Bienvenue sur le nouveau Boursorama. Découvrez tout ce qui a changé
  1. Aide
    1. Espace client
    2. Connexion
Accès membre Boursorama

Erreur d'authentification

Vous êtes authentifié. Nous chargeons votre espace membre.

Mot de passe oublié ?

Nouveau sur Boursorama ? Devenez membre

Identifiant/Mot de passe oublié
Si vous êtes Membre de la Communauté Boursorama, veuillez indiquer l'adresse email que vous avez fournie lors de votre enregistrement pour recevoir votre identifiant et/ou ré-initialiser votre mot de passe :

Nouveau sur Boursorama ? Devenez membre




Ouverture théorique 3.0400

FR0005175080 TNG

Euronext Paris données temps réel
Politique d'exécution
  • ouverture


  • clôture veille


  • + haut


  • + bas


  • volume

    96 373

  • valorisation

    189 MEUR

  • capital échangé


  • dernier échange

    23.03.18 / 17:35:19

  • limite à la baisse

    Qu'est-ce qu'une limite à la hausse/baisse ?



  • limite à la hausse

    Qu'est-ce qu'une limite à la hausse/baisse ?



  • Éligibilité


    Qu'est-ce que le SRD ?


    Qu'est-ce que le PEA ?


Autres places de cotation

  • + Alerte

  • + Portefeuille

    Ajouter TRANSGENE à un portefeuille virtuel

  • + Liste

    Ajouter TRANSGENE à mes listes


Transgene receives FDA Fast Track Status for its Targeted Immunotherapy Product TG4010 for the Treatment of Non-Small Cell Lung Cancer

Boursorama01/12/2009 à 18:45


Transgene Receives FDA Fast Track Status for its Targeted Immunotherapy

Product TG4010 for the Treatment of Non-Small Cell Lung Cancer

Parc d’Innovation, Illkirch, France, December 1, 2009 – Transgene (Euronext Paris: FR0005175080) today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track development designation to its immunotherapy product TG4010 (MVA-MUC1-IL2) for the first-line treatment of advanced non-small cell lung cancer (NSCLC) in combination with chemotherapy.

The FDA determined that TG4010 meets the criteria for the Fast Track designation, facilitating the development of TG4010 for the first-line treatment in combination with chemotherapy to improve survival in patients with advanced MUC1-positive NSCLC and normal levels of activated Natural Killer (NK) cells. The granting of Fast Track status follows the FDA’s earlier clearance to proceed to phase III trial based on positive clinical data from a controlled phase IIb trial of TG4010 in patients with advanced NSCLC (see press release dated June 9, 2009 on

The Fast Track program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process. In addition, the designation allows the TG4010 Biological License Application (BLA) to be considered for submission on a rolling basis, allowing the FDA to review sections of the BLA as they are completed.

“We are very pleased with the FDA’s decision to grant Fast Track status to TG4010, which represents a key achievement in our regulatory strategy” said Philippe Archinard, Chief Executive Officer of Transgene. “We are actively preparing the next development steps for the product and look forward to working closely with the FDA. Discussions for the partnering of TG4010 have progressed and we hope to reach a collaborative agreement around year-end 2009.”

About the Phase IIb trial in NSCLC:

The phase IIb trial was a randomized, open label and controlled study designed to assess the efficacy of TG4010 in combination with cisplatin and gemcitabine compared to the chemotherapy regimen alone. The trial completed the enrolment of 148 patients at the end of May 2007 in 27 centres located in France, Poland, Germany, and Hungary. The trial met its primary end point with a progression-free survival at 6 months of 45 % in the experimental arm.

Additionally, the phase IIb clinical data after 24 months of median follow-up confirmed a 6-month increase in median survival (17.1 months in the experimental arm versus 11.3 months in the control arm) in patients with normal levels of activated NK cells at baseline (some 75% of the patients in the trial) a sub-population identified by Transgene’s biomarker programme[1]. Furthermore, all other relevant parameters confirmed an improved clinical outcome for patients of this sub-population treated with TG4010. Further information on the phase IIb results for TG4010, including previous press releases, and the ASCO and ESMO posters, is available on Transgene’s website (

About TG4010 cancer vaccine

TG4010 (MVA-MUC1-IL2) uses the Modified Vaccinia Ankara virus vector, a poxvirus that combines distinguishing advantages for an optimized systemic vaccination:

· MVA is a highly attenuated strain which has been tested extensively in humans as a smallpox vaccine and is known to strongly stimulate innate and adaptive immune responses to antigens.

· MUC1 is a major tumor-associated antigen that provides a viable target for immunotherapy.

· TG4010 expresses the entire MUC1 gene sequence and has the potential to generate an immune response to all antigenic epitopes of MUC1.

· The sequence coding for the cytokine Interleukin 2 (IL2) is included to help stimulate specific T-cell response.

About Non-Small-Cell Lung Cancer (NSCLC)

Lung cancer is a major public health issue with over 1 million new cases a year across the world, and accounts for some 350,000 deaths per year in Europe and the United States alone. Around 80% of lung cancer patients are diagnosed with non-small-cell lung cancer. Of these, some 60% overexpress MUC1, which is the target for TG4010. The efficacy of current treatments for NSCLC is limited, and TG4010 is targeting first line treatment of metastatic NSCLC in combination with chemotherapy. Other NSCLC stages of disease and all other epithelial cancers expressing MUC1 (prostate, breast, kidney, pancreatic and colorectal cancers) are also potential future targets for TG4010.

