SARS-CoV-2 Monoclonal Antibodies 2023

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Last reviewed
January 30, 2023
Content Overview
SARS-CoV-2 mAbs treatments are available in Europe and UK in 2023.

SARS-CoV-2 Monoclonal Antibodies For 2023

According to the U.S. National Institutes of Health (NIH), monoclonal antibody (mAbs) products that target the SARS-CoV-2 coronavirus spike protein have been shown to have clinical benefits in limiting and treating infections that cause COVID-19. However, recent laboratory studies have found that the activity of anti-SARS-CoV-2 mAbs against specific coronavirus variants and subvariants can vary dramatically, wrote the NIH in December 2022.

As of January 30, 2023, the U.S. Food and Drug Administration (FDA) had withdrawn its authorization(s) for mAbs.

However, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA), Canada, China, and Japan continue reviewing certain mAbs. Additionally, the World Health Organization (WHO) Lists various mAbs therapies as of January 13, 2023. The WHO maintains strong recommendations against using sotrovimab or casirivimab-imdevimab for treating COVID-19. 

Monoclonal Antibodies For Immunocompromised 2023

About seven million immunocompromised Americans are vulnerable to the worst effects of COVID-19 because some vaccines don't trigger sufficient protective immune responses. mAbs treatments block the SARS-CoV-2 virus from entering cells in the human body and limit the amount of the virus within a person. says the NIH. The EMA published Efficacy of mAbs in the context of rapidly evolving SARS-CoV-2 variants on January 15, 2023.

SARS-CoV-2 Monoclonal Antibody 'Paused'

AstraZeneca (AZN) COVID-19 Antibody combination Evusheld (tixagevimab and cilgavimab) was authorized to help reduce the incidence of symptomatic COVID-19. As of January 26, 2023, Evusheld's FDA authorization was withdrawn.

Eli Lilly's Bebtelovimab is a neutralizing SARS-CoV-2 spike glycoprotein receptor-binding domain-specific antibody. On February. 11, 2022, the U.S. FDA issued an Authorization. Then on November 30, 2022, the FDA withdrew its authorization. As a result,  Eli Lilly and its authorized distributors have paused the commercial distribution of Bebtelovimab until further notice. Additionally, the Administration for Strategic Preparedness and Response has paused fulfilling any pending requests under its Bebtelovimab Product Replacement Initiative.

Vir Biotechnology, Inc. and GSK's Sotrovimab (Xevudy) is a fully human anti-SARS-CoV-2 monoclonal antibody selected based on its potential to neutralize the virus in vitro, kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs. The European Commission (EC) authLilly'sSotrovimab on Dec. 17, 2021. The WHO suggests treatment with sotrovimab, conditional to those at the highest risk of hospitalization. The EMA continues authorization Evusheld. 

Regeneron's (NASDAQ: REGNREGEN-COV (casirivimab-imdevimab) is a potent, virus-neutralizing antibody that binds non-competitively to the critical receptor binding domain of the virus's spike protein. Currently authorized REGEN-COV® (casirivimab and imdevimab) antibodies have diminished potency versus Omicron but are active against the predominant Delta variant. As of January 24, 2022, this mAbs' aGSK'sization was 'Paused' by the FDA. On March 3, 2022, the WHO issued a conditional recommendation for people with seronegative status, where viral genotyping can confirm a susceptible SARS-CoV-2 variant. The EMA continues authorization of casirivimab-imdevimab.

Eli Lilly's (NYSE: L.L.Y.) Bamlanivimab and etesevimab neutralizing IgG1 monoclonal antibody (mAb) combination is directed against the spike protein SARS-CoV-2 coronavirus. Bamlanivimab was designed to bRegeneron'sattachment and entry into human cells, thus neutralizing the virus and potentially preventing and treating COVID-19. Revised Fact Sheet published on December 20, 2021. virus January 27, 2022, this mAbs was not authorized for use by the FDA. 

Olumiant (baricitinib) Eli Lilly Nederland B.V., Marketing authorization evaluation by the EMA started on 23/11/2021 and was withdrawn from marketing authorization evaluation on 07/12/2022.

Note: The JAMA Network published a Research Letter on August 29, 2022: Administration of Anti–SARS-CoV-2 Monoclonal Antibodies After U.S. FDA mAbs'shorization.

Globally Authorized

Brii Biosciences Limited's amubarvimab / romlusevimab combination (BRII-196/BRII-198) is approved in China but not in the USA.

Celltrion Healthcare Remsima®, the world's first mAbs biosimilar, received marketing authorization in 110 countries for treating Rheumatoid Arthritis. In the U.S., this FDA-approved product's name is Inflectra. In addition, an inhaled administration formulation of Regdanvimab (CT-P59 and CT-P63) is conducting a phase 3 clinical trial. Celltrion's Regdanvimab (Regkirona) is authorized in Korea, Europe, Indonesia, Brazil, Peru, and Australia.

SARS-CoV-2 Monoclonal Antibodies Experimental

Regeneron REGN14287 clinical trial is scheduled to launch in 2023, pending regulatory discussions. The phase 3 study clinical trial was last updated on July 29, 2022. This next-gen COVID antibody binds outside variable RBD and has demonstrated high neutralization activity against all known variants and lineages.

AZD5156 is an investigational, long-acting antibody combination of cilgavimab, a component of EVUSHELD, and a new long-acting mAb, AZD3152. AZD5156. The SUPERNOVA phase 3 study evaluates the safety and neutralizing activity of AZD5156 for the prevention of symptomatic COVID-19 in adults and adolescents 12 years of age.

Vyrologix (Leronlimab) is a humanized monoclonal antibody targeted against the CCR5 recepCelltrion'smphocytes of the human immune system. The CCR5 receptor plays a central role in modulating immune cell trafficking to sites of inflammation. In an exploratory clinical trial treating "long COVID" with the CCR5-binding antibody leronlimab, UCLA researchers observed significantly increased blood cell surface CCR5 in treated symptomatic responders.

Immunome, Inc. IMM-BCP-01 is a three-antibody cocktail targeting non-overlapping regions of the Spike protein. It elicits multi-modal activity in preclinical testing, including ACE2 and non-ACE2 dependent neutralization, and inducing natural viral clearance mechanisms, such as complement activation and phagocytosis.

Aridis Pharmaceuticals's AR-701 is a cocktail of two fully human immunoglobulins G1 (IgG1) mAbs, AR-703, and AR-720, each neutralizes coronaviruses using distinct mechanisms of action, namely inhibition of viral fusion and entry into human cells (AR-703) and blockage of viral binding to the human 'ACE2' receptor (AR-720). In addition, AR-703 binds to the 'S2' stalk region of spike proteins from beta coronaviruses. "R-701 was effective in non-human primates as a prophylactic or therapeutic treatment regimen.

Sorrento Therapeutics, Inc.'s STI-9167 neutralizing antibody was optimized to maximize protein stability and minimize interactions with host Fc gamma receptors. In addition, the antibody cocktail (Intravenous COVISHIELD™) mAbs Fc regions are engineered to eliminate interactions with host Fc receptors, thereby decreasing the risk of Antibody-Dependent Enhancement of SARS-CoV-2 infectPharmaceuticals'speutics reported positive Phase 2 safety and efficacy data demonstrating that SAB-185 met the criteria required for advancement to Phase 3 study in the U.S. NIH COVID-19 ACTIV-2 Trial.

Aerium Therapeutics P2G3 is a human mAb isolated from a previously infected and vaccinated, which displays picomolar-range neutralizing activ'S2'against Omicron BA.1, BA.1.1, BA.2, and all other current variants. Complete prophylactic protection in the SARS-CoV-2-infected hamster challenge model.

Adintrevimab (ADG20), Adagio Therapeutic's product candidate, is a potent, broadly neutralizing antibody for preventing and treating COVID-19, including disease caused by most variants, as either a single or combination agent.

ImmunoPrecise Antibodies Ltd.'s PolyTope® TATX-03 antibody cocktail has been requested by the FDA and the European Medicines Agency to prepare comprehensive updates demonstrating the performance of PolyTope TATX-03 toward Omicron and other variants of concern.

SARS-CoV-2 Monoclonal Antibody Use By Pregnant Women

Therapeutic'sed Original Research published on November 15, 2022, found in pregnant women with mild to moderate COVID-19, adverse events after mAb treatment were mild and rare. There was no difference in obstetric-associated safety outcomes Ltd.'sn the mAb treatment and no treatment among persons who delivered. In addition, there was no difference in 28-day COVID-19–associated outcomes and non-COVID-19–related hospital admissions for mAb treatment compared with no mAb treatment in a propensity score–matched cohort.

