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Journal articles on the topic 'B. E. Robuck, Inc'

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Published: 27 July 2024

Last updated: 31 July 2025

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1

Bartolome, Amelita, Anna Almazan, Salina Abusali, et al. "1089. Analytical Performance of an Ultrasensitive Immunoassay for Detection of Clostridium difficile Toxins in Stool." Open Forum Infectious Diseases 5, suppl_1 (2018): S326. http://dx.doi.org/10.1093/ofid/ofy210.924.

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Abstract Background Clostridium difficile infection (CDI) is the main cause for nosocomial diarrhea. Currently available assays for the diagnosis of CDI show deficits in sensitivity, specificity, and/or turnaround time. The Singulex Clarity® C. diff toxins A/B assay, in development for the Singulex Clarity® system, was designed to provide an accurate and automated detection of C. difficile toxins A (TcdA) and B (TcdB) in stool. Here, the analytical performance of the assay is reported. Methods Limits of detection (LoD) for TcdA and TcdB in stool and buffer was determined, and a preliminary cut

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Gomperts, Edward D., Shashikant Apte, Utpal Chaudhuri, et al. "IB1001, an Investigational Recombinant Factor IX, Pharmacokinetics in Pediatric Patients with Hemophilia B." Blood 120, no. 21 (2012): 2225. http://dx.doi.org/10.1182/blood.v120.21.2225.2225.

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Abstract Abstract 2225 Introduction IB1001 is a recombinant factor IX product being investigated for the treatment and prevention of bleeding in individuals with hemophilia B. Pharmacokinetics (PK) in adults (>12 years) demonstrated that IB1001 had results similar to the currently available recombinant FIX with respect to parameters such as terminal phase half-life and incremental recovery. We report the interim findings from a PK assessment in children <12 years, with severe hemophilia B (FIX <2%), >50 prior exposure days to FIX, and no history of or currently detectable inhibitor

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Karasiewicz, Kathy, Shuyang He, Mary Ng, et al. "Preclinical Evaluation of Human Placental-Derived Allogeneic CD19 CAR-T Cells Against B Cell Malignancies." Blood 134, Supplement_1 (2019): 3222. http://dx.doi.org/10.1182/blood-2019-130782.

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Celularity, Inc. is developing a CD19 CAR-T Cell therapy using an allogeneic platform derived from postpartum human placental cells. T cells isolated from placenta/ umbilical cord blood and genetically modified to express CD19 chimeric antigen receptor (CAR), termed Placental-derived (P-) CD19 CAR T cells, are in development for the treatment of B cell malignancies. Unlike adult peripheral blood mononuclear cell (PBMC)-derived T cells, P-T cells are mostly naïve (CD45RA+) and can be readily expanded while maintaining an earlier differentiation phenotype such as greater expression of naïve/ mem

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Coyne-Beasley, Tamera, Joseph Bocchini, Alejandro Cane, Cindy Burman, Maria J. Tort, and Jessica Presa. "01. Serum Bactericidal Activity Against Circulating and Reference Strains of Meningococcal Serogroup B in the United States: A Review of Meningococcal Serogroup B (MenB) Vaccines in Adolescents and Young Adults." Open Forum Infectious Diseases 8, Supplement_1 (2021): S124—S125. http://dx.doi.org/10.1093/ofid/ofab466.204.

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Abstract Background US adolescents and young adults are at particular risk of invasive meningococcal disease (IMD). In 2018, menincococcal serogroup B was responsible for 36% of IMD cases in the US overall and for 66% of cases in adolescents and young adults. This age group is at high risk of IMD during outbreaks, which result in significant response-related costs. MenB vaccine efficacy against IMD relies on its ability to provide broad protection against diverse disease-causing strains. MenB-FHbp (Trumenba) and MenB-4C (Bexsero) are MenB vaccines licensed in the US as 2-dose series with an in

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Lasater, Elisabeth A., An D. Do, Luciana Burton, et al. "Resistance of Natural Killer and T Cells to Venetoclax Allows for Combination Treatment with Cancer Immunotherapy Agents." Blood 132, Supplement 1 (2018): 1118. http://dx.doi.org/10.1182/blood-2018-99-116405.

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Abstract Introduction: Intrinsic apoptosis is regulated by the BCL-2 family of proteins, which consists of both anti-apoptotic (BCL-2, BCL-XL, MCL-1) and pro-apoptotic (BIM, BAX, BAK, BAD) proteins. Interaction between these proteins, as well as stringent regulation of their expression, mediates cell survival and can rapidly induce cell death. A shift in balance and overexpression of anti-apoptotic proteins is a hallmark of cancer. Venetoclax (ABT-199/GDC-0199) is a potent, selective small molecule BCL-2 inhibitor that has shown preclinical and clinical activity across hematologic malignancies

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He, Jie, Jose A. Bufill, Michelle K. Nahas, et al. "Clinical Utility of Comprehensive Profiling of Genomic Alterations in Hematologic Malignancies." Blood 124, no. 21 (2014): 1072. http://dx.doi.org/10.1182/blood.v124.21.1072.1072.

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Abstract Background: The clinical utility of mutation profiling in hematologic malignancies requires robust detection of all classes of genomic alterations in a single analysis across different tumor types. We developed a novel, hybrid capture-based NGS assay (FoundationOne® Heme) designed to comprehensively assess the genomic landscape of hematologic malignancies from archived FFPE, blood and bone marrow aspirate samples, sequencing both DNA and RNA to improve sensitivity for driver fusion events. We have analyzed the genomic alterations including substitutions, indels, copy number alteration

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Ge, Jianning, Chunhui Yang, Jing Sun, et al. "Preclinical Results of an Allogeneic, Universal CD19/CD7-Targeting CAR-T Cell Therapy (GC502) for B Cell Malignancies." Blood 138, Supplement 1 (2021): 1722. http://dx.doi.org/10.1182/blood-2021-148500.

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Abstract Background Autologous CD19 CAR-T therapies show very promising clinical efficacy, but are limited in their applicability by several factors including cost, time to manufacture, and other factors involving patients own T-cell qualities. GC027, a CD7 targeting allogeneic, universal CAR-T (UCAR-T) currently in development for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) has demonstrated robust expansion and anti-leukemia efficacy with a manageable safety profile in an investigator-initiated trial in China. These data suggest that, a single CD7 targeting CAR-T therapy is a

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Lilley, Graham, Alden Ladd, Daniel Cossette, et al. "Characterization of Lentiviral Vector Derived Anti-Bcma CAR T Cells Reveals Key Parameters for Robust Manufacturing of Cell-Based Gene Therapies for Multiple Myeloma." Blood 126, no. 23 (2015): 3243. http://dx.doi.org/10.1182/blood.v126.23.3243.3243.

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Abstract T cells engineered with chimeric antigen receptors (CAR) specific to CD19 have caused rapid and durable clinical responses in ~90% of patients with acute lymphoblastic leukemia. These data support the development of additional CAR T cell products for the treatment of other hematological malignancies. Recently, B cell maturation antigen (BCMA) expression has been proposed as a marker for identification of malignant plasma cells in patients with multiple myeloma (MM). Nearly all MM and some non-Hodgkin's lymphoma tumor cells express BCMA, while normal tissue expression is restricted to

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Tran, Thai Hong, Krupa Scott, Shyun-Shyun Lee, et al. "Quantitative Multiplexed Immunohistochemistry Assays for Exploring CAR Modified T Cells and Checkpoint Inhibitors in Lymphoma Trials." Blood 126, no. 23 (2015): 2659. http://dx.doi.org/10.1182/blood.v126.23.2659.2659.

