Transgene: Promising Final Data from the Phase 2 HCVac Trial of TG4040 Presented at EASL 2013

April 29, 2013 01:45 AM Eastern Daylight Time

EASL 2013

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

Transgene SA (Paris:TNG) (Euronext Paris: FR0005175080), a biopharmaceutical company that develops targeted immunotherapy products to treat major unmet medical needs in cancer and chronic infectious diseases, announced final data of the Phase 2 HCVac trial of TG4040 for the treatment of genotype 1 chronic hepatitis C (CHC) at an oral presentation of the European Association for the Study of the Liver (EASL) Congress in Amsterdam, the Netherlands.

Professor Heiner Wedemeyer, University of Hanover, Germany and Principal Investigator of the HCVac trial, today presented the final data at EASL and stated: “This trial is unique in the field of hepatitis C, representing one of the largest randomized studies ever investigating an immunotherapeutic product against a persistent infection. It is remarkable that TG4040 induced a decline in HCV viral load and that early response rates of standard therapy with peg-interferon alpha and ribavirin were increased. In addition, very important general findings were made that will help Transgene optimize the future clinical development of TG4040.”

This open label study evaluated in 153 randomized patients two schedules of TG4040 in combination with PegIFNα2a (P) and ribavirin (R) versus P/R alone (Arm A): Arm B with six TG4040 injections initiated 4 weeks after P/R and pre-vaccination Arm C with thirteen TG4040 injections initiated 12 weeks before P/R.

The positive effect of TG4040 was seen with pre-treatment of TG4040 in Arm C. The benefit of pre-treatment was observed as early as one week after initiation of PEG-IFNα/RBV with a 40% improvement in decline of mean HCV RNA viral load. The primary endpoint was met in Arm C with a complete early viral response (cEVR) of 64% as compared to 30% in the control arm (p=0.0037).

The virologic response was sustained over time with a SVR24 of 58% in Arm C, compared to 48% in the control arm.

The key immunologic findings were that induction of MVA and HCV specific T-cell responses were essentially seen in Arm C before the addition of PEG-IFNα/RBV. The viral response seen in Arm C was observed in spite of the development of anti-MVA responses.

Overall, safety was similar across the three arms (percentage of adverse events and grade). The investigation of the four cases of severe blood toxicity led to the conclusion of an exacerbation of IFN-known immune side effects in patients with autoimmune predisposition (see press release of 23^rd April 2012).

Philippe Archinard, Chairman and Chief Executive Officer of Transgene, stated: “Today’s oral presentation at EASL once again verifies the high level of scientific and medical interest in Transgene’s immunotherapy products. The final results of the HCVac study demonstrated that a specific vectored immunotherapeutic can improve treatment of CHC. While new treatment paradigms are currently emerging, and are likely to enter the market as early as 2014, Transgene is examining different opportunities for TG4040’s future clinical development. Given the results of our Phase 2 study, immunotherapy with TG4040 may warrant further evaluation in combination with IFN-free direct-acting antivirals treatment regimens once they are approved.”

About TG4040

Transgene’s TG4040 immunotherapeutic product 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

In this Phase 2 HCVac study, a total of 153 treatment-naïve patients were enrolled in 28 sites from Europe, the United States and Israel. Patients were randomized in three arms: one control arm (48 weeks of Peg-IFN/RBV) or one of the two experimental arms. In one experimental arm, the TG4040 dosage (subcutaneous injections at the dose of 10⁷ pfu) was administered six times and Peg-IFN/RBV was given as a 4 week lead-in prior to the initiation of TG4040. In the other experimental arm, the same TG4040 dosage was administered 13 times and Peg-IFN/RBV was introduced twelve weeks after initiation of pre-treatment with TG4040. The HCVac trial evaluated the efficacy and safety of these two different schedules of TG4040 administration in combination with Peg-IFN and RBV as compared to Peg-IFN/RBV alone.

About Transgene

Transgene (NYSE-Euronext: TNG), a member of the Institut Mérieux Group, is a biopharmaceutical company. We create, develop and manufacture targeted immunotherapeutics for the treatment of cancers and infectious diseases. Our products are major technological breakthroughs that use well tolerated viruses to indirectly or directly kill infected or cancerous cells. Our 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). We have 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. We also have a non-exclusive agreement with Sanofi/Genzyme for the future commercial production of our products. Most of our 280 employees are based in Strasbourg, France, and we have 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 plans for the future development of TG4040 as a treatment against chronic hepatitis C, in combination with new treatments. These plans are subject to changes and uncertainties and we could never be able to develop, manufacture or sell TG4040 in the future. 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 on Transgene’s website at www.transgene.fr.

Contacts

Transgene
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
or
MC Services
Raimund Gabriel, +49 89 210 228 30
Shaun Brown, +44 207 148 5998

Source

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

Strasbourg, April 8th, 2013 - Transgene SA (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.”

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 .

Contacts:

Transgene
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

MC Services
Raimund Gabriel, +49 89 210 228 30
Shaun Brown, +44 207 148 5998

Source

EASL 2012: TRANSGENE : Reports Positive Follow Up Phase 2 Data on Its HCV Therapeutic Vaccine TG4040

04/23/2012 | 02:05am

• Primary endpoint (efficacy at week-12) met
• Both faster effect on viral load decrease and significant improvement of viral response over time (week-24) in TG4040 pre-vaccination arm
• Late-breaker oral presentation at EASL in Barcelona

Regulatory News:

Transgene S.A. (Paris:TNG) (Euronext Paris : FR0005175080) announces today the presentation, during the EASL (European Association for the Study of Liver) congress in Barcelona, Spain, of follow up interim data showing both a more rapid response as well as an improved long term effect on viral load decrease in a combination of TG4040 with PEG-IFN? (pegylated interferon alpha) and ribavirin (the current standard of care) in patients chronically infected with genotype 1 hepatitis C virus.

