Policy & Regulation
New AbCellera-Discovered Antibody that Neutralizes Viral Variants of COVID-19, LY-CoV1404, Enters Clinical Trials
4 May 2021 - - A second antibody from Canadian biotechnology company AbCellera's (NASDAQ: ABCL) collaboration with US-based pharmaceutical company Eli Lilly and Company (NYSE: LLY), LY-CoV1404, has entered clinical trials in patients with mild-to-moderate COVID-19, the company said.

Lilly has expanded its ongoing BLAZE-4 trials to evaluate LY-CoV1404 alone and together with other monoclonal antibodies.

In support of this clinical study, AbCellera released preclinical data showing LY-CoV1404 binds to a rarely mutated region of the SARS-CoV-2 spike protein and neutralizes all currently known variants of concern, including those first identified in the UK (B.1.1.7), South Africa (B.1.351), Brazil, California (B.1.426 and B.1.429), and New York (B.1.526).

LY-CoV1404 is highly potent, which could have implications for reducing the amount of antibody necessary for clinical dosing, and potentially enabling a subcutaneous route of administration for either treatment or prophylaxis of COVID-19.

LY-CoV1404 is developed from a fully human monoclonal antibody identified from a blood sample obtained approximately 60 days after symptom onset from a convalescent COVID-19 patient.

Preclinical data show LY-CoV1404 potently neutralizes SARS-CoV-2 and all current variants identified and reported to be of concern in this pandemic.

LY-CoV1404 blocks viral binding to ACE2 by targeting a highly conserved epitope on the SARS-CoV-2 spike glycoprotein receptor binding domain, providing a strong, well-documented mechanism for the potent neutralizing activity.

Furthermore, LY-CoV1404 is substantially more potent in viral neutralization assays compared to other broadly neutralizing antibodies.

LY-CoV1404 uniquely binds a conserved region of the SARS-CoV-2 RBD that is distinct from other neutralizing antibodies.

While the LY-CoV1404 binding epitope includes amino acid residues N501 and N439, LY-CoV1404 neutralizes B.1.1.7 and B.1.351, which both carry the N501Y mutation, as potently as wild type virus in pseudovirus assays and retains full functional neutralization against pseudovirus with the N439K mutant.

An in-depth assessment of mutations that could inhibit neutralization of LY-CoV1404 identified two specific amino acid positions that are very rarely mutated in the general population (0.027%), as reported in the GISAID database as of April 2021.

The potent activity of LY-CoV1404 against the currently known variants of concern and against pseudoviruses carrying various single amino acid mutations suggests that LY-CoV1404 binds to an epitope that is highly conserved across all SARS-CoV-2 isolates that have been collected worldwide.

The preclinical data for LY-CoV1404 can be found at https: //doi.org/10.1101/2021.04.30.442182.

AbCellera initially mobilized its pandemic response platform against COVID-19 in March of 2020, resulting in the discovery of bamlanivimab, the first monoclonal antibody therapy for COVID-19 to reach human testing and to be authorized for emergency use by the US FDA.

Bamlanivimab alone and together with other antibodies has treated hundreds of thousands of patients, preventing COVID-19-related hospitalizations and death. Bamlanivimab alone and together with other antibodies has been authorized under emergency/special use pathways by more than 15 countries worldwide.

In the US, bamlanivimab is currently only authorized for emergency use with etesevimab.
AbCellera's ongoing efforts to respond to the COVID-19 pandemic have identified thousands of unique anti-SARS-CoV-2 human antibodies.

These include bamlanivimab, LY-CoV1404, and other antibodies that are in various stages of testing by AbCellera and its partners.

AbCellera's pandemic response capabilities were developed over the past three years as part of the Defense Advanced Research Projects Agency (DARPA) Pandemic Prevention Platform program.

The goal of the P3 program is to establish a robust technology platform for pandemic response capable of developing field-ready medical countermeasures within 60 days of isolation of an unknown viral pathogen.

AbCellera is a technology company that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease.
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