Transgene Provides Update on Timing of Upcoming Milestone for TG4010
Strasbourg, France, November 4, 2013 – Transgene S.A. (NYSE-Euronext: TNG) today provided an update on the expected timing for a key milestone event for one of its lead cancer immunotherapy programs, TG4010 MUC-1 targeted immunotherapy. The Company reported that the number of disease progression events required per protocol to perform the progression-free survival (PFS) analysis for the Phase 2b part of the TIME study evaluating TG4010 in lung cancer was reached later than expected. This has resulted in a delay in the time to topline data, now expected early in the first quarter of 2014 instead of the fourth quarter of 2013.
“We look forward to reporting topline clinical data from the TIME trial in lung cancer with TG4010 early in the new year” said Philippe Archinard, Chairman and CEO of Transgene. “It is an exciting time for Transgene as we make plans for this important program and our other clinical-stage immunotherapeutics”.
TG4010 is a novel MUC-1 targeted immunotherapy. The TIME trial is a randomized, placebo-controlled, global Phase 2b/3 trial evaluating TG4010, a novel MUC-1 targeted immunotherapy, in combination with chemotherapy in patients with Stage IV MUC-1 positive non-small cell lung cancer. The Phase 2b part of the study is ongoing, with the objective of validating a predictive biomarker for efficacy (PFS). If confirmed, this biomarker would enable selection of the patient population for the Phase 3 portion of study.
Transgene has signed an exclusive option agreement with Novartis for the development and commercialization of TG4010 for the first-line treatment of NSCLC and other potential cancer indications. Following receipt of the report on the results of the Phase 2b part of the TIME trial, Novartis has 90 days to decide if it will exercise its option to TG4010.
Transgene, a member of the Institut Mérieux Group, is a publicly traded French biopharmaceutical company focused on discovering, developing and manufacturing targeted immunotherapies for the treatment of oncology and infectious diseases. Transgene’s programs utilize well-tolerated viruses with the goal of indirectly or directly killing infected or cancerous cells. The Company’s four clinical-stage programs are: TG4010 for non-small cell lung cancer; Pexa-Vec for liver cancer; TG4001 for oropharyngeal cancer (under a collaboration agreement with the EORTC) and TG4040 for chronic Hepatitis C. Transgene has concluded corporate strategic agreements for the development of two of its immunotherapy products: an exclusive option agreement with Novartis for the development and commercialization of TG4010 and an in-licensing agreement with US-based Jennerex, Inc. for the development and commercialization of Pexa-Vec in certain territories. The Company also has several programs in research and pre-clinical development that are based on its core viral vector technology, including novel immunotherapeutics to treat chronic Hepatitis B and tuberculosis. Transgene is based in Strasbourg, France, and has additional operations in Lyon, as well as satellite offices in China and the U.S. Additional information about Transgene is available at www.transgene.fr.
This press release contains certain forward-looking statements, including statements about the timing of clinical trial results. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. In particular, the Company’s ability to commercialize its first product depends on but is not limited to the following factors: the success of clinical studies, the ability to obtain financing and/or partnerships for product 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 Document de Référence, which is available on the AMF website (http://www.amf-france.org) or on Transgene’s website (www.transgene.fr).
Philippe Archinard, Chairman & CEO, +33 (0)3 88 27 91 22
Stéphane Boissel, Executive Vice President & CFO, +33 (0)3 88 27 91 02
Elisabetta Castelli, Director IR, +33 (0)3 88 27 91 21
Raimund Gabriel, +49 89 210 228 30
Shaun Brown, +44 207 148 5998
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