- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Journal: New-onset seizures after bamlanivimab infusion. (Pubmed Central) - Apr 27, 2022
A comparative analysis with a matched control cohort (who did not receive MoAbs) will be provided at the meeting. No abstract available
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Journal: Initial Experience With SARS-CoV-2-Neutralizing Monoclonal Antibodies in Kidney or Combined Kidney-Pancreas Transplant Recipients. (Pubmed Central) - Apr 19, 2022
Recently, the U.S. FDA has granted an emergency use authorization (EUA) to two monoclonal antibodies (mAb) targeting the viral spike protein: bamlanivimab and casivirimab and imdevimab...All six patients infected with the B 1.1.7 variant were alive at last contact. mAb treatment appears effective when administered early to SARS-CoV-2-infected transplant recipients.
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Journal: Emergence and onward transmission of a SARS-CoV-2 E484K variant among household contacts of a bamlanivimab-treated patient. (Pubmed Central) - Apr 14, 2022
The timing and patterns of spread were consistent with de novo emergence of this E484K variant in the bamlanivimab-treated index patient. Our study suggests that the selective pressures introduced by the widespread administration of these antibodies may warrant increased genomic surveillance to identify and mitigate spread of therapy-induced variants.
- |||||||||| REGEN-COV (casirivimab/imdevimab) / Regeneron, Roche, bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Retrospective data, Journal: SARS-CoV-2 Neutralizing Monoclonal Antibodies for the Treatment of COVID-19 in Kidney Transplant Recipients. (Pubmed Central) - Apr 12, 2022
Patients who received mAbs demonstrated measurable anti-SARS-CoV-2 IgG with angiotensin-converting enzyme 2 (ACE2) receptor blocking activity at the highest level detectable at 90 days postinfusion, whereas ACE2 blocking activity acquired from natural immunity in the mAb-untreated group was weak. Bamlanivimab and casirivimab-imdevimab combined with immunosuppression reduction were well tolerated and associated with favorable clinical outcomes in kidney transplant recipients diagnosed with mild to moderate COVID-19.
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Journal: An outbreak of SARS-CoV-2 on a transplant unit in the early vaccination era. (Pubmed Central) - Apr 8, 2022
Bamlanivimab and casirivimab-imdevimab combined with immunosuppression reduction were well tolerated and associated with favorable clinical outcomes in kidney transplant recipients diagnosed with mild to moderate COVID-19. SARS-CoV-2 outbreaks on immunocompromised units can be mitigated through prompt identification of cases and robust infection prevention practices.
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Clinical data, Journal: Clinical Outcomes of Monoclonal Antibody Therapy During a COVID-19 Outbreak in a Skilled Nursing Facility-Arizona, 2021. (Pubmed Central) - Apr 8, 2022
Treatment with bamlanivimab reduced 21-day mortality and reduced initiation of oxygen therapy. As the COVID-19 pandemic evolves and newer immunotherapies gain FDA authorization, more studies of the effectiveness of mAb therapies for treating emerging SARS-CoV-2 variants of concern in high-risk congregate settings are needed.
- |||||||||| Review, Journal: An update of antispike severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) monoclonal antibodies. (Pubmed Central) - Apr 5, 2022
This review summarizes their mechanism of action, salient pharmacokinetic profile, safety and clinical trial (ongoing and completed) data. Despite evidence to support its use for the indication, the high cost of these biologics may make it unaffordable for many patients, but further clinical studies on their cost-benefit profile shall provide useful information to the scientific community and patients.
