Therapeutic Monoclonal Antibodies Approved by FDA in 2015

Cai, Henry Hongrong

doi:10.15406/moji.2016.03.00087

Cited by 16 publications

(11 citation statements)

References 1 publication

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“…Monoclonal antibodies (mAbs) represent the fastest growing class of therapeutics [1,2] and have been especially beneficial in the treatment of cancer [3]. Since the approval of the first anti-cancer monoclonal antibody in 1986 [4], several innovations have improved the potency of monoclonal antibodies used in immunotherapies that offer increased drug efficiency and/or lower drug dosage for a specific treatment.…”

Section: Introductionmentioning

confidence: 99%

In Vivo Glycan Engineering via the Mannosidase I Inhibitor (Kifunensine) Improves Efficacy of Rituximab Manufactured in Nicotiana benthamiana Plants

Kommineni¹,

Markert²,

Ren³

et al. 2019

IJMS

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N-glycosylation has been shown to affect the pharmacokinetic properties of several classes of biologics, including monoclonal antibodies, blood factors, and lysosomal enzymes. In the last two decades, N-glycan engineering has been employed to achieve a N-glycosylation profile that is either more consistent or aligned with a specific improved activity (i.e., effector function or serum half-life). In particular, attention has focused on engineering processes in vivo or in vitro to alter the structure of the N-glycosylation of the Fc region of anti-cancer monoclonal antibodies in order to increase antibody-dependent cell-mediated cytotoxicity (ADCC). Here, we applied the mannosidase I inhibitor kifunensine to the Nicotiana benthamiana transient expression platform to produce an afucosylated anti-CD20 antibody (rituximab). We determined the optimal concentration of kifunensine used in the infiltration solution, 0.375 µM, which was sufficient to produce exclusively oligomannose glycoforms, at a concentration 14 times lower than previously published levels. The resulting afucosylated rituximab revealed a 14-fold increase in ADCC activity targeting the lymphoma cell line Wil2-S when compared with rituximab produced in the absence of kifunensine. When applied to the cost-effective and scalable N. benthamiana transient expression platform, the use of kifunensine allows simple in-process glycan engineering without the need for transgenic hosts.

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Section: Introductionmentioning

confidence: 99%

In Vivo Glycan Engineering via the Mannosidase I Inhibitor (Kifunensine) Improves Efficacy of Rituximab Manufactured in Nicotiana benthamiana Plants

Kommineni¹,

Markert²,

Ren³

et al. 2019

IJMS

View full text Add to dashboard Cite

show abstract

“…8 years later, in 1992 FDA approved first therapeutic mAb Muromonab-CD3 (trade name Orthoclone OKT3) to reduce acute rejection in patients with organ transplants, since then, as of January 11, 2017, FDA has approved 68 therapeutic mAbs [1]. Among them, in 2015, FDA totally approved 10 therapeutic monoclonal antibodies [2], it is historical high since first approval in 1992; in 2016, once again FDA approved 10 therapeutic antibodies. This mini review focuses briefly on the characteristics of the antibodies approved in 2016 by FDA [3-12], (…”

Section: Mini Reviewmentioning

confidence: 99%