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Abstract Although there have been compelling advances in the cancer immunotherapy space recently in the form of chimeric antigen receptor (CAR) modified T-cells and checkpoint inhibitors, advanced tools to explore the therapeutic mechanisms of their combination are not adequately developed or widely available. To address this growing need, we developed a robust quantitative fluorescent immunohistochemistry platform using multiplex AQUA (Automated Quantitative Analysis) technology to evaluate checkpoint inhibitor expression, enumerate CAR T cells and determine the interaction between tumor cell

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Totman, Jennifer, Dorothy Brach, Vinny Motwani, et al. "Pharmacologic Inhibition of the Histone Methyltransferase SETD2 with EZM0414 As a Novel Therapeutic Strategy in Relapsed or Refractory Multiple Myeloma and Diffuse Large B-Cell Lymphoma." Blood 138, Supplement 1 (2021): 1142. http://dx.doi.org/10.1182/blood-2021-151147.

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Abstract Introduction: SETD2 is the only known histone methyltransferase (HMT) capable of catalyzing H3K36 trimethylation (H3K36me3) in vivo. It plays an important role in several biological processes including B cell development and maturation, leading to the hypothesis that SETD2 inhibition in these settings could provide anti-tumor effects. The normal process of B cell development/maturation renders B cells susceptible to genetic vulnerabilities that can result in a dysregulated epigenome and tumorigenesis, including in multiple myeloma (MM) and diffuse large B-cell lymphoma (DLBCL). For ex

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Chang, Kai-Hsin, Minerva Sanchez, Jack Heath, et al. "Comparative Studies Reveal Robust HbF Induction By Editing of HBG1/2 Promoters or BCL11A Erythroid-Enhancer in Human CD34+ Cells but That BCL11A Erythroid-Enhancer Editing Is Associated with Selective Reduction in Erythroid Lineage Reconstitution in a Xenotransplantation Model." Blood 132, Supplement 1 (2018): 409. http://dx.doi.org/10.1182/blood-2018-99-114780.

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Abstract Beta hemoglobinopathies resulting from dysfunctional or deficient adult beta-globin expression are some of the most prevalent inherited blood disorders in the world. Upregulation of developmentally-silenced fetal gamma-globin would replace adult beta-globin to ameliorate disease symptoms. One of the approaches to reactivate fetal globin expression in erythroid cells is through gene editing by zinc finger or CRISPR-Cas9 nucleases to disrupt the expression of a transcription factor BCL11A, which mediates fetal globin silencing. As BCL11A-deficiency leads to hematopoietic stem cells (HSC

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Schomer, Nathan Thomas, Laurent Boissel, Karen Jiang, Hans Klingemann, John H. Lee, and Patrick Soon-Shiong. "Providing a Homing Receptor for CAR Engineered NK Cells - Improving Cellular Immunotherapy for B-Cell Lymphoma." Blood 132, Supplement 1 (2018): 4547. http://dx.doi.org/10.1182/blood-2018-99-116890.

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Abstract Background Despite some robust initial responses, anti-CD19 Chimeric Antigen Receptor (CAR) T-cell therapy can be associated with significant short-term (cytokine release syndrome) and long-term (B-cell deficiency) toxicities. CAR-engineered natural killer (NK) cells potentially provide a safer alternative while maintaining efficacy. Activated Natural Killer (aNKTM) cells are a clinical grade cell line derived from the NK-92R cell line that has demonstrated potent cytotoxicity towards a broad spectrum of malignant cell lines as well as safety and efficacy in phase I trials. Variants o

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Toudjarska, Ivanka, Zuhua Cai, Tim Racie, et al. "RNAi-Mediated Inhibition of Activated Protein C- A New Approach for Hemophilia Treatment." Blood 118, no. 21 (2011): 1204. http://dx.doi.org/10.1182/blood.v118.21.1204.1204.

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Abstract Abstract 1204 Protein C is a major anticoagulation factor that serves as a key regulator of the clotting cascade. Activated protein C (APC), which is formed by limited proteolysis of the zymogen protein C by the thrombin–thrombomodulin complex, modulates thrombin generation. The anticoagulant effect of APC is due to subsequent inactivation of both activated factors V (FVa) and VIII (FVIIIa). The important role of APC in coagulation is highlighted in FV Leiden (FVL), the most common inherited form of thrombophilia. FVL is caused by a mutation in the FV gene at the initial APC cleavage

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Campbell, Veronica, Ryan Thompson, Vivian Villegas та ін. "The Potent PI3K-δ,γ Inhibitor IPI-145 Exhibits Differential Activity In Diffuse Large B-Cell Lymphoma (DLBCL) Cell Lines". Blood 122, № 21 (2013): 1832. http://dx.doi.org/10.1182/blood.v122.21.1832.1832.

