{"id":52616,"date":"2023-01-06T08:03:14","date_gmt":"2023-01-06T07:03:14","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/transgene-receives-approval-to-start-a-phase-i-trial-of-tg6050-a-novel-il-12-armed-oncolytic-virus-given-by-intravenous-administration\/"},"modified":"2023-01-06T08:03:14","modified_gmt":"2023-01-06T07:03:14","slug":"transgene-receives-approval-to-start-a-phase-i-trial-of-tg6050-a-novel-il-12-armed-oncolytic-virus-given-by-intravenous-administration","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/transgene-receives-approval-to-start-a-phase-i-trial-of-tg6050-a-novel-il-12-armed-oncolytic-virus-given-by-intravenous-administration\/","title":{"rendered":"Transgene Receives Approval to Start a Phase I Trial of TG6050, a Novel IL-12-Armed Oncolytic Virus Given by Intravenous Administration"},"content":{"rendered":"
\n

\nTG6050 is a proprietary oncolytic virus derived from Transgene\u2019s Invir.IO\u2122 platform encoding interleukin-12 (IL-12) and an anti-CTLA4 antibody.\n<\/p>\n

<\/a><\/p>\n

\nThe Phase I trial, named Delivir, will evaluate the intravenous (IV) administration of this novel multi-armed immunotherapy in patients with non-small cell lung cancer.\n<\/p>\n

STRASBOURG, France–(BUSINESS WIRE)–#HBV<\/a>–Regulatory News:\n<\/p>\n

\nTransgene (Euronext Paris: TNG)<\/b> (Paris:TNG),<\/b> a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer,<\/b> today announces it has received clinical trial application (CTA) approval from the French National Agency for the Safety of Medicines and Health Products (ANSM) to proceed with a Phase I clinical trial of TG6050, a<\/b> novel oncolytic virus (OV) that will be administered intravenously<\/b> in patients with advanced non-small cell lung cancer (NSCLC)<\/b>.\n<\/p>\n

\nTG6050 has been generated using Transgene\u2019s patented Invir.IO\u2122 platform.<\/b> It has been engineered to express human IL-12, a cytokine that triggers a powerful antitumor immune response, and a full length anti-CTLA4 antibody.\n<\/p>\n

\nBy selectively targeting tumor cells and expressing IL-12 and the anti-CTLA4 antibody in the tumor microenvironment, TG6050 is expected to elicit a powerful and multi-pronged antitumor response<\/b>. A short video detailing the mechanism of action can be found here<\/a>.\n<\/p>\n

\nTG6050 has been designed to be administered intravenously, a route of administration that has been demonstrated to be safe and feasible with an Invir.IO\u2122 based OV.<\/b> Intravenous administration will significantly enhance the therapeutic and market potential of this OV as it allows a more targeted approach to many internal cancer lesions and metastases inaccessible by intratumoral injection. Intratumoral injection, where the drug is injected directly into the tumor, is currently the only approved route of administration for an oncolytic virus. IV administration would represent a significant advantage.\n<\/p>\n

\nThe Delivir trial will enroll up to 36 patients with advanced NSCLC <\/b>who have failed standard therapeutic options, including immune checkpoint inhibitors (ICIs). TG6050 is expected to overcome tumor resistance by the initiation of an antitumor response through multiple mechanisms of action that include oncolysis, the induction of an immune response and high intra-tumoral concentrations of IL-12 and anti-CTLA4 antibody. The IV route is considered the most appropriate route of administration for this patient population with disseminated disease and multiple overt and occult metastases.\n<\/p>\n

\nHedi Ben Brahim, CEO of Transgene commented:<\/b> \u201cTG6050 is an exciting new asset within Transgene\u2019s growing oncolytic virus pipeline, and further demonstrates the ability of our Invir.IO\u2122 platform to generate highly targeted immuno-oncology drugs. These multi-armed drug candidates are expected to have significant advantages over existing therapies. Acting like a Trojan horse, they induce the production of potent therapies such as IL-12 directly in the tumor. The goal: to achieve high concentrations of these drugs only in the tumor, for improved efficacy and fewer side effects compared to systemic administration of these drugs. Intravenous administration addresses a broader range of patients with solid tumors who are not suitable for intratumoral administration. IV administration has the potential to improve the outcomes of patients with advanced lung cancer patients who are in great need of new treatment options.<\/i>\n<\/p>\n

\nThis CTA approval is an important milestone for Transgene, and we look forward to the first patient being recruited and providing further updates on TG6050\u2019s clinical development.\u201d<\/i>\n<\/p>\n

\nThe first patient is expected to be enrolled in this multicenter trial in the first half of 2023.\n<\/p>\n

\n***\n<\/p>\n

\nAbout the Delivir trial<\/i><\/b>\n<\/p>\n

\nThe Delivir trial is a multicenter, open label, dose-escalation Phase I trial evaluating TG6050 as a single agent. The trial will enroll up to 36 patients with metastatic\/advanced non-small cell lung cancer (NSCLC), who have failed standard therapeutic options including immunotherapies such as ICIs. Patients will receive single and repeated escalating doses of TG6050 administered intravenously, to determine the recommended dose and best schedule of administration for subsequent clinical development.\n<\/p>\n

