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Biosimilars/Research

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ADCC enhancement technologies for monoclonal antibodies

Biosimilars/Research | Posted 17/02/2010

In a 2009 article by Dr Cheng Liu, founder and CEO of Eureka Therapeutics in California, and Andreia Lee in Trends in Bio/Pharmaceutical Industry on Antibody Therapeutics, it is stated that ADCC (Antibody Dependent Cell-mediated Cytotoxicity) enhancement is a key strategy for improving therapeutic antibody drug efficacy against cell-surface targets in cancer and chronic inflammation. It takes advantage of patients’ innate immune cells to kill target cells. The functions are primarily triggered through direct interaction of the Fc domain of human immunoglobulin (in most cases IgG1) with the corresponding receptors. Therapeutic antibodies with enhanced ADCC are anticipated to have a clinical advantage owing to increased specific lysis of target cells, such as cancer cells, mediated by Fc receptors present on natural killer cells, macrophages, and other immune cell types.

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Xencor: Via Fc engineering enhanced antibody half-life improves in vivo activity

Biosimilars/Research | Posted 17/02/2010

Improved affinity for the neonatal Fc receptor (FcRn) is known to extend antibody half-life in vivo. However, this has never been linked with enhanced therapeutic efficacy. Mr Jonathan Zalevsky and Dr John Desjarlais et al. of Xencor at Monrovia, CA, USA, studied if such enhanced antibody half-life improves in vivo activity, as published online in Nature Biotechnology on 17 January 2010.

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Ustekinumab better than etanercept in psoriasis trial

Biosimilars/Research | Posted 05/02/2010

In a study by Christopher Griffiths et al. of the University of Manchester, UK, Johnson & Johnson (J&J)’s monoclonal antibody STELARA (ustekinumab, an interleukin-12 and interleukin-23 blocker) and Amgen’s Enbrel (etanercept, an inhibitor of tumour necrosis factor: anti-TNF) have been compared for the treatment of psoriasis, as published in The New England Journal of Medicine (NEJM) of 14 January 2010. The Phase 3, Multicenter, Randomized Study Comparing CNTO 1275 and Etanercept for the Treatment of Moderate to Severe Plaque Psoriasis’ was sponsored by J&J’s Centocor.

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FTC- Biosimilars to spur innovation and competitive prices

Biosimilars/Research | Posted 02/02/2010

In the Journal of Generic Medicines (published online 8 September 2009), Michael Wroblewski and Elizabeth Jex of the US Federal Trade Commission (FTC) write about the promise of follow-on biologics (FOBs) to spur both biological drug innovation and competitive prices.

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Time for a re-evaluation of ESAs

Biosimilars/Research | Posted 01/02/2010

In an article in The New England Journal of Medicine (NEJM) by Ellis F Unger, Aliza M Thompson, Melanie J Blank, and Robert Temple, published on 6 January 2010 at NEJM.org, it is stated that it is time for a re-evaluation of erythropoiesis-stimulating agents (ESAs).

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Modify Fc fucosylation and β-galactosylation for biobetter MAbs

Biosimilars/Research | Posted 28/01/2010

In an article by Dr Claire Morgan and Dr Daryl Fernandes of Ludger, published in IPI of Autumn 2009, it is shown how both the original drug manufacturers and the designers of follow-on biologics could produce biobetter monoclonal antibodies (MAbs) through glycoengineering. (see also Ludger’s GTO-QbD: Defining glycovariant biobetter MAbs, When is a glycoengineered biobetter commercially better than a biosimilar? and Strategy and tools for building glycoengineered biobetter MAbs)

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When is a glycoengineered biobetter commercially better than a biosimilar?

Biosimilars/Research | Posted 28/01/2010

In an article by Dr Claire Morgan and Dr Daryl Fernandes of Ludger, published in IPI of Autumn 2009, it is shown how both the original drug manufacturers and the designers of follow-on biologics could produce biobetter monoclonal antibodies (MAbs) through glycoengineering. (see also Modify Fc fucosylation and β-galactosylation for biobetter MAbs, Design out NeuGc, Fab glycosylation for biobetter MAbs, Design out Gal-α(1,3)-Gal for biobetter MAbs, Strategy and tools for building glycoengineered biobetter MAbs and Ludger’s GTO-QbD: Defining glycovariant biobetter MAbs)

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Design out NeuGc, Fab glycosylation for biobetter MAbs

Biosimilars/Research | Posted 28/01/2010

In an article by Dr Claire Morgan and Dr Daryl Fernandes of Ludger, published in IPI of Autumn 2009, it is shown how both the original drug manufacturers and the designers of follow-on biologics could produce biobetter monoclonal antibodies (MAbs) through glycoengineering. (see also Ludger’s GTO-QbD: Defining glycovariant biobetter MAbs, When is a glycoengineered biobetter commercially better than a biosimilar? and Strategy and tools for building glycoengineered biobetter MAbs)

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Design out Gal-α(1,3)-Gal for biobetter MAbs

Biosimilars/Research | Posted 28/01/2010

In an article by Dr Claire Morgan and Dr Daryl Fernandes of Ludger, published in IPI of Autumn 2009, it is shown how both the original drug manufacturers and the designers of follow-on biologics could produce biobetter monoclonal antibodies (MAbs) through glycoengineering. (see also Ludger’s GTO-QbD: Defining glycovariant biobetter MAbs, When is a glycoengineered biobetter commercially better than a biosimilar? and Strategy and tools for building glycoengineered biobetter MAbs)

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Strategy and tools for building glycoengineered biobetter MAbs

Biosimilars/Research | Posted 28/01/2010

In an article by Dr Claire Morgan and Dr Daryl Fernandes of Ludger, published in IPI of Autumn 2009, it is shown how both the original drug manufacturers and the designers of follow-on biologics could produce biobetter monoclonal antibodies (MAbs) through glycoengineering. (see also Modify Fc fucosylation and β-galactosylation for biobetter MAbs, Design out NeuGc, Fab glycosylation for biobetter MAbs, Design out Gal-α(1,3)-Gal for biobetter MAbs, When is a glycoengineered biobetter commercially better than a biosimilar? and Ludger’s GTO-QbD: Defining glycovariant biobetter MAbs)