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Understanding Nanobodies | Ablynx

Understanding Nanobodies | Ablynx | Top Selling Monoclonal Antibodies 2013 | Scoop.it
Krishan Maggon 's insight:

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 Faure au nom de l'ASSIM's curator insight, February 3, 10:09 AM
a nice picture of nanobodies for students
Top Selling Monoclonal Antibodies 2013
Top Selling Monoclonal Antibodies 2013
A review of the best selling monoclonal antibodies in 2013 and 2012 is provided. Humira with sales of over $11 billion ($9.3 billion in 2012) remains the best selling monoclonal antibody, biologic as well prescription drug brand in 2013 as in 2012. The ranks of the next 4 top selling mabs remained unchanged from the 2012 Table. Remicade (8 Bn), Rituxan (7.5 Bn) , Herceptin (6.5 Bn) and Avastin (6.5 Bn) were the second, third, fourth and fifth top selling mabs in 2013. The projected sales for 2013 are provided. These projections will be replaced by the companies reported actual sales in due course. The projected and actual global sales of all the approved blockbuster sales or potential (sales >1 billion) monoclonal antibodies in 2013 is provided. Besides the top 5 mabs, there were 2 other monoclonal antibodies with sales of over 2 billion dollars and 5 with sales of over $ 1 billion in 2013. In addition 5 recently launched mabs were nearing to reach sales of $ 1 billion this year. Currently 30 monoclonal antibodies are marketed in the US and Europe (January 2014).
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Best Selling Monoclonal Antibodies 2013

Best Selling Monoclonal Antibodies 2013 | Top Selling Monoclonal Antibodies 2013 | Scoop.it

From today, it is a free open public access article about the marketing success of therapeutic mabs. It will be revised regularly and must be properly cited and with direct links. It needs lots of readers, followers and rescoops.

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Abstract

 

A review of the best selling monoclonal antibodies in 2013 and 2012 is provided. Humira with sales of over $11 billion ($9.3 billion in 2012) remains the best selling monoclonal antibody, biologic as well prescription drug brand in 2013 as in 2012. The ranks of the next 4 top selling mabs remained unchanged from the 2012 Table.  Remicade (9.7 Bn), Rituxan (7.5 Bn) , Herceptin (6.5 Bn) and Avastin (6.5 Bn) were the second, third, fourth and fifth top selling mabs in 2013. The actual sales for 2013 as reported by the companies are provided. The total sales of the top selling blockbuster mabs were $63 billion in 2013. The actual global sales of all the approved blockbuster sales or potential (sales >1 billion) monoclonal antibodies in 2013 is provided. Besides the top 5 mabs, there were 2 other monoclonal antibodies with sales of over 2 billion dollars and 5 with sales of over $ 1 billion in 2013. In addition 5 recently launched mabs were nearing to reach sales of $ 1 billion this year. Currently 30 monoclonal antibodies are marketed in the US and Europe (January 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.

 

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Gilbert Faure au nom de l'ASSIM's curator insight, January 6, 8:51 AM

impressive for immunologists so far away from so big amounts of money

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UK Continues to Invest in GMP Manufactured Biologics and Advanced Therapies - Genetic Engineering & Biotechnology News

UK Continues to Invest in GMP Manufactured Biologics and Advanced Therapies - Genetic Engineering & Biotechnology News | Top Selling Monoclonal Antibodies 2013 | Scoop.it
Difficult business requires investment in the right infrastructure and skilled people, as well as developing the right processes for efficient and profitable manufacturing.
Krishan Maggon 's insight:

http://www.genengnews.com/insight-and-intelligence/u-k-continues-to-invest-in-gmp-manufactured-biologics-and-advanced-therapies/77900346/

 

The scoop it link does not work?

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The development of immunomodulatory monoclonal antibodies as a new therapeutic modality for cancer: The Bristol-Myers Squibb experience

The development of immunomodulatory monoclonal antibodies as a new therapeutic modality for cancer: The Bristol-Myers Squibb experience | Top Selling Monoclonal Antibodies 2013 | Scoop.it

Abstract

The discovery and increased understanding of the complex interactions regulating the immune system have contributed to the pharmacologic activation of antitumor immunity. The activity of effector cells, such as T and NK cells, is regulated by an array of activating and attenuating receptors and ligands. Agents that target these molecules can modulate immune responses by exerting antagonistic or agonistic effects.

Several T- or NK-cell modulators have entered clinical trials, and two have been approved for use. Ipilimumab (Yervoy®, Bristol-Myers Squibb) and nivolumab (OPDIVO, Ono Pharmaceutical Co., Ltd./Bristol-Myers Squibb) were approved for the treatment of metastatic melanoma, in March 2011 in the United States, and in July 2014 in Japan, respectively.