\nAbout TG6050<\/i><\/b>\n<\/p>\n

\nTG6050 is an oncolytic virus developed with Transgene\u2019s Invir.IO\u2122 platform for intravenous administration. Invir.IO\u2122\u2019s viruses are based on the patented large capacity Vaccinia virus<\/i> Copenhagen strain genetically modified with the double deletion TK-RR- (VVCOP<\/sub>TK–<\/sup>RR–<\/sup>). TG6050 has been engineered to encode human IL-12, a cytokine that triggers a powerful antitumor immune response and a full length anti-CTLA4 antibody. It has also been optimized with the deletion of the gene encoding for the M2L viral protein that targets CD80 and CD86, two ligands of CTLA4 [source: Kleinpeter et al., J Virol. 2019 Jun 1; 93(11): e00207-19<\/a>]. The use of an oncolytic virus to deliver these immunotherapies locally and selectively in the tumor microenvironment allows high intratumoral concentrations of both therapeutic proteins eliciting a stronger and more effective antitumor response. By reducing systemic exposure to a very low level, this local therapeutic activity furthermore allows to increase the safety and tolerability profile of IL-12 and the anti-CTLA4 antibody.\n<\/p>\n

\nIt will be evaluated in the Delivir trial, a Phase I trial conducted in advanced NSCLC patients.\n<\/p>\n

\nAbout Transgene<\/i><\/b>\n<\/p>\n

\nTransgene (Euronext: TNG) is a biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. Transgene\u2019s programs utilize viral vector technology with the goal of indirectly or directly killing cancer cells.\n<\/p>\n

\nThe Company\u2019s clinical-stage programs consist of two therapeutic vaccines (TG4001 for the treatment of HPV-positive cancers, and TG4050, the first individualized therapeutic vaccine based on the myvac<\/i>\u00ae platform) as well as three oncolytic viruses based on the Invir.IO\u2122 viral backbone (TG6002, BT-001 and TG6050).\n<\/p>\n

\nWith Transgene\u2019s myvac<\/i>\u00ae platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The myvac<\/i>\u00ae 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.\n<\/p>\n

\nWith its proprietary platform Invir.IO\u2122, Transgene is building on its viral vector engineering expertise to design a new generation of multifunctional oncolytic viruses. Transgene has an ongoing Invir.IO\u2122 collaboration with AstraZeneca.\n<\/p>\n

\nAdditional information about Transgene is available at: www.transgene.fr<\/a>\n<\/p>\n

\nFollow us on social media: Twitter: @TransgeneSA<\/a> \u2013 LinkedIn: @Transgene<\/a><\/span><\/span>\n<\/p>\n

\nDisclaimer<\/i><\/b>\n<\/p>\n

\nThis 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\u2019s activities, perspectives, financial situation, results, regulatory authorities\u2019 agreement with development phases, and development. The Company\u2019s 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\u2019s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (\u201cFacteurs de Risque\u201d) section of the Universal Registration Document, available on the AMF website (http:\/\/www.amf-france.org<\/a>) or on Transgene\u2019s website (www.transgene.fr<\/a>). 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.<\/i>\n<\/p>\n

Contacts<\/b> <\/p>\n

\nTransgene:<\/b>
Lucie Larguier<\/b>
Director Corporate Communications & IR
\n
+33 (0)3 88 27 91 04
\n
investorrelations@transgene.fr<\/span><\/a>\n<\/p>\n

\nMedia: MEDiSTRAVA Consulting<\/b>
David Dible\/Sylvie Berrebi\/George Underwood<\/b>
+44 (0)203 928 6900
\n
transgene@medistrava.com<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

TG6050 is a proprietary oncolytic virus derived from Transgene\u2019s Invir.IO\u2122 platform encoding interleukin-12 (IL-12) and an anti-CTLA4 antibody. The Phase I trial, named Delivir, will evaluate the intravenous (IV) administration of this novel multi-armed immunotherapy in patients with non-small cell lung cancer. STRASBOURG, France–(BUSINESS WIRE)–#HBV–Regulatory News: Transgene (Euronext Paris: TNG) (Paris:TNG), a biotech company that … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-52616","6":"format-standard","7":"category-industry"},"yoast_head":"\nTransgene Receives Approval to Start a Phase I Trial of TG6050, a Novel IL-12-Armed Oncolytic Virus Given by Intravenous Administration - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/transgene-receives-approval-to-start-a-phase-i-trial-of-tg6050-a-novel-il-12-armed-oncolytic-virus-given-by-intravenous-administration\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Transgene Receives Approval to Start a Phase I Trial of TG6050, a Novel IL-12-Armed Oncolytic Virus Given by Intravenous Administration - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"TG6050 is a proprietary oncolytic virus derived from Transgene\u2019s Invir.IO\u2122 platform encoding interleukin-12 (IL-12) and an anti-CTLA4 antibody. 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The Phase I trial, named Delivir, will evaluate the intravenous (IV) administration of this novel multi-armed immunotherapy in patients with non-small cell lung cancer. STRASBOURG, France–(BUSINESS WIRE)–#HBV–Regulatory News: Transgene (Euronext Paris: TNG) (Paris:TNG), a biotech company that ... 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