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Press Release

First Patient Randomized in Multiple Dose Cohort of Phase 1/1b Trial with Transgene’s TG1050 in Chronic Hepatitis B Patients

Transgene
Posted on: 19 Oct 16

Strasbourg, France, October 17, 2016 - Transgene (Euronext Paris: TNG), a company focused on designing and developing targeted immunotherapies for the treatment of cancer and infectious diseases, today announced that the first patient has been included in the multiple dose cohort of the Phase 1/1b trial with TG1050, Transgene’s immunotherapy product candidate for the treatment of chronic hepatitis B virus (HBV) infection (NCT: 02428400).

 

The continuation of the trial in the multiple dose cohorts follows the positive recommendation of the Safety Review Committee (July 2016) as no severe adverse events have been observed in patients receiving a single dose of TG1050.

 

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. First data readout is expected in H2 2017.

 

TG1050 is a targeted immunotherapy candidate for the treatment of chronic hepatitis B, based on a viral vector expressing three HBV antigens. It is a therapeutic vaccine that has been designed and developed by Transgene’s antiviral research team. Preclinical 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 resolved[1]. Antiviral effects of TG1050, including seroconversion to the surface antigen (HBsAg), have also been shown1, [2].

 

Chronic hepatitis B is a major unmet medical need, as current treatments only cure about 3% of the patients. With TG1050, Transgene is 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.

 

 

[1] Gut. 2015 Dec; 64(12):1961-71. doi: 10.1136/gutjnl-2014-308041

2 J Hepatol, 2015, Vol 62 (Suppl N° 2), S205

 

Contacts

 

Transgene:

 

Lucie Larguier

Director Corporate Communications & IR

+33 (0)3 88 27 91 04

investorrelations@transgene.fr

 

Media contacts:

 

Citigate Dewe Rogerson

David Dible / Marine Perrier

+ 44 (0)20 7638 9571

transgene@citigatedr.co.uk

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 19/10/2016

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