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Abstract Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin lymphoma (NHL). Despite aggressive chemoimmunotherapy, ∼40% of patients die of their disease. Molecular differences in the tumor genome are likely to be major contributors to the heterogeneity of clinical response. Several investigators have identified molecular subtypes, including a “cell-of-origin” (COO) signature with activated B-cell-like (ABC) and germinal center B-cell-like (GCB) sub-types (Alizadeh, et al. Nature 2000), and a “consensus clustering” (CC) signature with oxidative phosphorylation, B-cell

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Coiffier, Bertrand, Juan-Manuel Sancho, Wojciech Jurczak, et al. "Pharmacokinetic and Safety of CT-P10, a Biosimilar Candidate to the Rituximab Reference Product, in Patients with Newly Diagnosed Advanced Stage Follicular Lymphoma (AFL)." Blood 128, no. 22 (2016): 1807. http://dx.doi.org/10.1182/blood.v128.22.1807.1807.

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Abstract Background: CT-P10 is a biosimilar candidate to the reference rituximab product, EU-approved MabThera® and US-licensed Rituxan®. CT-P10 has an identical amino acid sequence and highly similar physicochemical and in vitro functional properties to its reference drug. In patients with rheumatoid arthritis, CT-P10 has demonstrated compelling similarity in pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety and immunogenicity (Yoo DH, et al. Arthritis Rheum. 2013;65(10):1736). Objective: The goal of this study was to demonstrate PK similarity of CT-P10 to rituximab, each adminis

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Storhoff, James, Brett Wallden, Rita M. Braziel, et al. "Analytical Performance of Nanostring's Companion Diagnostic (CDx) Lymphoma Subtyping Test (LST) with Diffuse Large B-Cell Lymphoma Core Needle Biopsy Samples." Blood 126, no. 23 (2015): 1481. http://dx.doi.org/10.1182/blood.v126.23.1481.1481.

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Abstract Background: Diffuse large B-cell lymphoma (DLBCL) is an aggressive non-Hodgkin's lymphoma with two distinct molecular cell-of-origin (COO) subtypes known as germinal center B-cell (GCB) or activated B-cell (ABC). DLBCL subtypes have been reported to be prognostic and potentially predictive of treatment benefit, underscoring the need for a precise and accurate CDx test (Roschewski, Nat Rev Clin Oncol, 2014). NanoString's LST was developed to enable identification of the COO subtypes on the nCounter® Dx Analysis System using formalin fixed paraffin embedded (FFPE) tissue specimens based

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Ganesan, Harish, Vipul Kumar, Sujata M. Bhavnani, David Melnick, and Christopher M. Rubino. "1105. Population Pharmacokinetic Analyses for Tebipenem After the Administration of Tebipenem Pivoxil Hydrobromide." Open Forum Infectious Diseases 8, Supplement_1 (2021): S644—S645. http://dx.doi.org/10.1093/ofid/ofab466.1299.

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Abstract Background Tebipenem pivoxil hydrobromide (TBP-PI-HBr) is an oral prodrug that is converted to tebipenem (TBP), the active moiety. TBP is a carbapenem with activity against multidrug-resistant Gram-negative pathogens, including extended-spectrum-β-lactamase-producing Enterobacterales and is being developed for treating complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). Data from three Phase 1 studies and one Phase 3 study in patients with cUTI/AP were used to develop a population pharmacokinetic (PPK) model for TBP and identify covariates that described the var

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Merrill, J. T., J. Guthridge, D. Zack, et al. "SAT0187 DISCRIMINATION OF SYSTEMIC LUPUS (SLE) PATIENTS WITH CLINICAL RESPONSE TO OBEXELIMAB (XMAB®5871) BASED ON A PATTERN OF IMMUNOLOGIC MARKERS." Annals of the Rheumatic Diseases 79, Suppl 1 (2020): 1035–36. http://dx.doi.org/10.1136/annrheumdis-2020-eular.2972.

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Background:We recently reported Phase 2 SLE trial results of obexelimab, an FcγRIIb agonist (suppressor of B cell activation). Obexelimab did not meet the primary endpoint (% of patients without flare at Day 225) (p=0.183) but other endpoints such as time to flare (p=0.025) were met.Objectives:1. To assign SLE patients to phenotypic subsets based on patterns of gene expression in immune-related pathways.12. To explore the association of immune patterns and clinical response to obexelimab.Methods:This analysis included 71 of the 104 participants in the obexelimab study, those who either complet

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Dias, Lizalynn, Venkata Thodima, Geetu Mendiratta, et al. "Cross-Platform Assessment Of Genomic Imbalance In Diffuse Large B-Cell Lymphoma Identifies Novel Candidate Loci and Genes With Prognostic Value and Roles In Lymphomagenesis." Blood 122, no. 21 (2013): 4259. http://dx.doi.org/10.1182/blood.v122.21.4259.4259.

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Abstract Diffuse large B-cell lymphomas (DLBCL) display marked clinical, pathologic, and genetic heterogeneity. With current frontline immunotherapy (RCHOP), only about 40% of patients are cured, with most relapses occurring within the first 2-3 years. Patients are currently risk-stratified based primarily on clinical features where the inclusion of molecular biomarkers into risk assessment could impact the potential to identify those patients most likely to have refractory disease or have an early relapse. Various cytogenomic studies have revealed the prognostic significance of genomic gain/l

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Hsieh, Y. T., C. Hubeau, V. Massa, et al. "OP0316 EMERGING BEST-IN-CLASS IL-2 VARIANT HIGHLIGHTS TREG-DIRECTED THERAPY FOR AUTOIMMUNE DISEASE." Annals of the Rheumatic Diseases 79, Suppl 1 (2020): 195.1–195. http://dx.doi.org/10.1136/annrheumdis-2020-eular.1999.

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Background:Impairment or deficiency of regulatory T cells (Treg) is associated with chronic inflammation and autoimmune diseases. Interleukin 2 (IL-2) is a cytokine indispensable for Treg expansion and immunosuppressive function. However, expansion of cytotoxic effector T (Teff) and NK cells and the associated vascular leakage side effect limit the use of IL-2 in autoimmune diseases [1].Objectives:Cugene developed a long-acting IL-2 variant with high Treg specificity and low toxicity to restore immune homeostasis and self-tolerance, and potentially cure autoimmune and inflammatory diseases.Met

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Riley, Brigit E., Jeff Boonsripisal, Alicia Goodwin, et al. "Development of an Optimized rAAV2/6 Human Factor 8 cDNA Vector Cassette for Hemophilia a Gene Therapy." Blood 128, no. 22 (2016): 1173. http://dx.doi.org/10.1182/blood.v128.22.1173.1173.

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Abstract Hemophilia A, which is caused by a mutation in the Factor 8 (F8) gene resulting in a deficiency or lack of the Factor VIII (FVIII) protein, is the most common inherited bleeding disorder in humans with an estimated worldwide incidence of half a million people. The disorder is X-linked and occurs in approximately 1 in 5,000 males; however there is also a growing appreciation of the impact on carrier females having a single mutant allele, with at least 10% of hemophilia A female carriers having less than normal clotting activity. Even modest increases in Factor V III activity (>1% of

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Harrington, Deirdre M., Sarahjane Belton, Tara Coppinger, et al. "Results from Ireland’s 2014 Report Card on Physical Activity in Children and Youth." Journal of Physical Activity and Health 11, s1 (2014): S63—S68. http://dx.doi.org/10.1123/jpah.2014-0166.

