Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1913 |
| INN | Lomtegovimab |
| Status | Terminated |
| Drug code(s) | BI 767551, DZIF-10c |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | SARS-CoV-2 (spike protein) |
| Indications of clinical studies | COVID-19 |
| Primary therapeutic area | Infectious diseases |
| Most advanced stage of development (global) | Terminated at Phase 2/3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | November 23, 2020 |
| Start of Phase 2 | |
| Start of Phase 3 | April 21, 2021 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Boehringer Ingelheim |
| Licensee/Partner | None |
| Comments about company or candidate | NCT04894474 Phase 2/3 due to start in June 2021 withdrawn in July 2021. NCT04822701 Phase 2/3 started in April 2021 terminated in July 2021. NCT04631705 and NCT04631666 are Phase 1/2 studies evaluating inhaled and infused formuations of DZIF-10c. Sponsor is University of Cologne, with BI as collaboator. A team of researchers led by Prof. Florian Klein (Cologne University Hospital) and the German Center for Infection Research (DZIF) has further elucidated how these antibodies develop and has isolated potent SARS-CoV-2 neutralizing antibodies. Together with Boehringer Ingelheim, these antibodies are currently being further characterized and developed. It is expected that they will enter the stage of clinical development later this year. The results were published today (July 07, 2020) in the journal Cell. (Longitudinal Isolation of Potent Near-Germline SARS-CoV-2-Neutralizing Antibodies from COVID-19 Patients; https://pubmed.ncbi.nlm.nih.gov/32946786/) In close collaboration with scientists from Marburg, Frankfurt, Munich, Tübingen and Israel, the researchers investigated the SARS-CoV-2 antibody response in twelve individuals recovered from COVID-19. They examined more than 4000 SARS-CoV-2-specific B cells on a single cell level and were able to partly decode the humoral immune response to SARS-CoV-2. They reconstructed 255 antibodies in the laboratory, which were examined by Prof. Stephan Becker’s laboratory in Marburg for their ability to neutralise the novel coronavirus SARS-CoV-2. In total, 28 neutralising antibodies were found. The antibodies have been developed for protecting against and treating COVID-19. In addition, these antibodies could be used for ‘post-exposure prophylaxis. Here antibodies would be applied after contact with an infected individual. “This form of intervention could be of particularly interest for stopping localised outbreaks and for preventing disease progression in people at risk,” said Prof. Klein. The scientists expect that first clinical trials will be performed at the end of 2020. |
| Full address of company | Binger Strasse 173 , 55216 Ingelheim am Rhein, Germany Europe Germany https://www.boehringer-ingelheim.com/contact-us |
Boehringer Ingelheim will now pursue further development of the new candidates and integrate them in their initiatives that are aimed at finding medical solutions to contain and cope with the global spread of COVID-19. In this context, the company is actively engaged in various projects of institutional consortia, including the Innovative Medicines Initiative of the European Union together with the German Center for Infectious Research (DZIF).
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |