Transgene

Illkirch-Graffenstaden, France

Transgene

Illkirch-Graffenstaden, France
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NEW YORK & STRASBOURG, France--(BUSINESS WIRE)--#HBV--Regulatory News: Bristol-Myers Squibb Company (NYSE: BMY) and Transgene (Paris:TNG) today announced a new clinical research collaboration to evaluate the safety, tolerability and efficacy of Transgene’s investigational therapeutic vaccine TG4010 in combination with Bristol-Myers Squibb’s Opdivo (nivolumab) + standard chemotherapy (CT) as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC) in patients whose tumors ha


Transgene (Paris:TNG), société de biotechnologie qui conçoit et développe des immunothérapies reposant sur des vecteurs viraux, a traité le premier patient dans son essai clinique de Phase 1/2 évaluant la combinaison de Pexa-Vec avec Opdivo® (nivolumab) en première ligne de traitement du carcinome hépatocellulaire (CHC) au stade avancé, une maladie qui représente 75 % des cancers du foie. Cet essai ouvert évaluera la sécurité et la tolérabilité de cette association d’immunothérapies, ainsi que son activité antitumorale et son efficacité. Cette étude recrutera jusqu’à 36 patients (NCT03071094). L’association de Pexa-Vec et de nivolumab a pour objectif de viser deux étapes différentes de la réponse immunitaire contre les cellules cancéreuses et pourrait s’avérer significativement plus efficace que chacun des deux traitements administrés seuls. Les experts reconnaissent le bien-fondé scientifique de cette combinaison, qui permet d’augmenter l’activité anti-tumorale de Pexa-Vec en l’associant avec nivolumab qui supprime la capacité des cellules cancéreuses à échapper à la réponse immunitaire. Le Professeur Olivier Rosmorduc, chef du service de gastroentérologie de l’hôpital de La Pitié Salpêtrière à Paris et investigateur principal de cet essai clinique innovant, commente : « L’amélioration du traitement du CHC nécessite une approche thérapeutique capable de stimuler considérablement le système immunitaire. Je suis convaincu que la combinaison d’immunothérapies avec des effets locaux et systémiques tels que l’anti-PD1 nivolumab et le virus oncolytique Pexa-Vec est une stratégie pertinente pour mieux traiter les patients ayant un carcinome hépatocellulaire avancé. » Maud Brandely, Directeur, Développement Clinique, Opérations Cliniques & Affaires Réglementaires, conclut : « Le pronostic du CHC reste mauvais, avec des options thérapeutiques qui n’ont apporté qu’une amélioration marginale. Les données précliniques et cliniques de Pexa-Vec et de nivolumab suggèrent que l’association de ces immunothérapies innovantes et de leurs mécanismes d’action complémentaires, a le potentiel d’être plus active que chacun des traitements en monothérapie. Ceci pourrait résulter en une amélioration du taux de réponse et en une augmentation de la survie globale des patients souffrant de CHC. » À propos de Transgene Transgene (Euronext : TNG), qui fait partie de l’Institut Mérieux, est une société de biotechnologie qui conçoit et développe des produits d’immunothérapie ciblée contre les cancers et les maladies infectieuses. Ces produits utilisent des vecteurs viraux pour détruire directement ou indirectement les cellules infectées ou cancéreuses. Transgene a deux produits principaux en développement clinique : TG4010, un vaccin thérapeutique contre le cancer du poumon non à petites cellules et Pexa-Vec, un virus oncolytique contre le cancer du foie. La Société a également plusieurs autres programmes en recherche et en développement préclinique et clinique basés sur sa technologie des vecteurs viraux, dont TG4001 (cancers positifs au HPV), TG1050 (hépatite B chronique) et TG6002 (tumeurs solides). Transgene est basée à Strasbourg et a des activités opérationnelles à Lyon et une joint-venture en Chine. Plus d’informations sur www.transgene.fr. Plus d’informations sur www.transgene.fr. Transgene détient les droits exclusifs en Europe pour le développement et la commercialisation de Pexa-Vec en tumeurs solides. Son partenaire SillaJen, Inc. développe Pexa-Vec pour le marché nord-américain et a conclu un partenariat accordant à Lee’s Pharmaceutical les droits pour Hong Kong et la Chine. Déclarations prospectives Ce communiqué de presse contient des informations et/ou déclarations prospectives de Transgene concernant sa situation financière, y compris sa consommation de trésorerie. Bien que la Société considère que ces informations et projections sont fondées sur des hypothèses raisonnables, elles peuvent être remises en cause par un certain nombre d’aléas et d’incertitudes, de sorte que les résultats effectifs pourraient différer significativement de ceux anticipés et pourraient avoir un impact négatif significatif sur les activités de la Société, ses perspectives, sa situation financière, ses résultats ou ses développements. La capacité de la Société à commercialiser ses produits est soumise notamment, mais pas exclusivement, aux facteurs suivants : la reproduction chez l’homme de résultats précliniques positifs ; la réussite d’essais cliniques, la capacité à obtenir des financements et/ou des partenariats pour le développement et la commercialisation des produits, et l’obtention des autorisations réglementaires de mise sur le marché. Pour une description des risques et incertitudes de nature à affecter les résultats, la situation financière, les performances ou les réalisations de la Société et ainsi à entraîner une variation par rapport aux déclarations prospectives, veuillez-vous référer à la section « Facteurs de Risque » du Document de Référence déposé auprès de l’AMF et disponible sur les sites internet de l’AMF (www.amf-france.org) et de la Société (www.transgene.fr).


