TG1050 / Transgene, Tasly - LARVOL DELTA

Integrated network pharmacology and metabolomics to reveal the mechanism of QiShenYiQi Dripping Pills (T101) against cardiac structural and functional abnormalities. (PubMed, Front Pharmacol) - "Metabolomics analysis obtained 23 significantly altered metabolites, revealing that QSYQ (T101) significantly regulated the abnormal levels of fatty acids, carnitines, organic acids pyridines, nucleosides, which were mostly involved in myocardial energy metabolism related pathways. Based on serum and myocardium metabolomics and network pharmacology, the present study revealed that the actions of QSYQ (T101) in treating HF depend on multi-components, multi-targets and multi-pathways."

Journal • Cardiovascular • Congestive Heart Failure • Fibrosis • Heart Failure • Hypertension • Immunology • HIF1A

Safety and Efficacy of Therapeutic Hepatitis B Adenovirus Injection (T101) Combined With Nucleoside (Acid) Analogues in Chronic Hepatitis B Patients (clinicaltrials.gov) - P2; N=100; Active, not recruiting; Sponsor: Tasly Tianjin Biopharmaceutical Co., Ltd.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Hepatitis B • Hepatology • Infectious Disease

Safety and Efficacy of Therapeutic Hepatitis B Adenovirus Injection (T101) Combined With Nucleoside (Acid) Analogues in Chronic Hepatitis B Patients (clinicaltrials.gov) - P2; N=100; Active, not recruiting; Sponsor: Tasly Tianjin Biopharmaceutical Co., Ltd.; Trial primary completion date: Dec 2020 ➔ Jun 2021

Clinical • Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease

META-ANALYSIS OF TWO PHASE 1b RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED CLINICAL TRIALS OF THE HBV THERAPEUTIC VACCINES TG1050 AND T101 DEVELOPED IN EUROPE/CANADA OR CHINA. (AASLD 2019) - "No significant decline in HBsAg levels was found in the meta-analysis performed for the TG1050 and T101 phase 1 clinical studies. However, it is noteworthy that all responders were in the 1010 cohort and that no impact of pre-existing Ad5 Abs was found. T101 vaccine will move to phase 2 evaluation."

P1 data • Retrospective data

Safety and Immunogenicity of the Therapeutic Vaccine TG1050 in Chronic Hepatitis B Patients: A Phase 1b Placebo-Controlled Trial. (PubMed, Hum Vaccin Immunother) - "In CHB patients under NUC, TG1050 exhibited a good safety profile and was capable to induce HBV-specific cellular immune response. These data support further clinical evaluation, especially in combination studies."

Clinical • Journal • P1 data

a phase 1 clinical trial of therapeutic vaccine t101 in chronic hepatitis b(chb) patients: a randomized, double-blind, placebo-controlled, single and multiple injections, dose escalation study (EASL-ILC 2019) - "...T101, the Chinese counterpart of TG1050, is a replication-defective adenovirus serotype 5 (Ad5) expressing multiple HBV-specific antigens(polymerase, core and envelope) and it is used as a therapeutic vaccine for CHB patients... Subcutaneous injections of T101 are safe and tolerated in CHB patients. T101 can break the immune tolerance and stimulate HBV-specific (POL, Core or ENV) T cell immune response in CHB patients, at the same time the HBsAg level decreased. Data support future trials to explore the antiviral activity and safety of T101 in more CHB patients."

Clinical • Late-breaking abstract • P1 data