The clinical activity of these two antibodies has not been limited to tumor types considered sensitive to immunotherapy, and promising activity has been reported in other solid and hematologic tumors.

Clinical development of ipilimumab and nivolumab has presented unique challenges in terms of safety and efficacy, requiring the establishment of new evaluation criteria for adverse events and antitumor effects. Guidelines intended to help oncologists properly manage treatment in view of these non-traditional features have been implemented.

The introduction of this new modality of cancer treatment, which is meant to integrate with or replace the current standards of care, requires additional efforts in terms of optimization of treatment administration, identification of biomarkers and application of new clinical trial designs. The availability of immune modulators with different mechanisms of action offers the opportunity to establish immunological combinations as new standards of care.

Krishan Maggon 's insight:
Pharmacology & Therapeutics

Available online 1 December 2014

In Press, Corrected Proof — Note to users

 The development of immunomodulatory monoclonal antibodies as a new therapeutic modality for cancer: The Bristol-Myers Squibb experienceDavid Berman, Alan Korman, Ronald Peck, David Feltquate, Nils Lonberg, Renzo Canetta,   doi:10.1016/j.pharmthera.2014.11.017
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MacroGenics Licenses MGD011 for Multiple B-Cell Malignancies to Janssen, deal worth $ 700 million

MacroGenics Licenses MGD011 for Multiple B-Cell Malignancies to Janssen, deal worth $ 700 million | Top Selling Monoclonal Antibodies 2013 | Scoop.it

Rockville, Maryland, Dec. 22, 2014 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as various autoimmune disorders and infectious diseases, today announced a global collaboration and license agreement for MGD011 with Janssen Biotech, Inc. This product candidate incorporates MacroGenics' proprietary platform for Dual-Affinity Re-Targeting (DART®) to simultaneously target CD19 and CD3 for the potential treatment of B-cell malignancies.

 

Under the terms of the agreement and subject to the termination or expiration of any applicable waiting periods under Hart-Scott-Rodino Act,MacroGenics will receive a $50 million upfront license fee and Johnson & Johnson Innovation - JJDC, Inc. will invest $75 million to purchase 1,923,077 new shares of MacroGenics common stock at a price of $39.00 per share.  Janssen will be fully responsible for developing MGD011 following submission of the IND, which is planned for 2015.  Assuming successful development and commercialization, MacroGenics could receive up to an additional $575 million in clinical, regulatory and commercialization milestone payments.  MacroGenics may elect to fund a portion of late-stage clinical development in exchange for a profit share in the U.S. and Canada. If commercialized, MacroGenics would be eligible to receive double-digit royalties on any global net sales and has the option to co-promote the molecule with Janssen in the U.S.

Krishan Maggon 's insight:
MacroGenics licenses MGD011 (CD19 x CD3 DART®) to Janssen$50 million upfront license fee paid to MacroGenics, and a $75 million equity investment by Johnson & Johnson Innovation - JJDC, Inc.MacroGenics may elect to fund a portion of late-stage development costs in exchange for a U.S. and Canada profit shareMacroGenics may elect to co-promote in the United States

About MGD011

MGD011, a humanized CD19 x CD3 bispecific DART protein, is being developed for the treatment of B-cell hematological malignancies.  CD19, a lymphocyte-specific marker expressed from early B-lymphocyte development through mature memory B cells, is highly represented in B-cell malignancies. This makes it attractive for targeted interventions. MGD011 is designed to redirect T cells, via their CD3 component, to eliminate CD19-expressing cells found in many hematological malignancies.  MGD011 has been engineered to address half-life challenges posed by other programs targeting CD19 and CD3. This product candidate has an Fc domain, which allows for extended pharmacokinetic properties and convenient dosing at a once-a-week or longer interval.  In addition, MGD011 and the Company's other DART molecules that redirect T cells against cancer targets are manufactured using a conventional antibody platform without the complexity of having to genetically modify T cells from individual patients as required by approaches such as chimeric antigen receptor (CAR) T-cells.

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Baxter Submits BLA for FDA Approval of BAX111, Investigational Recombinant Treatment for Von Willebrand Disease

Baxter Submits BLA for FDA Approval of BAX111, Investigational Recombinant Treatment for Von Willebrand Disease | Top Selling Monoclonal Antibodies 2013 | Scoop.it
Baxter Submits Application for U.S. FDA Approval of BAX111, Investigational Recombinant Treatment for Von Willebrand Disease

 

 Baxter International Inc. (NYSE:BAX) today announced that the company has submitted a biologics license application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for the approval of BAX111, the first highly-purified recombinant von Willebrand Factor (rVWF) in clinical development as a treatment for patients with von Willebrand disease, the most common type of inherited bleeding disorder.

