Monoclonal Antibody Treatment
Anti-SARS-CoV-2 Monoclonal Antibody Treatment Description
Anti-SARS-CoV-2 monoclonal antibodies (mAbs) that target the spike protein have been shown to have a clinical benefit in treating SARS-CoV-2 infection.
As of December 7, 2021, the U.S. FDA has not Approved an experimental anti-SARS-CoV-2 monoclonal antibody treatment. In the U.S.A, anti-SARS-CoV-2 monoclonal antibody products are Authorized to treat non-hospitalized patients with mild to moderate COVID-19.
And to date, there have been no direct data testing the Omicron variant's resistance to monoclonal antibody-conveyed immunity.
Anti-SARS-CoV-2 Monoclonal Antibodies Authorized
Regeneron's (NASDAQ: REGN) REGEN-COV is a potent, virus-neutralizing antibody that binds non-competitively to the critical receptor binding domain of the virus's spike protein. The UK's Medicines and Healthcare products Regulatory Agency Approved REGEN-COV use in August 2021. And the European Commission issued Approval for REGEN-COV on November 12, 2021. And the U.S. FDA Authorized it on November 21, 2021.
Eli Lilly's (NYSE: LLY) 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, potentially preventing and treating COVID-19.
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.
AstraZeneca's COVID-19 Antibody combination Evusheld AZD7442 (tixagevimab and cilgavimab) achieved a statistically significant reduction in the incidence of symptomatic COVID-19, the trial's primary endpoint. As a result, the country of Bahrain Authorized emergency use of EVUSHELD o November 14, 2021.
Celltrion Healthcare Hungary Kft Remsima® is the world's first monoclonal antibody biosimilar has received marketing authorization in drug approval agencies in 110 countries, including the U.S. FDA and European EMA. In addition, the EMA has started evaluating an application 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.
In the USA, to find out how many mAbs doses have been distributed to your area, check out the latest distribution numbers at this weblink.
Monoclonal Antibodies - Experimental
Brii Biosciences Limited - BRII-196/BRII-198 are non-competing SARS-CoV-2 monoclonal neutralizing antibodies derived from convalesced COVID-19 patients. They have been specifically engineered to reduce the risk of antibody-dependent enhancement and prolong the plasma half-lives for potentially more durable treatment effect. In addition, their non-overlapping epitope binding regions provide a high degree of neutralization activity against SARS-CoV-2. Authorizations are pending in the USA and China.
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. The first patient was dosed in a pivotal Phase 3 trial (CD16) in Brazil for critically ill COVID-19 patients on October 25, 2021.
Immunome, Inc. IMM-BCP-01 is a three-antibody cocktail targeting non-overlapping regions of the Spike protein and elicits multi-modal activity in preclinical testing, including ACE2 and non-ACE2 dependent neutralization, as well as inducing natural viral clearance mechanisms, such as complement activation and phagocytosis.
AutoAntibodies and SARS-CoV-2
Nature Communications published a study on September 14, 2021, that concluded 'that the SARS-CoV-2 virus causes the development of new-onset IgG autoantibodies in a significant proportion of hospitalized COVID-19 patients and is positively correlated with immune responses to SARS-CoV-2 proteins. Thus, autoantibodies can be early harbingers of full-blown autoimmune disease.'
Furthermore, "To an extent never seen for any other acute infectious disease, four studies collectively provide a molecular and immunological explanation for about 20% of critical COVID-19 cases." Moreover, autoantibodies are found even in uninfected individuals, suggesting that they cause, rather than an effect, severe COVID-19.
Anti-SARS-CoV-2 Monoclonal Antibodies News
December 3, 2021 - The Lancet published the WHO international standard for SARS-CoV-2 antibodies to determine markers of protection.
December 3, 2021 - The U.S. FDA 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 has conducted an assessment of the reported mutations in the Omicron (B.1.1.529) variant. Based upon the mapping of those mutations and activity against previous and current CDC variants of concern, Immunome expects its antibody cocktail, IMM-BCP-01, to neutralize the Omicron variant.
November 29, 2021 - Immunome, Inc. announced that it has submitted an Investigational New Drug Application to the U.S. FDA for IMM-BCP-01, a three-antibody cocktail, for the treatment of COVID-19.
November 21, 2021 - The U.S. FDA issued a EUA for casirivimab and imdevimab (REGEN-COV) to be administered together for the treatment of mild to moderate COVID-19 in certain adults and pediatric patients.
November 18, 2021 - The EMA announced it started evaluating a GlaxoSmithKline Trading Services Limited application for marketing authorization for Xevudy (sotrovimab).
November 17, 2021 - GlaxoSmithKline plc and Vir Biotechnology, Inc. announced U.S. government contracts totaling approximately $1 billion to purchase sotrovimab, an investigational monoclonal antibody. GSK will supply these doses to the US government by December 17, 2021. In addition, the US government will have the option to purchase additional doses through March 2022. In vitro data indicate sotrovimab maintains activity against the Delta variant of concern.
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 US.
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 EMA'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 BMI 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 BMI ≥ 35 suggests a mortality benefit.