Transgene (Paris:TNG), a company that designs and develops viral-based immunotherapies, today announces that the first patient has been treated in a Phase 1/2 clinical trial evaluating the combination of Pexa-Vec with Opdivo® (nivolumab) as a first-line treatment of advanced hepatocellular carcinoma (HCC), which accounts for approximately 75% of liver cancers. This open-label trial will assess the safety and tolerability as well as the anti-tumor activity and efficacy of this immunotherapy combination regimen in up to 36 patients (NCT03071094). The principal investigator of this multi-center trial is Prof Olivier Rosmorduc, MD, Head of Hepato-gastroenterology department at La Pitié-Salpêtrière Hospital in Paris (France). More information on the trial is available on clinicaltrials.gov. Pexa-Vec: an oncolytic immunotherapy that has shown efficacy Pexa-Vec is an oncolytic immunotherapy product based on an oncolytic vaccinia virus expressing GM-CSF. In a Phase 2 trial of Pexa-Vec in first-line HCC, overall survival was improved in a dose dependent manner. The median overall survival was 14.1 months for the high-dose group compared to 6.7 months for the low-dose group. Pexa-Vec’s mechanism of action and its safety profile make it an appropriate candidate for use in combination with immune checkpoint inhibitors (ICIs) such as nivolumab. Nivolumab (Opdivo®, Bristol-Myers Squibb) is a monoclonal antibody targeted against the PD-1 receptor. It is approved in several cancer indications and is currently being investigated in HCC within a global Phase 3 trial. By targeting two distinct steps in the immune response against cancer cells, the combination of Pexa-Vec and nivolumab has the potential to be significantly more effective than either product alone. There is a strong scientific rationale that suggests that Pexa-Vec’s anti-cancer effects could be enhanced by combining it with nivolumab, which suppresses the cancer cells’ ability to escape the body’s immune response. Commenting on this innovative clinical trial, Prof Olivier Rosmorduc, MD, head of Hepato-gastroenterology department at La Pitié-Salpêtrière Hospital in Paris and principal investigator of the trial, added: “Improving the treatment of HCC needs a therapeutic approach capable of significantly boosting the immune system. I am confident that combining immunotherapies with local and systemic effects such as anti-PD1 nivolumab and the oncolytic virus Pexa-Vec is a powerful strategy to better treat patients with advanced hepatocellular carcinoma.” Maud Brandely, Chief Medical Officer of Transgene, said: “HCC has a dismal prognosis which has been marginally improved by current therapeutic options. Preclinical and clinical data generated respectively with Pexa-Vec and nivolumab suggest that, in combination, these novel immunotherapies, with their complimentary modes of action, have the potential to be more active than each single agent alone. This may translate into better response rate and increased overall survival in HCC patients.” About Transgene 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 two lead clinical-stage programs are: TG4010, a therapeutic vaccine against non-small cell lung cancer and Pexa-Vec, an oncolytic virus against liver cancer. The Company has several other programs in clinical and preclinical development, including TG4001 (HPV-positive head and neck cancers), 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 About Pexa-Vec Pexa-Vec (JX594/TG6006 - pexastimogene devacirepvec) is an oncolytic immunotherapy product based on an oncolytic vaccinia virus armed with a GM-CSF gene that promotes an anti-tumor immune response. Pexa-Vec is designed to selectively target and destroy cancer cells through three different mechanisms of action: selectively destroy cancer cells through the direct lysis (breakdown) of cancer cells through viral replication, reduce the blood supply to tumors through vascular disruption, and stimulate the body’s immune response against cancer cells. The lead indication for Pexa-Vec is hepatocellular carcinoma (HCC, liver cancer); trials in other cancer types are underway or planned. Transgene has exclusive rights to develop and commercialize Pexa-Vec for the treatment of solid tumors in Europe. Its partner SillaJen, Inc. is focused on developing Pexa-Vec for the North American market and has also granted exclusive development and commercial rights to Pexa-Vec in Hong Kong and The People’s Republic of China to Lee’s Pharmaceutical. 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 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.


