Celltrion initiates phase 1 clinical trial of therapeutic antibody.
- Expected to be effective for various strains of flu viruses including the recent lethal influenza virus in China (H7N9).
- Collaborated with the United States Centers for Disease Control and Prevention (CDC) and Severance Hospital of the Yonsei University Health System.
- Designated as Transgovernmental Enterprise for Pandemic Influenza in Korea (TEPIK) project and has received government funding for its R&D
- Innovative antibody for influenza, effective even for Tamiflu-resistant viruses and other subtypes of viruses.
On April 26, 2013, Celltrion received IND approval from England’s Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a phase 1 clinical trial for CT-P27, an influenza antibody shown to have efficacy for pandemic and seasonal flu strains, including various subtypes of influenza viruses. Celltrion will initiate a phase 1 clinical trial in England on healthy human subjects in May to verify toxicity and safety dosages of CT-P27.
CT-P27 binds to the stem region of hemagglutinin (HA), the major viral surface protein, and inhibits the entry of influenza virus into host cells by blocking HA-mediated membrane fusion. Because the stem region is relatively conserved among influenza viruses, this class of antibody has shown the ability to neutralize a broad spectrum of influenza subtypes.
CT-P27 has demonstrated efficacy over various epidemic and seasonal influenza subtypes affecting humans, including the avian influenza subtypes (H1, H2, H3, H5, H7, H9) through in vitro and in vivo experiments utilizing mice and ferrets.
Moreover, due to CT-P27 using a different mechanism of action from the Sialidase inhibitor, CT-P27 has the ability to neutralize influenza viruses that have become resistant to currently existing treatments such as Tamiflu or Relenza. According to a 2009 report from the World Health Organization (WHO), more than 50% of North American and Western European H1N1 influenza virus strains showed resistance to Tamiflu.
Celltrion has jointly collaborated with the United States CDC and Severance Hospital of the Yonsei University Health System in Korea on the development of CT-P27. In addition, in 2011, the Transgovernmental Enterprise for Pandemic Influenza in Korea (TEPIK) designated CT-P27 as a governmental project and has been supporting its R&D to enhance the possibility of a successful clinical trial. Furthermore, in order to raise the prospect of all-encompassing successful global clinical trials, Celltrion has been in communication with the United States FDA through Pre-IND Meetings since August 2012, with the phase 1 clinical trial starting in May designed in accordance with these pre-IND meetings.
CT-P27 is expected to have the ability to neutralize the recent lethal Chinese avian flu (H7N9) since CT-P27 revealed a neutralizing effect against H7N2, which has same subtype HA as the current Chinese H7N9, during joint research with the United States CDC. To confirm CT-P27’s effectiveness, Celltrion has already contacted relevant Chinese expert groups to begin testing the efficacy of CT-P27 against H7N9 while urgently preparing for clinical trials in China.
Moreover, Celltrion is in discussions with the US Department of Health & Human Services (HHS) for R&D funds. The US HHS has funded approximately USD 250 million each for the R&D of the influenza treatments, Peramivir and Inavier, through the Biomedical Advanced Research and Development Authority (BARDA) program. Products selected for BARDA are likely to be registered as Strategic National Stockpile (SNS) in many countries including the US.
Influenza treatments are expected to have significant market potential. In 2009, when the Swine flu (A/California/04/09(H1N1)) was endemic, Tamiflu and Relenza recorded total sales of KRW 180 billion in Korea. In the same year, Roche’s Tamiflu recorded sales of more than USD 3 billion globally. Industry experts estimate global economic costs of influenzas which are widely known as SARS and AI as USD 50 billion and USD 30 billion, respectively. In addition, if an influenza strain were to become pandemic in Korea, Korea’s GDP is expected to decline by 7.8%.