 

The filing was based on the completion of a Phase III, multi-center, open-label clinical trial assessing the safety, efficacy and pharmacokinetics of BAX111. The study met its primary efficacy endpoint defined by the number of patients who achieved treatment success for control of bleeding episodes. All patients treated in the full analysis set (n=22) experienced a 100% treatment success rating based on a 4-point efficacy rating scale, comparing prospectively estimated number of infusions needed to treat the bleeding episodes to the actual number of infusions administered. The median number of infusions required to treat bleeding events in the trial was 1.0 and the majority of events (81.1%) were resolved with a single infusion.

A total of 125 adverse events (AE's) following 318 infusions occurred in 25/37 subjects. Eight AEs were considered causally related to BAX111: six non-serious related AEs (tachycardia, infusion site paresthesia, electrocardiography (ECG) T-wave inversion, dysgeusia, generalized pruritis and hot flush) occurred in four patients, and two related SAEs (chest discomfort and increased heart rate) occurred in one patient.

Baxter expects to publish additional data from the trial in the coming months.

Krishan Maggon 's insight:

 Both the European Commission and the U.S. Food and Drug Administration have granted orphan-drug designation for BAX111.

 

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Preclinical screening for acute toxicity of therapeutic monoclonal antibodies ... - Nature.com

Preclinical screening for acute toxicity of therapeutic monoclonal antibodies ... - Nature.com | Top Selling Monoclonal Antibodies 2013 | Scoop.it
Abstract

Monoclonal antibodies (mAbs) have been a spectacular clinical and commercial success in the treatment of cancer and autoimmune diseases. Many of these mAbs (for example, OKT3, Campath-1H, rituximab and infliximab) are against surface or secreted products of lymphocytes. However, mAbs can have a variety of adverse effects including fever, chills and nausea. This is probably a result of cytokine release, which is most seriously manifested as a ‘cytokine storm’ as highlighted by the TGN1412 (anti-CD28) trial. Prediction of adverse effects of mAbs would be clinically advantageous and numerous in vitro assays attempting to predict adverse effects have been reported. Here, we report an in vivo humanized mouse model to detect adverse effects in response to OKT3, Campath-1H or the polyclonal Ab preparation anti-thymocyte globulin. We found that the administration of each of these Abs to humanized mice led to acute clinical symptoms such as piloerection, hypomotility and hypothermia, particularly when delivered via the intravenous route. A cytokine storm occurred in the humanized mice receiving OKT3. This model system is a potentially useful tool to predict adverse effects and select initial doses for first-in-human trials. We would advocate this in vivo model, in addition to current in vitropreclinical testing, as a more representative and robust means of assessing potential adverse effects of mAb before their human use.

Krishan Maggon 's insight:

Citation: Clinical & Translational Immunology (2014) 3, e29; doi:10.1038/cti.2014.28
Published online 19 December 2014

Preclinical screening for acute toxicity of therapeutic monoclonal antibodies in a hu-SCID model
OPEN

Jamie L Brady1,2, Leonard C Harrison1,2, David J Goodman3, Peter J Cowan4,5, Wayne J Hawthorne6, Philip J O'Connell6, Robyn M Sutherland1,2,7 and Andrew M Lew1,2,7

1Walter and Eliza Hall Institute of Medical Research, Parkville, Victoria, Australia2Department of Medical Biology, The University of Melbourne, Parkville, Victoria, Australia3Department of Nephrology, St Vincent’s Hospital, Fitzroy, Victoria, Australia4Immunology Research Centre, St Vincent’s Hospital, Fitzroy, Victoria, Australia5Department of Medicine, The University of Melbourne, Parkville, Victoria, Australia6Centre for Transplant and Renal Research, Westmead Millennium Institute, University of Sydney at Westmead Hospital, Westmead, New South Wales, Australia

Correspondence: Professor AM Lew, Walter and Eliza Hall Institute of Medical Research, 1G Royal Parade, Parkville 3052, Victoria, Australia. E-mail: lew@wehi.edu.au

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Gilbert Faure au nom de l'ASSIM's comment, December 20, 12:53 PM
applicable to biosimilars?!
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New class of synthetic molecules mimics antibodies

New class of synthetic molecules mimics antibodies | Top Selling Monoclonal Antibodies 2013 | Scoop.it
RT @_bioengineer: #Immunology #SyntheticBiology New class of synthetic molecules ... - Read more: http://t.co/WiXJO7rTHc http://t.co/pEVbOn…

