Development Pipeline
INFLUENZA PROGRAM
Theraclone is developing human antibodies as acute-use therapeutics for the treatment of severe hospitalized flu and for the national pandemic stockpile. Research is focused on two influenza targets: M2e and hemagglutinin (HA).
M2e:
TCN-032 is an IgG monoclonal antibody that binds to a novel conformational epitope on the N-terminus of the M2e protein. The epitope recognized by TCN-032 is conserved in over 98% of known influenza A strains, including avian and swine strains. TCN-032 binds influenza virus and infected cells and has demonstrated potent protection in vivo against H5N1 and 2009 S-OIV H1N1 influenza strains. A Phase 1 clinical trial is ongoing with top line results expected in Q2 2012. A Phase 2 viral challenge study is planned in H2 2012.
HA:
Theraclone is screening human donors for broadly neutralizing, cross-reactive human antibodies to hemagglutinin. To date, several candidates have been identified that bind and broadly neutralize Group 1 as well as the H3 subtype of Group 2 influenza strains.
HCMV PROGRAM
Human cytomegalovirus (HCMV) disease remains an unmet medical need: In the US, the estimated prevalence of congenital HCMV infection is ~1% and is one of the leading causes of permanent hearing loss and neurological deficits in children. In immunocompromised individuals such as transplant recipients it can cause serious life-threatening disease and may significantly increase the risk of graft rejection.
With the goal of developing safer and more effective therapy, Theraclone has isolated and characterized a potent, neutralizing antibody that recognizes a broadly conserved functional epitope on HCMV: TCN-202.
TCN-202 neutralizes HCMV infection in many cell types including epithelial cells, endothelial cells, and fibroblasts, as well as across multiple viral strains, including primary clinical isolates. In preclinical studies, TCN-202 demonstrated efficacy in an in vivo animal model of HCMV infection. A Phase 1 study is anticipated to commence in H2 2012.