FDA Grants Lilly EUA for COVID-19 Antibody Bebtelovimab
Bebtelovimab is an IgG1 monoclonal antibody that is designed to work by binding to an epitope within the receptor binding domain of the spike protein of…
The FDA has granted emergency use authorization (EUA) to Eli Lilly for a third COVID-19 antibody, bebtelovimab (LY-CoV1404), after it showed neutralization against all circulating SARS-CoV-2 variants of concern—including Omicron and its subvariant BA.2.
Bebtelovimab is authorized for the treatment of mild-to-moderate COVID-19 in patients 12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.
The authorized dosage of bebtelovimab is 175 mg given as an intravenous injection over at least 30 seconds.
“With the emergence of variants such as Omicron, treatment options remain limited. Lilly is pleased to provide another treatment option to help address the ongoing needs of patients and health care providers who continue to battle this pandemic,” Daniel Skovronsky, MD, PhD, Lilly’s chief scientific and medical officer, and president of Lilly Research Laboratories, said in a statement.
Bebtelovimab is an IgG1 monoclonal antibody that is designed to work by binding to an epitope within the receptor binding domain of the spike protein of SARS-CoV-2. Bebtelovimab is the second antibody co-developed by Lilly and AbCellera to fight COVID-19—as well as several variants of the virus that had shown resistance to the companies’ first co-developed antibody, bamlanivimab (LY-CoV555).
The FDA on January 24 limited the EUA for bamlanivimab, another Lilly antibody (etesevimab (LY-CoV016 or JS-16, developed with Shanghai Junshi Biosciences) and Regeneron Pharmaceuticals’ REGEN-COV (co-marketed by Roche as Ronapreve in some nations) to no longer authorize its use as a treatment for the Omicron variant of SARS-CoV-2 in any U.S. states, territories, and jurisdictions “at this time.”
According to a chart published Thursday in Cell Reports Medicine, the efficacy of COVID-19 antibodies has varied widely, from 30% (Merck & Co./Ridgeback Biotherapeutics’ molnupiravir [MK-4482, EIDD-2801]) to 90% (Pfizer’s PAXLOVID (nirmatrelvir; PF-07321332). The Lilly combination of bamlanivimab and etesevimab showed 70% effectiveness.
The FDA granted its EUA for bebtelovimab a day after the U.S. government agreed to purchase up to 600,000 doses of the antibody for at least $720 million. Lilly agreed to supply the up to 600,000 doses by no later than March 31, with an option of 500,000 additional doses no later than July 31.
“We view the purchase agreement as a positive potentially providing a strong near-term cash injection [for AbCellera] while validating ABCL’s discovery platform,” Puneet Souda, Managing Director, Life Science Tools and Diagnostics and a senior research analyst with SVB Leerink, wrote in a research note.
Question about option
Whether the government will exercise the option for the additional 600,000 doses is in question, he added, because “the additional 500k doses are optional and the pandemic continues to subside in the U.S. which may drive demand for additional antibodies lower.”
However, under its collaboration agreement with Lilly covering COVID-19 antibodies, AbCellera stands to gain royalty percentages from the low- to mid-teens for aggregate sales below $125 million, and royalties from the mid-teens to mid-twenties on aggregate sales above $125 million.
“Assuming 13% royalties on the first $125M and 21% royalties on the additional $595M [toward the up-to-$720 million price], we see a ~$141M of upside in 1Q. Applying the same assumptions, we see potentially ~$126M of upside in 2Q,” Souda added.
Bebtelovimab and bamlanivimab were developed from antibodies that were discovered using AbCellera’s pandemic response platform, in partnership with the Vaccine Research Center (VRC) at the National Institutes for Allergy and Infectious Diseases (NIAID).
AbCellera’s pandemic response capabilities were developed over the past four years as part of the Defense Advanced Research Projects Agency (DARPA) Pandemic Prevention Platform (P3) program. The P3 program aims 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.
Lilly and AbCellera advanced the AbCellera-discovered bebtelovimab into the clinic last year after it successfully neutralized SARS-CoV-2 and five regional variants of the virus, according to preclinical data included in a preprint posted on bioRxiv.
Bebtelovimab was entered into the Phase II BLAZE-4 trial (NCT04634409), which was expanded to study the antibody’s safety and effectiveness in patients with mild-to-moderate COVID-19, alone and in several combinations—including one with bamlanivimab, and one with etesevimab.
Data from BLAZE-4 showed that bebtelovimab retained full neutralizing activity against Omicron and neutralization against all other known variants of interest and concern, including BA.2, Lilly said.
“The discovery of two authorized therapeutic antibodies within a year of each other demonstrates the power of our platform, and its potential to quickly generate best-in-class therapeutics for our partners,” added AbCellera CEO Carl Hansen, PhD.
Lilly is responsible for development, manufacturing and distribution of bebtelovimab as well as bamlanivimab.
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