- |||||||||| REGEN-COV (casirivimab/imdevimab) / Regeneron, bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Clinical, Journal: Initial Guidance on Use of Monoclonal Antibody Therapy for Treatment of COVID-19 in Children and Adolescents. (Pubmed Central) - Jun 4, 2021
Based on evidence available as of December 20, 2020, the panel suggests against routine administration of monoclonal antibody therapy (bamlanivimab, or casirivimab and imdevimab), for treatment of COVID-19 in children or adolescents, including those designated by the FDA as at high risk of progression to hospitalization or severe disease. Clinicians and health systems choosing to use these agents on an individualized basis should consider risk factors supported by pediatric-specific evidence and ensure the implementation of a system for safe and timely administration that does not exacerbate existing healthcare disparities.
- |||||||||| REGEN-COV (casirivimab/imdevimab) / Regeneron, bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases, bamlanivimab/etesevimab (LY-CoV555/LY-CoV016) / Eli Lilly
Review, Journal: Neutralizing Antibody Therapeutics for COVID-19. (Pubmed Central) - Jun 4, 2021
Two nAb cocktails (casirivimab/imdevimab and bamlanivimab/etesevimab) and one nAb monotherapy (bamlanivimab) have been granted Emergency Use Authorization by the US Food and Drug Administration for the treatment of ambulatory patients who have a high risk of progressing to severe disease, and the European Medicines Agency has similarly recommended both cocktails and bamlanivimab monotherapy for use in COVID-19 patients who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19...However, early data suggest a promising prophylactic role for nAbs in providing effective COVID-19 protection. We also review the risk of treatment-emergent antiviral resistant "escape" mutants and strategies to minimize their occurrence, discuss the susceptibility of newly emerging SARS-COV-2 variants to nAbs, as well as explore administration challenges and ways to improve patient access.
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Journal: Cross-reactive coronavirus antibodies with diverse epitope specificities and Fc effector functions. (Pubmed Central) - Jun 1, 2021
When tested in vivo in murine models, two of the antibodies demonstrate a reduction in hemorrhagic pathology in the lungs. The identification of cross-reactive epitopes recognized by functional antibodies expands the repertoire of targets for pan-coronavirus vaccine design strategies.
- |||||||||| REGEN-COV (casirivimab/imdevimab) / Regeneron, bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases, sotrovimab (VIR-7831) / GSK, National Institutes of Health, Vir Biotech, National Institute of Allergy and Infectious Diseases
Pricing: 💰 Added :-) The price of sotrovimab is likely to be similar to what the US government paid for casirivimab/imdevimab and bamlanivimab/etesivimab, which is from $1,250 a dose to $2,100 a dose (Twitter) - May 31, 2021
- |||||||||| REGEN-COV (casirivimab/imdevimab) / Regeneron, bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases, bamlanivimab/etesevimab (LY-CoV555/LY-CoV016) / Eli Lilly
Review, Journal: Development and application of therapeutic antibodies against COVID-19. (Pubmed Central) - May 21, 2021
Four products, i.e., convalescent plasma, bamlanivimab, REGN-Cov2, and the cocktail of bamlanivimab and etesevimab have been authorized by the U.S. Food and Drug Administration (FDA) for emergency use...Therapeutic antibody therapies have been a very active and crucial part of COVID-19 treatment. In this review, we focus on the progress of therapeutic COVID-19 antibody development and application, discuss corresponding problems and challenges, suggesting new strategies and solutions.
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Journal: Identification of and Surveillance for the SARS-CoV-2 Variants B.1.427 and B.1.429 - Colorado, January-March 2021. (Pubmed Central) - May 21, 2021
On January 24, the Colorado Department of Public Health and Environment (CDPHE) identified the first Colorado case of COVID-19 attributed to these variants. B.1.427 and B.1.429 were considered a single variant described as CAL.20C or B.1.427/B.1.429 in the 20C clade (1,3); in this report "B.1.427/B.1.429" refers to B.1.427 or B.1.429 lineage, including those reported as B.1.427/B.1.429 without further differentiation.
