Top Selling Monoclonal Antibodies 2014
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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 2017

Best Selling Blockbuster Monoclonal Antibodies 2017 | Top Selling Monoclonal Antibodies 2014 | Scoop.it

 

Abstract

 

A review of the best selling monoclonal antibodies in 2017 and previous years is provided. Humira with sales of over $19 billion ($9.3 bn in 2012, $14.5 bn in 2015 and $16 bn in 2016) remains the best selling monoclonal antibody, biologic as well the prescription drug brand in 2017. Humira has remained the top selling global brand since 2012. The ranks of the next 4 top selling mabs changed rankings from the 2012-2016 Table due to competition from biosimilars.  Rituxan (9.2 Bn) , Herceptin (7.4 Bn), Remicade (7.1 Bn) and Avastin (7.1 Bn) and were the second, third, fourth and fifth top selling mabs in 2017. The actual sales for 2017 as reported by the companies are provided. 



The global pharma biotech market for prescription medicinal brands was over $1 trillion dollar in 2017. Biologics accounted for $220 billion and  mabs for $95 billion

 

The total sales of the top selling blockbuster mabs listed in the Table were $95 billion in 2017.  Besides the top 5 mabs with sales over $7 billion, there were two monoclonal antibody with sales of over $4 billions, four with sales over $3 billion, five with sales over $ 2 billion and 3 with sales of over $ 1 billion in 2015. There were 19 blockbuster mabs in 2019. At least 5 new recently launched mabs are likely to cross sales of $ 1 billion in 2018.

 

Currently 73 monoclonal antibodies are marketed in the US and Europe (Dec. 2017).  FDA approved 6 new monoclonal antibodies in 2014, 9 in 2015, 9 in 2016 and 9 in 2017. The FDA has already approved 4 new mabs in 2018 and EMA CHMP has recommended 2 new mabs in the 1Q2018.

 

The FDA has approved only 9 biosimilar so far while EMA/CHMP has cleared 28 biosimilar so far.

 

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 $2.6 billion in 2017.

 

The full report is not for public release or for request by email

 

 

 

 

Krishan Maggon 's insight:

The full report is not available for public release or for request by email

 

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Engineered DNA-Encoded mAbs Successfully Target Zaire Ebolavirus

Engineered DNA-Encoded mAbs Successfully Target Zaire Ebolavirus | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Researchers at The Wistar Institute and colleagues say they have successfully engineered novel DNA-encoded monoclonal antibodies (DMAbs) targeting Zaire Ebolavirus that were effective in preclinical models. Their study (“In Vivo Delivery of Synthetic Human DNA-Encoded Monoclonal Antibodies Protect...
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Antibody-drug conjugates manufacturing -bioconjugation, production of payload, linker and mAbs - Novasep

Antibody-drug conjugates manufacturing -bioconjugation, production of payload, linker and mAbs - Novasep | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Looking for a manufacturing partner for your antibody drug conjugates (ADCs)? Novasep has been a leading contract service provider in the ADC arena for more than 10 years....
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Antigen-based immune modulation therapy for type 1 diabetes: the era of precision medicine

Antigen-based immune modulation therapy for type 1 diabetes: the era of precision medicine | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Precision medicine has emerged as a mantra for therapeutic approaches to complex diseases. The defining concept relies on a detailed insight into disease pathogenesis and therapeutic mechanism. Although the type 1 diabetes field has gained new insights into disease endotypes and indications of efficacy for several therapies, none of these is yet licensed, partly because of immune suppressive side-effects beyond control of islet autoimmunity. New strategies designed to regulate the immune system continue to emerge as basic science discoveries are made, including the use of antigen-based immunotherapies. A single agent or approach seems unlikely to halt disease progression in all people with or at risk of type 1 diabetes; as such, tailored methods relying on patient subgroups and knowledge of disease endotypes are gaining attention. Recent insights into disease mechanisms and emerging trial data are being translated into opportunities for tissue-specific prevention of progressive loss of β-cell function and survival. Results so far point to feasibility, safety, and tolerability of administration of islet autoantigens and peptides thereof into recipients with or at risk of type 1 diabetes. Findings from mechanistic studies suggest favourable changes in islet autoimmunity, with signs of immune regulation. Major challenges remain, including those related to dose and dosing frequency, route of administration, and use of adjuvants. However, the first steps towards tissue-specific and personalised medicine in type 1 diabetes have been made, which will guide future studies into induction of immune tolerance to intervene in the initiation and progression of islet autoimmunity and disease.
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Intact monoclonal antibodies separation and analysis by sheathless capillary electrophoresis-mass spectrometry.

