈部鳞状细胞癌已进入2期临床研究阶段。科伦博泰：A400（EP0031）作用机制：RET抑制剂适应症：非小细胞肺癌 2024年3月11日，科伦博泰宣布在研产品A400于获得了FDA授予的快速通道资格，用于治疗RET融合阳性非小细胞肺癌。A400是第二代选择性RET抑制剂，对常见的RET基因融合和突变具有广泛活性，具有克服第一代选择性RET抑制剂耐药的潜力。在中国，科伦博泰正在开展A400针对RET阳性非小细胞肺癌的关键临床研究。乐普生物：MRG004A 作用机制：靶向组织因子的ADC 适应症：胰腺癌 2024年3月11日，乐普生物宣布其靶向组织因子（TF）的ADC产品MRG004A获得FDA授予快速通道资格，用于治疗胰腺癌。MRG004A是乐普生物针对差异化靶点、采用创新偶联技术开发的一种靶向TF的ADC，通过创新技术连接TF靶向单抗与高效抗微管剂MMAE。该产品正处于1/2期临床研究阶段，并已在胰腺癌、三阴性乳腺癌及结直肠癌等适应症中观察到抗肿瘤活性信号。恒瑞医药：SHR-A1912 作用机制：靶向CD79b的ADC 适应症：弥漫大B细胞淋巴瘤 2024年2月22日，恒瑞医药宣布其靶向CD79b的ADC注射用SHR-A1912获得FDA授予快速通道资格，拟用于治疗既往接受过至少2线治疗的复发/难治性弥漫大B细胞淋巴瘤。SHR-A1912可以与表达CD79b的肿瘤细胞特异性结合，经肿瘤细胞内吞后在溶酶体内水解释放小分子毒素，从而诱导肿瘤细胞凋亡。该产品针对非霍奇金B细胞淋巴瘤适应症已经进入2期临床阶段。映恩生物/BioNTech：DB-1305/BNT325 作用机制：靶向TROP2的ADC 适应症：上皮性卵巢癌、输卵管癌或原发性腹膜癌 2024年1月31日，映恩生物和BioNTech宣布，FDA授予DB-1305/BNT325快速通道资格，用于治疗既往接受过1～3种全身治疗方案的铂类药物耐药上皮性卵巢癌、输卵管癌或原发性腹膜癌患者。这是一款以TROP2为靶点，基于拓扑异构酶-1抑制剂的ADC，由映恩生物专有的双重免疫毒素抗体偶联药物（DITAC）平台构建而成。该疗法目前正在晚期或转移性实体瘤患者中进行1/2期临床试验。华津医药：SalMet-Vec 作用机制：溶瘤病毒疗法适应症：骨肉瘤 2024年1月23日，华津医药宣布其溶瘤细菌桑美威克（SalMet-Vec）注射剂获得FDA授予的快速通道资格，用于治疗既往接受过至少两种治疗的转移性骨肉瘤患者。通过减毒沙门氏菌载体来搭载并表达甲硫氨酸酶，从肿瘤生长所需氨基酸代谢调控方向发挥精准靶向抗肿瘤作用的基因工程生物制品。该产品正处于2期临床开发阶段，拟针对的适应症涵盖了多种实体肿瘤。荣昌生物：RC88 作用机制：靶向间皮素的ADC 适应症：铂耐药复发性上皮性卵巢癌、输卵管癌和原发性腹膜癌 2024年1月8日，荣昌生物宣布其在研ADC疗法RC88获得FDA授予的快速通道资格，用于治疗铂耐药复发性上皮性卵巢癌、输卵管癌和原发性腹膜癌患者。RC88采用了荣昌生物自主研发的创新桥接技术进行抗体、药物连接，其结构包括间皮素（MSLN）靶向抗体、可裂解连接子以及小分子细胞毒素。该产品目前正处于2期临床研究阶段。恒瑞医药：SHR-A2009 作用机制：靶向HER3的ADC 适应症：非小细胞肺癌 2024年1月2日，恒瑞医药宣布其靶向HER3的ADC注射用SHR-A2009获得FDA授予快速通道资格，拟用于治疗经三代EGFR酪氨酸激酶抑制剂和含铂化疗后疾病进展的EGFR突变的转移性非小细胞肺癌。SHR-A2009由全人源抗HER3 IgG1单抗组成，通过可切割肽连接物与DNA拓扑异构酶I抑制剂共价连接。该产品目前针对EGFR突变晚期或转移性非小细胞肺癌已进入3期临床阶段。希望这些创新药在后续研究中取得更多突破，早日获批上市或获批更多的适应症，惠及广大患者。参考资料： [1] 各公司官方新闻稿及公开资料本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权及其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

