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Transgene Presents New Data with TG1050
http://www.fiercebiotech.com/press-releases/transgene-presents-new-data-tg1050-immunotherapy-being-developed-treat-chro
Transgene Presents New Data with TG1050, an Immunotherapy Being Developed to Treat Chronic Hepatitis B, at The International Liver Congress™ 2015
Regulatory News:
Transgene SA (Paris:TNG) today announced that new pre-clinical data with TG1050, an immunotherapy being developed for the treatment of chronic hepatitis B, were presented at The International Liver Congress™ 2015, the 50 Congress of the European Association for the Study of the Liver (EASL) in Vienna, Austria. The TG1050 data were presented as part of a Liver Immunology session in an oral presentation entitled: (Abstract O031).
The data presented today demonstrate the antiviral potential of TG1050 in a persistent hepatitis B virus (HBV) model. In this model, TG1050 was shown to significantly reduce circulating HBV DNA, to reduce the circulating HBV surface antigen (HBsAg), and to trigger seroconversion to HBsAg (i.e., to develop anti-HBsAg antibodies). The development of anti-HBsAg antibodies has been associated with HBV cure.
The presentation is available on Transgene’s website in the “Our Pipeline/Publications” section at .
"” said Eric Quéméneur, PhD, Executive Vice President and Vice President, Research & Development. “”
TG1050 is an adenovirus-based targeted immunotherapy candidate for the treatment of chronic hepatitis B, 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 150,000 in total in the United States, Germany, France, Italy, Spain and the United Kingdom and 200,000 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.
The pre-clinical package for TG1050 has been completed, demonstrating the immunotherapy’s antiviral activity and the capacity of TG1050 to induce robust, broad, long-lasting and cross-reactive (i.e., capable of recognizing HBV strains from different genotypes) T cells with characteristics similar to those found in patients whose infection is resolved. Pharmaceutical development and pre-clinical toxicity studies have been completed. Transgene expects to begin patient enrollment in a first-in-humans clinical trial in mid-2015. The Company plans to first evaluate TG1050 in combination with standard of care anti-viral treatment with the aim of improving the cure rate. Additional development could include evaluating TG1050 in combination with immune checkpoint inhibitors and/or with novel classes of antivirals.
Transgene (Euronext: TNG), part of Institut Mérieux, is a publicly traded French biopharmaceutical company focused on discovering, developing and manufacturing 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 that are based on its core viral vector technology. Transgene is based in Strasbourg, France, and has additional operations in Lyon, as well as satellite offices in China and the U.S. Additional information about Transgene is available at .
Société anonyme au capital de 88.155.914,18 R.C. Strasbourg B 317 540 581400 Boulevard Gonthier d’Andernach – 67400 Illkirch-Graffenstaden (France)Tél : + 33-03 88 27 91 00 - Fax : +33-03 88 27 91 11
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Transgene Presents New Data with TG1050, an Immunotherapy Being Developed to Treat Chronic Hepatitis B, at The International Liver Congress™ 2015
Regulatory News:
Transgene SA (Paris:TNG) today announced that new pre-clinical data with TG1050, an immunotherapy being developed for the treatment of chronic hepatitis B, were presented at The International Liver Congress™ 2015, the 50 Congress of the European Association for the Study of the Liver (EASL) in Vienna, Austria. The TG1050 data were presented as part of a Liver Immunology session in an oral presentation entitled: (Abstract O031).
The data presented today demonstrate the antiviral potential of TG1050 in a persistent hepatitis B virus (HBV) model. In this model, TG1050 was shown to significantly reduce circulating HBV DNA, to reduce the circulating HBV surface antigen (HBsAg), and to trigger seroconversion to HBsAg (i.e., to develop anti-HBsAg antibodies). The development of anti-HBsAg antibodies has been associated with HBV cure.
The presentation is available on Transgene’s website in the “Our Pipeline/Publications” section at .
"” said Eric Quéméneur, PhD, Executive Vice President and Vice President, Research & Development. “”
TG1050 is an adenovirus-based targeted immunotherapy candidate for the treatment of chronic hepatitis B, 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 150,000 in total in the United States, Germany, France, Italy, Spain and the United Kingdom and 200,000 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.
The pre-clinical package for TG1050 has been completed, demonstrating the immunotherapy’s antiviral activity and the capacity of TG1050 to induce robust, broad, long-lasting and cross-reactive (i.e., capable of recognizing HBV strains from different genotypes) T cells with characteristics similar to those found in patients whose infection is resolved. Pharmaceutical development and pre-clinical toxicity studies have been completed. Transgene expects to begin patient enrollment in a first-in-humans clinical trial in mid-2015. The Company plans to first evaluate TG1050 in combination with standard of care anti-viral treatment with the aim of improving the cure rate. Additional development could include evaluating TG1050 in combination with immune checkpoint inhibitors and/or with novel classes of antivirals.
