Top Selling Monoclonal Antibodies 2014
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Understanding Nanobodies | Ablynx

Understanding Nanobodies | Ablynx | Top Selling Monoclonal Antibodies 2014 | Scoop.it
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Nanobodies are highly specific and affinity for their target, are stable and may be given orally and are easy to manufacture.

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Gilbert C FAURE's curator insight, February 3, 2014 10:09 AM
a nice picture of nanobodies for students
Top Selling Monoclonal Antibodies 2014
Top Selling Monoclonal Antibodies 2014
Abstract A review of the best selling monoclonal antibodies in 2014 and 2013 is provided. Humira with sales of over $12.7 billion ($9.3 bn in 2012, $11bn 2013) remains the best selling monoclonal antibody, biologic as well prescription drug brand in 2014 and since 2012. The ranks of the next 4 top selling mabs remained unchanged from the 2012-2013 Table.  Remicade (9.8 Bn), Rituxan (7.6 Bn) , Avastin (7.0 Bn) and Herceptin (6.8 Bn)  were the second, third, fourth and fifth top selling mabs in 2014. The actual sales for 2014 as reported by the companies are provided. The total sales of the top selling blockbuster mabs listed in the Table were $68 billion in 2014. The global sales of all the approved therapeutic monoclonal antibodies were $78 billion in 2014. Besides the top 5 mabs, there was two monoclonal antibody with sales of over $3 billions, three with sales over $ 2 billion and 6 with sales of over $ 1 billion in 2014. In addition 5 recently launched mabs were nearing to reach sales of $ 1 billion this year. Currently 36 monoclonal antibodies are marketed in the US and Europe (January 2015).  FDA approved 6 new monoclonal antibodies in 2014. Alexion Soliris was the most expansive marketed monoclonal antibody with a price tag of $440,000 per year of treatment, a sort of Rolls-Royce of mabs and had sales of $2.2 billion in 2014.
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Best Selling Blockbuster Monoclonal Antibodies 2015

Best Selling Blockbuster Monoclonal Antibodies 2015 | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Abstract 

 A review of the best selling monoclonal antibodies in 2015 and previous years is provided. Humira with sales of over $14.5 billion ($9.3 bn in 2012, $11bn 2013, $12.7 billion in 2014) remains the best selling monoclonal antibody, biologic as well prescription drug brand in 2015. Humira has remained the top selling global brand since 2012. The ranks of the next 4 top selling mabs remained unchanged from the 2012-2013 Table. Remicade (8.8 Bn), Rituxan (7.7 Bn) , Avastin (7.5 Bn) and Herceptin (7.3 Bn) were the second, third, fourth and fifth top selling mabs in 2014. The actual sales for 2015 as reported by the companies are provided. The total sales of the top selling blockbuster mabs listed in the Table were $72 billion in 2015. The global sales of all the approved therapeutic monoclonal antibodies were $80 billion in 2015. Besides the top 5 mabs, there was one monoclonal antibody with sales of over $4 billions, six with sales over $ 2 billion and 5 with sales of over $ 1 billion in 2015. There were 17 blockbuster mabs in 2015. At least 3 new recently launched mabs are likely to cross sales of $ 1 billion in 2016.
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No public access as the article is in preparation and not completed


Best Selling Monoclonal Antibodies 2015 by Krishan Maggon

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Multiplex Identification of Antigen-Specific T Cell Receptors Using a Combination of Immune Assays and Immune Receptor Sequencing

Multiplex Identification of Antigen-Specific T Cell Receptors Using a Combination of Immune Assays and Immune Receptor Sequencing | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Monitoring antigen-specific T cells is critical for the study of immune responses and development of biomarkers and immunotherapeutics. We developed a novel multiplex assay that combines conventional immune monitoring techniques and immune receptor repertoire sequencing to enable identification of T cells specific to large numbers of antigens simultaneously. We multiplexed 30 different antigens and identified 427 antigen-specific clonotypes from 5 individuals with frequencies as low as 1 per million T cells. The clonotypes identified were validated several ways including repeatability, concordance with published clonotypes, and high correlation with ELISPOT. Applying this technology we have shown that the vast majority of shared antigen-specific clonotypes identified in different individuals display the same specificity. We also showed that shared antigen-specific clonotypes are simpler sequences and are present at higher frequencies compared to non-shared clonotypes specific to the same antigen. In conclusion this technology enables sensitive and quantitative monitoring of T cells specific for hundreds or thousands of antigens simultaneously allowing the study of T cell responses with an unprecedented resolution and scale.
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Citation: Klinger M, Pepin F, Wilkins J, Asbury T, Wittkop T, Zheng J, et al. (2015) Multiplex Identification of Antigen-Specific T Cell Receptors Using a Combination of Immune Assays and Immune Receptor Sequencing. PLoS ONE 10(10): e0141561. doi:10.1371/journal.pone.0141561
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Strategies for the Characterisation of Biopharmaceuticals - Aug 25 2015 12:00 AM - by Koen Sandra, Maureen Joseph and Pat Sandra - Chromatography Today Articles - Chromatography Today

