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  • ||||||||||  bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases, bamlanivimab/etesevimab (LY-CoV555/LY-CoV016) / Eli Lilly, bebtelovimab (LY-CoV1404) / AbCellera, Eli Lilly
    Journal:  Mutational Scanning and Binding Free Energy Computations of the SARS-CoV-2 Spike Complexes with Distinct Groups of Neutralizing Antibodies: Energetic Drivers of Convergent Evolution of Binding Affinity and Immune Escape Hotspots. (Pubmed Central) -  Feb 26, 2025   
    In this study, we conducted a comprehensive structural and energetic analysis of SARS-CoV-2 spike receptor-binding domain (RBD) complexes with neutralizing antibodies from four distinct groups (A-D), including group A LY-CoV016, group B AZD8895 and REGN10933, group C LY-CoV555, and group D antibodies AZD1061, REGN10987, and LY-CoV1404...The results demonstrate excellent qualitative agreement between the predicted binding hotspots and the latest experiments on antibody escape. These findings provide valuable insights into the molecular determinants of antibody binding and viral escape, highlighting the importance of targeting conserved epitopes and leveraging combination therapies to mitigate the risk of immune evasion.
  • ||||||||||  bebtelovimab (LY-CoV1404) / AbCellera, Eli Lilly
    Journal:  Impact of Bebtelovimab Treatment Timing on COVID-19 Outcomes in Ambulatory Solid Organ Transplant Recipients. (Pubmed Central) -  Feb 14, 2025   
    Early bebtelovimab treatment in outpatient SOTRs was associated with a lower risk of hospitalization compared to no treatment, while late administration did not show a significant advantage over no treatment. Although bebtelovimab is no longer authorized, these findings suggest that the timing of COVID therapies for SOTRs may be important to optimize outcomes.
  • ||||||||||  Casgevy (exagamglogene autotemcel) / Vertex, CRISPR Therap, Molecular Templates
    Durable Clinical Benefits in Transfusion-Dependent ?-Thalassemia with Exagamglogene Autotemcel (HCC Exhibit Hall 3; In-Person) -  Dec 19, 2024 - Abstract #TCTASTCTCIBMTR2025TCT_ASTCT_CIBMTR_1066;    
    Durable transfusion independence was achieved in >94% of pts receiving exa-cel, with associated clinically meaningful and sustained increases in HbF and total Hb for up to 5yrs of available follow-up. Exa-cel
  • ||||||||||  bebtelovimab (LY-CoV1404) / AbCellera, Eli Lilly
    Journal:  SARS-CoV-2 variants and bebtelovimab: immune escape mechanisms revealed by computational studies. (Pubmed Central) -  Dec 11, 2024   
    Our findings revealed that certain residues, including 440(N/K), Lys444, 452(L/R), 484(E/A), 498(Q/R), and THR500, are directly or indirectly responsible for altering the binding position and efficacy of bebtelovimab antibody with the RBD when mutations are introduced. The binding energy studies on three different variants, wild-type, delta, and omicron, revealed that the binding efficacy of bebtelovimab with the RBD diminished over time as additional mutations were introduced.
  • ||||||||||  bebtelovimab (LY-CoV1404) / AbCellera, Eli Lilly, Xevudy (sotrovimab) / GSK, National Institutes of Health, Vir Biotech, National Institute of Allergy and Infectious Diseases
    Journal:  Therapeutic Potential of Neutralizing Monoclonal Antibodies (nMAbs) against SARS-CoV-2 Omicron Variant. (Pubmed Central) -  Nov 17, 2024   
    Subsequently, WKS13, mAb-39, 19n01, F61-d2 cocktail, etc., have become effective. This review has highlighted the therapeutic implications of nMAbs in SARS-CoV-2 Omicron treatment and the progress of COVID-19 drug discovery.
  • ||||||||||  bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
    Journal:  SARS-CoV-2 monoclonal antibody treatment followed by vaccination shifts human memory B cell epitope recognition suggesting antibody feedback. (Pubmed Central) -  Nov 16, 2024   
    Subsequently, after mRNA COVID-19 vaccination, memory B cell differences persisted and mapped to a specific reduction in recognition of the class II RBD site, the same RBD epitope recognized by bamlanivimab. These findings indicate a substantial role of antibody feedback in regulating memory B cell responses to infection, and single mAb administration can continue to impact memory B cell responses to additional antigen exposures months later.
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer, bebtelovimab (LY-CoV1404) / AbCellera, Eli Lilly, Lagevrio (molnupiravir) / Ridgeback Biotherap, Merck (MSD)
    Clinical, Observational data, Journal, Adverse events:  Investigating the Safety Profile of Fast-Track COVID-19 Drugs Using the FDA Adverse Event Reporting System Database: A Comparative Observational Study. (Pubmed Central) -  Nov 14, 2024   
    This study demonstrated that real-world data and real-time safety reviews could be effective methods for the timely detection of ADR signals of drugs that have received fast-track approval, as exemplified by COVID-19 drugs. These findings underscore the importance of the continued surveillance, efficient data processing, and establishment of automated pipelines for real-time safety reviews.
  • ||||||||||  Journal:  Identification of Antibody-Resistant SARS-CoV-2 Mutants via N4-Hydroxycytidine Mutagenesis. (Pubmed Central) -  Nov 13, 2024   
    From the Omicron B.1.1.529 variant, the strongly selected mutations were: Bebtelovimab - V445A; Sotrovimab - E340K and K356M; Cilgavimab - K444R, V445A and N450D...Notably, many of the identified resistance-conferring mutations are prevalent in real-world SARS-CoV-2 variants, but some of them (G485S, D428G, and K462E) have not yet been observed in circulating strains. Our approach offers a strategy for predicting the therapeutic efficacy of antibodies against emerging virus variants.
  • ||||||||||  Casgevy (exagamglogene autotemcel) / Vertex, CRISPR Therap, Molecular Templates
    Durable Clinical Benefits with Exagamglogene Autotemcel for Transfusion-Dependent ?-Thalassemia (Room 30 (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_1800;    
    The safety profile of exa-cel remains consistent with myeloablative busulfan conditioning and autologous transplantation. These results confirm the potential for exa-cel to provide a one-time functional cure to patients with TDT.
  • ||||||||||  bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases, Xevudy (sotrovimab) / GSK, National Institutes of Health, Vir Biotech, National Institute of Allergy and Infectious Diseases
    Journal:  Characterisation of the antibody-mediated selective pressure driving intra-host evolution of SARS-CoV-2 in prolonged infection. (Pubmed Central) -  Oct 25, 2024   
    In conclusion, the onset of an IgM-dominated endogenous immune response in an immunocompromised patient coincided with the appearance of additional mutations in the NTD and RBD of S in a bamlanivimab-resistant virus. Although virus elimination was ultimately achieved, this humoral immune response escaped detection by routine diagnosis and created a situation temporarily favouring the rapid emergence of various antibody escape mutants with known epidemiological relevance.
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer, bebtelovimab (LY-CoV1404) / AbCellera, Eli Lilly, Lagevrio (molnupiravir) / Ridgeback Biotherap, Merck (MSD)
    Journal:  Reprint of: Evaluation of physicians prescribing of COVID-19 guideline-directed outpatient treatments in a primary care walk-in clinic. (Pubmed Central) -  Oct 3, 2024   
    Nirmatrelvir-ritonavir was the most prescribed medication for the treatment of mild-to-moderate COVID-19, consistent with its position as first-line therapy and widespread accessibility. The study results will inform future educational opportunities, such as in-service presentations and handouts, that may improve the prescribing of outpatient treatment for mild-to-moderate COVID-19 moving forward.
  • ||||||||||  bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases, Lokelma (sodium zirconium cyclosilicate) / AstraZeneca
    COVID-ASSOCIATED ORGANIZING PNEUMONIA WITH CLAD IN A LUNG TRANSPLANT PATIENT (Convention Center Exhibit Hall: Poster Area 2) -  Sep 11, 2024 - Abstract #CHEST2024CHEST_6542;    
    Patients with post COVID pneumonia must be evaluated for organizing pneumonia in order to initiate early treatment. In addition, lung transplant patients who develop COVID infection must be monitored for decline in their lung function.
