Are 25 antibodies better than 1?

Cuker, Adam

doi:10.1182/blood-2012-09-452771

Cited by 6 publications

(6 citation statements)

References 8 publications

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“…Phase II trials demonstrated similar activity for Sym001 at much lower doses than anti-RhesusD IVIG [40 ]. The key question is, are all 25 antibodies are essential [79 ]? Whether 25, 24, or only three antibodies provide the pharmacological effect is relevant primarily for its effects on manufacturing complexity and dose.…”

Section: Regulatory Approval Routes For Oligoclonal and Recombinant Pmentioning

confidence: 98%

Back to the future: recombinant polyclonal antibody therapeutics

Wang

Coljee

Maynard

2013

Current Opinion in Chemical Engineering

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Antibody therapeutics are one of the fastest growing classes of pharmaceuticals, with an annual US market over $20 billion, developed to treat a variety of diseases including cancer, auto-immune and infectious diseases. Most are currently administered as a single molecule to treat a single disease, however there is mounting evidence that cocktails of multiple antibodies, each with a unique binding specificity and protective mechanism, may improve clinical efficacy. Here, we review progress in the development of oligoclonal combinations of antibodies to treat disease, focusing on identification of synergistic antibodies. We then discuss the application of modern antibody engineering technologies to produce highly potent antibody preparations, including oligoclonal antibody cocktails and truly recombinant polyclonal antibodies. Specific examples illustrating the synergy conferred by multiple antibodies will be provided for diseases caused by botulinum toxin, cancer and immune thrombocytopenia. The bioprocessing and regulatory options for these preparations will be discussed.

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Section: Regulatory Approval Routes For Oligoclonal and Recombinant Pmentioning

confidence: 98%

Back to the future: recombinant polyclonal antibody therapeutics

Wang

Coljee

Maynard

2013

Current Opinion in Chemical Engineering

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“…Rozrolimupab (Symphogen) is a first-in-class mixture of 25 recombinant monoclonal IgG1 antibodies against RhD, with similar efficacy to plasma-derived anti-RhD in the treatment of ITP. [70][71][72][73][74] Rozrolimupab is produced using a proprietary technology from Symphogen and is not dependent on human plasma supply. Currently, this agent is being evaluated for the prevention of hemolytic disease among fetuses and newborns and for the therapy of refractory ITP.…”

Section: Rozrolimupabmentioning

confidence: 99%

“…Rozrolimupab (Symphogen) is a first‐in‐class mixture of 25 recombinant monoclonal IgG1 antibodies against RhD, with similar efficacy to plasma‐derived anti‐RhD in the treatment of ITP . Rozrolimupab is produced using a proprietary technology from Symphogen and is not dependent on human plasma supply.…”

Section: Novel Drugsmentioning

confidence: 99%

Autoimmune thrombocytopenia: Current treatment options in adults with a focus on novel drugs

Witkowski

Witkowska

Robak

2019

European J of Haematology

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Immune thrombocytopenia (ITP) is an autoimmune disease characterized by platelet destruction and reduced platelet production resulting in decreased platelet level and an increased risk of bleeding. Based on the immunologic mechanism of ITP, frontline standard therapy consists of corticosteroids and intravenous immunoglobulins (IVIG). If patients do not respond to the first-line treatment, or if continuous therapy is required, the disorder is called refractory ITP, and second-line therapy is indicated.This treatment may consist of rituximab, thrombopoietin receptor agonists, splenectomy, or cytotoxic drugs. Despite significant advances, many patients do not respond to any the treatments listed below, and new treatment options need to be developed for this relapsed and refractory group. Recent clinical studies have indicated promising outcomes for novel drugs, either as single agents or in combination with traditional drugs. This review discusses the latest and the most promising novel drugs for ITP in adults. K E Y W O R D Savatrombopag, eltrombopag, immune thrombocytopenia, indirubin, receptor antagonist, rituximab, romiplostim, rozanolixizumab, rozrolimupab, thrombopoietin

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“…The only available second-trimester FMH data primarily include induction abortions for fetal anomalies [6,7], and no studies specifically evaluate FMH with dilation and evacuation (D&E). Given recent RhIG shortages around the world such as in Australia and Poland [8,9], and the cost of higher doses of RhIG to healthcare systems, we sought to begin to understand if a RhIG dose less than 300 mcg might be sufficient in the second trimester. We designed this study to evaluate FMH with routine D&E from 15 weeks 0 days to 23 weeks 6 days of gestation using Kleihauer-Betke (KB) acid elution testing.…”

Section: Introductionmentioning

confidence: 99%

Prospective quantification of fetomaternal hemorrhage with dilation and evacuation procedures

et al. 2019

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To describe fetomaternal hemorrhage (FMH) during second-trimester dilation and evacuation (D&E) to evaluate if Rhesus-immune globulin (RhIG) 100 mcg (used in the United Kingdom) and 300 mcg (used in the United States) provide adequate prophylaxis. Study design: We conducted an exploratory prospective descriptive study of women undergoing D&E between 15 weeks 0 days and 23 weeks 6 days of gestation. Enrolled participants had Kleihauer-Betke testing on specimens obtained before and after D&E. We assessed the main outcome measures of FMH in mL suggesting need for more than 100 mcg and 300 mcg RhIG (FMH of 10 mL and 30 mL fetal whole blood, respectively) and association of postprocedure FMH with demographic characteristics and procedure-related variables. Results: The 300 participants had a mean gestational age of 19 weeks 6 days±2 weeks 2 days. The median preprocedure FMH was 0 mL (range 0-50 mL) with 2 (0.67%) women exceeding 10 mL (19 mL and 50 mL). The median postprocedure FMH was 1 mL (range 0-60 mL). Almost all participants had postprocedure FMH b10 mL (n=295, 98.3%) and b30 mL (n=298, 99.3%). All participants under 18 weeks had FMH b10 mL. We found no demographic or procedure-related factors to be predictive of FMH quantity. Conclusions: FMH occurring with routine second-trimester D&E procedures is minimal. Adequate prophylaxis with RhIG 100 mcg and 300 mcg occurred in N98% of women and in all cases b18 weeks of gestation. This study is the first step to potentially reducing the dose and costs of RhIG administration with D&E. Implications: This study is a first step in quantifying fetomaternal hemorrhage with routine dilation and evacuation procedures; larger trials are needed, especially to understand why some women have recognizable hemorrhage preprocedure. If dosing requirements are too high with current guidelines, lower doses will result in resource and cost savings.

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Are 25 antibodies better than 1?

Cited by 6 publications

References 8 publications

Back to the future: recombinant polyclonal antibody therapeutics

Back to the future: recombinant polyclonal antibody therapeutics

Autoimmune thrombocytopenia: Current treatment options in adults with a focus on novel drugs

Prospective quantification of fetomaternal hemorrhage with dilation and evacuation procedures

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