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
[VIRTUAL] Short Term Outcomes in Previously Covid Positive Living Kidney Donors and Their Recipients () - May 18, 2021 - Abstract #ATC2021ATC_1191;
Recipients of LKD with resolved COVID tend to do well. Questions remain regarding optimal timing of donation and transplant after COVID resolution, to minimize risk of SARS-CoV2 transmission through tissue, even with negative nasopharyngeal PCR
- |||||||||| REGEN-COV (casirivimab/imdevimab) / Regeneron, bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
[VIRTUAL] Nurse and Nurse Practitioner-lead Monoclonal Antibody Initiative for Solid Organ Transplant (sot) Recipients with Covid-19 () - May 18, 2021 - Abstract #ATC2021ATC_1186;
Compared to prior published COVID-19 outcomes in SOT recipients, patients who received mAB may have reduce hospitalization and low mortality. As mAB therapy may be underutilized in the general population, these results support efforts to educate transplant centers to implement efficient interventions for the screening and referral of COVID+ SOT recipients for mAB therapy.
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
[VIRTUAL] Monoclonal Antibodies for Covid-19 in Patients with Solid Organ Transplant Recipients () - May 18, 2021 - Abstract #ATC2021ATC_1185;
As mAB therapy may be underutilized in the general population, these results support efforts to educate transplant centers to implement efficient interventions for the screening and referral of COVID+ SOT recipients for mAB therapy. Infusion of monoclonal antibodies for the treatment of mild to moderate Covid-19 was a safe strategy for Solid Organ Transplant Recipients, reducing hospitalizations and mortality from SARS-CoV2 infections in such high-risk population.
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
[VIRTUAL] Bamlanivimab for Covid-19 in Kidney Transplant Patients () - May 18, 2021 - Abstract #ATC2021ATC_1169;
It showed a beneficial effect in immunosuppressed patients with mild to moderate COVID 19 symptoms with majority avoiding hospitalization. It appears to be well tolerated with no significant major adverse effects or allergic reactions in our cohort.
- |||||||||| Comirnaty (tozinameran) / Pfizer, Fosun Pharma, BioNTech, bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Journal: SARS-CoV-2 variants B.1.351 and P.1 escape from neutralizing antibodies. (Pubmed Central) - May 14, 2021
Here, using pseudoparticles, we show that entry of all variants into human cells is susceptible to blockade by the entry inhibitors soluble ACE2, Camostat, EK-1, and EK-1-C4...Moreover, entry of these variants was less efficiently inhibited by plasma from convalescent COVID-19 patients and sera from BNT162b2-vaccinated individuals. These results suggest that SARS-CoV-2 may escape neutralizing antibody responses, which has important implications for efforts to contain the pandemic.
- |||||||||| 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 date: BLAZE-1: A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness (clinicaltrials.gov) - May 11, 2021
P2/3, N=3160, Recruiting,
Although not statistically significant, there was a trend towards a lower risk of hospitalization in patients treated with LY-CoV555. Trial completion date: Jun 2021 --> Jun 2022
- |||||||||| 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
Enrollment open: CATCO-NOS: Treatment of Nosocomial COVID-19 (clinicaltrials.gov) - May 2, 2021
P4, N=648, Recruiting,
Trial completion date: Jun 2021 --> Jun 2022 Not yet recruiting --> Recruiting
- |||||||||| Clinical, Review, Journal: Emerging antibody-based therapeutics against SARS-CoV-2 during the global pandemic. (Pubmed Central) - Apr 30, 2021
As of 11 October 2020, 13 human monoclonal antibodies targeting the SARS-CoV-2 spike protein have entered clinical trials with three (REGN-COV2, LY3819253/LY-CoV555, and VIR-7831/VIR-7832) in phase 3...A cocktail strategy such as REGN-COV2, or engineered multivalent and multispecific molecules, combining two or more antibodies might improve the efficacy and protect against resistance due to virus escape mutants. Besides the receptor-binding domain, other viral antigens such as the S2 subunit of the spike protein and the viral attachment sites such as heparan sulfate proteoglycans that are on the host cells are worth investigating.
