Phase 1/1b Trial for Chronic Hepatitis B Therapy to Continue, Based on Safety Panel Recommendation

Phase 1/1b Trial for Chronic Hepatitis B Therapy to Continue, Based on Safety Panel Recommendation

Based on preliminary positive safety data, a Safety Review Committee has recommended that a Phase 1/1b clinical trial be continued with TG1050, an immunotherapy candidate being developed by Transgene for the treatment of chronic hepatitis B virus (HBV) infection.

“We are pleased to be continuing the development of our internally discovered and developed immunotherapy TG1050,” Maud Brandely, chief medical officer of Transgene, said in a press release. “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,” she added.

TG1050 is an adenovirus-based targeted immunotherapy candidate that expresses three HBV antigens, capable of inducing robust, broad, and long-lasting immune cells that are specific for HVB, as shown in pre-clinical studies. These cells are very similar to those found in patients whose infection has been resolved.

TG1050-educated immune cells have the ability to recognize all strains of HBV, and have been shown to induce strong antiviral properties, including reduction of HBV circulating DNA, reduction of circulating HBV surface antigen HBsAg, and the development of antibodies against HBsAg, which have been associated with HBV cure.

In November 2015, Transgene initiated its randomized, double-blind, placebo-controlled, multicenter Phase 1/1b study (NCT02428400), which is planned to enroll up to 48 patients who are currently being treated for chronic HBV infection with standard of care antiviral therapy, to evaluate the safety and tolerability of TG1050.

The study’s primary objectives include the evaluation of TG1050 safety and tolerability when administered in single and multiple doses, and to determine the schedule and appropriate dose administration for further development in clinical trials. Secondary objectives included addressing TG1050-induced immune responses and antiviral activity.

Hepatitis B is among the major causes of liver cirrhosis and liver cancer, exhibiting potentially life-threatening effects. The currently available antiviral treatments cure only about 3 percent of patients, and patients need to take these treatments their entire life, revealing the urgent need to develop new therapies that not only improve the cure rate, but also don’t require a lifelong treatment.

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