Transgene (Euronext: TNG), part of Institut Mérieux, is a publicly traded French biopharmaceutical company focused on discovering, developing and manufacturing 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 that are based on its core viral vector technology. Transgene is based in Strasbourg, France, and has additional operations in Lyon, as well as satellite offices in China and the U.S. Additional information about Transgene is available at .
Société anonyme au capital de 88.155.914,18 R.C. Strasbourg B 317 540 581400 Boulevard Gonthier d’Andernach – 67400 Illkirch-Graffenstaden (France)Tél : + 33-03 88 27 91 00 - Fax : +33-03 88 27 91 11
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SIGN UP FOR OUR
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Thanks :)
What do you mean fresh T cells ? I though that T-cell lives few hours/days and it dies and new one is created like many other cells in our body ?
What do you mean fresh T cells ? I though that T-cell lives few hours/days and it dies and new one is created like many other cells in our body ?
You are really testing my knowledge here, so I will be brief and hope I got it right. I will also skip over details I don't know or understand. So the story is incomplete.
Whenever protein is produced in a cell, part of the protein, an epitope, is expressed on the surface of the cell in a MHC complex. Since various HBV antigens, s, e, c, are produced in an effected liver cells, there are MHC complexes with s-epitopes, e-epitopes, and c-epitopes on the surface of infected cells.
HBV infection causes our immune system to produce from B cells various types of antibodies to the various HBV antigens. These are good to attach to their respective antigens. However, since only a HBV virion has the s-antigen as its coat, the s-antibodies can attach to HBV virions circulating in the blood, thus preventing its entry to a liver cell and cause them to be destroyed by immune cells. However antibodies are not useful against an infected cell.
Fortunately, our immune system has T cells that will be transformed to effective CD8+ T cells with HBV viral epitopes expressed in MHC complexes on their surface that will recognise their matching HBV viral epitopes in MHC complexes on the surface of infected cells. These CD8+ T cells can kill or cure infected liver cells. Viola, so we should all be cured. Unfortunately, the HBV virus has evolved various mechanisms to render these CD8+ T cells infective, by making them "exhausted" through massive stimulation with vast quantity of hbvdna and viral antigens (both s & e) and by mutations so that the various epitopes are no longer expressed on the surface of infected liver cells. Hence we have chronic infection.
The aim of therapeutic vaccine is to cause our immune system to produce fresh T cells with the right viral epitopes so that they can recognise infected liver cells, kill or cure them.
Whenever protein is produced in a cell, part of the protein, an epitope, is expressed on the surface of the cell in a MHC complex. Since various HBV antigens, s, e, c, are produced in an effected liver cells, there are MHC complexes with s-epitopes, e-epitopes, and c-epitopes on the surface of infected cells.
HBV infection causes our immune system to produce from B cells various types of antibodies to the various HBV antigens. These are good to attach to their respective antigens. However, since only a HBV virion has the s-antigen as its coat, the s-antibodies can attach to HBV virions circulating in the blood, thus preventing its entry to a liver cell and cause them to be destroyed by immune cells. However antibodies are not useful against an infected cell.
Fortunately, our immune system has T cells that will be transformed to effective CD8+ T cells with HBV viral epitopes expressed in MHC complexes on their surface that will recognise their matching HBV viral epitopes in MHC complexes on the surface of infected cells. These CD8+ T cells can kill or cure infected liver cells. Viola, so we should all be cured. Unfortunately, the HBV virus has evolved various mechanisms to render these CD8+ T cells infective, by making them "exhausted" through massive stimulation with vast quantity of hbvdna and viral antigens (both s & e) and by mutations so that the various epitopes are no longer expressed on the surface of infected liver cells. Hence we have chronic infection.
The aim of therapeutic vaccine is to cause our immune system to produce fresh T cells with the right viral epitopes so that they can recognise infected liver cells, kill or cure them.
How HBcAg may improve induced by vaccacine, sustained viral response ? Could you also explain please in simple words how therapeutic vaccacines work ?
China had investigated two therapeutic vaccines. One failed completely, the other, YIC, failed in a Phase 3 trial to better the placebo, alum. After further investigations and re-design, it is now awaiting CDFA approval, however I think its efficacy is low. By now, it is obvious that therapeutic vaccine that uses only S-antigen will not be successful, as Studyforhope explained many times before, but those including HBcag seem to offer success. In the pipeline, we have ASX203, now recruiting in Sydney and other places for a Phase 2/3 clinical trial, I think GS4772 is currently in Phase 2, TG1050 is expected to begin Phase 1 in 2015.
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