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-IFNα (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-IFNα 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-IFNα. These adverse
events should also have no impact in future developments without
PEG-IFNα.
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 α 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.
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