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: ACTIV-2: A Study for Outpatients With COVID-19 (clinicaltrials.gov) - Mar 31, 2022
P2/3, N=4044, Active, not recruiting,
Despite evidence to support its use for the indication, the high cost of these biologics may make it unaffordable for many patients, but further clinical studies on their cost-benefit profile shall provide useful information to the scientific community and patients. Recruiting --> Active, not recruiting | N=8797 --> 4044 | Trial completion date: Dec 2023 --> Jun 2023 | Trial primary completion date: Dec 2023 --> Mar 2022
- |||||||||| REGEN-COV (casirivimab/imdevimab) / Regeneron, Roche, bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Trial completion date, Trial primary completion date: Use of Monoclonal Antibodies for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting (clinicaltrials.gov) - Mar 29, 2022
P2, N=1000, Recruiting,
Further study is needed to validate these findings. Trial completion date: Jan 2022 --> Jan 2023 | Trial primary completion date: Dec 2021 --> Dec 2022
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases, bamlanivimab/etesevimab (LY-CoV555/LY-CoV016) / Eli Lilly
Clinical, Retrospective data, Journal: Bamlanivimab plus etesevimab treatment have a better outcome against COVID-19: A meta-analysis. (Pubmed Central) - Mar 24, 2022
Combinations of bamlanivimab and etesevimab has a significant relative risk reduction (RRR) for COVID-related hospitalization or death for patients than monotherapy 700mg group. Well-designed clinical trials to identify the clinical and biochemical characteristics in COVID-19 patients' population that could benefit from bamlanivimab or plus etesevimab are warranted in the future.
- |||||||||| etesevimab (JS016) / Chinese Academy of Sciences, Shanghai Junshi Biosci, Eli Lilly, bebtelovimab (LY-CoV1404) / AbCellera, Eli Lilly
Journal: An EUA for bebtelovimab for treatment of COVID-19. (Pubmed Central) - Mar 23, 2022
Well-designed clinical trials to identify the clinical and biochemical characteristics in COVID-19 patients' population that could benefit from bamlanivimab or plus etesevimab are warranted in the future. No abstract available
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
UNILATERAL DIAPHRAGMATIC PARALYSIS SECONDARY TO COVID-19 ([VIRTUAL]) - Mar 23, 2022 - Abstract #SCCM2022SCCM_1210;
Theories regarding the pathophysiology of this condition include neurotropism, autoimmunity, and microvascular damage. While current publications highlight the importance of this condition in mechanically ventilated patients, our case demonstrates that unilateral diaphragmatic paralysis can occur in COVID-19 patients in the outpatient setting who were also treated with bamlanivimab.
- |||||||||| 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
Bebtelovimab, Alone and Together with Bamlanivimab and Etesevimab, as a Broadly Neutralizing Monoclonal Antibody Treatment and a Slow Intravenous Push Option for Ambulatory COVID-19 (Area D, Hall F (North Building, Exhibition Level), Moscone Center) - Mar 23, 2022 - Abstract #ATS2022ATS_7186;
While current publications highlight the importance of this condition in mechanically ventilated patients, our case demonstrates that unilateral diaphragmatic paralysis can occur in COVID-19 patients in the outpatient setting who were also treated with bamlanivimab. The safety and efficacy data support the further development of bebtelovimab delivered via slow intravenous push of at least 30 seconds.
- |||||||||| REGEN-COV (casirivimab/imdevimab) / Regeneron, Roche, bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Retrospective data, Journal: Comparative Efficacy of Early COVID-19 Monoclonal Antibody Therapies: A Retrospective Analysis. (Pubmed Central) - Mar 19, 2022
There was a higher failure rate with bamlanivimab vs casirivimab/imdevimab. No difference in efficacy was found between early vs late administration of either mAb.
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Enrollment change, Trial termination: UNITED: At-Home Infusion Using Bamlanivimab in Participants With Mild to Moderate COVID-19 (clinicaltrials.gov) - Mar 18, 2022
P4, N=139, Terminated,
No difference in efficacy was found between early vs late administration of either mAb. N=4000 --> 139 | Completed --> Terminated; In April 2021 FDA revoked the Emergency Use Authorization after determining that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks for its authorized use.