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Background:Physical activity (PA) levels are a key performance indicator for policy documents in Ireland. The first Ireland Report Card on Physical Activity in Children and Youth aims to set a robust baseline for future surveillance of indicators related to PA in children and youth.Methods:Data collected between 2003−2010 on more than 35,000 7- to 18-year-old children and youth were used and graded using a standardized grading system for 10 indicators.Results:Grades assigned for the indicators were as follows: overall physical activity levels, D-; sedentary behavior (TV viewing), C-; organized

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Dias, Lizalynn, Venkata Thodima, Asha Guttapalli, Geetu Mendiratta, Sergei I. Syrbu, and Jane Houldsworth. "Robust Assessment of Genomic Imbalance in Diffuse Large B-Cell Lymphoma Confirms Inferior Outcome Is Associated with Genomic Complexity and Identifies Potential Therapeutic Pathway Targets." Blood 124, no. 21 (2014): 2993. http://dx.doi.org/10.1182/blood.v124.21.2993.2993.

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Abstract Despite excellent initial responses of diffuse large B-cell lymphoma (DLBCL) patients to current frontline immunotherapy (RCHOP), only about 40% of patients are ultimately cured, with most relapses occurring within the first 2-3 years. Apart from clinical features, very few biomarkers are available and validated for risk stratification of DLBCL patients, other than cell-of-origin (COO) subtyping and MYC rearrangement. Genomic copy number changes identified using a variety of genomic profiling technologies including massively parallel sequencing, have variously been reported to have pr

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Anguela, Xavier M., Rajiv Sharma, Yannick Doyon, et al. "In Vivo Genome Editing of Liver Albumin for Therapeutic Gene Expression: Rescue of Hemophilic Mice Via Integration of Factor 9." Blood 120, no. 21 (2012): 751. http://dx.doi.org/10.1182/blood.v120.21.751.751.

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Abstract Abstract 751 Gene correction using zinc finger nuclease (ZFN) technology can be applied to target virtually any locus in the human genome. Beyond correcting mutated genes causative of disease, ZFNs can also be utilized to target transgene insertion into genomic “safe harbors.” Ideally, specific gene targeting to such “safe harbor” sites would (i) ensure therapeutically relevant levels of transgene expression and (ii) tolerate transgene addition without deleterious effect on the host organism. For liver-derived protein replacement, albumin represents an attractive target locus. Firstly

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Timmerman, John M., Kristopher K. Steward, Reiko E. Yamada, et al. "Antibody-Interferon-Alpha Fusion Protein Therapy for the Treatment of B-Cell Non-Hodgkin Lymphoma: Enhanced ADCC, Inhibition of Proliferation, and In Vivo Eradication of CD20+ Human Lymphomas." Blood 126, no. 23 (2015): 2762. http://dx.doi.org/10.1182/blood.v126.23.2762.2762.

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Abstract Background: Interferon-alpha (IFNα) is a pleiotrophic cytokine with direct anti-tumor and immunostimulatory effects. Currently IFNα is approved for the treatment of multiple hematologic malignancies, including non-Hodgkin lymphoma (NHL). However, its clinical utility has been hindered by dose-limiting toxicitiy due to systemic activation of the interferon receptor. To overcome this limitation, we engineered anti-tumor antibody-IFNα fusion proteins to selectively increase delivery of IFN to the tumor site and reduce systemic toxicity. We previously reported that IGN002, an anti-CD20-IF

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Chekmasova, Alena A., Holly M. Horton, Tracy E. Garrett, et al. "A Novel and Highly Potent CAR T Cell Drug Product for Treatment of BCMA-Expressing Hematological Malignances." Blood 126, no. 23 (2015): 3094. http://dx.doi.org/10.1182/blood.v126.23.3094.3094.