November 2, 2021 - Eli Lilly and Company announced an additional $1.29 billion purchase by the U.S. government for bamlanivimab with etesevimab for administration together. As part of the agreement, Lilly will supply a minimum of 400,000 doses provided no later than December 31, 2021. And 614,000 doses of bamlanivimab with etesevimab are scheduled for delivery on/before January 31, 2022.
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 29, 2021 - Eli Lilly Netherlands BV informed the EMA of the decision to no longer continue with the ongoing submissions and responses under rolling review for an eventual marketing authorization application for bamlanivimab and etesevimab for the treatment of confirmed COVID-19 in patients. The EMA confirmed this action on November 2, 2021.
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 25, 2021 - Nader Pourhassan, Ph.D., CytoDyn's President and CEO, commented, "The CytoDyn team, along with others, have worked diligently to initiate two pivotal Phase 3 trials (Leronlimab) in Brazil."
October 14, 2021 - The JAMA Network published a Research Letter describing how nurses in Michigan reduced ER 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 MAB infusions while successfully preventing high-risk patients from progression to severe disease and hospitalization.
October 14, 2021 - Regeneron Pharmaceuticals, Inc. announced that the U.S. FDA has accepted for priority review a Biologics License Application for REGEN-COV® (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis in specific individuals. The FDA has assigned a target action date of April 13, 2022.
October 14, 2021 - The European Medicines Agency committee (CHMP) has started a rolling review of Evusheld (also known as AZD7442), a combination of two monoclonal antibodies: AstraZeneca AB is developing for the prevention of COVID-19 in adults.
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 US 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 (CDC) 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 have been treated with monoclonal antibodies. No anaphylactic reactions or other serious adverse events have been reported.
October 4, 2021 - South Dakoda-based SAB Biotherapeutics announced that the first patient had been dosed with SAB-185 in the Phase 3 ACTIV-2 COVID-19 trial. SAB-185 is a fully human, specifically targeted, broadly neutralizing polyclonal antibody therapeutic candidate for the treatment of 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 EMA 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.
October 3, 2021 – Brii Biosciences Limited presented interim results from Phase 3 of the ACTIV-2 trial, which showed that BRII-196/BRII-198, achieved a similar reduction in hospitalization or death among patients who initiated treatment early (within five days) versus late (six to 10 days) following symptom onset. These initial results suggest that combination BRII-196/BRII-198 may remain effective in a majority of patients who are late to treatment, potentially extending its clinical benefit in a real-world setting, where rapid access to care can be a challenge.
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 21, 2021 - The Jama Network published a Research Letter: Outcome Comparison of High-Risk Native American Patients Who Did or Did Not Receive Monoclonal Antibody Treatment for COVID-19. To our knowledge, this study is the first to report mAb used for Native American individuals and is among the few studies to report a significantly lower proportion of deaths among patients receiving mAbs. The magnitude of our findings is attributable in part to a higher baseline hospitalization rate.
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 20, 2021 - Gov. Ron DeSantis Tweeted: 'Since Florida opened monoclonal antibody treatment sites in August: +100,000 Floridians have received treatments; COVID hospital admissions have fallen by over 60%; COVID hospital census has declined for 28 consecutive days; ER visits for COVID have reduced by over 70%.
September 20, 2021 - Texas Governor Greg Abbott announced that the Texas Division of Emergency Management would expand operations at an active COVID-19 therapeutic infusion center in Segu in partnership with local officials. The expansion is expected to double the number of daily infusions from 25-30 to approximately fifty.
September 19, 2021 - BreatheMD.com posted unverified, self-reported Monoclonal Antibody Treatment results based on 410 patients' responses. About 97% of Regen-CoV patients would recommend the treatment to a loved one, and 83% did not report side effects.
September 16, 2021 - The U.S FDA confirmed it concluded that revising this EUA is appropriate to protect public health or safety under section 564(g)(2) of the Act; FDA 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 - UK medicines regulator has approved Ronapreve (REGEN-COV) for COVID-19 treatment. Ronapreve is administered as an infusion or multiple injections. This product is already licensed for emergency use in more than 20 countries – including the US, Japan, and India.
August 25, 2021 - Brii Biosciences (HKG: 2137) announced positive results from the NIAID-sponsored Activ-2 trial in outpatients. "We are thrilled to announce the interim Phase 3 results from ACTIV-2, which demonstrate a significant reduction in the endpoint of hospitalizations or death among non-hospitalized people with mild COVID-19 who were treated with BRII-196/BRII-198," said Teresa H. Evering, M.D., M.S., Weill Cornell Medicine, co-lead investigator of BRII-196/BRII-198 in ACTIV-2.
June 5, 2021 - The journal Cell published an article: The monoclonal antibody combination REGEN-COV protects against SARS-CoV-2 mutational escape in preclinical and human studies. Our study demonstrates that the combination of non-competing antibodies in REGEN-COV protects against all current SARS-CoV-2 variants of concern/interest and protects against the emergence of new variants and their potential seeding into the population in a clinical setting.
August 21, 2020 - The journal Science published: Studies in humanized mice and convalescent humans yield a SARS-CoV-2 antibody cocktail.
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 EUA for details regarding specific variants and resistance. You should also refer to the CDC 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.