These data were observed in a randomized phase 2 trial that has enrolled 153 patients (the "HCVac" study). HCVac had three treatment arms: one control arm (Arm A) with the current standard of care alone and two arms (B and C) with a combination of this standard of care and TG4040 delivered in two different administration schedules, including one schedule (Arm C) with pre-vaccination by TG4040 (i.e. TG4040 injected prior to the introduction of PEG-IFN? and ribavirin).

As reported in November 2011 at the AASLD meeting in San Francisco, the primary endpoint of the HCVac study was met in the pre-vaccination arm C with 64% (34/53) evaluable patients having achieved a complete early viral response¹ ("cEVR") at week-12 after initiation of treatment with the standard of care compared to 30% (9/30) in the control arm A (p=0.003).

The positive effect of TG4040 pre-vaccination was observed as early as one week after initiation of treatment with the standard of care: the slope of mean viral load decrease was significantly steeper in Arm C (1.4 log10 IU/ml) compared to Arms A and B (respectively 0.9 and 1.0 log10 IU/ml) (p=0.04), meaning a faster viral response in Arm C than in other arms.

When following the viral response at week-24 after the initiation of treatment with the standard of care in the patients evaluable for cEVR (week-12), the responses continue to improve as expected in all arms: 70% in the control Arm A, 67% in the Arm B (initiation of treatment with the standard of care before introduction of TG4040) and 79% (vs. 64% at week-12) in the Arm C.

Preliminary End-of-Treatment Response measurement ("ETR", or viral response measured at the end of 48 weeks of standard of care), is respectively 64% and 56% in Arm A and B. In arm C, 19 out of 19 patients analysed so far are undetectable.

"These data are important for TG4040 as they confirm the efficacy profile of our therapeutic vaccine. As far as we know, they are unheard of for an immunotherapy in HCV and this is one of the reasons why we were invited for a late breaker oral presentation in such a prestigious event" said Philippe Archinard, Chairman and CEO of Transgene. He added: "The benefit seen at week-12 in the pre-vaccination arm is further confirmed at week-24 and the preliminary data of ETR in this arm are also very encouraging".

Data were presented on Saturday April, 21, at the annual meeting of the European Association for the Study of Liver (EASL) in Barcelona, by Pr. Heiner Wedemeyer, MD, of the Department of Gastroenterology, Hepatology and Endocrinology at Hannover Medical School (Germany) and principal investigator of the HCVac study.

Pr. Wedemeyer said: "The data accumulated so far in the HCVac study illustrate the importance of immunity in the treatment of chronic hepatitis C". He added: "The assessment of TG4040 in a combination with directly acting agents (DAA) should be the next development step".

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 1

Phase 1 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 naïve 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. Phase 1 data were published in the journal Gastroenterology and reported in Nature Reviews in 2011.

Phase 2

153 patients in the 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) or one of the two experimental arms (Arms B and C). In the Arm B, the TG4040 dosage was administered 6 times and the standard of care was given 4 weeks prior to the initiation of TG4040. In the Arm C, the TG4040 dosage was administered 13 times and the standard of care was introduced 12 weeks after the initiation of treatment with TG4040. The HCVac study is investigating 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 Peg-IFN and RBV.

About SAEs:

The three cases of severe haematological adverse events, one aplastic anemia and two cases of thrombocytopenia, reported in October 2011, all recovered within 1 to 4 months. A fourth case corresponding to a thrombocytopenia was recorded recently. Of interest, the three cases of thrombocytopenia share all a same class 2 Human Leukocyte Antigen ("HLA") allele. This association is statistically significant and, as these HLA types could be excluded a priori in a new clinical trial, this will be taken into account in future developments of the therapeutic vaccine, should it be combined with standard of care including PEG-IFN?. These adverse events should also have no impact in future developments without PEG-IFN?.

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 commonly used treatment regimen 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, a member of the Institut Mérieux Group, is a publicly traded French biopharmaceutical company dedicated to the development of therapeutic vaccines and immunotherapeutic products in oncology and infectious diseases and has four compounds in phase 2 clinical development: TG4010 and JX594/TG6006 having already completed initial phase 2 trials, TG4001 and TG4040. Transgene has concluded strategic agreements for the development of two of its immunotherapy products: an option agreement with Novartis for the development of TG4010 to treat various cancers and an in-licensing agreement with US-based Jennerex, Inc. to develop and market JX594/TG6006, an oncolytic virus. Transgene has bio-manufacturing capacities for viral-based products. Additional information about Transgene is available at transgene.fr.

Disclaimer:

This press release contains certain forward-looking statements. 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 the continuing success of clinical studies, ongoing financing for further product developments and marketing launch, a positive response from the medical community regarding the product's costs and effectiveness. 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 Reference prospectus, which is available on the AMF website (http://www.amf-france.org) or on Transgene's website (www.transgene.fr). This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Transgene in any country.

¹ Limit of detection for the HCV RNA quantification test: 10IU/ml.

Transgene
Philippe Archinard, CEO
Phone: +33 (0)3 88 27 91 22
Stéphane Boissel, Executive Vice President & CFO
Phone: +33 (0)3 88 27 91 02
Elisabetta Castelli, Director IR
Phone: +33 (0)1 44 08 55 05
or
MC Services
Raimund Gabriel
Phone: +49 89 210 228 30
Shaun Brown
Phone: +44 207 148 5998

Source

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

31.03.2011 18:31

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 a2a 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 a 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 http://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 http://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

Contacts:

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

Source