Via Gilbert Faure au nom de l'ASSIM
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Biosimilars entering the clinic without animal studies

Biosimilars entering the clinic without animal studies | Top Selling Monoclonal Antibodies 2013 | Scoop.it
(2014). Biosimilars entering the clinic without animal studies. mAbs: Vol. 6, No. 5, pp. 1155-1162. doi: 10.4161/mabs.29848

 

AbstractThe concept of biosimilars has spread from Europe to other regions throughout the world, and many regions have drafted regulatory guidelines for their development. Recently, a paradigm shift in regulatory thinking on the non-clinical development of biosimilars has emerged in Europe: In vivo testing should follow a step-wise approach rather than being performed by default. To not require animal testing at all in some instances can well be seen as a revolutionary, but science-based, step. Here, we describe the internal discussions that led to this paradigm shift. The mainstay for the establishment of biosimilarity is the pharmaceutical comparability based on extensive physicochemical and biological characterization. Pharmacodynamic comparability can be evaluated in in vitro assays, whereas pharmacokinetic comparability is best evaluated in clinical studies. It is considered highly unlikely that new safety issues would arise when comparability has been demonstrated based on physicochemical and in vitro comparative studies.
Krishan Maggon 's insight:
mAbsVolume 6, Issue 5, 2014 Biosimilars entering the clinic without animal studiesA paradigm shift in the European Union View full textDownload full textOpen accessDOI:10.4161/mabs.29848Leon AGJM van Aertsabc*, Karen De Smetdef, Gabriele Reichmannceg, Jan Willem van der Laanah & Christian K Schneiderij

pages 1155-1162

Publishing models and article dates explainedReceived: 1 Jun 2014Accepted: 7 Jul 2014Accepted author version posted online: 30 Oct 2014
Published online: 05 Aug 2014Article Views: 573
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Blocking monoclonal antibodies of TIM proteins as orchestrators of anti-tumor immune response

Blocking monoclonal antibodies of TIM proteins as orchestrators of anti-tumor immune response | Top Selling Monoclonal Antibodies 2013 | Scoop.it
MAbs. 2014 Sep 3;6(5):1124-32. doi: 10.4161/mabs.32107. Epub 2014 Oct 30.

 

Abstract

Monoclonal antibody (mAb)-based treatment of cancer has a significant effect on current practice in medical oncology, and is considered now as one of the most successful therapeutic strategies for cancer treatment. MAbs are designed to initiate or enhance anti-tumor immune responses, which can be achieved by either blocking inhibitory immune checkpoint molecules or triggering activating receptors. TIM gene family members are type-I surface molecules expressed in immune cells, and play important roles in the regulation of both innate and adaptive arms of the immune system. Therapeutic strategies based on anti-TIMs mAbs have shown promising results in experimental tumor models, and synergistic combinations of anti-TIMs mAbs with cancer vaccines, adoptive T-cell therapy, radiotherapy and chemotherapy will have great impact on cancer treatment in future clinical development.

Krishan Maggon 's insight:
    MAbs. 2014 Sep 3;6(5):1124-32. doi: 10.4161/mabs.32107. Epub 2014 Oct 30.Blocking monoclonal antibodies of TIM proteins as orchestrators of anti-tumor immune response.Baghdadi M1, Takeuchi S, Wada H, Seino K.
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Immunotherapy for patients with acute psychosis and serum N-Methyl d-Aspartate receptor (NMDAR) antibodies: A description of a treated case series - Schizophrenia Research

Immunotherapy for patients with acute psychosis and serum N-Methyl d-Aspartate receptor (NMDAR) antibodies: A description of a treated case series - Schizophrenia Research | Top Selling Monoclonal Antibodies 2013 | Scoop.it
RT @PPiPStudy: We're officially published online #nmdar #psychosis #immunotherapy http://t.co/liASgzJULS
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Plantibodies Could Pave the Road to Wellness - Newsweek

Plantibodies Could Pave the Road to Wellness - Newsweek | Top Selling Monoclonal Antibodies 2013 | Scoop.it
Newsweek Plantibodies Could Pave the Road to Wellness Newsweek The “plantibody,” as this and other antibodies grown in plants have been dubbed by the handful of companies that develop them, is the product of decades of sky-high hopes and...
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Gilbert Faure au nom de l'ASSIM's curator insight, December 18, 3:56 AM

the dream of decades may decrease the costs of MoAbs?