Intact monoclonal antibodies separation and analysis by sheathless capillary electrophoresis-mass spectrometry. | Top Selling Monoclonal Antibodies 2014 | Scoop.it
A new interesting article has been published in Eur J Mass Spectrom (Chichester). 2018 Oct 23:1469066718807798. doi: 10.1177/1469066718807798.[Epub ahead of print] and titled: Intact monoclonal antibodies separation and analysis by sheathless …...
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Next Gen IO update – early phase clinical trials of anti-TIGIT/LAG3 antibodies

Next Gen IO update – early phase clinical trials of anti-TIGIT/LAG3 antibodies | Top Selling Monoclonal Antibodies 2014 | Scoop.it
By Ajay V.Patil Development of immunotherapy drugs aga…...
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Namilumab (Amgen, Takeda, Izana  BioSciences) Ineffective in Treatment of Moderate to Severe Plaque Psoriasis

Namilumab (Amgen, Takeda, Izana  BioSciences) Ineffective in Treatment of Moderate to Severe Plaque Psoriasis | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Investigators examined the safety and efficacy of namilumab in patients with moderate to severe plaque psoriasis.

 

The drug tested in this study is called namilumab. Namilumab was tested to prove its effectiveness in treating moderate to severe chronic plaque psoriasis. This study looked at improvement of plaque psoriasis in participants who take namilumab.

The study enrolled 122 participants. Participants were randomly assigned (by chance, like flipping a coin) to one of five treatment groups that were undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):

 

Izana Bioscience is preparing to run a Phase II study of IZN-101, an anti GM-CSF monoclonal antibody in AS. It will take place in the UK, and aims to demonstrate the efficacy of IZN-101 as measured by changes in clinical symptoms, markers of inflammation and MRI appearance of the spine. The trial will be a randomised, double-blind, placebo-controlled study in patients with moderately to severely active AS.

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You're Invited! ASH 2018 & BsAbs for AML

You're Invited! ASH 2018 & BsAbs for AML | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Bispecific Antibody Treatments, AML and Immumotherapy Treatments  With the ASH 2018 annual meeting right around the corner (in sunny San Diego, a great place to be in December), it is a good time to highlight the progress of immunotherapy treatments in hematology. Acute myeloid leukemia (AML) is one disease that has essentially relied upon the same treatment for the past 40 years. This current standard, intensive induction therapy followed by hematopoietic stem cell transplantation, is somewhat effective in patients under 60 years of age, but far less effective for elderly patients. Thus, many researchers have been focusing on small molecules and immunotherapies to find more efficacious treatments for AML. One class of immunotherapeutic agents that is showing promise for AML are bispecific antibodies. Bispecific antibodies (BsAbs) are capable of binding two targets simultaneously and can potentially induce a powerful anti-tumor immune response. Bispecific Antibody History Bispecific antibodies were described in the 1960s, with the first monoclonal BsAbs generated in the 1980s. The first article describing the therapeutic use of BsAbs was published in 1992, with trifunctional hybrid antibodies (Triomab) being introduced in 1995. The Triomab platform offered a solution to the random association of heavy/light chains observed in classic quadroma technology by combining the halves of two distinct antibodies into a full-size, functional mAb. Research then slowed and didn’t pick up until 14 years later, when two Triomabs were approved for therapeutic use: catumaxomab in 2009 and blinatumomab in 2014. Recent papers have focused on generating BsAb via genetic engineering and chemical conjugation and their performance in preclinical and clinical studies. The dual specificities of bispecific antibodies – one for a tumor-associated surface antigen and the other for a surface antigen on the effector cells (T cells or NK cells) – bring tumor cells into close proximity to the effectors. This is positive for AML because, if the binding to the second specificity is agonistic, the cytotoxic functions of effectors can be activated at close proximity to the leukemic cells ...
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Structural basis of Gip1 for cytosolic sequestration of G protein in wide-range chemotaxis