Strategies for the Characterisation of Biopharmaceuticals - Aug 25 2015 12:00 AM - by Koen Sandra, Maureen Joseph and Pat Sandra - Chromatography Today Articles - Chromatography Today | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Protein biopharmaceuticals such as monoclonal antibodies and recombinant proteins have emerged as important therapeutics for the treatment of life-threatening diseases including cancer and autoimmune diseases.
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Monoclonal Antibody Shown to Prevent Migraine Attacks : Neurology Today

Monoclonal Antibody Shown to Prevent Migraine Attacks : Neurology Today | Top Selling Monoclonal Antibodies 2014 | Scoop.it
An abstract is unavailable.
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Hyperforin promotes post-stroke functional recovery through interleukin (IL)−17A-mediated angiogenesis

Hyperforin promotes post-stroke functional recovery through interleukin (IL)−17A-mediated angiogenesis | Top Selling Monoclonal Antibodies 2014 | Scoop.it
"Hyperforin promotes post-stroke functional recovery through interleukin (IL)−17A-mediated angiogenesis" #HMRP https://t.co/tNkquzmBws

Abstract The application of neuroimaging methods to product marketing — neuromarketing — has recently gained considerable popularity. We propose that there are two main reasons for this trend. First, the possibility that neuroimaging will become cheaper and faster than other marketing methods; and second, the hope that neuroimaging will provide marketers with information that is not obtainable through conventional marketing methods. Although neuroimaging is unlikely to be cheaper than other tools in the near future, there is growing evidence that it may provide hidden information about the consumer experience. The most promising application of neuroimaging methods to marketing may come before a product is even released — when it is just an idea being developed.
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Targeting Glycans Puts Icing on T-Cell Therapy | GEN News Highlights | GEN

Targeting Glycans Puts Icing on T-Cell Therapy | GEN News Highlights | GEN | Top Selling Monoclonal Antibodies 2014 | Scoop.it
CAR T cells hit distinctive target, aberrantly glycosylated antigens, on solid tumors
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Kite Pharma opens cell therapy plant as lead CAR-T candidate gathers steam

Kite Pharma opens cell therapy plant as lead CAR-T candidate gathers steam | Top Selling Monoclonal Antibodies 2014 | Scoop.it
The company expects a 2017 commercial launch for its flagship CAR-T therapy, which is currently in testing for several types of blood cancer.
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Enhancement of Immune Effector Functions by Modulating IgG’s Intrinsic Affinity for Target Antigen

Enhancement of Immune Effector Functions by Modulating IgG’s Intrinsic Affinity for Target Antigen | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Antibody-mediated immune effector functions play an essential role in the anti-tumor efficacy of many therapeutic mAbs. While much of the effort to improve effector potency has focused on augmenting the interaction between the antibody-Fc and activating Fc-receptors expressed on immune cells, the role of antibody binding interactions with the target antigen remains poorly understood. We show that antibody intrinsic affinity to the target antigen clearly influences the extent and efficiency of Fc-mediated effector mechanisms, and report the pivotal role of antibody binding valence on the ability to regulate effector functions. More particularly, we used an array of affinity modulated variants of three different mAbs, anti-CD4, anti-EGFR and anti-HER2 against a panel of target cell lines expressing disparate levels of the target antigen. We found that at saturating antibody concentrations, IgG variants with moderate intrinsic affinities, similar to those generated by the natural humoral immune response, promoted superior effector functions compared to higher affinity antibodies. We hypothesize that at saturating concentrations, effector function correlates most directly with the amount of Fc bound to the cell surface. Thus, high affinity antibodies exhibiting slow off-rates are more likely to interact bivalently with the target cell, occupying two antigen sites with a single Fc. In contrast, antibodies with faster off-rates are likely to dissociate each binding arm more rapidly, resulting in a higher likelihood of monovalent binding. Monovalent binding may in turn increase target cell opsonization and lead to improved recruitment of effector cells. This unpredicted relationship between target affinity and effector function potency suggests a careful examination of antibody design and engineering for the development of next-generation immunotherapeutics.
Krishan Maggon 's insight:
Citation: Mazor Y, Yang C, Borrok MJ, Ayriss J, Aherne K, Wu H, et al. (2016) Enhancement of Immune Effector Functions by Modulating IgG’s Intrinsic Affinity for Target Antigen. PLoS ONE 11(6): e0157788. doi:10.1371/journal.pone.0157788
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Autoantibody-­mediated encephalitis: Not just paraneoplastic, not just limbic, and not untreatable : Cleveland Clinic Journal of Medicine