Les éléments clés de l’article, intitulé « Immune checkpoint blockade, immunogenic chemotherapy or IFN-α blockade boost the local and abscopal effects of oncolytic virotherapy », sont les suivants : Les données publiées dans Cancer Research ont été présentées dans un poster lors de la réunion annuelle de l’association américaine pour la recherche contre le cancer (American Association for Cancer Research, AACR) qui s’est tenue en avril 2017 à Washington. L’article est téléchargeable sur le site de Cancer Research. Cancer Research, une publication de l’AACR, est l’une des revues à comité de lecture parmi les plus influentes en matière de recherche et de médecine appliquées au cancer. À propos de Transgene Transgene (Euronext : TNG), qui fait partie de l’Institut Mérieux, est une société de biotechnologie qui conçoit et développe des produits d’immunothérapie ciblée contre les cancers et les maladies infectieuses. Ces produits utilisent des vecteurs viraux pour détruire directement ou indirectement les cellules infectées ou cancéreuses. Transgene a deux produits principaux en développement clinique : TG4010, un vaccin thérapeutique contre le cancer du poumon non à petites cellules et Pexa-Vec, un virus oncolytique contre le cancer du foie. La Société a également plusieurs autres programmes en recherche et en développement préclinique et clinique basés sur sa technologie des vecteurs viraux, dont TG4001 (cancers positifs au HPV), TG1050 (hépatite B chronique) et TG6002 (tumeurs solides). Transgene est basée à Strasbourg et a des activités opérationnelles à Lyon et une joint-venture en Chine. Plus d’informations sur www.transgene.fr. Suivez-nous sur Twitter : @TransgeneSA Avertissement Ce communiqué de presse contient des informations et/ou déclarations prospectives de Transgene concernant sa situation financière, y compris sa consommation de trésorerie. Bien que la Société considère que ces informations et projections sont fondées sur des hypothèses raisonnables, elles peuvent être remises en cause par un certain nombre d’aléas et d’incertitudes, de sorte que les résultats effectifs pourraient différer significativement de ceux anticipés et pourraient avoir un impact négatif significatif sur les activités de la Société, ses perspectives, sa situation financière, ses résultats ou ses développements. La capacité de la Société à commercialiser ses produits est soumise notamment, mais pas exclusivement, aux facteurs suivants : la reproduction chez l’homme de résultats précliniques positifs ; la réussite d’essais cliniques, la capacité à obtenir des financements et/ou des partenariats pour le développement et la commercialisation des produits, et l’obtention des autorisations réglementaires de mise sur le marché. Pour une description des risques et incertitudes de nature à affecter les résultats, la situation financière, les performances ou les réalisations de la Société et ainsi à entraîner une variation par rapport aux déclarations prospectives, veuillez-vous référer à la section « Facteurs de Risque » du Document de Référence déposé auprès de l’AMF et disponible sur les sites internet de l’AMF (www.amf-france.org) et de la Société (www.transgene.fr).


