EASL- Transgene to Present New Data on TG1050 and TG4040 to Treat Chronic Hepatitis B and C

Transgene to Present New Data on TG1050 and TG4040 to Treat Chronic Hepatitis B and C at EASL 2013 

STRASBOURG, France--(BUSINESS WIRE)--Regulatory News:

“TG4040 has recently completed successful phase 2 trial in patients with CHC”

Transgene SA (Paris:TNG) (Euronext Paris: FR0005175080), a biopharmaceutical company that develops targeted immunotherapy products to treat major unmet medical needs in cancer and infectious diseases, today announced that favourable pre-clinical and clinical data on two Transgene products – TG1050 and TG4040 to treat chronic hepatitis B (CHB) and chronic hepatitis C (CHC), respectively – will be presented in oral presentations at this year’s European Association for the Study of the Liver (EASL) Conference (Amsterdam, Netherlands, April 24-28, 2013). The full abstracts are available at http://www.easl.eu.

“We are delighted to have the opportunity to present data at EASL, Europe’s largest liver conference. TG1050 is a novel immunotherapeutic to treat CHB that has shown very promising preclinical results and will soon be moving to early clinical development” stated Philippe Archinard, Chairman and CEO of Transgene. He added: “In addition to the preclinical proof-of-concept data published in September 20121, we have today released supplementary information, obtained in pre-clinical naïve and HBV murine models, on the immunogenicity of TG1050 and its capacity to induce long-term T cell response. This evidence further underlines our belief in the product’s potential to become an important new first in class immunotherapeutic to treat CHB, an area of unmet medical need.”

“TG4040 has recently completed successful phase 2 trial in patients with CHC” stated Nathalie Adda, Chief Medical Officer of Transgene. She added: “Following interim data published in April last year for TG4040 in combination with PegIFNα2a and ribavirin, we report the final results of the phase 2 HCVac trial with sustained viral response at 24 weeks (SVR24) and additional immunogenicity, specific T-cell and humoral responses. The study has demonstrated that pre-treatment with TG4040 has a positive impact on viral response as shown by cEVR and SVR improvement compared to PegIFN alpha 2a and Ribavirin alone. HCV Immunotherapy now could be explored in combination with an IFN-free DAA regimen.”

1 Poster Presentation of TG1050 at the International HBV Meeting in Oxford, England

The oral presentations will take place on Friday, April 26 and Saturday, April 27, 2013.

Friday, April 26, Session entitled: HCV Direct Acting Antivirals (abstract No 62)

Phase 2 HCVac Study of TG4040 immunotherapeutic in combination with PegIFNα2a and ribavirin in genotype 1 CHC treatment naïve patients: SVR24 Final Results

Oral presentation by Pr. Heiner Wedemeyer, Principal Investigator of the HCVac study, University of Hanover, Germany

Session Time: 16:00-18:00

Saturday, April 27, Session entitled: Hepatitis B and D Experimental (abstract No 130)

A Multivalent Adenovirus-Based Immunotherapeutic for Treatment of Chronic Hepatitis B Induces Broad, Robust and Polyfunctional T Cells in Naïve and HBV Tolerant Mice

Oral presentation by Dr. Perrine Martin, Scientific Coordinator of the Hepatitis B Program, Department of Infectious Diseases, Transgene SA.

Session Time: 15:30-17:30

About TG1050

The novel immunotherapeutic product TG1050 developed by Transgene to treat chronic infection by hepatitis B is based on a recombinant non-replicative human adenovirus serotype 5, expressing multiple specific HBV antigens (Core, Polymerase and Envelope) from genotype D. The product has been designed to prime de novo and/or stimulate functional T cells expected to control the HBV replication and to elicit viral clearance.

According to the World Health Organization’s (WHO) estimates, 350 million people are chronic carriers (WHO, 2009) of HBV. Hepatitis B is more common in some parts of the world than others. In China and other parts of Asia, up to 10% of the population is believed to be chronically infected. In addition to the significant burden of disease, CHB is responsible for 1 million deaths each year due to related complications such as liver failure, cirrhosis or hepatocellular carcinoma (liver cancer).

