STRASBOURG, France--(BUSINESS WIRE)--Regulatory News:
Transgene (Paris:TNG), a company focused on designing and developing targeted immunotherapies for the treatment of cancer and infectious diseases, today announced that the Safety Review Committee of the Phase 1/1b trial with TG1050, Transgene’s immunotherapy product candidate for the treatment of chronic hepatitis B virus (HBV) infection, has recommended that the study should continue.
Maud Brandely, Chief Medical Officer of Transgene, said: “We are pleased to be continuing the development of our internally discovered and developed immunotherapy TG1050. The Phase 1/1b trial is progressing well with no severe adverse events observed. We are now moving ahead with the enrollment of the multiple dose cohorts of this study. Chronic hepatitis B is a major unmet medical need, and with TG1050, we are looking to provide a much more-effective treatment that is urgently needed for this viral liver disease, which can lead to cirrhosis and liver cancer.”
This first-in-man trial is an international, randomized, multi-center, double-blind, placebo-controlled study evaluating TG1050 in patients who are currently being treated for chronic HBV infection with standard-of-care antiviral therapy.
The primary objectives of the Phase 1/1b study are to evaluate the safety and tolerability of TG1050 administered in single and multiple doses and to determine the dose and schedule of TG1050 administration for further development. Secondary objectives include evaluating the antiviral activity of and immune responses to TG1050
TG1050 is a targeted immunotherapy candidate for the treatment of chronic hepatitis B, based on a viral vector expressing 3 HBV antigens. Pre-clinical results have demonstrated TG1050’s capacity to induce robust, broad and long-lasting HBV-specific T cells with characteristics similar to those found in patients whose infection has been resolved1. Antiviral effects of TG1050, including seroconversion to the surface antigen (HBsAg), have also been shown1 2.
About Chronic Hepatitis B
Hepatitis B is a
potentially life-threatening liver infection caused by HBV infection. It
can result in chronic infection and liver disease and, if left
untreated, puts people at high risk of death from cirrhosis of the liver
and liver cancer. Recent figures indicate the number of patients being
treated for chronic hepatitis B was 200,000 in total in the United
States, Germany, France, Italy, Spain and the United Kingdom and 100,000
patients in Japan. The eligible Chinese market represents 500,000
patients. Those numbers are expected to increase as more patients are
diagnosed and treated for their disease. Currently available antiviral
treatments cure only an estimated 3% of cases, and patients in the
developed world must take these treatments for an average of 15 years
and often for their lifetime. Therefore, there is an urgent need to
develop new therapeutic approaches to improve the cure rate.
About TG1050
TG1050 is a targeted immunotherapy
candidate for the treatment of chronic hepatitis B, based on a viral
vector expressing 3 HBV antigens. Transgene has initiated a randomized,
multi-center, double-blind, placebo-controlled safety and dose-finding
first-in-man study (NCT02428400) evaluating the safety and tolerability
of TG1050 in patients who are currently being treated for chronic HBV
infection with standard-of-care antiviral therapy. TG1050 is also being
developed in China, where Transgene operates a joint-venture with Tasly
Biopharmaceutical Technology, TG1050 has been recently granted an IND
number.
The latest publications on TG1050 are available on Transgene’s website: www.transgene.fr.
About Transgene
Transgene S.A. (Euronext: TNG), part
of Institut Mérieux, is a publicly traded French biopharmaceutical
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 for non-small cell lung cancer and
Pexa-Vec for liver cancer. The Company has several other programs in
clinical and pre-clinical 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.
Follow us on Twitter: @TransgeneSA
Disclaimer
This press release contains
forward-looking statements about the future development of TG1050. 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. The occurrence of any of these risks
could have a significant negative outcome for the Company’s activities,
perspectives, financial situation, results 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
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, which is
available on the AMF website (http://www.amf-france.org)
or on Transgene’s website (www.transgene.fr).
1 Gut. 2015 Dec;64(12):1961-71. doi:
10.1136/gutjnl-2014-308041
2 J Hepatol, 2015, Vol
62 (Suppl N°2), S205