Autoantibody-­mediated encephalitis: Not just paraneoplastic, not just limbic, and not untreatable : Cleveland Clinic Journal of Medicine | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Suspect these syndromes in cases of unexplained, seizure, encephalitis, or acute-onset psychiatric syndromes.
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Biosimilar Era Gets Rolling in Oncology

Biosimilar Era Gets Rolling in Oncology | Top Selling Monoclonal Antibodies 2014 | Scoop.it
After years of anticipation, biosimilar versions of the most widely administered monoclonal antibodies in oncology care are moving closer to fruition for the US market, starting with a new form of trastuzumab (Herceptin).
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Roche licenses Eleven Bio IL-6 Antagonist Antibody Technology, Including EBI-031 for 

Roche licenses Eleven Bio IL-6 Antagonist Antibody Technology, Including EBI-031 for  | Top Selling Monoclonal Antibodies 2014 | Scoop.it

Eleven Biotherapeutics is transforming protein drug discovery by expanding possibilities beyond traditional protein engineering.


CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, today announced that it has entered into an exclusive license agreement with F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. (Roche) relating to Eleven's Interleukin-6 (IL-6) technology. Under the terms of the agreement, Eleven has agreed to grant an exclusive, worldwide license to Roche to develop and commercialize EBI-031, a humanized monoclonal antibody that potently binds IL-6 and inhibits all known forms of IL-6 cytokine signaling, currently being developed for the potential treatment of ocular diseases, and all other IL-6 antagonist antibody technology owned by Eleven. 


 Under the agreement, Eleven will be entitled to an upfront payment of $7.5 million, along with potential future milestone payments of up to $262.5 million. The first potential future milestone payment is subject to the effectiveness of an investigational new drug application (IND) for EBI-031. This first milestone payment will equal $22.5 million if the IND becomes effective on or before September 15, 2016 or $20.0 million if the IND becomes effective after September 15, 2016. In addition, Eleven could be entitled to receive royalties for net sales of potential future products containing EBI-031 or any other potential future products containing other Eleven IL-6 compounds. Effectiveness of the license agreement is subject to approval of the license by holders of at least a majority of the outstanding shares of Eleven's common stock.

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About EBI-031 Eleven Biotherapeutics' most advanced preclinical product candidate is EBI-031 for treatment of diabetic macular edema, or DME, and uveitis. EBI-031 was designed and engineered for intravitreal delivery using Eleven's AMP-Rx platform. EBI-031 is a potent blocker of both free IL-6 and IL-6 complexed to the soluble IL-6 receptor (IL-6R).
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Phase 1 study of tabalumab, a human anti-B-cell activating factor antibody, and bortezomib in patients with relapsed/refractory multiple myeloma. - PubMed - NCBI

Phase 1 study of tabalumab, a human anti-B-cell activating factor antibody, and bortezomib in patients with relapsed/refractory multiple myeloma. - PubMed - NCBI | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Clin Cancer Res. 2016 Jun 10. pii: clincanres.0201.2016. [Epub ahead of print]

Abstract 

PURPOSE: Tabalumab, a human monoclonal antibody that neutralizes B-cell activating factor (BAFF), demonstrated anti-tumor activity in xenograft models of multiple myeloma. Here we report on a phase 1 study of relapsed/refractory multiple myeloma patients in which the primary objective was to identify a tolerable and potentially efficacious dose of tabalumab when combined with bortezomib. 

EXPERIMENTAL DESIGN: Forty-eight patients were enrolled; 20 to the dose-escalation cohort, and 28 to cohort expansion in which a dose of 100 mg of tabalumab was evaluated. All patients had received either prior bortezomib or an immunomodulatory drug; the median number of prior therapies was 3. Bortezomib was administered intravenously on days 1, 4, 8, and 11 of a 21-day schedule. Tabalumab was given every 21 days for 3 cycles, then every 42 days thereafter. 

