Nirsevimab: First Approval

Keam, Susan J.

doi:10.1007/s40265-022-01829-6

Cited by 56 publications

(57 citation statements)

References 11 publications

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Section: History Of Antibody Use Against Hrsvmentioning

confidence: 99%

“… 127 , 128 Nirsevimab features targeted mutations to the Fc region of palivizumab, namely a three amino acid substitution (YTE), which has resulted in a significantly enhanced half-life compared to palivizumab when administered through the intramuscular route. 94 , 95 Additionally, clinical studies showed a decrease of 70% in developing lower tract respiratory infections (LTRIs) associated with hospitalizations. 94 This fact makes it attractive from economic and patient compliance perspectives, as fewer immunizations per person per season should be required, saving costs and helping achieve better patient compliance.…”

Section: Novel Investigational Agentsmentioning

confidence: 99%

“… 86 , 94 , 129 After being granted Fast Track designation in the United States (US) in 2015, nirsevimab cleared its first Phase 1/2 clinical trial in 2016, entered Phase 3 trials in 2019, and attained its first two approvals in the EU and the UK in 2022. 95 …”

Section: Novel Investigational Agentsmentioning

confidence: 99%

“…70,[84][85][86][87][88][89][90] Two antibodies are undergoing clinical research: 80,85 motavizumab (MEDI-524), which failed in Phase III clinical trial to promote cutaneous reaction in volunteers, 85,88,89,[91][92][93] and nirsevimab (MEDI8897), 86,94 which recently attained regulatory approval in the United Kingdom (UK) and in the European Union (EU). 95 They are both anti-F immunoglobulins that act as neutralizing antibodies. 86,88 Palivizumab, motavizumab, and nirsevimab all target F-hRSV.…”

Section: Types Of Antibodies Against Hrsv In Current Clinical Usementioning

confidence: 99%

“…As previously mentioned, only palivizumab sees current regular use due to the discontinuation of IVIG, 25,30 although, because of its recent approval, nirsevimab is also expected to soon reach common use. 95 Palivizumab is reserved for preterm infants with biomedical complications, most notably bronchopulmonary dysplasia. 30,79,82 Efficacy is moderate: nearly 55% in preventing hospitalization.…”

Section: Clinical Value Efficacy and Outcomes Of Current Antibody Pro...mentioning

confidence: 99%

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New Developments and Challenges in Antibody-Based Therapies for the Respiratory Syncytial Virus

Diethelm‐Varela¹,

Soto²,

Riedel³

et al. 2023

IDR

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Since the discovery of the human respiratory syncytial virus (hRSV), multiple research efforts have been conducted to develop vaccines and treatments capable of reducing the risk of severe disease, hospitalization, long-term sequelae, and death from this pathogen in susceptible populations. In this sense, therapies specifically directed against hRSV are mainly based on monoclonal and polyclonal antibodies such as intravenous IgG (IVIG)-RSV and the monoclonal antibody palivizumab. However, these therapies are associated with significant limitations, including the need for the recruitment of a high number of convalescent volunteers who donate blood to procure IVIG-RSV and the costs associated with the need for repeated administrations of palivizumab. These limitations render this product not cost-effective for populations other than high-risk patients. These problems have underscored that it is still necessary to identify new safe and effective therapies for human use. However, these new therapies must benefit from a comparatively cheap production cost and the opportunity to be available to the high-risk population and anyone who requires treatment. Here, we review the different antibodies used to prevent the pathology caused by hRSV infection, highlighting therapies currently approved for human use and their clinical value. Also, the new, most promising candidates based on preclinical studies and clinical trial results are revised.

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Section: History Of Antibody Use Against Hrsvmentioning

confidence: 99%

Section: Novel Investigational Agentsmentioning

confidence: 99%

Section: Novel Investigational Agentsmentioning

confidence: 99%

Section: Types Of Antibodies Against Hrsv In Current Clinical Usementioning

confidence: 99%

Section: Clinical Value Efficacy and Outcomes Of Current Antibody Pro...mentioning

confidence: 99%

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New Developments and Challenges in Antibody-Based Therapies for the Respiratory Syncytial Virus

Diethelm‐Varela¹,

Soto²,

Riedel³

et al. 2023

IDR

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Utilizing targeted integration CHO pools to potentially accelerate the GMP manufacturing of monoclonal and bispecific antibodies

Barnard,

Zhou,

Shen

et al. 2023

Biotechnology Progress

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Monoclonal antibodies (mAbs) are effective therapeutic agents against many acute infectious diseases including COVID‐19, Ebola, RSV, Clostridium difficile, and Anthrax. mAbs can therefore help combat a future pandemic. Unfortunately, mAb development typically takes years, limiting its potential to save lives during a pandemic. Therefore “pandemic mAb” timelines need to be shortened. One acceleration tool is “deferred cloning” and leverages new Chinese hamster ovary (CHO) technology based on targeted gene integration (TI). CHO pools, instead of CHO clones, can be used for Phase I/II clinical material production. A final CHO clone (producing the mAb with a similar product quality profile and preferably with a higher titer) can then be used for Phase III trials and commercial manufacturing. This substitution reduces timelines by ~3 months. We evaluated our novel CHO TI platform to enable deferred cloning. We created four unique CHO pools expressing three unique mAbs (mAb1, mAb2, and mAb3), and a bispecific mAb (BsAb1). We then performed single‐cell cloning for mAb1 and mAb2, identifying three high‐expressing clones from each pool. CHO pools and clones were inoculated side‐by‐side in ambr15 bioreactors. CHO pools yielded mAb titers as high as 10.4 g/L (mAb3) and 7.1 g/L (BsAb1). Subcloning yielded CHO clones expressing higher titers relative to the CHO pools while yielding similar product quality profiles. Finally, we showed that CHO TI pools were stable by performing a 3‐month cell aging study. In summary, our CHO TI platform can increase the speed to clinic for a future “pandemic mAb.”

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Strategies for overcoming resistance to Bruton's tyrosine kinase inhibitor zanubrutinib

Dostálová,

Kryštof

2024

Hematological Oncology

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Bruton's tyrosine kinase (BTK) inhibitors have revolutionized the treatment of B‐cell malignancies. They target BTK, a key effector in the B‐cell receptor (BCR) signaling pathway, crucial for B‐cell survival and proliferation. The first‐in‐class irreversible BTK inhibitor, ibrutinib, was approved for various B‐cell malignancies but has limitations due to off‐target effects. Second‐generation inhibitors, such as acalabrutinib and zanubrutinib, offer improved selectivity and reduced side effects. However, resistance to BTK inhibitors, driven by BTK mutations, remains a challenge. Combinatorial therapies with PI3K inhibitors, immune checkpoint inhibitors, BH3 mimetics, and anti‐CD20 antibodies show promise in overcoming resistance. Noncovalent BTK inhibitors and proteolysis‐targeting chimeras (PROTACs) are emerging strategies with potential to combat resistance. Overall, advancements in BTK‐targeted therapies provide hope for improved outcomes in patients with B‐cell malignancies and a promising avenue to address drug resistance. Further research is needed to optimize combination therapies and identify optimal treatment regimens.

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Nirsevimab: First Approval

Cited by 56 publications

References 11 publications

New Developments and Challenges in Antibody-Based Therapies for the Respiratory Syncytial Virus

New Developments and Challenges in Antibody-Based Therapies for the Respiratory Syncytial Virus

Utilizing targeted integration CHO pools to potentially accelerate the GMP manufacturing of monoclonal and bispecific antibodies

Strategies for overcoming resistance to Bruton's tyrosine kinase inhibitor zanubrutinib

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