Transgene (Paris:TNG) (Euronext Paris: TNG), a biotech company that designs and develops viral-based immunotherapies, announces that new and encouraging preclinical data on its next generation armed engineered oncolytic virus platform have been published in Cancer Research. The publication presents key findings of Transgene’s latest improved vaccinia virus backbone expressing the Fcu1 gene, which is engineered to transform the non-cytotoxic pro-drug, flucytosine (5-FC), into 5-FU, a widely-used cancer chemotherapy. These preclinical data further strengthen the preclinical data package of Transgene’s most advanced next generation oncolytic virus, TG6002, which is expected to enter the clinic in the coming months in patients with recurrent glioblastoma. The key results reported in the publication titled, “Immune checkpoint blockade, immunogenic chemotherapy or IFN-α blockade boost the local and abscopal effects of oncolytic virotherapy” are: Eric Quéméneur, PhD, Executive VP, Chief Scientific Officer, Transgene, said, “The publication of these very promising data in Cancer Research highlight the growing interest in the potential of engineered oncolytic viruses to play an important role in the treatment of cancer. Oncolytic virus drugs hold great promise given their ability to directly kill cancer cells, modulate the tumor micro-environment as well as act systemically to address distant metastases. Transgene is making significant progress in the development of its next generation of multifunctional oncolytic viruses. We believe that, armed with new enzymes, monoclonal antibodies, chemokines and cytokines, this next generation of oncolytic viruses will have the potential to transform the treatment of cancer.” The data in the Cancer Research publication was originally presented in a poster in April 2017 at the American Association for Cancer Research (AACR) annual meeting in Washington, DC. The publication can be accessed on the Cancer Research website. Cancer Research, a publication from AACR, is one of the most influential peer-reviewed journals in cancer research and medicine. About Transgene Transgene S.A. (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 two lead clinical-stage programs are: TG4010, a therapeutic vaccine against non-small cell lung cancer and Pexa-Vec, an oncolytic virus against liver cancer. The Company has several other programs in clinical and preclinical development, including TG4001 (HPV-positive head and neck cancers), 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. 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 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.


Servier and Transgene (Paris:TNG), a biotechnology company that designs and develops immunotherapies based on viral vectors, announced today the signature of a research agreement on the application of viral vectorization technology for the production of allogenic CAR-T cell therapies. The aim is to obtain more efficient products for patients. “Allogenic cell therapies using CAR-T open a major field of innovation in the treatment of cancer,” stated Patrick Therasse, Oncology Research and Development Director at Servier. “However, each of the steps in their complex manufacturing process requires specific development and optimization efforts, in order to provide patients with the best possible therapeutic options. And we look for the best partners to move these products forward. ". The aim of the collaboration between the scientific teams at both Servier and Transgene is to evaluate and select innovative vectorization methods based on Transgene’s viral vector collection, which may be applied to the engineering of CAR-T cell therapies. In addition to the development of simpler, faster and more effective methods, the aim is also to obtain a tighter control of the modified genome areas. Servier and Transgene thus aim to achieve an original allogenic CAR-T preparation method with better transgene integration yields and fewer steps. Servier has been engaged in the development of cell therapies since November 2015 (see About UCART19). Transgene has a large collection of viral vectors and is renowned for its competence in the genome engineering of these vectors. These assets will be used to develop new vectorization tools that will allow us to increase the possibility of fine and precise modification of the genome of CART cells, in order to adapt these cells’ properties to the tumor environment and improve the therapeutic efficacy. Eric Quéméneur, Scientific Director of Transgene, explains: “We are proud of the recognition of our vectorization know-how and of our capacity for innovation by a pharmaceutical company of importance such as Servier. We will enthusiastically contribute to the development of CAR-T, these new promising products in cancer immunotherapy. Thanks to this collaboration, Transgene broadens the domain of the application of viral vectors from its technological platform. ". “Cellectis is pleased about Servier and Transgene’s collaboration on allogenic CAR-T cell therapies, stated André Choulika, Chairman and Chief Executive Officer of Cellectis. “Transgene stands among the most advanced companies in the world in the development of vector technologies. We are convinced that this collaboration will result in a next generation of UCART19 that will confirm the initial results of this product candidate, but also, will lead to ways to optimize production, costs, and potentially explore its use in other leukemia indications”. Transgene may receive more than 30 million Euro for this contract, with an initial duration of three years. As for Servier, it will be able to use these new vectors to develop its cell immunotherapy portfolio. Servier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes). With a strong international presence in 148 countries and a turnover of 4 billion euros in 2016, Servier employs 21,000 people worldwide. Entirely independent, the Group reinvests 25% of its turnover (excluding generic drugs) in research and development and uses all its profits for development. Corporate growth is driven by Servier’s constant search for innovation in five areas of excellence: cardiovascular, immune-inflammatory and neuropsychiatric disease, oncology and diabetes, as well as by its activities in high-quality generic drugs. Becoming a key player in oncology is part of Servier’s long-term strategy. Currently, there are nine molecular entities in clinical development in this area, targeting gastric and lung cancers and other solid tumors, as well as different types of leukemia and lymphomas. This portfolio of innovative cancer treatments is being developed with partners worldwide, and covers different cancer hallmarks and modalities, including cytotoxics, proapoptotics, immune, cellular and targeted therapies, to deliver life-changing medicines to patients. Transgene (Euronext: TNG), part of Institut Mérieux, is a biotechnology company focused on discovering and developing immune-targeted therapies for the treatment of cancer and infectious diseases. These products use viral vectors to destroy, directly or indirectly, infected or cancer cells. Transgene has two main products in clinical development: TG4010, a therapeutic vaccine against non-small cell lung cancer and Pexa-Vec, an oncolytic virus against liver cancer. The Company also has several other pre-clinical and clinical research and development programmes based on its viral vector technology, including TG4001. Transgene is based in Strasbourg and has operational activities in Lyons and a joint-venture in China. For further information on www.transgene.fr. In November 2015, Servier acquired the exclusive rights to UCART19 from Cellectis. Following further agreements, Servier and Pfizer began collaborating on a joint clinical development program for this cancer immunotherapy, currently I phase I. Pfizer has exclusive rights from Servier to develop and commercialize UCART19 in the United States, while Servier retains exclusive rights for all other countries. This press release contains forward-looking information and/or statements of Transgene concerning its financial situation, including its cash flow. Although the Company considers that this information and expectations are based on reasonable assumptions, they may be subject to a certain number of risks and uncertainties, which could cause the actual results to differ significantly from those expected and could have a significant negative impact on the activities of the Company, its prospects, financial situation, results or developments. The capacity of the Company to market its products is subject primarily, but not exclusively, to the following factors: the reproduction in humans of positive pre-clinical results; the success of clinical trials, the capacity to obtain funding and/or partnerships for the development and marketing of its products, and obtaining regulatory marketing authorisations. For a description of risks and uncertainties which could affect the results, financial situation, performance or achievements of the Company, and thus cause a fluctuation with respect to the forward-looking statements, please refer to the “Risk Factors” section of the Reference Document and its Update filed with the AMF and available on the AMF website (www.amf-france.org) and the Company website (www.transgene.fr).