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Clinical, Journal: Antimicrobial Stewardship and Bamlanivimab: Opportunities for Outpatient Preauthorization? (Pubmed Central) - Mar 15, 2022
N=4000 --> 139 | Completed --> Terminated; In April 2021 FDA revoked the Emergency Use Authorization after determining that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks for its authorized use. No abstract available
- |||||||||| Actemra IV (tocilizumab) / Roche, JW Pharma, Soliris (eculizumab) / AstraZeneca
Review, Journal: TREATMENT OF MYASTHENIA GRAVIS PATIENTS WITH COVID-19: REVIEW OF THE LITERATURE. (Pubmed Central) - Mar 15, 2022
Concerning plasmapheresis and intravenous immunoglobulins, both can be used in COVID-19 while taking into consideration thromboembolic properties of the former and hemodynamic disturbances of the latter. As current data suggest, all known COVID-19 vaccines are safe to use in MG patients.
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases, bebtelovimab (LY-CoV1404) / AbCellera, Eli Lilly, Xevudy (sotrovimab) / GSK, National Institutes of Health, Vir Biotech, National Institute of Allergy and Infectious Diseases
Clinical: In summary, all neutralizing MCA’s can produce treatment emergent resistance. The incidence of the development of resistance in Sotrovimab treated patients is much less than that associated with other neutralizing MCA’s such as Bebtelovimab or Bamlanivimab. (Twitter) - Mar 12, 2022
- |||||||||| Journal: In-Silico Analysis of Monoclonal Antibodies against SARS-CoV-2 Omicron. (Pubmed Central) - Mar 11, 2022
Of all antibodies under EUA, the neutralisation potential of Etesevimab, Bamlanivimab, Casirivimab, Imdevima, Cilgavimab, Tixagevimab, Sotrovimab, and Regdanvimab might be dampened to varying degrees. Our analysis suggests the impact of Omicron on current therapeutic antibodies by the Omicron spike mutations may also apply to current COVID-19 vaccines.
- |||||||||| REGEN-COV (casirivimab/imdevimab) / Regeneron, Roche, bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Journal: Antibody escape and global spread of SARS-CoV-2 lineage A.27. (Pubmed Central) - Mar 11, 2022
Moreover, the therapeutic monoclonal antibody Bamlanivimab and partially the REGN-COV2 cocktail fail to block infection by A.27. Our data emphasize the need for continued global monitoring of novel lineages because of the independent evolution of new escape mutations.
- |||||||||| Informing a Conceptual Framework for a Patient-Centered Value Assessment of Emerging Therapies for Mild/Moderate COVID-19 (In-person & Virtual) - Mar 8, 2022 - Abstract #ISPOR2022ISPOR_894;
We searched PubMed [December 21, 2021] to identify relevant publications using the string: “(mild OR moderate) AND (COVID OR coronavirus 2019 OR COVID19) AND (bamlanivimab OR estesevimab OR sotrovimab OR casirivimab OR imdevimab OR REGN-COV2) OR (paxlovid) OR (molnupiravir) ” . Potential impacts on productivity and patient costs suggest that therapies for mild/moderate COVID-19 should be assessed with evaluations that include the patient-informed value elements .
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases, bamlanivimab/etesevimab (LY-CoV555/LY-CoV016) / Eli Lilly, etesevimab (JS016) / Chinese Academy of Sciences, Shanghai Junshi Biosci, Eli Lilly
Trial completion: BLAZE-1: A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness (clinicaltrials.gov) - Mar 7, 2022
P2/3, N=3290, Completed,
Potential impacts on productivity and patient costs suggest that therapies for mild/moderate COVID-19 should be assessed with evaluations that include the patient-informed value elements . Active, not recruiting --> Completed
- |||||||||| REGEN-COV (casirivimab/imdevimab) / Regeneron, Roche, bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Retrospective data, Journal: The use of monoclonal antibody therapy in pediatric patients with COVID-19: a retrospective case series. (Pubmed Central) - Mar 5, 2022
The administration of MCA therapy in high-risk pediatric patients in the pediatric ED was well-tolerated with subjective improvement noted in COVID-19 symptoms post-therapy. Further studies are necessary to determine the role MCA therapy may play in reducing morbidity from COVID-19 infection in high-risk pediatric patients.
- |||||||||| Journal: Omicron escapes the majority of existing SARS-CoV-2 neutralizing antibodies. (Pubmed Central) - Mar 3, 2022
Together, data suggest Omicron would cause significant humoral immune evasion, while NAbs targeting the sarbecovirus conserved region remain most effective. Our results offer instructions for developing NAb drugs and vaccines against Omicron and future variants.
