SARS-CoV-2 Monoclonal Antibodies April 2023

COVID-19 Monoclonal Antibodies April 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. mAbs treatments block the SARS-CoV-2 coronavirus from entering cells in the human body, says the NIH.

As of January 26, 2023, the U.S. Food and Drug Administration (FDA) had withdrawn its authorization(s) for mAbs. However, on April 4, 2023, Gohibic (vilobelimab), a first-in-class monoclonal anti-human complement factor C5a antibody, was granted an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation, or extracorporeal membrane oxygenation.

And the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), European Medicines Agency (EMA), Canada, China, and Japan continue reviewing specific mAbs. For example, the EMA published Efficacy of mAbs in the context of rapidly evolving SARS-CoV-2 variants on January 15, 2023. Additionally, the World Health Organization (WHO) Lists various mAbs therapies as of April 2023.

The Annals of Internal Medicine published results from a study on April 4, 2023, that concluded early mAb treatment among outpatients with COVID-19 is associated with a lower risk for hospitalization or death.

Monoclonal Antibodies For Immunocompromised 2023

About seven million immunocompromised Americans, Including Organ Transplant Recipients and Cancer Patients, are vulnerable to the worst effects of COVID-19 because some vaccines don't trigger sufficient protective immune responses, says the U.S. Centers for Disease Control and Prevention (CDC).

On April 14, 2023, AstraZeneca presented data regarding the implementation of Evusheld (AZD7442) (tixagevimab/cilgavimab) COVID-19 pre-exposure prophylaxis in the largest HMO in Israel: real-world uptake and sociodemographic and clinical characteristics across immunocompromised patient groups.

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to help reduce the incidence of symptomatic COVID-1However, as As of January 26, 2023, Evusheld's FDA authorization was withdrawn.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.

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) authorized Sotrovimab on Dec. 17, 2021. The WHO suggests treatment with sotrovimab, conditional to those at the highest risk of hospitalization. The EMA continues authorization Xevudy.

Regeneron's 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. 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's Revised Fact Sheet was published on December 20, 2021. On January 27, 2022, the FDA did not authorize this mAbs.

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.

SARS-CoV2 mAbs Globally Authorized

Brii Biosciences Limited's amubarvimab / romlusevimab combination (BRII-196/BRII-198) is approved in China but not in the USA. On April 18, 2023, a study funded by the U.S. government found administering amubarvimab plus romlusevimab was safe and significantly reduced the risk for hospitalization and/or death among nonhospitalized adults with mild to moderate SARS-CoV-2 infection at high risk for progression to severe disease.

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 InflectrIn addition, a. Celltrion's Regdanvimab (Regkirona) is authorized in Korea, Europe, Indonesia, Brazil, Peru, and Australia.

SARS-CoV-2 Monoclonal Antibodies Experimental 2023

AstraZeneca's SARS-CoV-2 mAbs AZD3152 potently neutralizes historical and currently circulating variants. Trial in progress: a Phase I/III, randomized, modified double-blind, placebo- and active-controlled pre-exposure prophylaxis study of the SARS-CoV-2–neutralizing antibody AZD3152 (SUPERNOVA).

Invivyd, Inc. - VYD222 is one of the mAb components of NVD200, a combination product. VYD222 was engineered from adintrevimab, Invivyd's investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 3 clinical trials for the prevention and treatment of COVIDAs a result, -19. VYD222 has advanced into the clinic as a novel monoclonal antibody therapeutic option for COVID-19.

Tonix Pharmaceuticals - TNX-3600 are fully human mAbs generated from SARS-CoV-2+ asymptomatic individuals or COVID-19 convalescent patients. And TNX-4100 are murine mAbs and their humanized counterparts generated from mice immunized with SARS-CoV-2 spike protein. Since mice have a different repertoire of antibodies than humans, murine mAbs have the potential for neutralizing a broader spectrum of SARS-CoV-2 variants than fully human mAbs.

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.

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.

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.

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. 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 activity 'S2' against Omicron BA.1, BA.1.1, BA.2, and all other current variants.

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 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

Original Research published on November 15, 2022, found in pregnant women with mild to moderate COVID-9 that adverse events after mAb treatment were mild and rare. There was no difference in obstetric-associated safety outcomes—another study found favorable results for hospitalized pregnant patients who received monoclonal antibodies due to COVID-es.

SARS-CoV-2 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 using human mAbs, on January 4, 2022. In addition, the NIH endorsed mAbsusede with certain cancer patients in 2022. UpToDate published an overview in Feb. 2023.

Covid Convalescent Plasma 2023

Covid convalescent plasma (CCP) contains anti-Covid-19 antibodies harvested from people who recovered from COVID-19. Following transfusion, CCP can effectively reduce hospitalizations in immunocompromised patients (JAMA, Jan. 12, 2023). However, the current FDA-EUA (Dec. 2022) limits authorization to use CCP products.

SARS-CoV-2 Monoclonal Antibody News 2023

February 13, 2023 - Tonix Pharmaceuticals Holding Corp. announced that it had exercised an option to obtain an exclusive license from Columbia University (NY) for the development of a portfolio of fully human (TNX-3600) and murine (TNX-4100) mAbs for the treatment or prevention of SARS-CoV-2 infection.

January 26, 2023 - U.S. FDA announces Evusheld is not currently authorized for emergency use in the U.S.

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.

August 30, 2022 - Evusheld was approved in Japan.

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 20, 2022 - The NEJM published a Correspondence: 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 6, 2022 - Brii Biosciences Limited and TSB Therapeutics Co., Ltd. announced the commercial launch of the amubarvimab/romlusevimab mAbs in China.

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.

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 14, 2022 - Health Canada authorized Evusheld.

March 30, 2022 - Brii Biosciences Limited is partnering with Sinopharm Holding Co. to advance stockpiling, channel distribution, and regional access to amubarvimab/romlusevimab.

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-0) to treat 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.

August 26, 2021 - U.K. medicines regulator has approved Ronapreve (REGEN-COV) for COVID-19 treatment. This product is licensed for emergency use in over 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.