Transgene (Euronext : TNG), qui fait partie de l’Institut Mérieux, est une société de biotechnologie qui conçoit et développe des produits d’immunothérapie ciblée contre les cancers et les maladies infectieuses. Ces produits utilisent des vecteurs viraux pour détruire directement ou indirectement les cellules infectées ou cancéreuses. Transgene a deux produits principaux en développement clinique : TG4010, un vaccin thérapeutique contre le cancer du poumon non à petites cellules et Pexa-Vec, un virus oncolytique contre le cancer du foie. La Société a également plusieurs autres programmes en recherche et en développement préclinique et clinique basés sur sa technologie des vecteurs viraux, dont TG4001 (cancers positifs au HPV), TG1050 (hépatite B chronique) et TG6002 (tumeurs solides). Transgene est basée à Strasbourg et a des activités opérationnelles à Lyon et une joint-venture en Chine. Plus d’informations sur www.transgene.fr. Ce communiqué de presse contient des informations et/ou déclarations prospectives de Transgene concernant sa situation financière, y compris sa consommation de trésorerie. Bien que la Société considère que ces informations et projections sont fondées sur des hypothèses raisonnables, elles peuvent être remises en cause par un certain nombre d’aléas et d’incertitudes, de sorte que les résultats effectifs pourraient différer significativement de ceux anticipés et pourraient avoir un impact négatif significatif sur les activités de la Société, ses perspectives, sa situation financière, ses résultats ou ses développements. La capacité de la Société à commercialiser ses produits est soumise notamment, mais pas exclusivement, aux facteurs suivants : la reproduction chez l’homme de résultats précliniques positifs ; la réussite d’essais cliniques, la capacité à obtenir des financements et/ou des partenariats pour le développement et la commercialisation des produits, et l’obtention des autorisations réglementaires de mise sur le marché. Pour une description des risques et incertitudes de nature à affecter les résultats, la situation financière, les performances ou les réalisations de la Société et ainsi à entraîner une variation par rapport aux déclarations prospectives, veuillez-vous référer à la section « Facteurs de Risque » du Document de Référence et de son Actualisation déposés auprès de l’AMF et disponibles sur les sites internet de l’AMF (www.amf-france.org) et de la Société (www.transgene.fr).