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Journal: Impact of New Variants on SARS-CoV-2 Infectivity and Neutralization: A Molecular Assessment of the Alterations in the Spike-Host Protein Interactions. (Pubmed Central) - Feb 24, 2022
Our study elucidates the molecular origin of the ability of Beta and Delta variants to evade selected antibodies, such as REGN10933, LY-CoV555, B38, C105 or H11-H4, while being insensitive to others including REGN10987...The substitutions T478K and L452R in Delta variant enhance the associations with ACE2, while P681R promotes recognition by proteases thus facilitating viral entry. The Ab-specific responses of variants highlight how full-atomic structure and dynamics analyses are required for assessing the response to newly emerging variants.
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Journal: Experience of Rwanda on COVID-19 Case Management: From Uncertainties to the Era of Neutralizing Monoclonal Antibodies. (Pubmed Central) - Feb 23, 2022
Moving forward, as we strive to continue detecting COVID-19 cases as early as possible, and promptly initiate supportive interventions, the use of neutralizing monoclonal antibodies constitutes an attractive and cost-effective therapeutic approach. If this approach is used strategically along with other measures in place (i.e., COVID-19 vaccine roll out, etc.), it will enable us to bring this global battle against the COVID-19 pandemic under full control and with a low case fatality rate.
- |||||||||| etesevimab (JS016) / Chinese Academy of Sciences, Shanghai Junshi Biosci, Eli Lilly
Journal: COVID-19 updates: NIH outpatient treatment guidelines. (Pubmed Central) - Feb 23, 2022
If this approach is used strategically along with other measures in place (i.e., COVID-19 vaccine roll out, etc.), it will enable us to bring this global battle against the COVID-19 pandemic under full control and with a low case fatality rate. No abstract available
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Review, Journal: SARS-CoV-2 Variants of Concern and Variants of Interest Receptor Binding Domain Mutations and Virus Infectivity. (Pubmed Central) - Feb 22, 2022
In this review, we focus on the impact of RBD mutations in SARS-CoV-2 variants of concern (VOC) and variants of interest (VOI) on ACE2 binding affinity and escape of serum antibody neutralization. We also provide protein structure models to show how the VOC and VOI RBD mutations affect ACE2 binding and allow escape of the virus from the therapeutic antibody, bamlanivimab.
- |||||||||| etesevimab (JS016) / Chinese Academy of Sciences, Shanghai Junshi Biosci, Eli Lilly
Journal: COVID-19 Updates: Monoclonal Antibodies for COVID-19. (Pubmed Central) - Feb 19, 2022
Availability of open-access codes and application of novel in silico model-based approaches supported the selection of bamlanivimab and identified the lowest dose evaluated in this study that was expected to result in the maximum therapeutic effect before the first-in-human clinical trial. No abstract available
- |||||||||| B-Cell Depletion Associated Prolonged COVID-19 and Response to Treatment with Monoclonal Antibodies: A Case Series (Area J, Hall F (North Building, Exhibition Level), Moscone Center) - Feb 19, 2022 - Abstract #ATS2022ATS_868;
Those with B-cell depletion due to therapies like Rituximab and Obinutuzumab, often experience more protracted courses, as demonstrated in this cohort. Immunocompetent patients have seroconversion at 7-14 days after symptom onset in most cases, but patients with B-cell depletion may fail to develop neutralizing antibodies weeks to months after.
- |||||||||| etesevimab (JS016) / Chinese Academy of Sciences, Shanghai Junshi Biosci, Eli Lilly
Journal, HEOR: Launching a comparative effectiveness adaptive platform trial of monoclonal antibodies for COVID-19 in 21 days. (Pubmed Central) - Feb 17, 2022
Within 2 months, we closed the gap of the likelihood of receiving mAb, conditional on background positivity rate, between Black and White patients (Black patients 0.238; White patients 0.241). We describe trial infrastructure, lessons learned, and future directions for a culture of learning while doing.
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