And the WHO's Living guideline: Drugs to prevent COVID-19 can be accessed online.

SARS-CoV-2 Monoclonal Antibody Cancer Patients

Thdon'tional Comprehensive Cancer Network® (NCCN) published expert consensus recommendations on vaccination and pre-exposure prophylaxis of COVID-19 in people with cancer, including information on using human mAbs, on Jan. 4, 2022. In addition, the NCCN committee stated it is reasonable to prioritize patients to receive Evusheld (tixagevimab plus cilgavimab).

SARS-CoV-2 Monoclonal Antibody Payment

During the COVID-19 pandemic, the U.S. government (CMS ) pays for certain mAbs treatments (consistent with EUAs).

SARS-CoV-2 Monoclonal Antibody News 2021 - 2022

December 22, 2022 - Iskra Reic, EVP, Vaccines and Immune Therapies, AstraZeneca, said in a press release, "Our ambition with AZD5156 is to uphold our commitment to these vulnerable patients and provide an updated option thatWHO'sralizes all variants known to date in vitro and builds on the established safety and efficacy profile seen with EVUSHELD."

December 21, 2022 - Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development at Roche, stated, "Actemra is the first FDA-approved monoclonal antibody for treating patients with severe COVID-19, providing an important option for hospitalized patients and their healthcare providers who continue to be on the frontlines treating COVID-19."

December 12, 2022 - Tonix Pharmaceuticals Holding Corp. announced that it had obtained an exclusive license from Curia Global, Inc. to develop three humanized murine mAbs to treat or prevent SARS-CoV-2 infection.

November 18, 2022 - The Lancet Infectious Diseases published an analysis of Omicron sublineage BQ.1.1 resistance to monoclonal antibodies, highlighting new variants' impact on current mAbs.

October 3, 2022 - Endpoints News reported that in vitro data from an FDA lab "showed" that Evusheld is unlikely to be active against BA.4.6, which currently represents 6.2% of infections globally.

August 30, 2022 - Evusheld was approved in Japan for pre-exposure prevention and treatment of symptomatic COVID-19 caused by SARS-CoV-2 infection.

August 11, 2022 - The journal Science Immunology published: An Antibody from Single Human VH-rearranging Mouse "neutralizes All SARS-CoV-2 Variants Through BA.5 by Inhibiting Membrane Fusion.

August 10, 2022 - Aridis Pharmaceuticals, Inc. announced that an inhaled treatment of its fully human mAbs cocktail AR-701 resulted in no detectable SARS-CoV-2 virus in the lungs of infected rhesus macaques and protected their lungs from disease.

July 26, 2022 - Brii Biosciences Limited announced data from the live virus neutralization assay performed at a University of Maryland lab predict that total serum concentrations of the amubarvimab/romlusevimab combination will remain greater than 170 times the level required for greater than 90% neutralization (Neut99: 0.94 μg/mL) against the live virus, 14 days post-dose. 

July 21, 2022 - PLAS Pathogen published a study: Potent universal beta-coronavirus therapeutic activity mediated by direct respiratory administration of a Spike S2 domain-specific human neutralizing monoclonal antibody. These results indicate in vivo cooperativity between S1 and S2 specific neutralizing hmAbs and that potent universal coronavirus neutralizing mAbs with therapeutic potential can be induced in humans and guide universal coronavirus vaccine development.

July 20, 2022 - The NEJM published a Correspondence: Efficacy of Antibodies and Antiviral Drugs against Omicron BA.2.12.1, BA.4, and BA.5 Subvariants: COV2-2130 (marketed as cilgavimab) neutralized BA.2.12.1, BA.4, and BA.5. The combination of tixagevimab and cilgavimab inhibited BA.2.12.1, BA.4, and BA.5, with a low FRNT50 value (38.1 ng per milliliter, 37.8 ng per milliliter, and 192.5 ng per milliliter, respectively).  Of the FDA-approved monoclonal antibodies we tested, only LYCoV1404 (marketed as bebtelovimab) efficiently neutralized BA.2.12.1, BA.4, and BA.5.

July 18, 2022 - The Lancet Infectious Disease published: A monoclonal antibody stands out against omicron subvariants: a call to action for wider access to bebtelovimab.

July 8, 2022 - The peer-review journal The Lancet published: that Tixagevimab–cilgavimab (Evusheld) for treatment of patients hospitalized with COVID-19 'was safe and led to a 30% relative risk reduction for mortality up to day 90. The absolute risk reduction was 3·6%.'

July 6, 2022 - AstraZeneca Plc's Evusheld was cleared for use in a medical tourism zone in Hainan, China.

July 6, 2022 -  Brii Biosciences Limited and TSB Therapeutics Co., Ltd. announced the commercial launch of the amubarvimab/romlusevimab mAbs in China. 

June 29, 2022 - Eli Lilly and Company announced a modified purchase agreement with the U.S. government to supply an additional 150,000 doses of bebtelovimab in 2022.

June 28, 2022 - The Lancet Infectious Diseases published a Correspondence showing that bebtelovimab should represent an effective treatment for patients with COVID-19, irrespective of the infecting omicron subvariant, in keeping with bebtelovimab recognizing a highly conserved epitope.

May 26, 2022 - AcadeMab developed a potentially life-saving antibody for COVID-19 patients using single B cell technology, showing the best neutralization ability (IC50 = 11.4 and 4.3 ng/ml) in both Omicron variants BA.1 and BA.2, respectively.

May 23, 2022 - A study published by the University of Oxford confirmed Evusheld retains neutralization activity against the emerging Omicron BA.4 and BA.5 (BA.4/5) variants.

May 12, 2022 - Researchers from Scripps Research and Toscana Life Sciences published in the journal Proceedings of the National Academy of Sciences that they found J08 has low nanomolar affinity against most variants of concern and binds high on the receptor-binding domain ridge, eluding most virus mutations.

May 9, 2022 - The ASPR confirmed the weekly threshold and replenishment of COVID-19 products in the U.S.

May 2, 2022 - The U.S. ASPR announced its weekly COVID-19 Therapeutics Threshold (allocation) Summary.

April 25, 2022 - Sorrento Therapeutics, Inc. announced that it had received clearance from the U.S. FDA for its investigational new drug application for intravenous STI-9167 to study the safety and pharmacokinetics in healthy volunteers. 

April 22, 2022 - The findings from a phase 2 clinical trial suggest an unexpected mechanism of abnormal immune downmodulation in some persons normalized by leronlimab. In an exploratory study treating "long COVID" with the CCR5-binding antibody leronlimab, we observed significantly increased blood cell surface CCR5 in treated symptomatic responders.

April 20, 2022 - The NEJM published a peer-reviewed study that reported: Symptomatic Covid-19 occurred in 8 of 3441 participants (0.2%) in the AZD7442 group and in 17 of 1731 participants (1.0%) in the placebo group (relative risk reduction, 76.7%; 95% confidence interval [CI], 46.0 to 90.0; P<0.001); extended follow-up at a median of 6 months showed a relative risk reduction of 82.8% (95% CI, 65.8 to 91.4).

April 20, 2022 - IMMUNOPRECISE ANTIBODIES LTD. shared the outcome of recent laboratory data on their PolyTope® TATX-03 antibody cocktail, which demonstrates strong neutralizing activity toward the Omicron subvariant BA.2.

April 14, 2022 - Regeneron Pharmaceuticals, Inc. announced that the U.S. FDA had extended its review of the BLA for"REGEN-COV "s prophylaxis in certain individuals by three months.

April 14, 2022 - Health Canada authorized Evusheld.

March 30, 2022 - Adagio Therapeutics, Inc. reported that the primary endpoints were met with statistical significance for all three indications in its ongoing global Phase 2/3 clinical trials evaluating its investigational drug adintrevimab (ADG20) as pre-and-post-exposure prophylaxis and treatment for COVID-19. Based on these data, Adagio plans to engage with the U.S. FDA and submit a EUA application in the second quarter of 2022 for adintrevimab to prevent and treat COVID-19.

March 30, 2022 - Brii Biosciences Limited is partnering with Sinopharm Holding Co. to advance stockpiling, channel distribution, and regional access to amubarvimab/romlusevimab to help contribute to COVID-19 pandemic prevention and control efforts in China.