Structural basis of Gip1 for cytosolic sequestration of G protein in wide-range chemotaxis | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Gip1 sequesters heterotrimeric G proteins in the cytosolic pool which regulates G protein-coupled receptor signalling for eukaryotic chemotaxis. Here the authors provide the crystal structure of Gip1's G protein-binding region and show that mutations in this region lead to G protein...
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Paper: GM-CSF Blockade during Chimeric Antigen Receptor T Cell Therapy Reduces Cytokine Release Syndrome and Neurotoxicity and May Enhance Their Effector Functions

Paper: GM-CSF Blockade during Chimeric Antigen Receptor T Cell Therapy Reduces Cytokine Release Syndrome and Neurotoxicity and May Enhance Their Effector Functions | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Despite its efficacy, chimeric antigen receptor T-cell therapy (CART) is limited by the development of cytokine release syndrome (CRS) and neurotoxicity (NT). While CRS is related to extreme elevation of cytokines and massive T cell expansion, the exact mechanisms for NT have not yet been elucidated. Preliminary studies suggest that NT might be mediated by myeloid cells that cross the blood brain barrier. This is supported by correlative analysis from CART19 pivotal trials where CD14+ cell numbers were increased in the cerebrospinal fluid of patients that developed severe NT (Locke et al, ASH 2017). Therefore, we aimed to investigate the role of GM-CSF neutralization in preventing CRS and NT after CART cell therapy via monocyte control. First, we investigated the effect of GM-CSF blockade on CART cell effector functions. Here, we used the human GM-CSF neutralizing antibody (lenzilumab, Humanigen, Burlingame, California) that has been shown to be safe in phase II clinical trials. Lenzilumab (10 ug/kg) neutralizes GM-CSF when CART19 cells are stimulated with the CD19+ Luciferase+ acute lymphoblastic leukemia (ALL) cell line NALM6, but does not impair CART cell function in vitro. We have found that malignancy associated macrophages reduce CART proliferation. GM-CSF neutralization with lenzilumab results in enhanced CART cell antigen specific proliferation in the presence of monocytes. To confirm this in vivo, NOD-SCID-g-/- mice were engrafted with high disease burdens of NALM6 and treated with low doses of CART19 or control T cells (to induce tumor relapse), in combination with lenzilumab or isotype control antibody. The combination of CART19 and lenzilumab resulted in significant anti-tumor activity and overall survival benefit compared to control T cells (Fig 1A), similar to mice treated with CART19 combined with isotype control antibody, indicating that GM-CSF neutralization does not impair CART cell activity in vivo. This anti-tumor activity was validated in an ALL patient derived xenograft model. Next, we explored the impact of GM-CSF neutralization on CART cell related toxicities in a novel patient derived xenograft model. Here, NOD-SCID-g-/- mice were engrafted with leukemic blasts (1-3x106 cells) derived from patients with high risk ALL. Mice were then treated with high doses of CART19 cells (2-5x106 intravenously). Five days after CART19 treatment, mice began to develop progressive motor weakness, hunched bodies, and weight loss that correlated with massive elevation of circulating human cytokine levels. Magnetic Resonance Imaging (MRI) of the brain during this syndrome showed diffuse enhancement and edema, associated with central nervous system (CNS) infiltration of CART cells and murine activated myeloid cells. This is similar to what has been reported in CART19 clinical trials in patients with severe NT. The combination of CART19, lenzilumab (to neutralize human GM-CSF) and murine GM-CSF blocking antibody (to neutralize mouse GM-CSF) resulted in prevention of weight loss (Fig 1B), decrease in critical myeloid cytokines (Fig 1C-D), reduction of cerebral edema (Fig 1E), enhanced leukemic disease control in the brain (Fig 1F), and reduction in brain macrophages (Fig 1G). Finally, we hypothesized that disrupting GM-CSF through CRISPR/Cas9 gene editing during the process of CART cell manufacturing would result in functional CART cells with reduced secretion of GM-CSF. We designed guide RNA targeting exon 3 of the GM-CSF gene and generated GM-CSFk/o CART19 cells. Our preliminary data suggest that these CARTs produce significantly less GM-CSF upon activation but continue to exhibit similar production of other cytokines and exhibit normal effector functions in vitro (Fig 1H). Using the NALM6 high tumor burden relapse xenograft model as described above, GM-CSFk/o CART19 cells resulted in slightly enhanced disease control compared to CART19 cells (Fig 1I). Thus, modulating myeloid cell behavior through GM-CSF blockade can help control CART mediated toxicities and may reduce their immunosuppressive features to improve leukemic control. These studies illuminate a novel approach to abrogate NT and CRS through GM-CSF neutralization that also potentially enhances CART cell functions. Based on these results, we have designed a phase II clinical trial using lenzilumab as a modality to prevent CART related toxicities in patients with diffuse large B cell lymphoma.
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Functional TCR T cell screening using single-cell droplet microfluidics - Lab on a Chip (RSC Publishing)

Adoptive T cell transfer, in particular TCR T cell therapy, holds great promise for cancer immunotherapy with encouraging clinical results. However, finding the right TCR T cell clone is a tedious, time-consuming, and costly process.
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A novel ternary heterostructure with dramatic SERS activity for evaluation of PD-L1 expression at the single-cell level

A novel ternary heterostructure with dramatic SERS activity for evaluation of PD-L1 expression at the single-cell level | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Surface-enhanced Raman scattering (SERS) probes based on a charge transfer (CT) process with high stability and reproducibility are powerful tools under open-air conditions. However, the key problem ahead of practical usage of CT-based SERS technology is how to effectively improve sensitivity. Here, a novel ternary heterostructure SERS substrate, Fe3O4@GO@TiO2, with a significant enhancement factor of 8.08 × 106 was first synthesized. We found the remarkable enhanced effect of SERS signal to be attributed to the resonance effect of CuPc, CT between GO and TiO2, and enrichment from a porous TiO2 shell. In addition, we developed a robust SERS probe with good recyclability under visible light illumination on Fe3O4@GO@TiO2 nanocomposites toward ultrasensitive detection of cancer cells down to three cells. We have now successfully applied this probe for in situ quantification and imaging of programmed cell death receptor ligand 1 (PD-L1) on triple-negative breast cancer cell surface at the single-cell level and for monitoring the expression variation of PD-L1 during drug treatment.
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Potent neutralizing monoclonal antibodies against Ebola virus infection

Potent neutralizing monoclonal antibodies against Ebola virus infection | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Ebola virus infections cause a deadly hemorrhagic disease for which no vaccines or therapeutics has received regulatory approval. Here we show isolation of three (Q206, Q314 and Q411) neutralizing monoclonal antibodies (mAbs) against the surface glycoprotein ...
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Novel human monoclonal antibodies targeting the F subunit of leukocidins reduce disease progression and mortality caused by Staphylococcus aureus | BMC Microbiology | Full Text