RESULTS: The most common grade 3/4 toxicities included thrombocytopenia, neutropenia, pneumonia and peripheral sensory neuropathy. There were no dose-limiting toxicities, the maximum tolerated dose was not reached. Pharmacokinetic data suggested serum exposure increased in a greater than dose-proportional manner up to a dose of 100 mg. Out of 46 evaluable patients, 20 had confirmed responses. The median time to progression (9 patients censored) was 4.8 months; the median response duration (4 patients censored) was 7.2 months. 

CONCLUSIONS: A dose of 100 mg tabalumab in combination with bortezomib was well tolerated and active and is currently under further investigation.
Krishan Maggon 's insight:
Clin Cancer Res. 2016 Jun 10. pii: clincanres.0201.2016. [Epub ahead of print] 
Phase 1 study of tabalumab, a human anti-B-cell activating factor antibody, and bortezomib in patients with relapsed/refractory multiple myeloma. 
Raje N1, Faber E2, Richardson PG3, Schiller G4, Hohl RJ5, Cohen AD6, Forero A7, Carpenter S8, Nguyen TS9, Conti I9, Kaiser C8, Cronier DM10, Wooldridge JE11, Anderson KC12.
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Anti-GRP75 Antibody [S52A-42] SMC-133

Anti-GRP75 Antibody [S52A-42] SMC-133 | Top Selling Monoclonal Antibodies 2014 | Scoop.it
GRP75 Antibody - Mouse Monoclonal antibody to Glucose Regulated Protein 75, S52A-42. Reactivity: Hu, Ms, Rt, C.el. Applications: WB, IHC, ICC, IP, ELISA.
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Merck Receives CHMP Positive Opinion for KEYTRUDA® (pembrolizumab) for the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)

Merck Receives CHMP Positive Opinion for KEYTRUDA® (pembrolizumab) for the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Merck Receives CHMP Positive Opinion for KEYTRUDA® (pembrolizumab) for the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
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Monoclonal Antibody Epitope Mapping - Creative Biolabs

Monoclonal Antibody Epitope Mapping - Creative Biolabs | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Creative BioLabs has been a leader in commercializing a comprehensive panel of methodologies in mapping both linear and conformational epitopes of monoclonal antibodies
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Dengue virus sero-cross-reactivity drives antibody-dependent enhancement of infection with zika virus : Nature Immunology : Nature Publishing Group

Dengue virus sero-cross-reactivity drives antibody-dependent enhancement of infection with zika virus : Nature Immunology : Nature Publishing Group | Top Selling Monoclonal Antibodies 2014 | Scoop.it

Infection with Zika virus has occurred in areas previously exposed to dengue virus, a closely related flavivirus. Screaton and colleagues find that monoclonal antibodies to dengue virus cross-react with Zika virus and enhance infection.


Our data indicate that immunity to DENV might drive greater ZIKV replication and have clear implications for disease pathogenesis and future vaccine programs for ZIKV and DENV.

Krishan Maggon 's insight:
Nat Immunol. 2016 Jun 23. doi: 10.1038/ni.3515. [Epub ahead of print] 

Dengue virus sero-cross-reactivity drives antibody-dependent enhancement of infection with zika virus. 

Dejnirattisai W1, Supasa P1,2,3, Wongwiwat W1, Rouvinski A4,5, Barba-Spaeth G4,5, Duangchinda T6, Sakuntabhai A7,8, Cao-Lormeau VM9, Malasit P2,6, Rey FA4,5, Mongkolsapaya J1,2, Screaton GR1.
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'FeverPhone' to Diagnose Six Febrile Diseases with a Single Blood Drop

'FeverPhone' to Diagnose Six Febrile Diseases with a Single Blood Drop | Top Selling Monoclonal Antibodies 2014 | Scoop.it
National Institute of Health's $2.3M grant will fund the app's creation.
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Agenus Announces Commencement of Phase 1/2 Clinical Trial of anti-GITR Checkpoint Antibody INCAGN1876 in Patients with Solid Tumors

Agenus Announces Commencement of Phase 1/2 Clinical Trial of anti-GITR Checkpoint Antibody INCAGN1876 in Patients with Solid Tumors | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company developing antibodies including checkpoint inhibitors and other checkpoint modulators, and cancer.
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INCAGN1876 is an agonist antibody targeting the glucocorticoid-induced TNFR-related protein, or GITR. Upon activation, GITR, a co-stimulatory receptor, can stimulate immune cells to target and potentially destroy cancer cells. This antibody was discovered during an earlier collaboration with Ludwig Cancer Research. INCAGN1876 is being co-developed with Incyte.
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Big pharma pursues next generation of antibodies | May 2, 2016 Issue - Vol. 94 Issue 18 | Chemical & Engineering News