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Imaging atlas for eligibility and on-study safety of potential knee adverse events in anti-NGF studies (Part 1) - Osteoarthritis and Cartilage

Imaging atlas for eligibility and on-study safety of potential knee adverse events in anti-NGF studies (Part 1) - Osteoarthritis and Cartilage | Top Selling Monoclonal Antibodies 2013 | Scoop.it

Summary

Monoclonal antibodies that bind and inhibit nerve growth factor (NGF) have demonstrated both, good analgesic efficacy and improvement in function in patients with osteoarthritis (OA). Despite initial promising data, trials in OA had been suspended by the Federal Food and Drug Administration (FDA) due to concerns over accelerated rates of OA progression. Imaging will play a crucial role in future clinical trials to define eligibility of potential participants and to monitor safety during the course of these studies. This will require baseline and frequent follow-up radiographs of both, the index joints and other large weight bearing joints to identify subjects at risk prior inclusion and on study so treatment can be discontinued.

This imaging overview in the form of an atlas describes and illustrates potential exclusionary joint imaging findings at eligibility and potential adverse joint events on radiography and magnetic resonance imaging (MRI) in studies investigating a-NGF compounds. The overarching goal of this atlas is to facilitate trial design and to promote a common language and understanding between potential expert readers. This first section of the atlas will focus on knee joint specific findings that are relevant to a-NGF studies.

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Apexigen Rabbit Derived Therapeutic Monoclonal Antibodies

Apexigen Rabbit Derived Therapeutic Monoclonal Antibodies | Top Selling Monoclonal Antibodies 2013 | Scoop.it

 Apexigen is pioneering a movement into therapeutics based on rabbit-derived humanized monoclonal antibodies as a means of providing therapeutic benefits that have not been achieved through the use of other technologies.

Several blockbuster antibody drugs have been developed with existing mouse and human antibody technologies and display libraries. However, the development of the next generation of antibody-based drugs will require capabilities that exceed those of current technologies in order to bind rare or intractable antigen epitopes and to exert novel effects on disease processes. The key to these next generation therapeutics lies in harnessing the inherent advantages of rabbit antibodies, which have been used successfully in research settings for decades. These advantages are the result of rabbit’s ability to generate a much greater diversity of unique high quality antibodies - with high affinity, high specificity and which bind unique antigen epitopes. These attributes enable the discovery of antibodies that are capable of targeting previously unreachable disease mechanisms.

The company’s proprietary platform technology has allowed Apexigen to build a strong and broad pipeline of seven unique humanized monoclonal antibody programs spanning indications including oncology, inflammatory disease and ophthalmology. Of these seven candidates, four are currently the subject of development partnerships with leading life science companies.

Apexigen’s most advanced internal development program, APX005, is a humanized monoclonal antibody targeting the CD40 protein for the treatment of cancers. Apexigen believes that CD40-induced activation of the immune system by APX005 has the potential to treat a variety of difficult to treat cancers, such as pancreatic cancer, and has exhibited potent anti-tumor effects in animal models.

R&D tie up with Alcon and Janssen.

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Seattle Genetics SGN-CD33A : Encouraging Activity Against AML | ADC Review

Seattle Genetics SGN-CD33A : Encouraging Activity Against AML | ADC Review | Top Selling Monoclonal Antibodies 2013 | Scoop.it
SGN-CD33A offers encouraging anti-leukemic activity with a manageable safety profile in primarily elderly, relapsed patients. ASH 2014
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Covered in previous scoops during ASH 2014 meeting

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Gilbert Faure au nom de l'ASSIM's comment, Today, 3:48 AM
Joyeux Noel
Krishan Maggon 's comment, Today, 4:03 AM
Gilbert thanks, Joyeux Noel to you and the Scoop community.
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A randomized trial of benralizumab (Astra Zeneca), an antiinterleukin 5 receptor α monoclonal antibody, after acute asthma

A randomized trial of benralizumab (Astra Zeneca), an antiinterleukin 5 receptor α monoclonal antibody, after acute asthma | Top Selling Monoclonal Antibodies 2013 | Scoop.it

AbstractBackground

Patients with frequent asthma exacerbations resulting in emergency department (ED) visits are at increased risk for future exacerbations. We examined the ability of 1 dose of benralizumab, an investigational antiinterleukin 5 receptor α monoclonal antibody, to reduce recurrence after acute asthma exacerbations.

Methods

In this randomized, double-blind, placebo-controlled study, eligible subjects presented to the ED with an asthma exacerbation, had partial response to treatment, and greater than or equal to 1 additional exacerbation within the previous year. Subjects received 1 intravenous infusion of placebo (n = 38) or benralizumab (0.3 mg/kg, n = 36 or 1.0 mg/kg, n = 36) added to outpatient management. The primary outcome was the proportion of subjects with greater than or equal to 1 exacerbation at 12 weeks in placebo vs the combined benralizumab groups. Other outcomes included the time-weighted rate of exacerbations at week 12, adverse events, blood eosinophil counts, asthma symptom changes, and health care resource utilization.