  • ||||||||||  bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
    Journal:  Impact of SARS-CoV-2 Resistance to Antiviral Monoclonal Antibody Therapy on Neutralizing Antibody Response. (Pubmed Central) -  Sep 9, 2024   
    P2/3
    In this study, we assessed host neutralizing antibody (nAb) responses against both ancestral virus and those with treatment-emergent E484K bamlanivimab resistance mutations...Emerging drug resistance after SARS-CoV-2-specific mAb therapy led to a heightened host neutralizing antibody response to the mAb-resistant variant that was associated with eventual viral clearance. This demonstrates the interplay between the antiviral treatment-directed viral evolution and subsequent host immune response in viral clearance.
  • ||||||||||  bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
    Clinical, Journal:  Comparison Study of the Bio-Plex and Meso Scale Multiplexed SARS-CoV-2 Serology Assays Reveals Evidence of Diminished Host Antibody Responses to SARS-CoV-2 after Monoclonal Antibody Treatment. (Pubmed Central) -  Aug 21, 2024   
    Assessment of immune responses in the four individuals treated with the 700 mg of bamlanivimab with emerging mAb resistance demonstrated a stronger anti-N IgG response (MSD) at day 28 (median 2.18 log BAU/mL) compared to participants treated with bamlanivimab who did not develop resistance (median 1.55 log BAU/mL). These data demonstrate the utility in using multiplex immunoassays for characterizing the immune responses with and without treatment in a study population and provide evidence that monoclonal antibody treatment in acute COVID-19 may have a modest negative impact on development of host IgG responses.
  • ||||||||||  bebtelovimab (LY-CoV1404) / AbCellera, Eli Lilly
    Journal:  Bebtelovimab-bound SARS-CoV-2 RBD mutants: resistance profiling and validation with escape mutations, clinical results, and viral genome sequences. (Pubmed Central) -  Aug 7, 2024   
    Through extensive physicochemical analysis, mutational preferences, precision-recall metrics, protein-protein docking, and energetic analyses, combined with all-atom, and coarse-grained molecular dynamics (MD) simulations, we elucidated the structural-dynamics-binding features of the bebtelovimab-RBD complexes. Identification of susceptible RBD residues under positive selection pressure, coupled with validation against bebtelovimab-escape mutations, clinically reported resistance mutations, and viral genomic sequences enhances the translational significance of our findings and contributes to a better understanding of the resistance mechanisms of SARS-CoV-2.
  • ||||||||||  ivermectin oral / Generic mfg.
    Journal:  Effective Treatment of COVID-19 Infection with Repurposed Drugs: Case Reports. (Pubmed Central) -  Aug 4, 2024   
    Multidrug therapy is effective because of the differing mechanisms of action of these drugs, and it may also mitigate the emergence of drug-resistant SARS-CoV-2 strains. The medicines were lopinavir/ritonavir (Kaletra), bamlanivimab (monoclonal antibody), glycopyrrolate-formoterol (Bevespi), ciclesonide (Alvesco), famotidine (Pepcid), and diphenhydramine (Benadryl).
  • ||||||||||  bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases, bamlanivimab/etesevimab (LY-CoV555/LY-CoV016) / Eli Lilly
    Journal:  Biophysical principles predict fitness of SARS-CoV-2 variants. (Pubmed Central) -  May 31, 2024   
    Our study sheds light on the impact of specific mutations on viral fitness and delivers a tool for predicting the future epidemiological trajectory of previously unseen or emerging low-frequency variants. These insights offer not only greater understanding of viral evolution but also potentially aid in guiding public health decisions in the battle against COVID-19 and future pandemics.
  • ||||||||||  Comparative Effectiveness of Outpatient COVID-19 Therapies in Solid Organ Transplant Recipients (Poster Hall, Exhibit Hall A, Level 2) -  May 6, 2024 - Abstract #ATC2024ATC_904;    
    SOTRs who received outpatient mAb or antiviral treatment for mild-to-moderate COVID-19 had comparable clinical outcomes, as measured by odds of hospitalization. Clinicians may use any of these treatment options according to the individual patient's circumstances and without concern for differential therapeutic efficacy.
