AbCellera-Discovered Neutralizing Antibody for COVID-19 Enters New Pragmatic Study in New Mexico
22 December 2020 - 1:00AM
Business Wire
Study will provide real-world data to evaluate
the effectiveness of bamlanivimab in reducing COVID-19
hospitalizations in a high-risk population
AbCellera (Nasdaq: ABCL) today announced that bamlanivimab
(LY-CoV555), a human antibody developed through AbCellera’s
collaboration with Eli Lilly and Company (Lilly), will be evaluated
in a new pragmatic study in high-risk patients with COVID-19.
Lilly’s trial, in collaboration with the state of New Mexico and
major local institutions, will collect data on the effectiveness
and safety of bamlanivimab in a real-world setting that includes a
diverse population and spans both rural and urban environments. As
part of this study, Lilly will employ its unique mobile research
units used successfully in other studies. Additional details
regarding the new trial can be found here.
“By deploying on-site infusion clinics, Lilly continues to lead
in finding ways to bring antibody treatments to patients,” said
Carl Hansen, Ph.D., CEO of AbCellera. “We applaud their continued
innovation and tireless efforts in fighting the COVID-19
pandemic.”
Bamlanivimab is currently authorized in the United States and
Canada for the treatment of mild to moderate COVID-19 patients who
are at high risk for progressing to severe COVID-19 and/or
hospitalization. Both the Emergency Use Authorization (EUA) granted
by the U.S. Food and Drug Administration and the interim
authorization granted by Health Canada under the Interim Order
Respecting the Importation, Sale and Advertising of Drugs for Use
in Relation to COVID-19 are based on data from BLAZE-1, a
randomized, double-blind placebo-controlled Phase 2 study in
patients with recently diagnosed mild to moderate COVID-19 in the
outpatient setting. Data from BLAZE-1 showed bamlanivimab reduced
viral load, symptoms, and hospitalizations.
AbCellera’s COVID-19 response was based on capabilities
developed over the past two years as part of the Defense Advanced
Research Projects Agency (DARPA) Pandemic Prevention Platform (P3)
program. The goal of P3 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.
About Bamlanivimab
Bamlanivimab is a recombinant, neutralizing human IgG1
monoclonal antibody (mAb) directed against the spike protein of
SARS-CoV-2. It is designed to block viral attachment and entry into
human cells, thus neutralizing the virus, potentially treating
COVID-19. Bamlanivimab emerged from the collaboration between Lilly
and AbCellera to create antibody therapies for the prevention and
treatment of COVID-19. Lilly scientists rapidly developed the
antibody in less than three months after it was discovered by
AbCellera and the scientists at the National Institute of Allergy
and Infectious Diseases (NIAID) Vaccine Research Center. It was
identified from a blood sample taken from one of the first U.S.
patients who recovered from COVID-19.
Lilly has successfully completed a Phase 1 study of bamlanivimab
in hospitalized patients with COVID-19 (NCT04411628). A Phase 2
study in people recently diagnosed with COVID-19 in the ambulatory
setting (BLAZE-1, NCT04427501) is ongoing, testing bamlanivimab
alone and in combination with a second antibody. Data from the
monotherapy arms of BLAZE-1 were published in the New England Journal of Medicine. A Phase 3 study
of bamlanivimab for the prevention of COVID-19 in residents and
staff at long-term care facilities (BLAZE-2, NCT04497987) is also
ongoing. In addition, bamlanivimab is being tested in the National
Institutes of Health-led ACTIV-2 study in ambulatory COVID-19
patients.
About AbCellera Biologics Inc.
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.
AbCellera partners with drug developers of all sizes, from large
pharmaceutical to small biotechnology companies, empowering them to
move quickly, reduce cost, and tackle the toughest problems in drug
development.
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