Novel human monoclonal antibodies targeting the F subunit of leukocidins reduce disease progression and mortality caused by Staphylococcus aureus | BMC Microbiology | Full Text | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Staphylococcus aureus is a leading cause of Gram-positive bacterial infections worldwide; however, the treatment of S. aureus infection has become increasingly difficult due to the prevalence of methicillin-resistant S. aureus strains, highlighting the urgent need for the development of novel strategies. The complexity of S. aureus pathogenesis relies on virulence factors. Recent studies have demonstrated that leukocidins expressed by the majority of clinical isolates play important roles in the pathogenesis of S. aureus. In this study, we developed three human monoclonal antibodies against all F-components of leukocidins HlgABC, LukSF, and LukED with high affinity. These antibodies were found to be capable of blocking leukocidin-mediated cell lysis in vitro. Furthermore, the antibodies dramatically reduced disease progression and mortality after S. aureus infection in vivo. Our findings revealed that neutralizing bicomponent leukocidins may be a promising strategy to combat infections caused by S. aureus.
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Evolution of monoclonal antibodies in multiple myeloma

Immunotherapy represents the most innovative approach developed in the past decades for the treatment of multiple myeloma.1 Monoclonal antibodies, in particular, differ substantially from all other agents used in this disease, because of their capacity to stimulate immune-competent cells to kill ...
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FDA Approval Summary: Axicabtagene Ciloleucel for Relapsed or Refractory Large B-Cell Lymphoma

FDA Approval Summary: Axicabtagene Ciloleucel for Relapsed or Refractory Large B-Cell Lymphoma | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Abstract
In October 2017, the U.S. Food and Drug Administration granted regular approval to axicabtagene ciloleucel, a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. Efficacy was based on complete remission (CR) rate and duration of response (DOR) in 101 adult patients with relapsed or refractory large B-cell lymphoma (median 3 prior systemic regimens) treated on a single-arm trial. Patients received a single infusion of axicabtagene ciloleucel, preceded by lymphodepleting chemotherapy with cyclophosphamide and fludarabine. The objective response rate per independent review committee was 72% (95% CI: 62, 81) with a CR rate of 51% (95% CI: 41, 62). With a median follow-up of 7.9 months, the median DOR was not reached in patients achieving CR (95% CI: 8.1 months, not estimable [NE]), whereas patients with partial remission had an estimated median DOR of 2.1 months (95% CI: 1.3, 5.3). Among 108 patients evaluated for safety, serious adverse reactions occurred in 52%. Cytokine release syndrome and neurologic toxicities occurred in 94% and 87% of patients, respectively, leading to implementation of a Risk Evaluation and Mitigation Strategy.
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The Possible Long-Term Side Effects of Prescribing CGRP Antagonists for Migraine Prevention: erenumab, eptinezumab, fremanezumab, galcanezumab

The Possible Long-Term Side Effects of Prescribing CGRP Antagonists for Migraine Prevention: erenumab, eptinezumab, fremanezumab, galcanezumab | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Headache expert Lawrence Robbins, MD, asks a series of questions clinicians need to address before prescribing the long-awaited CGRP antagonists for migraine prevention.
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HLA-B57 micropolymorphism defines the sequence and conformational breadth of the immunopeptidome

HLA-B57 micropolymorphism defines the sequence and conformational breadth of the immunopeptidome | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Human leukocyte antigens (HLA) are multi-allelic and polymorphic genes that present antigens to immune cells for inducing protective immunity. Here, using systems biology and structural approaches, the authors show that micropolymorphism of three HLA has effects beyond the modulation of antigen...
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Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome | NEJM

Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome | NEJM | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Original Article from The New England Journal of Medicine — Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome...
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Engineering allosteric regulation in protein kinases

Engineering allosteric regulation in protein kinases | Top Selling Monoclonal Antibodies 2014 | Scoop.it
The addition of phosphate moieties can alter protein conformation, function, abundance, and localization, thereby regulating a myriad of cellular behaviors and responses. These sites are often mutated in cancer and other diseases. Pincus et al . mapped the residue alignment and patterning of phosphoregulatory sites in eukaryotic kinases and determined that kinases share a conserved architecture, such that introducing a target motif of the kinase PKA at surface sites within two different yeast kinases altered their activity, pathway interactions, and subcellular localization, as well as the overall response of the yeast to pheromone and osmotic signals, in a PKA-dependent manner. These findings, which reveal insights into kinase evolution, also have implications for biological engineering and medicine.

