Clinical Trials

Date: 2017-10-23

Type of information: Results

phase: 1-1b

Announcement: results

Company: Transgene (France)

Product: TG1050 (therapeutic vaccine)

Action mechanism:

• immunotherapy product/therapeutic vaccine. TG1050 is an adenovirus-based targeted immunotherapy candidate for the treatment of chronic hepatitis B. This therapeutic vaccine is based on a recombinant non-replicative human adenovirus serotype 5, expressing multiple specific HBV antigens (Core, Envelope and Polymerase) from genotype D. The vaccine has been designed to prime de novo and/or stimulate functional T-cells expected to control the HBV replication and to elicit viral clearance.

Disease: chronic hepatitis B

Therapeutic area: Infectious diseases

Country: Canada, France, Germany

Trial details:

• This phase 1/1b study is a double-blind, randomized, placebo-controlled, multi-cohort Phase 1/1b study in patients that are currently being treated for chronic HBV infection. For all cohorts, patients must be receiving antiviral treatment with either tenofovir disoproxil fumarate (TDF) or entecavir (ENT) for at least two years, and have their HBV infection well-controlled. 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 to bring forward for further development. Secondary objectives include evaluating the antiviral activity of and immune responses to TG1050. Patients in the trial will continue to be treated with standard antiviral therapy.  (NCT02428400).

Latest news:

• • On October 23, 2017, Transgene announced that the analyses conducted on patients with chronic hepatitis B receiving standard antiviral therapies and a single dose of TG1050 in the Phase 1/1b trial, confirm the good tolerability profile and demonstrate the immunogenicity of this novel therapeutic vaccine. Transgene presented a poster describing the first promising clinical data of TG1050 on October 21, 2017, at the annual meeting of the AASLD (American Association for the Study of Liver Diseases).
• These results were obtained from the first cohort of patients included in the Phase 1/1b trial; patients that are currently treated with standard antiviral therapy also received a single dose of TG1050. The data presented further strengthen the first elements communicated in 20161 , i.e. a very satisfying tolerability profile of TG1050.
• They also confirm the product’s mechanism of action.The immunologic analyses show that TG1050 induces a specific immune response in the patients: • Strong immune responses against the different HBV antigens that are vectorized by TG1050 (core protein, polymerase and envelop protein – HbsAg) have been shown in the patients who received the two highest doses (1010 vp et 1011 vp); • A dose-effect relationship was observed in terms of number of patients developing responses against the different viral antigens, with a higher intensity of responses in the groups receiving the two highest doses (1010 vp et 1011 vp).
• •On October 17, 2016, Transgene announced that the first patient has been included in the multiple dose cohort of the Phase 1/1b trial with TG1050 for the treatment of chronic hepatitis B virus (HBV) infection. The continuation of the trial in the multiple dose cohorts follows the positive recommendation of the Safety Review Committee as no severe adverse events have been observed in patients receiving a single dose of TG1050. 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. • On July 21, 2016, Transgene 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. • On November 4, 2015, Transgene announced that the first patient has been dosed in a clinical trial with its immunotherapy product candidate TG1050 for the treatment of chronic hepatitis B virus (HBV) infection. The Phase 1 part of this trial is planned to enroll up to 48 patients.

Is general: Yes