News Article | June 8, 2017
Site: www.businesswire.com

Transgene’s (Paris:TNG) shareholders held their Combined General Meeting (ordinary and extraordinary) today, chaired by Philippe Archinard, Chairman and CEO, to approve the company financial statements for the year ended December 31, 2016 and to vote on the other resolutions submitted to their approval. At the Combined General Meeting, the shareholders have: Following the Combined General Meeting, the board of directors is composed of 10 members, including six independent directors. Marie Landel founded Marie Landel & Associates, now Axelia Partners, a consultancy based in Cambridge (Massachusetts) specialized in advising European companies on the creation and development of US subsidiaries. Marie has significant experience supporting French and European biotechnology companies in the United States. In her 27 years of practice, she has built an extensive network in the financial community focused on this sector. Marie is a French CPA (Expert-comptable), and she holds an MBA from the European Business School (Paris, Frankfurt and London). Marie also sits on the Boards of TxCell, Safe Orthopaedics and Cellnovo. Chevalier de la Légion d’Honneur, Marie was also a Foreign Trade Advisor to the French government (CCEF or Conseillers pour le Commerce Extérieur de la France for 10 years). Maya Saïd brings more than 15 years of international strategic, operational and research experience working across academia and the healthcare industry. She is the President and CEO of Outcomes4Me, a private company headquartered in Cambridge (Massachusetts), focusing on providing patients with personalized treatment options and outcomes information. Previously, she was Senior Vice-President, Global Head of Oncology Policy and Market Access at Novartis, and Vice President, Head of Strategy, Science Policy & External Innovation, Global R&D at Sanofi. Her career started within the healthcare and strategy practice of The Boston Consulting Group (BCG). Maya has a Doctor of Science in Electrical Engineering, Computer Science & Systems Biology from the Massachusetts Institute of Technology (MIT), two Master’s degrees in Electrical Engineering & Computer Science and in Toxicology, as well as two Bachelor’s degrees in Electrical Engineering & Computer Science and in Biology. She has also studied finance and healthcare systems excellence at the Harvard Business School. Maya is the author of more than 20 publications in refereed journals such as Nature and PNAS. About Transgene Transgene S.A. (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 two lead clinical-stage programs are: TG4010, a therapeutic vaccine against non-small cell lung cancer and Pexa-Vec, an oncolytic virus against liver cancer. The Company has several other programs in clinical and preclinical development. 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. 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 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.


Transgene (Euronext Paris:TNG), a biotech company that designs and develops viral-based immunotherapies, will host today an Immuno-Oncology R&D event for investors and analysts in Paris. The event, which features presentations by leading clinicians and scientists from around the world as well as key members of the Transgene management team, provides an update on: Philippe Archinard, PhD, Chairman and CEO, Transgene, commenting on the Company’s R&D day said : “Today’s event demonstrates that Transgene is rapidly positioning itself to become a key player in the field of immuno-oncology. We are confident that the read-out from our ongoing clinical trials that are expected over the next 18 months will clearly show the power of our immunotherapies in combination with ICIs to treat a broad range of solid tumors.” Amongst the R&D Day’s key speakers are: Eric Quéméneur, PhD, Executive VP, Chief Scientific Officer, Transgene, said, “Today’s presentations highlight Transgene’s competitive positioning in the development of oncolytic viruses. OV drugs hold great promise in the field of cancer therapy given their ability to directly kill cancer cells, modulate the tumor micro-environment as well as to act systemically. We are making significant progress in the development of the next generation of recombinant OVs that have the potential to deliver a step change in the treatment of cancer.” The full agenda of the Transgene Immuno-Oncology R&D can be accessed on Transgene’s website from 2:00 pm CET, www.transgene.fr, in the Investor Events and presentation section. Transgene S.A. (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 two lead clinical-stage programs are: TG4010, a therapeutic vaccine against non-small cell lung cancer and Pexa-Vec, an oncolytic virus against liver cancer. The Company has several other programs in clinical and preclinical development, including TG4001 (HPV-positive head and neck cancers), 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. 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 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.