About TG4040

Transgene’s TG4040 vaccine candidate is a recombinant vector based on the MVA virus carrying and expressing three of the major non-structural proteins (NS3, NS4 and NS5B) of the hepatitis C virus (HCV). The MVA vector is a highly attenuated strain of vaccinia virus, which has been tested extensively in humans as a vaccine against smallpox and is known to strongly stimulate innate and adaptive immune responses to antigens.

About TG4040 Clinical Development Program

153 patients in the phase 2 HCVac study were recruited in five countries in Europe, in the United States and in Israel, and were randomized in one control arm (Arm A; 48 weeks of Peg-IFN/RBV) or one of the two experimental arms (Arms B and C). In the Arm B, the TG4040 dosage (subcutaneous injections at the dose of 107 pfu) was administered 6 times and Peg-IFN/RBV was given 4 weeks prior to the initiation of TG4040. In the Arm C, the TG4040 dosage was administered 13 times and Peg-IFN/RBV was introduced 12 weeks after the initiation TG4040. The HCVac trial investigated the efficacy and safety of these two different schedules of TG4040 administration in combination with Peg-IFN and RBV.

About Transgene:

Transgene (NYSE-Euronext: TNG), a member of the Institut Mérieux Group, is a biopharmaceutical company. It creates, develops and manufactures targeted immunotherapeutics for the treatment of cancers and infectious diseases. Transgene’s products are major technological breakthroughs. They use well tolerated viruses to indirectly or directly kill infected or cancerous cells. Its four most advanced products have generated proof of concept data in randomized clinical studies: in lung cancer (TG4010), liver cancer (Pexa-Vec), hepatitis C (TG4040) and HPV-related cervical lesions (TG4001). Transgene has concluded strategic agreements for the development of three of these products: an option agreement with Novartis for the development of TG4010, an in-licensing agreement with US-based Jennerex, Inc. to develop and market Pexa-Vec and a strategic collaboration with EORTC to develop TG4001 in cancer of the oropharynx. Transgene also has a non exclusive agreement with Sanofi/Genzyme for its future commercial production. With 280 employees, it is based in Strasbourg, France, and has operations in Lyon, China and the USA. Additional information about Transgene is available at www.transgene.fr.

Transgene Forward Looking Statements

This press release contains forward-looking statements notably referring to an anticipated future BLA filing date by Transgene. Such anticipated future BLA filing date is based on the current plan of product development and testing. This plan may change in the future and, as such, Transgene could be in a position not to meet the currently anticipated development milestones, including such BLA filing. 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 http://www.amffrance.org and on Transgene’s website at www.transgene.fr .

Société anonyme au capital de 72.886.317 € – R.C. Strasbourg B 317 540 581
400 boulevard Gonthier d’Andernach – Parc d’Innovation - CS80166 – 67405 ILLKIRCH GRAFFENSTADEN CEDEX (France)
Tél : + 33 (0)3 88 27 91 00 

Contacts

Transgene
Philippe Archinard, +33 (0)3 88 27 91 22
Chairman & CEO
or
Stéphane Boissel, +33 (0)3 88 27 91 02
Executive Vice President & CFO
or
Elisabetta Castelli, +33 (0)3 88 27 91 21
Director IR
or
MC Services
Raimund Gabriel, +49 89 210 228 30
or
Shaun Brown, +44 207 148 5998

Phase II Trial of TG4040 for HCV Completes Enrollment in Europe,U.S. and Israel

TRANSGENE : Announces Completion of Enrolment in HCVac (Phase II Trial) of TG4040 for the Treatment of Chronic Hepatitis C


03/31/2011
12:35 pm

Regulatory News:

Transgene S.A. (Paris:TNG)(Euronext Paris: FR0005175080) announces that, with 154 patients randomized and treated, the enrolment of patients in the phase II HCVac trial is now complete. This study explores the combination of TG4040 (MVA-HCV) with standard of care (Pegylated-Interferon ?2a and Ribavarin) in treatment naive patients with chronic genotype 1 hepatitis C.

The patients were recruited in five countries in Europe, in the United States and in Israel, and were randomized in the three arms of the study (one control arm without TG4040 and two experimental arms). HCVac investigates the efficacy and safety of two different schedules of administration of TG4040 administered in subcutaneous injections at the dose of 107 pfu in combination with the standard of care.