Phosphoregulation, in which the addition of a negatively charged phosphate group modulates protein activity, enables dynamic cellular responses. To understand how new phosphoregulation might be acquired, we mutationally scanned the surface of a prototypical yeast kinase (Kss1) to identify potential regulatory sites. The data revealed a set of spatially distributed “hotspots” that might have coevolved with the active site and preferentially modulated kinase activity. By engineering simple consensus phosphorylation sites at these hotspots, we rewired cell signaling in yeast. Using the same approach with a homolog yeast mitogen-activated protein kinase, Hog1, we introduced new phosphoregulation that modified its localization and signaling dynamics. Beyond revealing potential use in synthetic biology, our findings suggest that the identified hotspots contribute to the diversity of natural allosteric regulatory mechanisms in the eukaryotic kinome and, given that some are mutated in cancers, understanding these hotspots may have clinical relevance to human disease.
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FDA Approves Empliciti® (elotuzumab, BMS), a New Immunotherapy Combination for Relapsed or Refractory Multiple Myeloma

FDA Approves Empliciti® (elotuzumab, BMS), a New Immunotherapy Combination for Relapsed or Refractory Multiple Myeloma | Top Selling Monoclonal Antibodies 2014 | Scoop.it

BMS today announced that the U.S. Food and Drug Administration (FDA) approved Empliciti (elotuzumab) injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.1 In ELOQUENT-3, a randomized, open-label, Phase 2 trial, EPd demonstrated benefit in patients with relapsed or refractory multiple myeloma, doubling both median progression-free survival (PFS) and overall response rate (ORR) versus pomalidomide and dexamethasone (Pd).1 

 

The most frequent serious adverse reactions in the population evaluated for safety (n=60 in the EPd arm and n=55 in the Pd arm) were pneumonia (13% vs. 11%) and respiratory tract infection (7% vs. 3.6%).1 Infusion reactions were reported in 3.3% of patients treated with EPd.1 Adverse reactions that occurred with a >/=10% incidence for Empliciti plus pomalidomide and dexamethasone-treated patients and >/=5% incidence than pomalidomide and dexamethasone-treated patients were constipation (22% vs. 11%), hyperglycemia (20% vs. 15%), pneumonia (18% vs. 13%), diarrhea (18% vs. 9%), respiratory tract infection (17% vs. 9%), bone pain (15% vs. 9%), dyspnea (15% vs. 7%), muscle spasms (13% vs. 5%), edema peripheral (13% vs. 7%) and lymphopenia (10% vs. 1.8%).1

INDICATIONS

EMPLICITI® (elotuzumab) is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies.

EMPLICITI is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

 

 

  • In the ELOQUENT-3 trial, treatment with Empliciti plus pomalidomide and dexamethasone (EPd) doubled median progression-free survival and overall response rate versus pomalidomide and dexamethasone (Pd) 1
  • Low discontinuation rates due to adverse reactions were observed with both EPd and Pd alone 1
  • Empliciti, when used in combination with pomalidomide and dexamethasone, can be administered once monthly after first two cycles 1
Krishan Maggon 's insight:

About Empliciti

Empliciti is an immunostimulatory antibody that specifically targets Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7), a cell-surface glycoprotein. SLAMF7 is expressed on myeloma cells independent of cytogenetic abnormalities. SLAMF7 also is expressed on Natural Killer cells, plasma cells and at lower levels on specific immune cell subsets of differentiated cells within the hematopoietic lineage.

Empliciti has a dual mechanism-of-action. It directly activates the immune system through Natural Killer cells via the SLAMF7 pathway. Empliciti also targets SLAMF7 on myeloma cells, tagging these malignant cells for Natural Killer cell-mediated destruction via antibody-dependent cellular toxicity.

