New SARS-CoV-2 neutralizing antibody enters clinical phase

18/12/2020

Cologne University Hospital/University of Cologne, University of Marburg, the German Center for Infection Research (DZIF) and Boehringer Ingelheim announcing the initiation of Phase 1/2a clinical investigation of BI 767551, a new SARS-CoV-2 neutralizing antibody.

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“With BI 767551, we aim to provide an effective option for preventing and treating COVID-19,” explains Prof. Florian Klein. (Foto:Michael Wodak)

By combining the expertise of scientists at the Cologne University Hospital and the Medical Faculty of the University of Cologne, the University of Marburg and the German Center for Infection Research (DZIF) in virology, immunology and clinical investigation with Boehringer Ingelheim’s expertise in developing and manufacturing therapeutic antibodies, the partners developed BI 767551 as a potential new therapeutic and preventive/prophylactic option for fighting COVID-19 - a new SARS-CoV2 neutralizing antibody.

Virus neutralizing antibodies are expected to become an important line of defense against SARS-CoV-2, complementing vaccines and nonpharmaceutical interventions. They are being investigated as a therapy option for individuals with mild or severe infections, but also as prevention or prophylaxis in non-infected people with a high risk of infection or at risk of serious outcomes. Directly delivering BI 767551 to the lung by inhalation has the potential to provide fast acting protection from virus infection in the respiratory tract.

The new antibody BI 767551 was derived from blood samples of recovered COVID-19 patients at University Hospital Cologne (UKK), examined for SARS-CoV-2 neutralization at University Marburg (UMR) and developed further in collaboration with Boehringer Ingelheim. The clinical study will be led by the Cologne Partners Prof. Florian Klein (Institute for Virology) and Prof. Gerd Fätkenheuer(Clinic I of Internal Medicine) and Boehringer Ingelheim will supply the antibody. 

“With BI 767551, we aim to provide an effective option for preventing and treating COVID-19,” explains Prof. Florian Klein, Director of the Institute for Virology at the Cologne University Hospital/the Medical Faculty of the University of Cologne and Principal Investigator at the DZIF as well as  ssociated with the Center for Molecular Medicine Cologne.

”Monoclonal antibodies are a promising component in the fight against new viruses, such as the SARS-CoV-2. If this antibody turns out to be effective against COVID-19, this finding could be helpful in the current and also in future epidemics and pandemics. I am glad that we are able to assist in the development of this compound," says Prof. Stephan Becker, Director of the Institute of Virology at University of Marburg and Coordinator Emerging Infections, DZIF.

“We are excited to contribute to the development of BI 767551 in collaboration with our partners, with the aim to provide an innovative SARS-CoV-2 neutralizing antibody, combining a systemic with an inhaled route of administration” said Michel Pairet, member of Boehringer Ingelheim’s Board of Managing Directors with responsibility for the company’s Innovation Unit.

The Phase 1/2a studies (NCT04631705, NCT04631666) will evaluate the safety, pharmacokinetics and antiviral activity of the antibody. In Phase 1, the antibody will be administered to participants either with a single infusion or a single inhalation. If the antibody is well tolerated, late-stage confirmatory studies will be conducted.

Scientific contact
Prof. Dr.  Florian Klein
Director - Institute of Virology, Faculty of Medicine and University Hospital Cologne, University of Cologne
Laboratory of Experimental Immunology
florian.klein[at]uk-koeln.de

Short introduction of the partners:
The University Hospital of Cologne is a maximum care hospital with more than 1.570 beds. The joined interaction with the University of Cologne and the University Hospital of Cologne results in important research activities as well as for high-class medical education and outstanding medical care and treatment to the patients. Further information: https://medfak.uni-koeln.de/en/ and https://www.uk-koeln.de/

The University of Marburg is the university with the longest tradition in Hessen. Founded in 1527, it offers excellent teaching in a wide range of subjects in a total of 16 departments to its approximately 24.000 students. Trendsetting topics with high relevance for society determine research in Marburg include research on highly pathogenic viruses. Further information: www.uni-marburg.de/en

Over 500 doctors and scientists from 35 establishments collaborate at the German Center for Infection Research (DZIF), jointly developing new approaches to prevent, diagnose and treat infectious diseases. The scientists at the DZIF pursue the aim of strategically transferring the results from basic research into clinical application. This process is called translation. Further information:  https://www.dzif.de/en

Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of 19 billion euros. Our significant investment of almost 3.5 billion euros in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life. We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come. Further information:  www.boehringer-ingelheim.com  or http://annualreport.boehringer-ingelheim.com.

 

The original press release was modified by Dr Debora Grosskopf-Kroiher | Center for Molecular Medicine Cologne - debora.grosskopf-kroiher[at]uni-koeln.de.
The following links lead to the original joint press release of Cologne University Hospital (UKK), University of Marburg (UMR), the the German Center for Infection Research (DZIF) and Boehringer Ingelheim

For further information, please find below the media contacts of the consortium: