SARS-CoV-2 Monoclonal Antibodies 2022

SARS-CoV-2 Monoclonal Antibodies For 2022

According to the U.S. NIH, monoclonal antibody (mAbs) products effectively prevent infections caused by the SARS-CoV-2 coronavirus, including Omicron subvariants. As of June 18, 2022, mAbs products are Authorized by the U.S. Food and Drug Administration (FDA), the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA), Canada, and Japan to prevent virus infections and treat COVID-19 patients.

On June 8, 2022, the EMA published a list of critical authorized medicines, including mAbs, for the COVID-19 public health emergency.

On June 27, 2022, the U.S. HHS/ASPR confirmed that about 28,710 additional Bebtelovimad and 201,168 Evusheld mAbs doses would be distributed to states, territories, and related agencies this week. Since Sept. 24, 2021, the U.S. government has distributed about 5.7 million mAbs.

Monoclonal Antibody Authorized

The U.S. CDC published: Interim Clinical Considerations for COVID-19 Treatment in Outpatients on June 15, 2022.

AstraZeneca (AZN) COVID-19 Antibody combination Evusheld AZD7442 (tixagevimab and cilgavimab) is authorized to help reduce the incidence of symptomatic COVID-19. On April 1, 2022, the U.S. NIH published an updated COVID-19 Treatment Guidelines Panel recommending using tixagevimab plus cilgavimab as SARS-CoV-2 PrEP for certain adults and adolescents. The EU granted marketing authorization for Evusheld (150/150) on March. 28, 2022.

Eli Lilly's Bebtelovimab is a highly potent, neutralizing SARS-CoV-2 spike glycoprotein receptor-binding domain-specific antibody. Eli Lilly announced on February. 3, 2022, a recent virus analysis of bebtelovimab confirmed it neutralizes variants, including Omicron. On February. 11, 2022, the U.S. FDA issued an Authorization. The NIH published an update regarding bebtelovimab's activity against a broad range of SARS-CoV-2 variants on April 8, 2022. A study published by the journal Nature on March 3, 2022, found that bebtelovimab was the only therapy adequately covering all sublineages of the Omicron BA.x variants.

Find facilities administering mAbs using the National Infusion Center Locator or the U.S. HHS Therapeutics Distribution locator map that displays public locations that have reported mAbs in stock.

Monoclonal Antibody Omicron BA.x Sublineages

The U.S. NIH OpenData Portal reported on June 16, 2022, in vitro Therapeutic Activity against Omicron variants, including BA.x. In addition, the U.S. CDC NowCast monitors active variants, and the CDC and Scripts publish updated coronavirus variant information in this Tracker App, as does the Stanford HIVDB team website. And the FDA updated related mAbs FAQs.

The U.S. NIH announced an updated version of the COVID-19 Treatment Guidelines Panel. And the WHO's Living guideline: Drugs to prevent COVID-19 can be accessed online and published Tracking SARS-CoV-2 Variants on this webpage. And the UK's Health Security Agency publishes mAbs effectiveness data on this webpage and at CoVariants. And the GISAID Initiative tracks variants worldwide.

Monoclonal Antibody 'Paused' By U.S. FDA

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, and kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs. The EC authorized Sotrovimab on Dec. 17, 2021. The WHO suggests treatment with sotrovimab, conditional to those at highest risk of hospitalization. During the week of Apr. 4, 2022, a total of 16,608 ​doses will be distributed in the U.S. On April 5, 2022, the U.S. government paused all product distribution in HHS Regions.

Regeneron's (NASDAQ: REGN) REGEN-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's authorization 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. On April 14, 2022, the FDA extended by three months its review of REGEN-COV's BLA to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals. The extension is due to ongoing discussions with the FDA on pre-exposure prophylactic use.

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 block viral attachment and entry into human cells, thus neutralizing the virus, and potentially preventing and treating COVID-19. Revised Fact Sheet published on December 20, 2021. As of January 27, 2022, this mAbs was not authorized for use by the FDA.

Monoclonal Antibody Repurposed

The U.S. FDA issued a EUA on June 25, 2021, for intravenous Actemra / RoActemra® (tocilizumab) for the treatment of COVID-19 in hospitalized adults and pediatric patients (two years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. In addition, the European Commission extended the marketing authorization for Actemra®/RoActemra on December 7, 2021. Actemra is designed to block the activity of IL-6, a type of inflammatory cytokine.

Monoclonal Antibody Globally Authorized

Brii Biosciences Limited amubarvimab / romlusevimab combination (BRII-196/BRII-198) is approved in China but not in the U.S. for the treatment of adults and certain pediatric patients with a mild and typical type of COVID-19. In addition, it has confirmed its effectiveness against the Omicron variant. Authorization is pending in the U.S.A.

Celltrion Healthcare Remsima®, the world's first monoclonal antibody biosimilar, has received marketing authorization in 110 countries for treating Rheumatoid Arthritis. In the U.S., this FDA-approved product's name is Inflectra. 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.

Monoclonal Antibodies Experimental

Vyrologix (Leronlimab) is a humanized monoclonal antibody targeted against the CCR5 receptor found on T lymphocytes 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 immunoglobulin 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.

Sorrento Therapeutics, Inc.'s STI-9167 neutralizing antibody was optimized to maximize protein stability and minimize interactions with host Fc gamma receptors. 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 infection.

SAB Biotherapeutics 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 donor, which displays picomolar-range neutralizing activity 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 lead mAbs product candidate, is a potent, broadly neutralizing antibody for the prevention and treatment of 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.

Monoclonal Antibody Immunocompromised

About seven million immunocompromised Americans are vulnerable to the worst effects of COVID-19 because vaccines don't always trigger a sufficient protective immune response. 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.

Monoclonal Antibody Cancer Patients

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

Revised mAbs Recommendations Proposed by the U.S. CDC For 2022

The U.S. NIH published updated COVID-19 Treatment Guidelines on Apr. 1, 2022. Previously, on Feb. 4, 2022, Elisha Hall, Ph.D., with the U.S. CDC's Advisory Committee on Immunization, presented Updates to Interim Clinical Considerations. Updated CDC guidance on February 11, 2022, says it is no longer necessary to delay COVID-19 vaccination after receiving monoclonal antibodies or convalescent plasma.

Monoclonal Antibody Guidelines

Anti-SARS-CoV-2 Monoclonal Antibodies treatment guidelines are published by the U.S. NIH, the U.S. CDC/ID Society, and the U.K. NICE.

Monoclonal Antibody Payment

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

Monoclonal Antibody ROI Estimates

And a study published by IDSA on Jan. 28, 2022, found a significant reduction in COVID-related hospitalization or death of 71.3% (1.3% vs. 4.6%; p<0.0001). Previously, MDPI published a peer-reviewed study from Italy on Oct. 24, 2021, which calculated the positive economic benefit of anti-SARS-CoV2 monoclonal use with hospitalized COVID-19 patients. These researchers estimated that mAbs use creates substantial savings from hospital admissions and related COVID-19 fatality costs in certain scenarios. And the HHS's free COVID-19 Monoclonal Antibody Infusion Calculator empowers informed staffing decisions and resource investments needed for infusion sites.

Monoclonal Antibody News 2021 - 2022

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 8, 2022 - AstraZeneca announced Evusheld was found to significantly prevented COVID-19 disease progression or related fatality.

May 26, 2022 - AcadeMab developed a potentially life-saving monoclonal 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 as 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 variant 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 15, 2022 - The EMA began reviewing AstraZeneca's Evusheld for use in Europe.

March 14, 2022 - The JAMA Network's Original Investigation found among nonhospitalized patients with mild to moderate COVID-19 and at risk of disease progression, a single intravenous dose of sotrovimab, compared with placebo, significantly reduced the risk of a composite endpoint of all-cause hospitalization or death through day 29.

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.

March 9, 2022 - The NEJM published a Correspondence - Efficacy of Antiviral Agents against the SARS-CoV-2 Omicron Subvariant BA.2. Clinical studies are warranted to determine whether antiviral therapies are indeed effective against omicron/BA.2 infections.

March 3, 2022 - The WHO published its 9th version of the COVID-19 Clinical management: Living guideline.

March 2, 2022 - The U.S. NIH announced new guidance on the role of bebtelovimab for nonhospitalized patients with mild to moderate COVID-19 who are at high risk of progressing to severe disease.

March 2, 2022 - Sorrento Therapeutics, Inc. announced that it has received clearance from the FDA for its investigational new drug application for intranasal STI-9199 (COVISHIELD) to study the safety and pharmacokinetics in healthy volunteers. The Phase 1 study will be at a single clinical site in San Diego followed by multinational (USA, U.K., and Mexico) Phase 2/3 trials.

February 24, 2022 - The U.S. FDA revised the authorization for Evusheld to change the initial dose. With this EUA revision, the FDA increased the initial authorized dose to 300 mg of tixagevimab and 300 mg of cilgavimab. Patients who have already received the previously authorized dose (150 mg of tixagevimab and 150 mg of cilgavimab) should receive an additional dose of 150 mg of tixagevimab and 150 mg of cilgavimab as soon as possible to raise their monoclonal antibody levels.

February 22, 2022 - Sorrento Therapeutics, Inc. announced that additional preclinical results demonstrate broad-spectrum COVISHIELD (STI-9167) neutralizing activity against Omicron BA.1, Omicron BA.1+R346K, and the increasingly prevalent sublineage, Omicron BA.2. STI-9167 neutralization activity was found the topmost performing nAb among the comparative nAb treatments, similar to the recently EUA-approved LY-1404 nAb but superior to all other EUA-approved nAbs in neutralizing Omicron BA.1, BA.1+R346K, and BA.2 viruses.

February 17, 2022 - Aridis Pharmaceuticals, Inc. announced that both of its fully human mAbs in the AR-701 cocktail neutralized the SARS-CoV-2 Omicron variant. Moreover, the mAbs conferred complete protection against Omicron infected animals when given either parenterally or by intranasal administration.

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 9, 2022 - Vir Biotechnology, Inc. confirmed preclinical data suggests sotrovimab retains neutralizing activity against the BA.2 subvariant of Omicron.

February 9, 2022 - The Lancet published: High-titre methylene blue-treated convalescent plasma as an early treatment for outpatients with COVID-19: a randomized, placebo-controlled trial. Finding: Methylene blue-treated convalescent plasma did not prevent progression from mild to severe illness and did not reduce viral load in outpatients with COVID-19.

February 8, 2022 - The Pew Charitable Trust published an article that stated: If the world fails to eradicate COVID-19, which seems likely, therapeutics will become an increasingly vital part of the arsenal against it, experts say.

February 7, 2022 - Celltrion Group submitted 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.

February 4, 2022 - The JAMA Network published a Research Letter that found, among Medicare beneficiaries who weren't hospitalized or who didn't pass away within seven days of their diagnosis, only 7.2% received mAb therapy. The likelihood of receiving mAbs was higher among those with fewer chronic conditions; 23.2% of those with no chronic conditions received mAbs, versus 6.3%, 6.0%, and 4.7% of those with 1-3, 4-5, and 6 or more chronic conditions, respectively.

February 4, 2022 - MarketWatch reported annual sales of Eli Lilly & Co.'s monoclonal antibodies ($2.2 billion), Gilead Sciences Inc.'s antiviral Veklury ($5.5 billion), and Regeneron monoclonals ($5.8 billion).

February 3, 2022 - The peer-reviewed journal Nature reported a New York City-specific SARS-CoV-2 coronavirus variant detected in wastewater may impede mAbs treatment effectiveness.

February 3, 2022 - PNAS published an early release (Feb. 8) of a study: Kallolimath et al. report up to 50-fold increased neutralization potency of an anti–SARS-CoV-2 monoclonal IgG3 antibody, compared to antibodies of the other three IgG subclasses with an identical antigen-binding site. They attribute this heightened potency to the long hinge region of IgG3, facilitating the cross-linking of the spike protein on the viral surface.

January 31, 2022 - The U.S. government confirmed 127,064 allocations of mAbs products - Evusheld and Sotrovimab - for U.S. states, territories, and agencies.

January 28, 2022 - A study published in PLOS Medicine concluded several studies have proven the efficacy of monoclonal antibodies for the treatment and prophylaxis of SARS-CoV-2 infection. However, the cost of monoclonal antibodies is probably one of the main barriers to their use. The upfront cost of monoclonal antibodies was found to be offset by the reduction of hospital admissions when used, with an overall reduction of costs.

January 28, 2022 - Acting FDA Commissioner Janet Woodcock informed STAT: And of course, there is a monoclonal that does neutralize the virus, the GSK-Vir (Sotrovimab) monoclonal, but it is in short supply.'

January 26, 2022 - The NEJM published a CORRESPONDENCE - Efficacy of Antibodies and Antiviral Drugs against Covid-19 Omicron Variant. The omicron variant was found to have at least 33 mutations (29 amino acid substitutions, one insertion of three amino acids, and three small deletions) in its spike protein, as compared with early SARS-CoV-2 strains identified in Wuhan, China. Notably, 15 of the 29 substitutions were in the receptor-binding domain of the S protein, which is the primary target for monoclonal antibody-based therapy. This finding suggests that the current mAbs approved by the U.S. FDA may be less effective against the omicron variant. However, The Evusheld combination inhibited beta, gamma, and Omicron. In addition, the FRNT50 values of this combination were higher by a factor of 24.8 to 142.9 for Omicron than for beta or gamma, respectively.

January 25, 2022 - Led by researchers at NYU Grossman School of Medicine, a study published by the JAMA Network found transfusions of blood plasma donated by people who have already recovered from the SARS-COV-2 virus may help other patients hospitalized with COVID-19. The treatment, known as convalescent plasma, is not a mAbs and is considered experimental by the U.S. FDA.

January 24, 2022 - @HealthyFla Tweeted 'As a result of the U.S. FDA's abrupt decision to remove the EUAs for two mAbs treatment, Florida sites will be closed until further notice.

January 24, 2022 - The U.S. FDA revised the authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and REGEN-COV to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments. Because data show, these treatments are highly unlikely to be active against the omicron variant. These treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time.

January 24, 2022 - The U.S. government confirmed local allocations of mAbs products for the next week.

January 23, 2022 - TwinCities reported Minnesota had implemented a lottery for mAbs treatment. The state recently removed race from consideration. Minnesota received 2,984 mAbs from the U.S. government's allocation during the week of Jan. 17.

January 21, 2022 - The Utah Department of Health announced eliminating race and sex in its mAbs allocation determinations. In addition, with the state's new prioritization process, some people will automatically qualify for treatment if they meet emergency use authorization criteria (people with severe immunocompromising conditions and unvaccinated individuals age 75 and older.

January 21, 2022 - The U.S. FDA took two actions to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients to treat mild-to-moderate COVID-19 disease. Previously, the U.S. NIH issued guidelines on December 23, 2021, stating 'Remdesivir (Veklury) is expected to be active against the Omicron VOC, and the Panel added a 3-day course of intravenous remdesivir as a treatment option.

January 20, 2022 - A non-peer-reviewed study characterized the activity of an extensive collection of Spike-binding antibodies and identified a lead neutralizing human IgG1 LALA antibody, STI-9167. STI-9167 has potent, broad-spectrum neutralizing activity against the current SARS-COV-2 variants of concern and retained activity against the Omicron and Omicron + R346K variants in both pseudotype and live virus neutralization assays. Furthermore, STI-9167 nAb administered intranasally or intravenously provided protection against weight loss and reduced virus lung titers to levels below the limit of quantitation in Omicron-infected K18-hACE2 transgenic mice.

January 20, 2022 - Sorrento Therapeutics, Inc. announced the release of new data on the Omicron variant neutralizing antibody (nAb) STI-9167, COVISHIELD is the first reported nAb with high potency against Omicron (+R346K mutation) and has demonstrated highly potent neutralization activities in vitro (IC50 of 25 ng/mL for Omicron live virus, 14.8 ng/mL and 23.9 ng/mL for Omicron and Omicron (+R346K mutation) pseudovirus, respectively).

January 20, 2022 - Northwestern University researchers investigated the serum of patients who recovered from COVID-19 to identify potential immune components that might be used to prevent or treat the disease. Compared to vesicle-free recombinant human ACE2 (rhACE2), evACE2 shows a 135-fold higher potency in blocking the binding of the viral spike protein RBD and a 60- to 80-fold higher efficacy in preventing infections by both pseudotyped and authentic SARS-CoV-2. Consistently, evACE2 protects the hACE2 transgenic mice from SARS-CoV-2-induced lung injury and mortality. Furthermore, evACE2 inhibits the infection of SARS-CoV-2 variants (α, β, and δ) with equal or higher potency than the wild-type strain, supporting a broad-spectrum antiviral mechanism of evACE2 for therapeutic development to block the infection of existing and future coronaviruses that use the ACE2 receptor.

January 19, 2022 - The peer-reviewed journal The Lancet published results from an ongoing study sponsored by the University College, London, that found Sotrovimab (Xevudy) was able to neutralize the Omicron SARS-CoV-2 B.1.1.529 variant (geometric mean IC50 385 ng/mL [95% CI 354–419]). However, Sotrovimab was six to eightfold less effective at neutralizing Omicron BA.1 sub-lineage than delta or alpha. But the mean serum concentration of sotrovimab 29 days after a 500 mg infusion (24·5 μg/mL) is 64 fold higher than the in vitro IC50 measured.

January 17, 2022 - The U.S. government confirmed 225,590​ mAbs doses would be distributed this week to states, territories, and agencies.

January 14, 2022 - The JAMA Network published the results of a phase 3 clinical study that reported treatment with subcutaneous casirivimab and imdevimab (REGEN-COV) mAbs compared with placebo significantly reduced the incidence of symptomatic COVID-19 among recently exposed, asymptomatic individuals. A related Editorial, intravenous infusion of REGEN-COV, compared with placebo, led to an approximately 70% relative reduction in hospitalization and all-cause mortality, with absolute rates of 1% vs. 3.2% in the 1200-mg treatment and placebo groups, respectively.

January 14, 2022 - The WHO has also conditionally recommended the use of sotrovimab for treating mild or moderate COVID-19 in patients who are at high risk of hospitalization and those unvaccinated. Sotrovimab is an alternative to casirivimab-imdevimab (REGEN-COV), a mAbs cocktail recommended by WHO in September 2021.

January 13, 2022 - Vir Biotechnology, Inc. and GSK announced the submission of an application to the U.S. FDA requesting an amendment to the EUA for the mAbs sotrovimab to include intramuscular administration.

January 12, 2022 - The Italian Society of Pediatrics invited its affiliated Scientific Societies to produce a Consensus document. This Consensus details which patients have the risk to develop severe COVID-19, analyzing the most common comorbidities in children, to detail the indications for mAbs administration, and guiding the clinicians in identifying eligible patients.

January 11, 2022 - The Utah Department of Health stated in a press release: Given the extreme scarcity of COVID-19 mAbs treatments due to the prevalence of the omicron variant, we are re-evaluating the calculator and comparing it to current data to determine what factors best capture those at most at-risk for severe disease, hospitalization, and death. Additionally, nobody automatically qualifies for treatment based on their race/ethnicity.

January 11, 2022 - GSK and Vir Biotechnology, Inc. announced that the US government would purchase an additional 600,000 doses of sotrovimab.

January 9, 2022 - AbCellera announced non-peer-reviewed preclinical data confirmed that the investigational antibody bebtelovimab, which is currently in Phase 2 clinical trials with Eli Lilly and Company, maintains both full and potent neutralization activity against the Omicron variant and all other known SARS-CoV-2 variants of concern. The breadth of reactivity to amino acid substitutions present among current VOC together with broad and potent neutralizing activity and the relatively conserved epitope suggests that LY-CoV1404 has the potential to be an effective therapeutic agent to treat all known variants causing COVID-19.

January 5, 2022 - Paramedics with the Ute Pass Regional Health Service in Teller County, Colorado, began giving mAbs treatments on November 23, 2021. They have given sixty-nine treatments since then.

January 5, 2022 - The U.S. NIH published an update to the COVID-19 Treatment Guidelines Panel's Statement on Tixagevimab Plus Cilgavimab (Evusheld) for Pre-Exposure Prophylaxis for SARS-CoV-2 Infection.

January 4, 2022 - The National Comprehensive Cancer Network® (NCCN) published significant updates to the expert consensus recommendations on vaccination and pre-exposure prophylaxis of COVID-19 in people with cancer. The NCCN committee states that it is reasonable to prioritize these patients for Evusheld (tixagevimab plus cilgavimab) before patients with solid tumor cancers in the event of a limited supply.

January 3, 2022 - Celltrion Group announced results for its cocktail therapy candidates, including neutralization data against the Omicron variant (B.1.1.529). In an experiment conducted in partnership with the National Institutes of Health, CT-P63 showed strong neutralizing activity against the Omicron variant based on structural analysis by X-ray crystallography and neutralization data from pseudo- virus testing.

December 31, 2021 - A non-peer-reviewed study: Structural basis of SARS-CoV-2 Omicron immune evasion and receptor engagement - reveals electrostatic remodeling of the interactions within the spike and those formed between the Omicron RBD and human ACE2, likely explaining enhanced affinity for the host receptor relative to the prototypic virus.

December 31, 2021 - The Texas Department of State Health Services has requested additional allocations of sotrovimab, a mAbs therapy that is proven to be effective in fighting the Omicron variant of COVID-19 and reducing hospitalizations. In addition, the agency also requested that the federal government continue to supply the State of Texas with Regeneron and bamlanivimab, monoclonal antibody treatments for other strains of COVID-19 that have also proven to help reduce hospitalizations across the state.

December 31, 2021 - The U.S. HHS published updated guidelines regarding the allocation of bamlanivimab/etesevimab, and REGEN-COV therapeutics States and Territories can continue to order both products.

December 30, 2021 - The U.S. NIH published updated COVID-19 Treatment Guidelines Panel's Statement on Therapies for High-Risk, Non-hospitalized Patients With Mild to Moderate COVID-19.

December 29, 2021 - The U.S. Department of HHS announced it would pause allocations of bamlanivimab/etesevimab and REGEN-COV COVID-19 therapeutics to states or territories within regions of the country that have greater than 80% prevalence of the Omicron variant based on CDC NOWCAST data.

December 27, 2021 - An international research team with the Howard Hughes Medical Institute at the University of Washington School of Medicine in Seattle identified four antibody classes that can neutralize not only the Omicron coronavirus variant but also other variants from related coronaviruses. The omicron variant has 37 mutations in the spike protein, which it uses to latch onto and invade cells. Broadly neutralizing mAbs recognizing RBD epitopes conserved among SARS-CoV-2 variants and other sarbecoviruses may prove key to controlling the ongoing pandemic and future zoonotic spillovers.

December 27, 2021 - The U.S. government distributed 202,330 mAbs to the states.

December 23, 2021 - A non-peer-reviewed study authored by researchers associated with the National Research Center for Epidemiology and Microbiology stated 'heterodimeric molecule could be a promising drug candidate for treatment for COVID-19 caused by virus variants of concern.'

December 23, 2021 - The U.S. NIH issued an interim statement is to provide guidance on which individuals might receive the most significant benefit from anti-SARS-CoV-2 therapeutics for treatment or prevention of COVID-19.

December 23, 2021 - AstraZeneca US EVUSHELD mAbs retained neutralization activity against the Omicron variant according to new authentic 'live' virus neutralization data from University College Oxford, UK, and Washington University School of Medicine, St. Louis, US. EVUSHELD's Inhibitory Concentration 50 (IC50), a measure of neutralizing potency of an antibody, was 273 ng/ml and 147 ng/ml in the Oxford and Washington University studies, respectively.

December 21, 2021 - Aridis Pharmaceuticals, Inc. announced today that its fully human monoclonal antibody cocktail AR-701 is broadly reactive against the Omicron and other COVID-19 (SARS-CoV-2) variants, SARS, MERS, and seasonal ('common cold') human coronaviruses.

December 16, 2021 - A non-peer-reviewed study: The effect of an anti-SARS-CoV-2 monoclonal antibody, bamlanivimab, on the endogenous immune response to COVID-19 vaccination - These findings are pertinent for informing public health policy with results that suggest a complementary role for COVID-19 mAbs with COVID-19 vaccines and that the benefit of receiving COVID-19 vaccination at the earliest opportunity outweighs the minimal effect on the endogenous immune response due to prior prophylactic COVID-19 mAb infusion.

December 16, 2021 - AstraZeneca announced EVUSHELD, a long-acting antibody combination to prevent COVID-19, retained neutralizing activity against the Omicron SARS-CoV-2 variant.

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

December 8, 2021 - The U.S. F.D.A. announced the emergency authorization of the Evusheld mAbs for the pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals.

December 3, 2021 - The Lancet published the WHO international standard for SARS-CoV-2 antibodies to determine protection markers.

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.

December 1, 2021 - A non-peer-reviewed study found the Sotrovimab (VIR-7831/VIR-7832) epitope does not overlap with mutational sites in current variants of concern and continues to be highly conserved among circulating sequences consistent with the high barrier to resistance observed in vitro.

December 1, 2021 - Immunome, Inc. announced that it had conducted an assessment of the reported mutations in the Omicron (B.1.1.529) variant. Based on mapping those mutations and activity against previous and current C.D.C. variants of concern, Immunome expects its antibody cocktail, IMM-BCP-01, to neutralize the Omicron variant.

November 29, 2021 - Immunome, Inc. announced that it had submitted an Investigational New Drug Application to the U.S. F.D.A. for IMM-BCP-01, a three-antibody cocktail, for the treatment of COVID-19.

November 21, 2021 - The U.S. F.D.A. issued a EUA REGEN-COV to be administered together to treat mild to moderate COVID-19 in certain adults and pediatric patients.

November 16, 2021 - A non-peer-reviewed study found repeated monthly administration of 1200 mg SC REGEN-COV was well-tolerated with low immunogenicity and showed a substantial risk reduction in COVID-19 occurrence.

November 15, 2021 - Global Times reported a neutralizing monoclonal antibody combination therapy (BRII-196/BRII-198) is expected to become the first in China to get approval for market use in December 2021. The combination therapy is co-developed by Tsinghua University, the Third People's Hospital of Shenzhen, and Brii Biosciences, with headquarters in China and the U.S.

November 14, 2021 - Bahrain's National Health Regulatory Authority approved the emergency use of the EVUSHELD to combat COVID-19.

November 12, 2021 - GlaxoSmithKline and Vir Biotechnology announced the primary endpoint was met in the COMET-TAIL Phase III trial evaluating intramuscular administration of sotrovimab for early treatment of COVID-19.

November 11, 2021 - The E.M.A.'s human medicines committee recommended authorizing Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab) for COVID-19. Ronapreve and Regkirona are the first monoclonal antibody medicines to receive a positive opinion from the CHMP for COVID-19 and join the list of COVID-19 products that have received a positive opinion since Veklury (remdesivir) was recommended for authorization in June 2020. In addition, on Nov. 12th, the European Commission approved Ronapreve™ in the European Union and other countries.

November 8, 2021 - Regeneron Pharmaceuticals, Inc. announced additional positive results from a Phase 3 trial: a single dose of REGEN-COV (1,200 mg subcutaneous) reduced the risk of COVID-19 by 81.6% during the pre-specified follow-up period (months 2-8), maintaining the 81.4% risk reduction previously reported during month 1; During the 8-month assessment period there were 0 hospitalizations for COVID-19 in the REGEN-COV group and 6 in the placebo group.

November 3, 2021 - Open Forum Infectious Disease published: Bamlanivimab efficacy in older and high B.M.I. outpatients with Covid-19 selected for treatment in a lottery-based allocation process. Finding - The effectiveness of bamlanivimab in reducing Covid-19 related hospitalizations in patients ≥ 65 or with B.M.I.≥ 35 suggests a mortality benefit.