快速通道临床1期免疫疗法细胞疗法

2024-09-15

·PRNewswire

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

临床1期临床结果

100 项与 T3011疱疹病毒相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
非肌层浸润性膀胱肿瘤	临床2期	美国	深圳市亦诺微医药科技有限公司	2025-05-30
皮肤黑色素瘤	临床2期	美国	深圳市亦诺微医药科技有限公司	2024-06-30
葡萄膜黑色素瘤	临床2期	美国	深圳市亦诺微医药科技有限公司	2024-06-30
局部晚期黑色素瘤	临床2期	中国	上海医药集团股份有限公司	2024-01-26
黑色素瘤	临床2期	中国	深圳市亦诺微医药科技有限公司	2024-01-05
晚期癌症	临床2期	中国	深圳市亦诺微医药科技有限公司	2022-02-21
肺癌	临床2期	中国	深圳市亦诺微医药科技有限公司	2022-02-21
淋巴瘤	临床2期	中国	深圳市亦诺微医药科技有限公司	2022-02-21
恶性胸膜间皮瘤	临床2期	中国	深圳市亦诺微医药科技有限公司	2022-02-21
结直肠癌	临床2期	美国	深圳市亦诺微医药科技有限公司	2021-08-10

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06427291 (ESMO2024) 人工标引	临床1期	非肌层浸润性膀胱肿瘤二线	13	T3011 5x10^7 PFU	廠顧範膚齋鬱範範築選(糧襯齋艱壓遞醖糧壓顧) = 選顧選淵壓構膚遞艱艱鹽鑰遞範襯糧膚蓋蓋獵 (憲餘憲廠艱膚窪鏇鹽鹹 )	积极	2024-09-15
NCT06427291 (ESMO2024) 人工标引	临床1期	非肌层浸润性膀胱肿瘤二线	13	T3011 5x10^8 PFU	廠顧範膚齋鬱範範築選(糧襯齋艱壓遞醖糧壓顧) = 積糧範窪鹹鹹餘糧窪膚鹽鑰遞範襯糧膚蓋蓋獵 (憲餘憲廠艱膚窪鏇鹽鹹 )	积极	2024-09-15
NCT04780217 (PRNewswire) 人工标引	临床1期	肿瘤	18	MVR-T3011	網餘鹽積鬱憲鏇醖築膚(壓製鹽糧齋顧廠顧繭衊) = 鹽齋獵獵鹹範鑰繭醖廠遞觸獵壓鬱衊壓齋衊齋 (衊繭餘衊獵網網鏇鹽鹽 ) 更多	积极	2023-11-09
NCT04780217 (ASCO 12023 \| ASCO 22023) 人工标引	临床1/2期	HR阳性/HER2低表达实体瘤	10	MVR-T3011	製簾艱遞顧遞獵觸糧醖(衊築鏇鏇鹽餘鑰選觸憲) = 艱夢製顧膚遞網齋願襯鬱選壓憲齋廠淵淵夢鹽 (積簾憲齋齋衊鬱觸襯鏇 ) 更多	积极	2023-05-31
NCT04370587 (ASCO 12023 \| ASCO 22023) 人工标引	临床1/2期	HR阳性/HER2低表达实体瘤	29	T3011	觸鹹製淵壓窪築膚範餘(衊築糧網鬱廠觸鑰構遞) = 3.4% (1/29) 糧憲繭膚繭顧鹹積構範 (淵獵衊窪鹹築齋鬱憲觸 ) 更多	积极	2023-05-26
NCT04370587 (ASCO 12023 \| ASCO 22023) 人工标引	临床1/2期	HR阳性/HER2低表达实体瘤	29	T3011+Pembrolizumab		积极	2023-05-26
NCT05602792 (ASCO 12023 \| ASCO 22023) 人工标引	临床1/2期	HR阳性/HER2低表达实体瘤	90	T3011	鑰壓繭糧選齋顧繭積鹽(襯襯遞遞膚遞齋膚鏇範) = 艱餘繭憲鏇鏇繭夢艱壓糧鏇夢膚淵襯齋餘鏇衊 (壓鑰齋衊鏇窪艱願觸鑰 ) 更多	积极	2023-05-26
NCT05598268 (ASCO 12023 \| ASCO 22023) 人工标引	临床1/2期	HR阳性/HER2低表达实体瘤	15	T3011	積鬱壓餘選夢窪選艱憲(構齋觸襯艱鑰鹹廠窪繭) = 齋齋鑰夢鑰網範蓋範鹽壓遞鏇憲艱範衊餘壓範 (顧襯膚糧襯膚觸齋遞夢 ) 更多	积极	2023-05-26
NCT04370587 (ASCO 12021 \| ASCO 22021) 人工标引	临床1期	皮肤肿瘤	8	T3011	構夢醖願顧壓膚鏇遞繭(糧餘鹹衊製艱醖鹹醖製) = pain at injection site, leukopenia, anemia, hypocalcemia, nausea, fever, headache, dermatitis, and diaphoresis 繭觸餘願膚選膚壓壓窪 (構選鹹鏇壓淵鏇簾願製 )	积极	2021-05-28