About NK Cells

Natural Killer cells (NK cells) are effector lymphocytes of the innate immune system that control several types of tumors and microbial infections by limiting their spread and subsequent tissue damage. Recent research highlights the fact that NK cells are also regulatory cells engaged in reciprocal interactions with dendritic cells, macrophages, T cells and endothelial cells. NK cells can thus limit or exacerbate immune responses.

About Transgene

Transgene is a France-based biopharmaceutical company dedicated to the development of therapeutic vaccines and immunotherapeutic products in oncology and infectious diseases. The company has three compounds in phase II trials (TG4001/R3484, TG4010 and TG1042) and two compounds in phase I studies (TG4040 and TG4023). Transgene has concluded a strategic partnership agreement with Roche for the development of its TG4001/R3484 therapeutic vaccine to treat HPV-mediated diseases. Transgene has bio-manufacturing capacities for viral-based vectors and technologies available for out-licensing. Additional information about Transgene is available on the Internet at

Cautionary note regarding forward-looking statements

This press release contains forward-looking statements referring to the planned clinical testing and development of one of Transgene’s therapeutic vaccine candidates. However, clinical testing and successful product development depend on a variety of factors, including the timing and success of future patient enrolment and the risk of unanticipated adverse patient reactions. Results from future studies with more data may show less favorable outcomes than prior studies, and there is no certainty that product candidates will ever demonstrate adequate therapeutic efficacy or achieve regulatory approval or commercial use. In addition, the entry into new partnerships involves a process of negotiation with partner candidates, including with respect to financial, technical, commercial and legal matters, and there is no certainty that appropriate partnerships will be established or will be successful. For further information on the risks and uncertainties involved in the testing and development of Transgene’s product candidates, see Trangene’s Document de référence on file with the French Autorité des marchés financiers on its website at and Transgene’s website at .

For further information please contact:

Transgene Capital MS&L

Philippe Archinard, CEO Mary Clark, Director

+33 (0)3 88279122 +44 (0)20 7307 5336

Philippe Poncet, CFO Anna Mitchell, Account Director

+33 (0)3 88279102 +44 (0)20 7307 5346

Elisabetta Castelli, Director IR

+33 (0)1 44085505

[1] The Biomarker program is partly financed by an OSEO grant as a part of the ADNA program (Advanced Diagnostics for New Therapeutic Approaches).

Valeurs associées


Mes listes




1.134 -4.71%
0.941 +1.29%
0.219 +40.79%
0.407 +5.99%
23.2 +2.11%

Les Risques en Bourse


Note d'information importante

Chère Cliente, Cher Client,

Nous souhaitons vous donner quelques règles à suivre pour investir dans les meilleures conditions et vous présenter les risques potentiels auxquels vous êtes susceptibles d'être exposés.

Vos connaissances, Votre profil d'investisseur
Tout d'abord évaluez vos connaissances boursières et financières et formez-vous en consultant le Guide de l'Investisseur, véritable introduction à la bourse et à l'épargne qui est disponible sur votre site Boursorama Banque sous la rubrique «Aide/Formation».
Définissez ensuite votre profil d'investisseur (prudent, équilibré, dynamique) et vos objectifs (durée de placement, rentabilité …). Ce constat vous permettra de vous orienter vers les produits et les marchés qui vous sont le mieux adaptés.

Pensez à vos besoins de liquidité
Adaptez votre durée de placement (1 mois, 1 an, 5 ans, …) à vos besoins de liquidités (projets, impôts …) et en tout état de cause, n'investissez pas en Bourse une partie trop importante de votre patrimoine.

La composition de votre portefeuille
Etudiez la composition de votre portefeuille : diversifiez vos placements afin de réduire au maximum le risque inhérent à un support ou à un secteur en particulier et n'investissez pas dans les produits optionnels (warrants, certificats), fortement risqués, si votre portefeuille n'est pas suffisamment important.

Connaître la vie des Sociétés
Renseignez-vous sur la société au sein de laquelle vous envisagez d'investir (actualités, santé financière, opérations à venir, …).

Agir en connaissance de cause
Soyez conscient des risques auxquels vous êtes exposés : de fait, si certains produits (actions volatiles, warrants, certificats, future…) ou certains modes d'investissement (Service de Règlement Différé) augmentent les espérances de gain, ils accroissent aussi fortement le risque de perte (totale). Ainsi, une connaissance technique préalable approfondie est requise, c'est pourquoi nous conseillons aux néophytes de s'écarter de ce type de produits.

Des risques différents selon les marchés
Prenez connaissance des caractéristiques des marchés sur lesquels vous allez investir : vous êtes confrontés à un risque variable (liquidité, volatilité, niveau d'information, change…) selon les marchés sur lesquels vous décidez d'intervenir (Premier Marché, Second Marché, Nouveau marché, Marché Libre, Marché étranger…).

Figez vos pertes
Enfin, la règle d'or à retenir est de savoir figer ses pertes : à vous de définir le montant de perte acceptable dès le début et une fois ce niveau atteint agissez en conséquence.

En appliquant ces quelques règles de bonnes conduite vous serez à même de mieux appréhender votre risque lorsque vous allez investir sur les Marchés

Un ensemble de cours complets sur la Bourse est également mis à votre disposition gratuitement et que vous pouvez retrouver sur votre site Boursorama Banque dans la rubrique «Aide/Formation». Si des questions resteraient en suspend, n'hésitez pas à contacter votre agence qui est à votre disposition.

L'équipe de Boursorama Banque.