Results

The proportion of subjects with greater than or equal to 1 asthma exacerbation at 12 weeks was not different between placebo and the combined benralizumab groups (38.9% vs 33.3%; P = .67). However, compared with placebo, benralizumab reduced asthma exacerbation rates by 49% (3.59 vs 1.82; P = .01) and exacerbations resulting in hospitalization by 60% (1.62 vs 0.65; P = .02) in the combined groups. Benralizumab reduced blood eosinophil counts but did not affect other outcomes, while demonstrating an acceptable safety profile.

Conclusions

When added to usual care, 1 dose of benralizumab reduced the rate and severity of exacerbations experienced over 12 weeks by subjects who presented to the ED with acute asthma.

Krishan Maggon 's insight:

The American Journal of Emergency Medicine

Volume 33, Issue 1, January 2015, Pages 14–20

Original Contribution A randomized trial of benralizumab, an antiinterleukin 5 receptor αmonoclonal antibody, after acute asthma ☆ ☆☆ ☆☆☆ ★ ★★Richard M. Nowak, MDa, , Joseph M. Parker, MDb, , , Robert A. Silverman, MDc, , Brian H. Rowe, MD, MScd, , Howard Smithline, MDe, , Faiz Khan, MDf, 1, , Jon P. Fiening, MSg, ,Keunpyo Kim, PhDh, , Nestor A. Molfino, MD, MSci, 2,  doi:10.1016/j.ajem.2014.09.036

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Gilbert Faure au nom de l'ASSIM's curator insight, December 23, 9:02 AM

Benralizumab is a humanised monoclonal antibody directed at the alpha sub-unit of the interleukin-5 receptor (IL-5Rα) that depletes eosinophils, a key target cell in inflammatory respiratory disease.

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Antibodies shaping up for cancer fight

Harnessing the body’s immune system to treat cancer could be made more effective by getting antibodies into a particular shape.
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Roche acquires Austrian Dutalys to augment development of bi-specific antibodies

Roche acquires Austrian Dutalys to augment development of bi-specific antibodies | Top Selling Monoclonal Antibodies 2013 | Scoop.it

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has agreed to acquire Dutalys GmbH, a privately held biotechnology company based in Vienna, Austria. Dutalys specializes in the discovery and development of fully human, bi-specific antibodies based on their proprietary DutaMab technology. The bi-specific antibodies developed with this platform are designed to provide novel, best-in-class molecules for several therapeutic areas. This deal further highlights Roche’s leadership in the development of therapeutic antibodies.


A bispecific antibody technology without the previous limitations, by combining the three essential criteria that would constitute a truly successful bispecific platform: (i) high affinity against all classes of targets, (ii) good stability, and (iii) good manufacturing properties, using any of the established and proven production systems.

Following ground-breaking research into antibody folding and CDR design, we have developed the proprietary DutaMab™ platform technology, thereby creating a novel class of fully human bispecific antibodies that succeed in retaining all the advantages of state-of-the-art monospecific antibody drugs:

DutaMabs™ comprise two independent, non-overlapping paratopes within the natural CDR regions of a fully human antibody, which can be independently selected and optimised in a robust and rapid manner to bind any two targets or epitopes with high affinity and specificity.DutaMabs™ are based on fully human VH-VL scaffolds of unprecedented biophysical stability, and the selected bispecific antibodies have best-in-class thermal stability of >90°C for the Fab fragment, excellent chemical stability as well as excellent in vivo stability.Crucially, DutaMabs™ comprise only one normal fully human heavy chain polypeptide and one normal fully human light chain polypeptide, and are efficiently produced with excellent expression levels using any of today’s proven antibody manufacturing platforms.

DutaMabs™ are therefore totally free of the problems frequently associated with the presence of appended domains, linkers, engineered constant domains, additional disulphide bonds, three polypeptides, four polypeptides or unnatural scaffold sequences within a bispecific drug molecule. DutaMabs™ can be readily produced as tetravalent, bispecific IgGs of any isotype or equally well as bivalent, bispecific Fab fragments. Since 2011 we have been applying the DutaMab™ technology to a range of therapeutic targets, and are developing an exciting proprietary pipeline. We are also in an excellent position to partner with pharmaceutical companies, and it is our goal to become the globally recognised leader in providing bispecific antibody technology.




Krishan Maggon 's insight:

Under the terms of the agreement, Roche will make an upfront cash payment of USD 133.75 million to shareholders and make additional contingent payments of up to USD 355 million based on the achievement of certain predetermined milestones.