HCVac will measure the proportion of patients who achieve complete Early Virologic Response (cEVR), i.e. have no detectable viral load 12 weeks after the beginning of the treatment. These data will be available during the fourth quarter of 2011. The study will also measure the patients' Sustained Virologic Response (SVR), i.e. the treatment's long term effects on the viral load, up to 24 weeks after the end of the treatment, as well as TG4040's ability to elicit an immune response. An additional expected outcome of the study is to identify molecular biomarkers related to TG4040 efficacy in combination with the standard of care. Final data are expected in the fourth quarter of 2012.

"We look forward to obtaining the first results of the study in order to begin preparing the next steps of the development of this promising product candidate for the treatment of patients suffering from chronic hepatitis C, a disease with a growing incidence and which is becoming a public health concern even in the most economically developed countries." stated Philippe Archinard, Chairman and CEO of Transgene.

About TG4040

Transgene's TG4040 vaccine candidate is a recombinant vector based on the MVA virus carrying and expressing three of the major non-structural proteins (NS3, NS4 and NS5B) of the hepatitis C virus ("HCV"). The MVA vector is a highly attenuated strain of vaccinia virus, which has been tested extensively in humans as a vaccine against smallpox and is known to strongly stimulate innate and adaptive immune responses to antigens.

About TG4040 clinical development program

Phase I clinical results in 39 treatment naïve genotype 1 HCV patients showed that the product is safe and well tolerated at all dose levels tested. Immunological analyses on 15 treatment naive patients were encouraging and supported the expected mechanism of action of TG4040 which aims at inducing an effective HCV-specific T cell based immune response, able to control viral replication.

About chronic hepatitis C

Hepatitis C currently represents a major public health concern. The population chronically infected with HCV in the world is estimated at 170 to 200 million and hepatitis-C-related deaths at approximately 470,000 annually. Peak of prevalence of HCV-related diseases is expected to occur in 2025-2030 in developed countries.

HCV infection leads to liver diseases such as fibrosis, cirrhosis and liver carcinoma, which are the prime indications for liver transplants. The current standard of care for patients infected with the HCV genotype 1 (a combination of Pegylated Interferon ? and Ribavirin) is lengthy, often poorly tolerated and effective in only approximately 50% of patients completing therapy. In addition, a substantial number of patients never receive therapy. Therefore, there is a strong medical need for new alternative approaches, including combination therapies.

About Transgene

Transgene is a France-based biopharmaceutical company focused on the development of therapeutic vaccines and immunotherapeutic products in oncology and infectious diseases. The Company has four compounds in Phase II clinical trials: TG4010, JX594/TG6006, TG4001/RG3484 and TG4040 and one compound in Phase I clinical trial: TG4023. Transgene has entered into strategic collaborative agreements for the development of two of its immunotherapy products:

An option agreement with Novartis for an exclusive license to develop TG4010 for the treatment of various cancers, including non small cell lung cancer (NSCLC)

An in-licensing agreement with US-based Jennerex Biotherapeutics, Inc., to develop and market JX594 (JX594/TG6006), an oncolytic product.

Transgene has bio-manufacturing capacities for viral-based vectors. Additional information about Transgene can be found at www.transgene.fr.

Disclaimer:

This press release contains forward-looking statements referring to the clinical testing and development of Transgene's product candidates. 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. 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 http://www.amf-france.org and Transgene's website at www.transgene.fr .

Société anonyme au capital de 72.470.137 ? - R.C. Strasbourg B 317 540 581
Boulevard Gonthier d'Andernach - Parc d'Innovation - CS80166 - 67405 ILLKIRCH GRAFFENSTADEN CEDEX (France)
Tél : + 33 (0)3 88 27 91 00 - Fax : + 33 (0)3 88 27 91 11

Transgene

Philippe Archinard, CEO

Phone: +33 (0)3 88 27 91 22

or

Stéphane Boissel, Executive Vice President & CFO

Phone: +33 (0)3 88 27 91 02

or

Elisabetta Castelli, Director IR

Phone: +33 (0)1 44 08 55 05

or

MC Services

Raimund Gabriel

Phone: +49 89 210 228 30

or

Shaun Brown

Phone: +44 207 148 5998

© Business Wire 2011