New SARS-CoV-2 neutralizing antibody enters clinical phase

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Credit: NIAID

Cologne, Marburg, Braunschweig and Ingelheim, Germany, 18 December 2020 – Cologne University Hospital (UKK), University of Marburg (UMR), the German Center for Infection Research (DZIF) and Boehringer Ingelheim today announced the initiation of Phase 1/2a clinical investigation of BI 767551, a new SARS-CoV-2 neutralizing antibody. By combining UKK, UMR and DZIF’s expertise 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.

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 UKK, examined for SARS-CoV-2 neutralization at UMR and developed further in collaboration with Boehringer Ingelheim. The clinical study will be led by Prof. Florian Klein and Prof. Gerd Fätkenheuer at UKK 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 and Principal Investigator at the DZIF.

“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.

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Partner

About Cologne University Hospital (UKK)

The University Hospital of Cologne is a maximum care hospital with more than 1.570 beds. It is recognized as an important research center as well as for its high-class medical education and outstanding medical care and treatment to its patients. More than 375,000 patients incl. more than 63,000 inpatients are treated per year. With nearly 11.000 employees the University Hospital of Cologne is one of largest employers in Cologne and one of Germanys largest medical centers.

About University of Marburg (UMR)

The University of Marburg is the university with the longest tradition in Hesse. 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:
http://www.uni-marburg.de/en

About German Center for Infection Research (DZIF)

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 can be found at
https://www.dzif.de/en

About Boehringer Ingelheim

Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

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.

More information about Boehringer Ingelheim can be found at http://www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com.

About Boehringer Ingelheim in COVID-19

As a research-driven company, Boehringer Ingelheim is part of the collective effort in fighting COVID-19, working closely with academic researchers, international institutions, and others in the pharma industry.

In October, Boehringer Ingelheim announced the initiation of a Phase 2 clinical trial of BI 764198, a TRPC6 inhibitor that may alleviate the damage to the lung and decrease the risk or severity of acute respiratory complications in patients hospitalized for COVID-19. Further, the company is involved in a broad set of initiatives to fight the disease and save patients’ lives, including the research and development of further SARS-CoV-2 antibodies that can neutralize the virus, small molecules to inhibit its replication, and therapy development to prevent microcoagulation (blood clots). Boehringer Ingelheim is also an active participant in the global access initiative with the Bill and Melinda Gates Foundation as well as global development initiatives including the COVID-19 Therapeutics Accelerator (CTA) and the CARE Consortium.

Media Contact
Prof. Florian Klein
[email protected]

Original Source

https://www.dzif.de/en/new-sars-cov-2-neutralizing-antibody-enters-clinical-phase

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