Empliciti was initially approved by the FDA in 2015 in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies.

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Krishan Maggon 's curator insight, November 8, 7:28 AM

About Empliciti

Empliciti is an immunostimulatory antibody that specifically targets Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7), a cell-surface glycoprotein. SLAMF7 is expressed on myeloma cells independent of cytogenetic abnormalities. SLAMF7 also is expressed on Natural Killer cells, plasma cells and at lower levels on specific immune cell subsets of differentiated cells within the hematopoietic lineage.

Empliciti has a dual mechanism-of-action. It directly activates the immune system through Natural Killer cells via the SLAMF7 pathway. Empliciti also targets SLAMF7 on myeloma cells, tagging these malignant cells for Natural Killer cell-mediated destruction via antibody-dependent cellular toxicity.

Empliciti was initially approved by the FDA in 2015 in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies.

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Antibody-Mediated CD4 Depletion Induces Homeostatic CD4+ T Cell Proliferation without Detectable Virus Reactivation in Antiretroviral Therapy-Treated Simian Immunodeficiency Virus-Infected Macaques

Antibody-Mediated CD4 Depletion Induces Homeostatic CD4+ T Cell Proliferation without Detectable Virus Reactivation in Antiretroviral Therapy-Treated Simian Immunodeficiency Virus-Infected Macaques | Top Selling Monoclonal Antibodies 2014 | Scoop.it
A major barrier to human immunodeficiency virus (HIV) eradication is the long-term persistence of latently infected CD4+ T cells harboring integrated replication-competent virus. It has been proposed that the homeostatic proliferation of these cells drives long-term reservoir persistence in the...
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Development of Autoantibodies before the Clinical Onset of Systemic Lupus Erythematosus | NEJM

Development of Autoantibodies before the Clinical Onset of Systemic Lupus Erythematosus | NEJM | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Original Article from The New England Journal of Medicine — Development of Autoantibodies before the Clinical Onset of Systemic Lupus Erythematosus...
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High Affinity and Specificity CD45 Monoclonal Antibody at Elabscience.com

High Affinity and Specificity CD45 Monoclonal Antibody at Elabscience.com | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Elabscience is a famous biology science research reagents manufacturer. Our CD45 Monoclonal Antibody price is reasonable. Check more details about CD45 Monoclonal Antibody now.
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Frontiers | Engineering of Fc Fragments with Optimized Physicochemical Properties Implying Improvement of Clinical Potentials for Fc-Based Therapeutics | Immunology

Frontiers | Engineering of Fc Fragments with Optimized Physicochemical Properties Implying Improvement of Clinical Potentials for Fc-Based Therapeutics | Immunology | Top Selling Monoclonal Antibodies 2014 | Scoop.it
Therapeutic monoclonal antibodies and Fc-fusion proteins are successfully used in treatment of various diseases mainly including cancer, immune disease, and viral infection, which belong to the Fc-based therapeutics. In recent years, engineered Fc-derived antibody domains have also shown potential for Fc-based therapeutics. To increase the druggability of Fc-based therapeutic candidates, many efforts have been made in optimizing physicochemical properties and functions mediated by Fc fragment. The desired result is that we can simultaneously obtain Fc variants with increased physicochemical properties in vitro and capacity of mediating appropriate functions in vivo. However, changes of physicochemical properties of Fc may result in alternation of Fc-mediated functions and vice versa, which leads to undesired outcomes for further development of Fc-based therapeutics. Therefore, whether modified Fc fragments are suitable for achievement of expected clinical results or not needs to be seriously considered. Now, this question comes to be noticed and should be figured out to make better translation from the results of laboratory into clinical applications. In this review, we summarize different strategies on engineering physicochemical properties of Fc, and preliminarily elucidate the relationships between modified Fc in vitro and the subsequent therapeutic influence in vivo.
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