Pathogens, such as bacteria and viruses, naturally elicit strong immune responses. Although these responses may not be sufficient in all people to resist disease — either because the virus overwhelms the immune system or mutates to escape it — Theraclone’s I-STAR™ Technology allows us to identify rare antibodies that could be therapeutically effective.
Our most advanced development program in infectious disease is focused on novel antibodies to fight pandemic and severe seasonal influenza.
Seasonal influenza results in over 200,000 hospitalizations and 36,000 deaths per year in the United States alone. The toll from a pandemic outbreak could be much higher. Because the virus mutates rapidly, new vaccines must be developed and administered each year and these vaccines are not always effective. Furthermore, strains of influenza have emerged that are resistant to the currently available therapies (e.g. Tamiflu, Symmetrel).
Theraclone is developing TCN-032 as an acute-use therapeutic for the treatment of severe hospitalized flu and for the national pandemic stockpile. 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 has completed with top line results announced in Q2 2012. A Phase 2a viral challenge study has completed with top line results announced in Q3 2013.
Click here to watch Dr. Michael G. Ison discuss TCN-032.
Theraclone, in collaboration with the Wellcome Trust, is using its powerful human memory B-cell interrogation platform, ISTAR™, to identify potential therapeutic antibodies against the Ebola virus. The ISTAR™ technology can rapidly screen antibodies from survivors of Ebola to uncover those with exceptional biologic activity that may lead to the development of a therapeutic antibody.
Human Immunodeficiency Virus (HIV)
Theraclone has entered into an exclusive license with Gilead Sciences, Inc. to develop and commercialize products incorporating Theraclone’s broadly neutralizing HIV-antibodies for therapeutic applications in HIV. These broadly neutralizing antibodies (bNAbs) were discovered in collaboration with the International AIDS Vaccine Initiative (IAVI) and The Scripps Research Institute using Theraclone’s proprietary I-STAR™ technology.
Theraclone conducts research on behalf of OncoResponse focused on discovery and development of therapeutic antibodies and novel targets derived from immunomodulator-treated cancer patients. Efforts are currently underway in triple negative breast cancer, melanoma, non-small cell lung cancer and gastric cancer.