Regulatory Filings • Oct 30, 2017
Regulatory Filings
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New Results from the Phase 2b TIME Trial, Including the Correlation of Vaccine-Induced Immunogenicity and Improved Overall Survival, Support Transgene's Ongoing Clinical Strategy to Develop TG4010 in Lung Cancer (NSCLC) in Combination Regimens with Immune Checkpoint Inhibitors (ICIs)
Strasbourg, France, October 30, 2017, 5:45 p.m. CET - Transgene (Euronext Paris: TNG), a biotech company that designs and develops viral-based immunotherapies, will be presenting a poster on additional immunology data generated from the randomized, placebo-controlled Phase 2b trial (TIME) that evaluated the combination regimen of TG4010 and chemotherapy in patients with advanced lung cancer at the Society for Immunotherapy of Cancer (SITC) Meeting 2017, in National Harbor, Maryland, November 8-12.
Poster title: Immune mechanisms of the response to TG4010, a viral-based vaccine, in patients with advanced non-small cell lung carcinoma
The abstract will be published on November 7, 2017, on the SITC website.
All publications on TG4010 can be accessed via www.transgene.fr, Pipeline>Publications.
Transgene:
Lucie Larguier Director Corporate Communications & IR +33 (0)3 88 27 91 04 [email protected]
Media contacts:
Citigate Dewe Rogerson David Dible/Marine Perrier + 44 (0)20 7638 9571 [email protected]
TG4010 is an immunotherapy that has been designed to express the coding sequences of the MUC1 tumor-associated antigen and the cytokine, Interleukin-2 (IL2) in a modified Vaccinia virus (MVA). The combination of TG4010 immunotherapy and chemotherapy has demonstrated significant efficacy in terms of progression-free survival and overall survival in patients with advanced stage NSCLC (Quoix et al. Lancet Oncol. 2015). TG4010 is currently being investigated in combination with nivolumab (ICI) for the 2nd -line treatment of advanced NSCLC (NCT02823990). A trial in 1st -line treatment of NSCLC is expected to begin at the end of 2017, evaluating the combination regimen of TG4010 + nivolumab + chemotherapy in patients whose tumors express low or undetectable levels of PD-L1.
Transgene (Euronext: TNG), part of Institut Mérieux, is a publicly traded French biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer and infectious diseases. Transgene's programs utilize viral vector technology with the goal of indirectly or directly killing infected or cancerous cells. The Company's lead clinical-stage programs are: TG4010, a therapeutic vaccine against non-small cell lung cancer, Pexa-Vec, an oncolytic virus against liver cancer, and TG4001, a therapeutic vaccine against HPV-positive head and neck cancers. The Company has several other programs in clinical development, including TG1050 (chronic hepatitis B) and TG6002 (solid tumors). Transgene is based in Strasbourg, France, and has additional operations in Lyon, as well as a joint venture in China. Additional information about Transgene is available at www.transgene.fr. Follow us on Twitter: @TransgeneSA
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 forwardlooking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the Document de Référence, available on the AMF website (http://www.amf-france.org) or on Transgene's website (www.transgene.fr). 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.
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