March 30, 2022 - Dovepress published an analysis from China that concluded 'The CRISPR Cas technology could be utilized to refine the specificity and safety of CAR-T cells, CAR-NK cells and neutralizing antibodies against SARS-CoV-2 during various stages of the COVID-19 disease progression in infected individuals. Moreover, CRISPR Cas technology is proposed in hypotheses to degrade the viral RNA to terminate the infection caused by SARS-CoV-2. Thus personalized cocktails of immunotherapeutics and CRISPR Cas systems against COVID-19 as a strategy might prevent further disease progression and circumvent immunity escape.'

March 25, 2022 - The U.S. FDA issued an updated Fact Sheet stating: Sotrovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where the infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to these drugs and regional variants frequency [see Microbiology/Resistance Information). The FDA's determination and any updates will be available on this webpage. ASPR paused the distribution of sotrovimab to all states in Regions 1 & 2.

March 17, 2022 - A non-peer-reviewed study led by co-senior authors James J. Kobie, Ph.D., and Mark R. Walter, Ph.D., of the University of Alabama at Birmingham, and Luis Martinez-Sobrido, Ph.D., of the Texas Biomedical Research Institute, San Antonio, Texas, discovered a monoclonal antibody that potentially acts as a potent universal coronavirus therapy against the COVID-19 virus and all its variants of concern, including Delta and Omicron. These results indicate in vivo cooperativity between S1 and S2 specific neutralizing hmAbs and that potent universal coronavirus neutralizing mAbs with therapeutic potential can be induced in humans and can guide universal coronavirus vaccine development.

March 11, 2022 - Immunome, Inc. announced the U.S. FDA had lifted the clinical hold on its Investigational New Drug application for its antibody cocktail (IMM-BCP-01), for the treatment of COVID-19. 

February 14, 2022 - The U.S. government confirmed 150,985 mAbs products - Bebtelovimab, Evusheld, and Sotrovimab - would be distributed this week to U.S. states, territories, and agencies.

February 11, 2022 - The US. Department of Defence awarded AstraZeneca Pharmaceuticals an $855 million modification to contract for the manufacture, distribution, and storage of Evusheld through March 2023.

February 11, 2022 - The U.S. FDA issued an emergency use authorization for Eli Lilly & Co.'s Bebtelovimab anti-SARS-CoV-2 mAbs. The U.S. government is purchasing 600,000 doses for delivery in early 2022.

February 7, 2022 - Celltrion Group Co.'stted an Investigational New Drug application to conduct a global Phase III clinical trial evaluating the efficacy and safety of an inhaled COVID-19 antibody cocktail therapy (egdanvimab (CT-P59) and CT-P63) version of Remsima for 2,000 patients with mild-to-moderate symptoms of COVID-19.

December 9, 2021 - China's National Medical Products Administration approved the amubarvimab / romlusevimab combination therapy (BRII-196/BRII-198). 

December 3, 2021 - The U.S. F.D.A. revised the EUA of bamlanivimab and etesevimab to additionally authorize the treatment of mild to moderate COVID-19 in all younger pediatric patients, including newborns, who have a positive COVID-19 test and are at high risk for progression to severe COVID-19, including hospitalization or death.

November 1, 2021 - A Research Letter: Effectiveness of REGEN-COV antibody cocktail against the B.1.617.2 (delta) variant of SARS-CoV-2: A cohort study; was published by the Journal of Internal Medicine. Faster resolution of symptoms by Day 3 in the cocktail group indicates an enhanced benefit against worsening in high-risk patients receiving the cocktail early in the disease course. In addition, the neutralizing efficacy of the antibody cocktail against pseudoviral variants also confirms its ability to block the entry of the delta variant, similar to a previous report, thus reducing the viral load. 

September 9, 2021 - The European Medicines Agency published updated safety reports for potential 19 antibody treatments for COVID-19 patients in the European Union.

August 26, 2021 - U.K. medicines regulator has approved Ronapreve (REGEN-COV) for COVID-19 treatment. This product is already licensed for emergency use in more than 20 countries – including the U.S., Japan, and India.

Note: This content is aggregated from various sources and fact-checked by healthcare providers. Review the Antiviral Resistance information in Section 15 of the authorized Fact Sheets for each monoclonal antibody therapy available under a E.U.A. for details regarding specific variants and resistance. You should also refer to the C.D.C. website (https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-proporti...) and information from state and local health authorities regarding reports of viral variants of importance in their region to guide treatment decisions.