News Article | June 8, 2017
Site: www.businesswire.com

Les actionnaires de Transgene (Paris:TNG) se sont réunis ce jour en Assemblée Générale Mixte (ordinaire et extraordinaire), sous la Présidence de Monsieur Philippe Archinard, Président-Directeur général, afin d’approuver les comptes sociaux et consolidés de l’exercice clos le 31 décembre 2016, et de se prononcer sur l’ensemble des résolutions qui leur ont été soumises. Marie Landel a fondé Marie Landel & Associates, maintenant Axelia Partners, un cabinet de conseil en création et développement de filiales américaines d’entreprises européennes, basé à Cambridge (Massachusetts, États-Unis). Marie a une solide expérience dans l’accompagnement de sociétés de biotechnologie françaises et européennes aux États-Unis, et a construit depuis plus de 27 ans de larges réseaux dans les milieux financiers et spécialisés dans ce domaine. Maya Saïd apporte plus de 15 ans d’expérience internationale à des postes de direction dans l’industrie de la santé, à la croisée de la recherche, de la conduite du changement et de l’excellence stratégique et opérationnelle. Elle est Président-Directeur général de Outcomes4Me, une société privée basée à Cambridge (Massachusetts, États-Unis) focalisée sur la prise en charge personnalisée des patients et le partage d’informations intégrées sur les résultats sur la santé. Elle a été Vice-Président Senior, Global Head of Oncology Policy and Market Access chez Novartis, et Vice-Président, Stratégie, Politique Scientifique et Innovation Externe, R&D Monde chez Sanofi. Elle a débuté sa carrière au sein de l’unité Santé et Stratégie du Boston Consulting Group (BCG). Maya a obtenu un Doctorat en Science du Massachusetts Institute of Technology (MIT) en Informatique et Systèmes Biologique, deux Masters en génie électrique & informatique et toxicologie, ainsi que deux Bachelor of Science en génie électrique & Informatique et Biologie. Elle a également étudié la finance et l’organisation des systèmes de santé à la Harvard Business School. À propos de Transgene Transgene (Euronext : TNG), qui fait partie de l’Institut Mérieux, est une société de biotechnologie qui conçoit et développe des produits d’immunothérapie ciblée contre les cancers et les maladies infectieuses. Ces produits utilisent des vecteurs viraux pour détruire directement ou indirectement les cellules infectées ou cancéreuses. Transgene a deux produits principaux en développement clinique : TG4010, un vaccin thérapeutique contre le cancer du poumon non à petites cellules, et Pexa-Vec, un virus oncolytique contre le cancer du foie. La Société a également plusieurs autres programmes en recherche et en développement préclinique et clinique basés sur sa technologie des vecteurs viraux, dont TG4001. Transgene est basée à Strasbourg et a des activités opérationnelles à Lyon et une joint-venture en Chine. Plus d’informations sur www.transgene.fr. Déclarations prospectives Ce communiqué de presse contient des informations et/ou déclarations prospectives de Transgene concernant sa situation financière, y compris sa consommation de trésorerie. Bien que la Société considère que ces informations et projections sont fondées sur des hypothèses raisonnables, elles peuvent être remises en cause par un certain nombre d’aléas et d’incertitudes, de sorte que les résultats effectifs pourraient différer significativement de ceux anticipés et pourraient avoir un impact négatif significatif sur les activités de la Société, ses perspectives, sa situation financière, ses résultats ou ses développements. La capacité de la Société à commercialiser ses produits est soumise notamment, mais pas exclusivement, aux facteurs suivants : la reproduction chez l’homme de résultats précliniques positifs ; la réussite d’essais cliniques, la capacité à obtenir des financements et/ou des partenariats pour le développement et la commercialisation des produits, et l’obtention des autorisations réglementaires de mise sur le marché. Pour une description des risques et incertitudes de nature à affecter les résultats, la situation financière, les performances ou les réalisations de la Société et ainsi à entraîner une variation par rapport aux déclarations prospectives, veuillez-vous référer à la section « Facteurs de Risque » du Document de Référence et de son Actualisation déposés auprès de l’AMF et disponibles sur les sites internet de l’AMF (www.amf-france.org) et de la Société (www.transgene.fr).

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