Theraclone Sciences Announces Positive Top-line Data from a Phase 1 Trial of its Therapeutic Antibody Directed at Influenza A
SEATTLE--(BUSINESS WIRE)--May 15, 2012 - Theraclone Sciences, Inc., a therapeutic antibody discovery and development company, today announced positive top-line data from its Phase 1 trial of TCN-032, a broadly protective, fully human monoclonal antibody, being developed for the treatment of influenza A infections. TCN-032 was well tolerated throughout the study, with no dose-limiting toxicities or serious adverse events observed, and demonstrated a favorable immunogenicity profile.
“TCN-032 is a therapeutic antibody drug candidate discovered with our I-STARTM platform, and we are extremely pleased with the safety and pharmacokinetic profile and lack of immunogenicity generated from its Phase 1 trial,” commented Eleanor Ramos, M.D., Chief Medical Officer, Theraclone Sciences. “Based on these data, we are confident moving forward to the next step in the development of TCN-032, a Phase 2 influenza viral challenge trial to be conducted in human subjects.”
The randomized, double-blind, placebo-controlled Phase 1 study enrolled 40 healthy adult volunteers in 5 single-dose cohorts of TCN-032, escalating from 1 mg/kg to 40 mg/kg. TCN-032 showed pharmacokinetic parameters consistent with a human antibody. No antibodies against TCN-032 were detected. The detailed results from this trial will be presented at an upcoming scientific conference.
The trial was supported in part by Zenyaku Kogyo Co., Ltd. through its multi-year research and development agreement with Theraclone to identify conserved, essential antibody targets and develop candidates for the treatment of pandemic and severe seasonal influenza. Zenyaku Kogyo has an exclusive license in the territory of Japan to Theraclone's influenza monoclonal antibody program. Theraclone retains worldwide development and commercialization rights outside of Japan.
Influenza is a contagious disease affecting the respiratory tract and sometimes other organs, which typically causes mild to severe illness, but, at times, can lead to death. Approximately 36,000 people die each year from flu-related causes in the U.S. Certain populations, including the elderly, young children and people with certain health conditions, are at particularly high risk for serious flu complications.
Influenza A viruses can replicate and mutate very rapidly. Reassortment or recombining of viral genetic material from human, swine and avian influenza strains presents the dangerous possibility of pathogenic strains capable of causing widespread infection including pandemics, as was the case with the swine?origin influenza virus pandemic in 2009. To date, international governments have established multi-billion dollar stockpiles of drugs and vaccines in an effort to provide protection against future influenza pandemics. The development of new, complementary therapeutic approaches is a high international public health priority.
About Theraclone Sciences
Theraclone Sciences is a Seattle-based biotechnology company focused on the development of novel therapeutic antibodies for the treatment of infectious disease and cancer. The Company's technology harnesses the power of the human immune system to identify rare, naturally evolved antibodies from the blood cells of immunologically relevant human subjects. Human monoclonal antibodies can be rapidly isolated using the I-STAR™ discovery platform and scaled for industrial production. Such human antibody drug candidates may be uniquely safe and relevant to combating disease across broad patient populations. Theraclone is a privately held company with venture investment from ARCH Venture Partners, Canaan Partners, Healthcare Ventures, MPM Capital, Amgen Ventures and Alexandria Real Estate Equities. For additional information, please visit www.theraclone-sciences.com.
Contact: MacDougall Biomedical Communications
Michelle Avery, 781-235-3060
Christine Labaree, 650-339-7533
Posted: May 2012