  • ||||||||||  bebtelovimab (LY-CoV1404) / AbCellera, Eli Lilly
    Journal:  Evaluating mAbs binding abilities to Omicron subvariant RBDs: implications for selecting effective mAb therapies. (Pubmed Central) -  Apr 18, 2024   
    Our results indicated that the antibody LY-COV1404 maintained binding affinities across all studied systems, suggesting the resilience of certain antibodies against variant-induced immune escape, as seen with the mAb 1D1-Fab...These findings enhance our comprehension of the binding interactions between mAbs and RBDs, contributing to the understanding of immune escape mechanisms. They also lay the groundwork for the design and optimization of antiviral drugs and have significant implications for the development of treatments against current and future coronaviruses.
  • ||||||||||  bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
    Retrospective data, Review, Journal:  Efficacy and safety of bamlanivimab in patients with COVID-19: A systematic review and meta-analysis. (Pubmed Central) -  Apr 15, 2024   
    They also lay the groundwork for the design and optimization of antiviral drugs and have significant implications for the development of treatments against current and future coronaviruses. Although the results suggest the efficacy and safety of bamlanivimab in COVID-19 patients, further research is required to confirm the efficacy of this drug for the current circulating SARS-CoV-2 variants.
  • ||||||||||  bebtelovimab (LY-CoV1404) / AbCellera, Eli Lilly
    mRNA delivery of epitope-specific monoclonal antibodies for treatment of viral infection (Exhibit Hall F1; Poster Board Number: B919) -  Mar 29, 2024 - Abstract #IMMUNOLOGY2024IMMUNOLOGY_893;    
    We generated mRNAs expressing two different mAbs, LY-CoV1404 (mRNA-1404) and 76E1 (mRNA-76E1), that target different SARS-CoV-2 epitopes and formulated them in LNPs...Following single mRNA-LNP administration (5ug and 15ug dose via intramuscular or subcutaneous route), serum antibodies remained detectable 5 weeks out. Our data indicate that mRNA is a promising platform for the delivery of therapeutic mAbs to treat human disease such as viral infections.
  • ||||||||||  bebtelovimab (LY-CoV1404) / AbCellera, Eli Lilly
    Journal:  Overcoming antibody-resistant SARS-CoV-2 variants with bispecific antibodies constructed using non-neutralizing antibodies. (Pubmed Central) -  Mar 19, 2024   
    Furthermore, we created a bispecific antibody by incorporating the scFv of bebtelovimab with our anti-S2 antibody, demonstrating significant restoration of effectiveness against bebtelovimab-resistant BQ.1.1 variants. This study highlights the potential of neutralizing bispecific antibodies, which combine existing less effective anti-RBD antibodies with anti-S2 antibodies, to revive the effectiveness of antibody therapeutics compromised by immune-evading variants.
  • ||||||||||  Paxlovid (nirmatrelvir/ritonavir) / Pfizer, bebtelovimab (LY-CoV1404) / AbCellera, Eli Lilly, Lagevrio (molnupiravir) / Ridgeback Biotherap, Merck (MSD)
    Journal:  Evaluation of Physicians Prescribing of COVID-19 Guideline-Directed Outpatient Treatments in a Primary Care Walk-In Clinic. (Pubmed Central) -  Mar 18, 2024   
    Nirmatrelvir-ritonavir was the most prescribed medication for the treatment of mild-to-moderate COVID-19, consistent with its position as first-line therapy and widespread accessibility. The study results will inform future educational opportunities, such as in-service presentations and handouts, that may improve the prescribing of outpatient treatment for mild-to-moderate COVID-19 moving forward.
  • ||||||||||  bebtelovimab (LY-CoV1404) / AbCellera, Eli Lilly, Xevudy (sotrovimab) / GSK, National Institutes of Health, Vir Biotech, National Institute of Allergy and Infectious Diseases
    Journal:  SARS-CoV-2 evolution during prolonged infection in immunocompromised patients. (Pubmed Central) -  Mar 14, 2024   
    All patients received remdesivir, but remdesivir-resistant substitutions were not detected...One model is that long-term viral persistence in infected individuals allows for viral evolution in response to host pressures, resulting in viruses more likely to replicate efficiently in humans. In this study, we characterize replication in several hospitalized and long-term infected individuals, documenting efficient pathways of viral evolution.