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.

October 27, 2021 - An Original Article published by the NEJM concluded by saying: Among high-risk patients with mild-to-moderate Covid-19, sotrovimab reduced the risk of disease progression. However, no safety signals were identified in this clinical trial.

October 27, 2021 - The JAMA Network published a News Article: Monoclonal Antibodies for COVID-19 Preexposure Prophylaxis Can't Come Fast Enough for Some People.

October 14, 2021 - The JAMA Network published a Research Letter describing how nurses in Michigan reduced E.R. visits and hospitalizations of high-risk COVID-19 patients by coordinating at-home administration of neutralizing mAbs during 2021. Our real-world approach leveraged the ability of nurses to identify, triage, and coordinate home M.A.B. infusions while successfully preventing high-risk patients from progression to severe disease and hospitalization.

October 11, 2021 - Positive high-level results from the TACKLE Phase III COVID-19 treatment trial showed AstraZeneca's AZD7442 long-acting antibody combination achieved a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalized patients with mild-to-moderate symptomatic COVID-19.

October 8, 2021 - The U.S. government published a Public Health Alert: Shipment of the bamlanivimab/etesevimab monoclonal antibody therapeutic to Hawaii has paused. The US Centers for Disease Control and Prevention has identified that the delta plus variant circulates with a frequency exceeding 5% in Hawaii. And results from in vitro assays suggest that bamlanivimab and etesevimab administered together are not active against this variant.

October 8, 2021 - South Carolina announced 32,686 COVID-19 patients in South Carolina had been treated with monoclonal antibodies. No anaphylactic reactions or other serious adverse events have been reported.

October 4, 2021 - South Dakoda-based S.A.B. Biotherapeutics announced that the first patient had been dosed with SAB-185 in the Phase 3 ACTIV-2 COVID-19 clinical trial. SAB-185 is a fully human, specifically targeted, broadly neutralizing polyclonal antibody therapeutic candidate for treating non-hospitalized patients with mild to moderate COVID-19. SAB-185 is the second agent to graduate to Phase 3 and the first polyclonal antibody therapeutic candidate in ACTIV-2, which is evaluating multiple investigational agents to treat early symptomatic COVID-19 in non-hospitalized individuals.

October 4, 2021 - The E.M.A. started evaluating an application from Celltrion Healthcare Hungary Kft for marketing authorization for the monoclonal antibody Regkirona (regdanvimab, also known as CT-P59) to treat adults with COVID-19 who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID 19.

September 30, 2021 - Regeneron Inc. issued a press release highlighting a REGEN-CoV clinical trial that met the primary endpoint, showing REGEN-COV significantly reduced viral load within seven days of treatment. This trial was conducted in patients hospitalized with COVID-19 who did not require high-flow oxygen or mechanical ventilation at baseline.

September 24, 2021 - The WHO issued a conditional recommendation for Regeneron's monoclonal antibody cocktail REGEN-COV (casirimivab and imdevimab) for patients with nonsevere COVID-19 who are at high risk for hospitalization and for people who have severe and critical infections who have no antibodies to SARS-COV-2.

September 23, 2021 - The NEJM published an ORIGINAL ARTICLE - Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19. CONCLUSIONS: Subcutaneous REGEN-COV prevented symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection in previously uninfected household contacts of infected persons. Among the phase 3 study participants who became infected, REGEN-COV reduced the duration of symptomatic disease and the duration of a high viral load.

September 20, 2021 - A new study was published by the journal Nature: High genetic barrier to SARS-CoV-2 polyclonal neutralizing antibody escape. Optimally elicited human polyclonal antibodies against SARS-CoV-2 should be resilient to substantial future SARS-CoV-2 variation and may confer protection against potential future sarbecovirus pandemics.

September 16, 2021 - The U.S. F.D.A. confirmed it concluded that revising this E.U.A. is appropriate to protect public health or safety under section 564(g)(2) of the Act; F.D.A. is reissuing the August 27, 2021 letter in its entirety also to authorize bamlanivimab and etesevimab administered together for emergency use as post-exposure prophylaxis in certain adults and pediatric individuals.

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.