- |||||||||| REGEN-COV (casirivimab/imdevimab) / Regeneron, bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Review, Journal: Neutralizing antibodies against SARS-CoV-2: current understanding, challenge and perspective. (Pubmed Central) - Apr 30, 2021
NAbs-based therapeutics against SARS-CoV-2 are being expedited to preclinical and clinical studies with two antibody drugs, LY3819253 (LY-CoV555) and REGN-COV2 (REGN10933 and REGN10987), approved by the US Food and Drug Administration for emergency use authorization for treating COVID-19...We also summarize the challenges of NAbs therapeutics such as antibody-dependent enhancement and viral escape mutations. Such evidence is urgently needed to the development of antibody therapeutic interventions that are likely required to reduce the global burden of COVID-19.
- |||||||||| Enrollment open: UPMC OPTIMISE-C19 Trial, a COVID-19 Study (clinicaltrials.gov) - Apr 29, 2021
P3, N=5000, Recruiting,
Such evidence is urgently needed to the development of antibody therapeutic interventions that are likely required to reduce the global burden of COVID-19. Not yet recruiting --> Recruiting
- |||||||||| REGEN-COV (casirivimab/imdevimab) / Regeneron, bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
[VIRTUAL] Outcomes of active cancer patients with COVID-19 infection treated with COVID-19 neutralizing monoclonal antibodies. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_944;
Key limitations of this analysis include the lack of a control group for comparison and a small sample size given the recent emergency use authorization of these agents . Given the high mortality rate of active cancer patients with C19, these data support the use of mAbs in cancer patients with C19.
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Enrollment closed, Real-world evidence, Real-world effectiveness, Real-world: BLAZE-5: A Real World Study of Bamlanivimab in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) - Apr 27, 2021
P2, N=3000, Active, not recruiting,
Further study is warranted to explore the scalability and efficacy of this program. Recruiting --> Active, not recruiting
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases, bamlanivimab/etesevimab (LY-CoV555/LY-CoV016) / Eli Lilly
Enrollment closed, Combination therapy: BLAZE-2: A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Preventing SARS-CoV-2 Infection and COVID-19 in Nursing Home Residents and Staff (clinicaltrials.gov) - Apr 20, 2021
P3, N=5000, Active, not recruiting,
Initiation date: Jan 2020 --> Oct 2020 | Trial primary completion date: Mar 2021 --> Aug 2021 Recruiting --> Active, not recruiting
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases
Review, Journal: In Translation: FcRn across the Therapeutic Spectrum. (Pubmed Central) - Apr 17, 2021
We further comment on therapeutic antibodies authorized for treating SARS-CoV-2 (bamlanivimab, casirivimab, and imdevimab) and evaluate their potential to saturate FcRn-mediated recycling. Finally, we discuss modeling and simulation studies that probe the quantitative relationship between in vivo IgG persistence and in vitro FcRn binding, emphasizing the importance of endosomal transit parameters.
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases, etesevimab (JS016) / Chinese Academy of Sciences, Shanghai Junshi Biosci, Eli Lilly
Journal: Complete map of SARS-CoV-2 RBD mutations that escape the monoclonal antibody LY-CoV555 and its cocktail with LY-CoV016. (Pubmed Central) - Apr 13, 2021
Furthermore, we identify single amino acid changes that escape the combined LY-CoV555+LY-CoV016 cocktail. We suggest that future efforts diversify the epitopes targeted by antibodies and antibody cocktails to make them more resilient to the antigenic evolution of SARS-CoV-2.
- |||||||||| bamlanivimab (LY-CoV555) / Eli Lilly, AbCellera, National Institute of Allergy and Infectious Diseases, bamlanivimab/etesevimab (LY-CoV555/LY-CoV016) / Eli Lilly
Journal: An EUA for bamlanivimab and etesevimab for COVID-19. (Pubmed Central) - Apr 10, 2021
No abstract available No abstract available
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