  • ||||||||||  bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
    Organizing Pneumonia With Surgical Pathology Positive for SARS-CoV2 a Year After Initial COVID-19 Diagnosis Despite Negative COVID-19 PCR From Nasal Swabs and Bronchial Alveolar Lavage in a Lymphopenic Cancer Patient (San Diego Convention Center, Area H (Hall H, Ground Level)) -  Feb 20, 2024 - Abstract #ATS2024ATS_4077;    
    He received monoclonal antibody, Bamlanivimab, with little improvement...Given symptoms, negative infectious work up including fungal markers and PET scan with new bilateral ground glass opacities (GGOs), he was started on prednisone 10mg daily for presumed long COVID-19...He tested COVID PCR negative multiple times and was treated for presumed pneumonia with Augmentin and Levofloxacin with minimal improvement in symptoms...While COVID PCR from a BAL has high sensitivity, the patient tested negative multiple times with the diagnosis ultimately made with immunohistochemical stains from biopsy. Steroids continue to be the treatment of choice for PCOP.
  • ||||||||||  Journal:  Coronavirus Disease 2019 (COVID-19) in Heart Transplant Recipients and Anti-SARS-CoV-2 Monoclonal Antibodies: Experience, Lessons Learnt, and Future Challenges. (Pubmed Central) -  Feb 9, 2024   
    We performed a retrospective chart review including adult HT recipients at Westchester Medical Center from January 1, 2020 to December 10, 2022, who received anti-SARS-CoV-2 monoclonal antibodies (mAbs) for treatment of mild-to-moderate COVID-19, and those who received tixagevimab/cilgavimab for preexposure prophylaxis...In this largest single-center study in this population, 42 adult HT recipients received casirivimab/imdevimab (36%), sotrovimab (31%), or bebtelovimab (29%) for treatment of mild-to-moderate COVID-19...Overall, the data suggests that HT recipients receiving mAbs have reduced rates of hospitalization, need for intensive care unit care, or death. Use of anti-SARS-CoV-2 mAbs in SOTRs is resource intensive and requires a programmatic team approach for optimal administration and to minimize any risk of disparities in their use.
  • ||||||||||  bebtelovimab (LY-CoV1404) / AbCellera, Eli Lilly
    Journal:  Allosteric Signal within the Receptor-Binding Domain of the SARS-CoV-2 Spike Protein Mediated by a Class 3 Monoclonal Antibody Revealed through Molecular Dynamics Simulations and Protein Residue Networks. (Pubmed Central) -  Feb 5, 2024   
    Simulations of explicitly solvated RBD of the BA.2.75 omicron subvariants were carried out both in the presence and in the absence of bebtelovimab, as a model example of class 3 monoclonal antibodies against the RBD of the SARS-CoV-2 spike protein...In terms of computational techniques, the communicability matrix could serve as a tool to visualize the effects of allostery, as the pairs of amino acids or secondary structures with high communicability could pinpoint the possible sites to transfer the allosteric signal. Additionally, the communicability gain/loss matrix could help elucidate the consequences of allosteric actions, which could be employed along with other allostery quantification techniques in some previous studies.
  • ||||||||||  bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
    Journal:  The Therapeutic Monoclonal Antibody Bamlanivimab Does Not Enhance SARS-CoV-2 Infection by FcR-Mediated Mechanisms. (Pubmed Central) -  Dec 22, 2023   
    Bamlanivimab did not induce ADE of SARS-CoV-2 infection in vitro or in an AGM model of infection at any dose evaluated. The findings suggest that high-affinity monoclonal antibodies pose a low risk of mediating ADE in patients and support their safety profile as a treatment of COVID-19 disease.
  • ||||||||||  bebtelovimab (LY-CoV1404) / AbCellera, Eli Lilly
    Journal:  Structural basis for broad neutralization of human antibody against Omicron sublineages and evasion by XBB variant. (Pubmed Central) -  Oct 19, 2023   
    To date, almost all available therapeutic nAbs, including those authorized under Emergency Use Authorization nAbs that were previously clinically useful against early strains, have recently been found to be ineffective against newly emerging variants. In this study, we provide a comprehensive structural basis about how the Class 3 nAbs, including 1G11 in this study and noted LY-CoV1404, are evaded by the newly emerged SARS-CoV-2 variants.