This study will include two parts:
Phase I part is a dose-escalation study to assess the safety of increasing doses of TG6002 in combination with oral flucytosine (5-FC) in consecutive cohorts of 3 to 6 patients with colorectal cancer and unresectable liver metastases according to a 3+3 design
Phase IIa part is an extension of the phase I part at the recommended phase II dose to evaluate the efficacy of TG6002 in combination with oral flucytosine (5-FC) in patients with colorectal cancer and unresectable liver metastases.
In both parts, tumor response will be evaluated on local assessment using RECIST 1.1.
All patients will be followed until disease progression, death due to any cause or the date of data cut-off, whichever occurs first.

开始日期2020-01-17

申办/合作机构

Transgene SA

NCT04226066 / Unknown status临床1/2期

A Phase I/IIa Study to Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of Recombinant Oncolytic Vaccinia Virus Injection T601 as a Single Drug or in Combination With Oral Flucytosine (5-FC), in Patients With Advanced Malignant Solid Tumors

This open, dose-escalation and extended PhI/IIa clinical trial aims to evaluate the safety, tolerability of T601 as a single-agent as well as combined with prodrug 5-FC to treat patients with advanced malignant solid tumors and to explore the pharmacokinetic characteristics of T601, 5-FC, 5-FU, FBAL, which includes PhI study of dose-escalation study and Ph IIa study of extending study.

开始日期2019-11-20

申办/合作机构

天士力医药集团股份有限公司

CTR20191807 / Recruiting临床1期

评价T601单药及结合前药5-FC治疗晚期恶性实体瘤的安全性、耐受性及药代动力学特征的 Ⅰ/Ⅱa期临床试验-T601单药单次给药剂量递增阶段

主要目的：评价T601安全性和耐受性，探索MTD 次要目的：探索药代动力学特征；初步评价抗肿瘤疗效

开始日期2019-11-20

申办/合作机构

天士力创世杰（天津）生物制药有限公司

100 项与重组溶瘤痘苗病毒 (天士力医药集团) 相关的临床结果

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项与重组溶瘤痘苗病毒 (天士力医药集团) 相关的文献（医药）

2023-09-01·Molecular therapy oncolytics

Oncolytic virotherapy with intratumoral injection of vaccinia virus TG6002 and 5-fluorocytosine administration in dogs with malignant tumors

Article

作者: Foloppe, Johann ; Klonjkowski, Bernard ; Farine, Isabelle ; Gantzer, Murielle ; Maurey, Christelle ; Quéméneur, Eric ; Guitton, Jérôme ; Balloul, Jean-Marc ; Béguin, Jérémy ; Tierny, Dominique ; Cochin, Sandrine ; Laloy, Eve ; Moreau, Baptiste ; Machon, Christelle ; Erbs, Philippe ; Pichon, Christelle

TG6002 is an oncolytic vaccinia virus expressing FCU1 protein, which converts 5-fluorocytosine into 5-fluorouracil. The study objectives were to assess tolerance, viral replication, 5-fluorouracil synthesis, and tumor microenvironment modifications to treatment in dogs with spontaneous malignant tumors. Thirteen dogs received one to three weekly intratumoral injections of TG6002 and 5-fluorocytosine. The viral genome was assessed in blood and tumor biopsies by qPCR. 5-Fluorouracil concentrations were measured in serum and tumor biopsies by liquid chromatography or high-resolution mass spectrometry. Histological and immunohistochemical analyses were performed. The viral genome was detected in blood (7/13) and tumor biopsies (4/11). Viral replication was suspected in 6/13 dogs. The median intratumoral concentration of 5-fluorouracil was 314 pg/mg. 5-Fluorouracil was not detected in the blood. An increase in necrosis (6/9) and a downregulation of intratumoral regulatory T lymphocytes (6/6) were observed. Viral replication, 5-fluorouracil synthesis, and tumor microenvironment changes were more frequently observed with higher TG6002 doses. This study confirmed the replicative properties, targeted chemotherapy synthesis, and reversion of the immunosuppressive tumor microenvironment in dogs with spontaneous malignant tumors treated with TG6002 and 5-fluorocytosine.