About the DutaMab Platform

A conventional bi-specific monoclonal antibody is a biotechnologically engineered artificial protein that is composed of fragments of two different monoclonal antibodies and consequently can bind to two different antigens. The DutaMab technology platform differs by enabling the development of fully human bi-specific antibodies where each arm of the antibody shows high affinity and simultaneous binding against both targets, excellent stability, and good manufacturing properties. This enables the treatment of disease mechanisms that could not be addressed with conventional bi-specific antibodies.

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Hybridoma technology

Introduction Hybridomas - The hybrid cells of myeloma (cancer) cells with antibody-producing cells (lymphocytes) from an immunized donor (animal) Hybridoma technique is a method of creating pure and uniform antibodies Antibodies produced are...

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Antigens and antibodies for an optimised ELISA test kit for Ebola - News-Medical.net

Antigens and antibodies for an optimised ELISA test kit for Ebola - News-Medical.net | Top Selling Monoclonal Antibodies 2013 | Scoop.it
AMSBIO has announced several products suitable for the development of an ELISA detection assay for the Ebola virus.
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Physicochemical characterization of Remsima®

Physicochemical characterization of Remsima® | Top Selling Monoclonal Antibodies 2013 | Scoop.it
(2014). Physicochemical characterization of Remsima®. mAbs: Vol. 6, No. 5, pp. 1163-1177. doi: 10.4161/mabs.32221

 

AbstractRemsima® (infliximab) was recently approved as the world's first biosimilar monoclonal antibody (mAb) in both the European Union and Korea. To achieve this, extensive physicochemical characterization of Remsima® in relation to Remicade® was conducted in order to demonstrate the highly similar properties between the two molecules. A multitude of state-of-the-art analyses revealed that Remsima® has identical primary as well as indistinguishable higher order structures compared with the original product. Monomer and aggregate contents of Remsima® were also found to be comparable with those of Remicade®. In terms of charge isoforms, although Remsima® was observed to contain slightly less basic variants than the original antibody, the difference was shown to be largely due to the presence of C-terminal lysine. On the other hand, this lysine was found to be rapidly clipped inside serum in vitro and in vivo, suggesting it has no effect on the biological potency or safety of the drug. Analysis of the glycan contents of the antibodies showed comparable glycan types and distributions. Recent results of clinical studies have further confirmed that the two antibody products are highly similar to each other. Based on this research as well as previous clinical and non-clinical comparability studies, Remsima® can be considered as a highly similar molecule to Remicade® in terms of physicochemical properties, efficacy, and safety for its final approval as a biosimilar product to Remicade®.
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mAbsVolume 6, Issue 5, 2014 Physicochemical characterization of Remsima® View full textDownload full textOpen accessDOI:10.4161/mabs.32221Soon Kwan Junga, Kyoung Hoon Leea, Jae Won Jeona, Joon Won Leea, Byoung Oh Kwona, Yeon Jung Kima, Jin Soo Baea, Dong-Il Kimb, Soo Young Leea & Shin Jae Changa*

pages 1163-1177

Publishing models and article dates explainedReceived: 30 Jun 2014Accepted: 30 Jul 2014Accepted author version posted online: 01 Nov 2014
Published online: 01 Sep 2014Article Views: 1197  http://www.celltrionhealthcare.com/remsima/com/
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ADCs: Analytical and Bioanalytical Challenges

Presentation by Dr. Alain Beck, Senior Director, Antibody Physico-Chemistry, Centre d’Immunologie Pierre Fabre (CIPF), St Julien-en-Genevois, France. Talk given at Waters Antibody Drug Conjugates (ADC) 2014 Meeting, Nov.

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Prothena Receives FDA Fast Track Designation for NEOD001, a Monoclonal ... - GlobeNewswire (press release)

DUBLIN, Ireland, Dec. 15, 2014 (GLOBE NEWSWIRE) -- Prothena Corporation plc (Nasdaq:PRTA), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel antibodies for the potential treatment of diseases that involve amyloid or cell adhesion, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to NEOD001, a novel monoclonal antibody for the potential treatment of AL amyloidosis. This is the first investigational immunotherapy specifically targeting the disease-causing protein in AL amyloidosis to receive Fast Track designation. 

