MVA-HCV: Additional Phase II data

Additional data from the open-label, international Phase II HCVac trial in 153 treatment-naïve patients with chronic HCV genotype 1 infection showed that 13 injections of TG4040 as monotherapy over 12 weeks plus standard of care (SOC; peginterferon alfa-2a and ribavirin) initiated at week 12 (Arm C) led to a viral response at 24 weeks after the start of SOC in 79% of patients who were evaluable for cEVR at week 12 vs. 70% for SOC alone for 48 weeks (Arm A, control) and 67% for SOC for 4 weeks alone followed by 6 injections of TG404 (Arm B). Viral response was defined as undetectable HCV RNA levels (<10 IU/mL). Additionally, patients in Arm C achieved significantly greater viral suppression 1 week after the start of SOC vs. patients in Arms A and B (1.4 vs. 0.9 and 1 log IU/mL, respectively; p=0.04). The proportion of evaluable patients achieving end-of-treatment response, defined as viral response at the end of 48 weeks of SOC, was 64%, 56% and 100% in Arms A, B and C, respectively. Data were presented at the European Association for the Study of the Liver meeting in Barcelona.

Transgene said that a fourth case of a severe hematological event, specifically thrombocytopenia, was recently reported. Last October, the company said it would discontinue dosing of TG4040 after 3 cases of severe hematological adverse events, including 1 case of aplastic anemia and 2 cases of thrombocytopenia, were observed in patients receiving the compound plus SOC. Transgene said all 3 cases of thrombocytopenia share the same class 2 human leukocyte antigen (HLA) allele and the HLA types could be excluded in a new clinical trial. Transgene said it plans to evaluate TG4040 in combination with direct-acting antivirals in hard-to-treat HCV populations, after which the company plans to seek a co-development partner. ...