2022-11-01·Seminars in cancer biology1区 · 医学

Oncolytic viruses as a promising therapeutic strategy against the detrimental health impacts of air pollution: The case of glioblastoma multiforme

1区 · 医学

Review

作者: Guillemin, Gilles J ; Peng, Wanxi ; Aghbashlo, Mortaza ; Kazemi Shariat Panahi, Hamed ; Dehhaghi, Mona ; Tabatabaei, Meisam ; Lam, Su Shiung

Human livelihood highly depends on applying different sources of energy whose utilization is associated with air pollution. On the other hand, air pollution may be associated with glioblastoma multiforme (GBM) development. Unlike other environmental causes of cancer (e.g., irradiation), air pollution cannot efficiently be controlled by geographical borders, regulations, and policies. The unavoidable exposure to air pollution can modify cancer incidence and mortality. GBM treatment with chemotherapy or even its surgical removal has proven insufficient (100% recurrence rate; patient's survival mean of 15 months; 90% fatality within five years) due to glioma infiltrative and migratory capacities. Given the barrage of attention and research investments currently plowed into next-generation cancer therapy, oncolytic viruses are perhaps the most vigorously pursued. Provision of an insight into the current state of the research and future direction is essential for stimulating new ideas with the potentials of filling research gaps. This review manuscript aims to overview types of brain cancer, their burden, and different causative agents. It also describes why air pollution is becoming a concerning factor. The different opinions on the association of air pollution with brain cancer are reviewed. It tries to address the significant controversy in this field by hypothesizing the air-pollution-brain-cancer association via inflammation and atopic conditions. The last section of this review deals with the oncolytic viruses, which have been used in, or are still under clinical trials for GBM treatment. Engineered adenoviruses (i.e., DNX-2401, DNX-2440, CRAd8-S-pk7 loaded Neural stem cells), herpes simplex virus type 1 (i.e., HSV-1 C134, HSV-1 rQNestin34.5v.2, HSV-1 G207, HSV-1 M032), measles virus (i.e., MV-CEA), parvovirus (i.e., ParvOryx), poliovirus (i.e., Poliovirus PVSRIPO), reovirus (i.e., pelareorep), moloney murine leukemia virus (i.e., Toca 511 vector), and vaccinia virus (i.e., vaccinia virus TG6002) as possible life-changing alleviations for GBM have been discussed. To the best of our knowledge, this review is the first review that comprehensively discusses both (i) the negative/positive association of air pollution with GBM; and (ii) the application of oncolytic viruses for GBM, including the most recent advances and clinical trials. It is also the first review that addresses the controversies over air pollution and brain cancer association. We believe that the article will significantly appeal to a broad readership of virologists, oncologists, neurologists, environmentalists, and those who work in the field of (bio)energy. Policymakers may also use it to establish better health policies and regulations about air pollution and (bio)fuels exploration, production, and consumption.

2020-12-01·BMC veterinary research2区 · 农林科学

Safety studies and viral shedding of intramuscular administration of oncolytic vaccinia virus TG6002 in healthy beagle dogs

2区 · 农林科学

ArticleOA

作者: Béguin, Jérémy ; Quemeneur, Eric ; Gantzer, Murielle ; Maurey, Christelle ; Foloppe, Johann ; Nourtier, Virginie ; Erbs, Philippe ; Cochin, Sandrine ; Balloul, Jean-Marc ; Klonjkowski, Bernard ; Laloy, Eve ; Tierny, Dominique

Abstract:

Background:

Cancer is a leading cause of mortality for both humans and dogs. As spontaneous canine cancers appear to be relevant models of human cancers, developing new therapeutic approaches could benefit both species. Oncolytic virotherapy is a promising therapeutic approach in cancer treatment. TG6002 is a recombinant oncolytic vaccinia virus deleted in the thymidine kinase and ribonucleotide reductase genes and armed with the suicide gene FCU1 that encodes a protein which catalyses the conversion of the non-toxic 5-fluorocytosine into the toxic metabolite 5-fluorouracil. Previous studies have shown the ability of TG6002 to infect and replicate in canine tumor cell lines, and demonstrated its oncolytic potency in cell lines, xenograft models and canine mammary adenocarcinoma explants. Moreover, 5-fluorouracil synthesis has been confirmed in fresh canine mammary adenocarcinoma explants infected with TG6002 with 5-fluorocytosine. This study aims at assessing the safety profile and viral shedding after unique or repeated intramuscular injections of TG6002 in seven healthy Beagle dogs.

Results:

Repeated intramuscular administrations of TG6002 at the dose of 5 × 107 PFU/kg resulted in no clinical or biological adverse effects. Residual TG6002 in blood, saliva, urine and feces of treated dogs was not detected by infectious titer assay nor by qPCR, ensuring the safety of the virus in the dogs and their environment.

Conclusions:

These results establish the good tolerability of TG6002 in healthy dogs with undetectable viral shedding after multiple injections. This study supports the initiation of further studies in canine cancer patients to evaluate the oncolytic potential of TG6002 and provides critical data for clinical development of TG6002 as a human cancer therapy.

项与重组溶瘤痘苗病毒 (天士力医药集团) 相关的新闻（医药）

2023-09-14

·BioSpace

Transgene Announces Upcoming Investor Meetings - September 14, 2023

STRASBOURG, France--(BUSINESS WIRE)-- Regulatory News: TRANSGENE (Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today announces that Management will participate in several investor events, as set out below. Cantor Global Healthcare Conference, New York, USA: September 26, 2023 Investor Access Forum, Paris, France: October 9, 2023 HealthTech Innovation Days 2023, Paris, France: October 24 & 25, 2023 Next scheduled financial communication First Half 2023 Financial Results September 20, 2023, after trading hours – The company will host a conference call at 6:00 pm CET *** About Transgene Transgene (Euronext: TNG) is a biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing cancer cells. The Company’s clinical-stage programs consist of a portfolio of therapeutic vaccines and oncolytic viruses: TG4050, the first individualized therapeutic vaccine based on the myvac® platform, TG4001 for the treatment of HPV-positive cancers, as well as TG6002, BT-001 and TG6050, three oncolytic viruses based on the Invir.IO® viral backbone. With Transgene’s myvac® platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The myvac® approach allows the generation of a virus-based immunotherapy that encodes patient-specific mutations identified and selected by Artificial Intelligence capabilities provided by its partner NEC. With its proprietary platform Invir.IO®, Transgene is building on its viral vector engineering expertise to design a new generation of multifunctional oncolytic viruses. Additional information about Transgene is available at: Follow us on Twitter: @TransgeneSA Disclaimer This press release contains forward-looking statements, which are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. The occurrence of any of these risks could have a significant negative outcome for the Company’s activities, perspectives, financial situation, results, regulatory authorities’ agreement with development phases, and development. The Company’s ability to commercialize its products depends on but is not limited to the following factors: positive pre-clinical data may not be predictive of human clinical results, the success of clinical studies, the ability to obtain financing and/or partnerships for product manufacturing, development and commercialization, and marketing approval by government regulatory authorities. For a discussion of risks and uncertainties which could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Universal Registration Document, available on the AMF website ( ) or on Transgene’s website ( ). Forward-looking statements speak only as of the date on which they are made, and Transgene undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future. View source version on businesswire.com: Contacts Transgene: Lucie Larguier Director Corporate Communications & IR +33 (0)3 88 27 91 04 investorrelations@transgene.fr Media: MEDiSTRAVA Consulting Frazer /Sylvie Berrebi +44 (0)203 928 6900 transgene@medistrava.com Source: Transgene View this news release online at:

疫苗免疫疗法

2023-08-28

·米内网

【瞩目】天士力1类新药来袭！冲击1300亿市场

精彩内容8月28日，天士力公告称，公司引进的新药STRO-002注射液获批临床，用于治疗晚期恶性实体瘤。这是一款靶向FRα的ADC产品，国内暂无同类药物获批。米内网数据显示，2022年中国三大终端六大市场（统计范围详见本文末）抗肿瘤药销售规模超过1300亿元。STRO-002注射液为第三代抗体偶联药物(ADC)，其靶点叶酸受体α(FRα)具有肿瘤细胞特异性，有望特异性治疗包括卵巢癌、非小细胞肺癌、乳腺癌和子宫内膜癌等多种实体瘤。2021年12月，天士力与Sutro签署许可协议，以最高3.85亿美元的首付款及里程碑付款，获得STRO-002在中国大陆、香港、澳门和台湾地区针对卵巢癌、非小细胞肺癌、三阴性乳腺癌以及其他适应症的独家开发和商业化权益。米内网数据显示，目前全球仅1款靶向FRα的ADC产品获批上市，为ImmunoGen的mirvetuximab soravtansine（商品名Elahere），该产品于2022年在美国获批附条件上市。而在国内市场，该产品正处于III期临床，适应症为叶酸受体α高表达的铂类耐药性晚期高级别上皮性卵巢癌、原发性腹膜癌或输卵管癌。全球已获批上市的FRα ADC药物来源：米内网全球新药研发数据库IMGN853国内临床开展情况来源：米内网中国临床试验数据库抗肿瘤药是目前国内新药研发最为火热的治疗领域。米内网数据显示，2019年中国三大终端六大市场抗肿瘤药销售规模突破1000亿元，2022年超过1300亿元，同比略有下滑。近年来中国三大终端六大市场抗肿瘤药销售情况（单位：亿元）来源：米内网格局数据库在抗肿瘤药领域，天士力已有多款1类新药在开展临床，其中TSL-1502胶囊（PARP抑制剂）、重组抗EGFR全人单克隆抗体注射液均处于II期临床，分别用于治疗乳腺癌、结直肠癌；B1962注射液、重组溶瘤痘苗病毒注射液T601处于I期临床，分别用于治疗实体瘤、晚期恶性消化道实体肿瘤。资料来源：米内网数据库、公司公告等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至8月28日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

临床3期引进/卖出临床1期抗体药物偶联物

2023-07-17

·BioSpace

Transgene Receives $15.3 Million from the Sale of Securities Held for Sale

STRASBOURG, France--(BUSINESS WIRE)-- Regulatory News: Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, announced that it has received $15.3 million (€ 14.0 million) as a result of the full disposal of its minority stake in a Chinese biopharmaceutical company. Following this transaction, which completion was expected for mid-2023, Transgene reaffirms its financial visibility until early 2024. *** About Transgene Transgene (Euronext: TNG) is a biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing cancer cells. The Company’s clinical-stage programs consist of a portfolio of therapeutic vaccines and oncolytic viruses: TG4050, the first individualized therapeutic vaccine based on the myvac® platform, TG4001 for the treatment of HPV-positive cancers, as well as TG6002, BT-001 and TG6050, three oncolytic viruses based on the Invir.IO® viral backbone. With Transgene’s myvac® platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The myvac® approach allows the generation of a virus-based immunotherapy that encodes patient-specific mutations identified and selected by Artificial Intelligence capabilities provided by its partner NEC. With its proprietary platform Invir.IO®, Transgene is building on its viral vector engineering expertise to design a new generation of multifunctional oncolytic viruses. Additional information about Transgene is available at: Follow us on social media: Twitter: @TransgeneSA – LinkedIn: @Transgene …/… Disclaimer This press release contains forward-looking statements, which are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. The occurrence of any of these risks could have a significant negative outcome for the Company’s activities, perspectives, financial situation, results, regulatory authorities’ agreement with development phases, and development. The Company’s ability to commercialize its products depends on but is not limited to the following factors: positive pre-clinical data may not be predictive of human clinical results, the success of clinical studies, the ability to obtain financing and/or partnerships for product manufacturing, development and commercialization, and marketing approval by government regulatory authorities. For a discussion of risks and uncertainties which could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Universal Registration Document, available on the AMF website ( ) or on Transgene’s website ( ). Forward-looking statements speak only as of the date on which they are made, and Transgene undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future. View source version on businesswire.com: Contacts Transgene: Lucie Larguier Director Corporate Communications & IR +33 (0)3 88 27 91 04 investorrelations@transgene.fr Media: MEDiSTRAVA Consulting David Dible/Sylvie Berrebi +44 (0)203 928 6900 transgene@medistrava.com Source: Transgene View this news release online at:

疫苗免疫疗法

100 项与重组溶瘤痘苗病毒 (天士力医药集团) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
结直肠癌肝转移	临床2期	法国	Transgene SA	2020-01-17
结直肠癌肝转移	临床2期	英国	Transgene SA	2020-01-17
转移性结直肠癌	临床2期	法国	Transgene SA	2020-01-17
转移性结直肠癌	临床2期	英国	Transgene SA	2020-01-17
晚期恶性实体瘤	临床2期	中国	天士力医药集团股份有限公司	2019-11-20
结直肠癌	临床2期	比利时	Transgene SA	2018-10-16
结直肠癌	临床2期	西班牙	Transgene SA	2018-10-16
复发性胶质母细胞瘤	临床2期	法国	Transgene SA	2017-10-12
胃肠道肿瘤	临床2期	-	Transgene SA	-
胶质母细胞瘤	临床2期	中国	天士力医药集团股份有限公司	-

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临床结果

适应症

分期

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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


NCT04194034 (TG6002.03, AACR2023) 人工标引	临床1期	转移性结直肠癌	15	TG6002+5-fluorocytosine	製糧餘淵簾顧衊憲憲餘(鹹顧範構鹽壓壓築鑰選) = 夢築繭獵遞構顧壓憲鑰鹽醖蓋顧鏇遞繭餘築鏇 (餘夢獵築獵築衊襯簾網 ) 更多	积极	2023-04-14
EUCTR2018-000039-28-BE (ESMO2022) 人工标引	临床1/2期	恶性上皮肿瘤	30	5-FC+TG6002	範鬱襯淵窪鏇廠艱淵繭(願鏇廠窪網窪壓範願網) = a single dose-limiting toxicity was observed among these 30 pts consisting of a disseminated pustular rash in one pt treated at the dose of 3x109 pfu 觸窪廠鹽鏇簾製夢構繭 (憲範廠憲蓋簾築齋憲艱 )	积极	2022-09-10
NCT03724071 (ESMO2021) 人工标引	临床1/2期	恶性上皮肿瘤	-	5-FC+ TG6002	鹹憲衊壓襯觸襯築淵窪(鏇鬱齋廠衊餘鹹襯膚繭) = no major ~ xicity 構壓壓夢蓋鹹廠選範膚 (淵夢鹹鬱齋網遞積鏇遞 )	积极	2021-09-16
AACR2021	临床1期	恶性上皮肿瘤	10	TG6002	廠壓選窪夢鑰鏇願襯觸(壓鑰窪窪繭窪選壓構艱) = 製網夢鑰簾積淵糧壓襯鏇觸齋鬱鹹醖鹽醖襯糧 (夢鏇觸憲糧憲蓋鏇壓襯 ) 更多	-	2021-07-01