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First Investigational Immunotherapy for AL Amyloidosis to Receive FDA Fast Track DesignationFollows Recent Initiation of The VITAL Amyloidosis Study, a Global Phase 3 Registrational Trial of NEOD001 for Patients with AL Amyloidosis

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A systematic review of the efficacy and general safety of antibodies to NGF in the treatment of OA of the hip or knee - Osteoarthritis and Cartilage

A systematic review of the efficacy and general safety of antibodies to NGF in the treatment of OA of the hip or knee - Osteoarthritis and Cartilage | Top Selling Monoclonal Antibodies 2013 | Scoop.it

Summary

To evaluate the efficacy and safety of anti-NGF antibody treatment in hip and knee osteoarthritis (OA), a systematic review and meta-analysis was undertaken utilizing the criteria described by the Cochrane collaboration. Both published and unpublished trials were identified for tanezumab, fulranumab and fasinumab in hip and knee OA; sponsors were contacted to provide and confirm data. Study quality was assessed by Jadad criteria; efficacy and safety data were extracted independently by two individuals and meta-analyses were performed using Revman 5.2. 13 randomized, controlled trials were identified: 10 of tanezumab, two of fulranumab and one with fasinumab. All agents demonstrated superiority in efficacy compared to placebo. The highest doses in the phase II studies of tanezumab had a standardized effect size for WOMAC pain of 0.73 (CI, 0.51, 0.95). Subsequent phase III studies of tanezumab and phase II studies of fulranumab and fasinumab reported standardized effect sizes for WOMAC pain of −0.15–0.5, with no clear distinction among dose levels. Tanezumab compared to NSAIDs and opioids showed greater efficacy with a standardized effect size for WOMAC pain of 0.23 (CI 0.17–0.29). WOMAC function and PGA results were similar to WOMAC pain. Safety, determined by odds ratios of withdrawals from studies due to adverse events (AEs), was better at the lower doses than higher doses and similar among all agents. These results demonstrate that antibodies to NGF provide efficacy in OA and that general safety at the lower doses appears similar to placebo. Additional data on both efficacy and safety of these antibodies are needed to define the optimal dose to maximize benefit to risk.

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Osteoarthritis and Cartilage

Volume 23, Supplement 1, January 2015, Pages S8–S17

Special Issue: Imaging Atlas for Anti Nerve Growth Factor (a-NGF) Studies

Review A systematic review of the efficacy and general safety of antibodies to NGF in the treatment of OA of the hip or kneeT.J. Schnitzer, , J.A. Marks   Show moredoi:10.1016/j.joca.2014.10.003
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Serious joint-related adverse events in randomized controlled trials of anti-nerve growth factor monoclonal antibodies

Serious joint-related adverse events in randomized controlled trials of anti-nerve growth factor monoclonal antibodies | Top Selling Monoclonal Antibodies 2013 | Scoop.it
Anti-nerve growth factor monoclonal antibodies resulted in severe knee joint damage in this study - !!! http://t.co/N60NWqlsWG

 

SummaryBackground

Reports of serious joint adverse events (AEs) due to osteonecrosis were noted during randomized placebo-controlled clinical trials of monoclonal antibodies to nerve growth factor (NGF), including tanezumab and fulranumab.

Methods

All available medical records from subjects with reported cases of osteonecrosis, as well as records of subjects who underwent joint replacement during these studies, were reviewed by an independent adjudication committee that was established by each company; the committees were different for each company and included distinct individual experts. Cases were categorized as having definite osteonecrosis, normal or rapid progression of osteoarthritis (OA), another diagnosis or unable to determine the underlying diagnosis.

Results

The vast majority of investigator reported cases of osteonecrosis were adjudicated as either normal or rapid progression of OA. Indeed, the syndrome of rapid progression of OA associated with chondrolysis and bone destruction appears to be a safety signal that is associated with not only increasing doses of anti-NGF antibodies but also concomitant therapy with nonsteroidal anti-inflammatory drugs.

Conclusions

These results have implications for future clinical trials of anti-NGF agents in OA and other painful conditions.

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Serious joint-related adverse events in randomized controlled trials of anti-nerve growth factor monoclonal antibodiesM.C. Hochberg, a, Received 27 June 2014, Accepted 16 October 2014, Available online 17 December 2014  doi:10.1016/j.joca.2014.10.005Osteoarthritis and Cartilage

Volume 23, Supplement 1, January 2015, Pages S18–S21

Special Issue: Imaging Atlas for Anti Nerve Growth Factor (a-NGF) Studies

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All available medical records from subjects with reported cases of osteonecrosis, as well as records of subjects who underwent joint replacement during these studies, were reviewed by an independent adjudication committee that was established by each company; the committees were different for each company and included distinct individual experts. 

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Antibodies discovery could lead to universal dengue vaccine 

Antibodies discovery could lead to universal dengue vaccine  | Top Selling Monoclonal Antibodies 2013 | Scoop.it
The discovery could lead to the development of better vaccines and laboratory tests  that eventually could lead to reductions in the incidence of dengue.
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