Big pharma pursues next generation of antibodies | May 2, 2016 Issue - Vol. 94 Issue 18 | Chemical & Engineering News | Top Selling Monoclonal Antibodies 2014 | Scoop.it
RT @GeproResearch: Big #pharma pursues next generation of antibodies |Chemical & Engineering News https://t.co/Uk28rnSHcd #mabs
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Antibody engineering and antibody therapy

Antibody engineering and antibody therapy | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Biotem has established a large technological platform to develop therapeutic antibodies
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Novel flow cytometry identified T-cell signatures of vedolizumab responders : Internal Medicine News

Novel flow cytometry identified T-cell signatures of vedolizumab responders : Internal Medicine News | Top Selling Monoclonal Antibodies 2014 | Scoop.it
SAN DIEGO – A novel test distinguished patients with inflammatory bowel disease (IBD) who responded to vedolizumab from nonresponders, investigators reported at
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High-Throughput, High-Resolution Peptide Maps | GEN Magazine Articles | GEN

High-Throughput, High-Resolution Peptide Maps | GEN Magazine Articles | GEN | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Thermo Fisher Scientific’s fast, sensitive protein characterization approach integrates enzymatic digestion, chromatographic separation, mass-spec detection, and data processing.
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FDG-PET imaging tracks ability of atezolizumab to bolster immunity against NSCLC

FDG-PET imaging tracks ability of atezolizumab to bolster immunity against NSCLC | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Non-small cell lung cancers have a collective reputation for not responding very well to chemotherapy. Researchers at the 2016 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) are presenting a means of evaluating an immunotherapy that fights off NSCLC by strengthening a patient's own immune system.
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Fc Receptor Family Proteins | amsbio

Fc Receptor Family Proteins | amsbio | Top Selling Monoclonal Antibodies 2014 | Scoop.it
AMSBIO offers a comprehensive collection of recombinant Fc receptor proteins, including their common variants, to help expedite your mAb development.
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The use of CrossMAb technology for the generation of bi- and multispecific antibodies

The use of CrossMAb technology for the generation of bi- and multispecific antibodies | Top Selling Monoclonal Antibodies 2014 | Scoop.it

The use of CrossMAb technology for the generation of bi- and multispecific antibodies. . . doi: 10.1080/19420862.2016.1197457


Abstract The major challenge in the generation of bispecific IgG antibodies is enforcement of the correct heavy and light chain association. The correct association of generic light chains can be enabled using immunoglobulin domain crossover, known as CrossMAb technology, which can be combined with approaches enabling correct heavy chain association such as knobs-into-holes (KiH) technology or electrostatic steering. Since its development, this technology has proven to be very versatile, allowing the generation of various bispecific antibody formats, not only heterodimeric/asymmetric bivalent 1+1 CrossMAbs, but also tri- (2+1), tetravalent (2+2) bispecific and multispecific antibodies. Numerous CrossMAbs have been evaluated in preclinical studies, and, so far, four different tailor-made bispecific antibodies based on the CrossMAb technology have entered clinical studies. Here, we review the properties and activities of bispecific CrossMAbs and give an overview of the variety of CrossMAb-enabled antibody formats that differ from heterodimeric 1+1 bispecific IgG antibodies.

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MAbs. 2016 Jun 10:0. [Epub ahead of print] The use of CrossMAb technology for the generation of bi- and multispecific antibodies. Klein C1, Schaefer W2, Regula JT2.
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Anti-Human Endoglin (hCD105) Immunotoxin—Containing Recombinant Single Chain Ribosome-Inactivating Protein Musarmin 1

Anti-Human Endoglin (hCD105) Immunotoxin—Containing Recombinant Single Chain Ribosome-Inactivating Protein Musarmin 1 | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Endoglin (CD105) is an accessory component of the TGF-β receptor complex, which is expressed in a number of tissues and over-expressed in the endothelial cells of tumor neovasculature. Targeting endoglin with immunotoxins containing type 2 ribosome-inactivating proteins has proved an effective tool to reduce blood supply to B16 mice tumor xenografts. We prepared anti-endoglin immunotoxin (IT)—containing recombinant musarmin 1 (single chain ribosome-inactivating proteins) linked to the mouse anti-human CD105 44G4 mouse monoclonal antibody via N-succinimidyl 3-(2-pyridyldithio) propionate (SPDP). The immunotoxin specifically killed L929 fibroblast mouse cells transfected with the short form of human endoglin with IC50 values in the range of 5 × 10−10 to 10−9 M.
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oxins 2016, 8(6), 184; doi:10.3390/toxins8060184 (registering DOI)
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