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Abstract Recently, B cell maturation antigen (BCMA) expression has been proposed as a marker for identification of malignant plasma cells in patients with multiple myeloma (MM). Nearly all MM and some lymphoma tumor cells express BCMA, while normal tissue expression is restricted to plasma cells and a subset of mature B cells. Targeting BCMA maybe a therapeutic option for treatment of patients with MM and some lymphomas. We are developing a chimeric antigen receptor (CAR)-based therapy for the treatment of BCMA-expressing MM. Our anti-BCMA CAR consists of an extracellular single chain variable

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Younes, Anas, Connie Lee Batlevi, Jonathon B. Cohen, et al. "A Multi-Center Dose-Finding Study to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Fimepinostat (CUDC-907) in Combination with Venetoclax in Patients with Relapsed/Refractory (R/R) Lymphoma." Blood 134, Supplement_1 (2019): 4104. http://dx.doi.org/10.1182/blood-2019-128857.

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Background High-grade B-cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 rearrangements (double- and triple-hit lymphoma), as well as diffuse large B-cell lymphoma (DLBCL), NOS with increased expression of MYC and BCL2 protein (double-expressor lymphoma) are associated with a poor prognosis after front-line treatment with standard immunochemotherapy. As such, therapies targeting MYC and BCL2 alterations are urgently needed. Currently, there are no approved therapies that target MYC. Fimepinostat is an investigational small molecule dual inhibitor of phosphotidyl-inositol-3-kinases (PI3Ks) an

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Bjordahl, Ryan, Raedun Clarke, Svetlana Gaidarova, et al. "Off-the-Shelf Natural Killer Cell Immunotherapy for Enhanced Antibody Directed Cellular Cytotoxicity." Blood 128, no. 22 (2016): 3363. http://dx.doi.org/10.1182/blood.v128.22.3363.3363.

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Abstract Natural Killer (NK) cells play a crucial role in immunosurveillance and form a first line of defense against cancer. In comparison to other lymphocytes, NK cells are unique in their capability to elicit tumoricidal responses without the need for antigen presentation or prior sensitization. Clinical data from bone marrow transplant and allogeneic NK immunotherapy suggest that MHC mismatch is advantageous in promoting graft-versus-leukemia without eliciting graft-versus-host, providing evidence that NK cells hold promisa as an allogeneic, universal immunotherapeutic. Further, the anti-t

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Sommer, Cesar, Hsin-Yuan Cheng, Yik Andy Yeung, et al. "Preclinical Evaluation of ALLO-819, an Allogeneic CAR T Cell Therapy Targeting FLT3 for the Treatment of Acute Myeloid Leukemia." Blood 134, Supplement_1 (2019): 3921. http://dx.doi.org/10.1182/blood-2019-129025.

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Autologous chimeric antigen receptor (CAR) T cells have achieved unprecedented clinical responses in patients with B-cell leukemias, lymphomas and multiple myeloma, raising interest in using CAR T cell therapies in AML. These therapies are produced using a patient's own T cells, an approach that has inherent challenges, including requiring significant time for production, complex supply chain logistics, separate GMP manufacturing for each patient, and variability in performance of patient-derived cells. Given the rapid pace of disease progression combined with limitations associated with the a

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Richon, Victoria M., Christopher J. Sneeringer, Margaret Porter Scott, et al. "Lymphoma-Associated Mutations of EZH2 Result In a Change-of-Function." Blood 116, no. 21 (2010): 707. http://dx.doi.org/10.1182/blood.v116.21.707.707.

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Abstract Abstract 707 EZH2, the catalytic subunit of the polycomb repressive complex 2 (PRC2), catalyzes the mono- through tri-methylation of lysine 27 on histone H3 (H3K27). While overexpression of EZH2 and increased H3K27 methylation have generally been associated with both hematologic malignancies and solid tumors, inactivating somatic mutations of Tyr641 (Y641F, Y641N, Y641S and Y641H) of EZH2 were recently reported to be associated with follicular lymphoma (FL) and the GCB subtype of diffuse large B-cell lymphoma (DLBCL) (Morin, Nat Genet 2010; 42: 181). In all cases, occurrence of the mu

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Huard, Justin, Laurie Tatalick, Carl Walkey, and Ryan Swanson. "NL-201, a De Novo Agonist of IL-2 and IL-15 Receptors, Demonstrates Synergistic Antitumor Activity with Anti-PD-1 Checkpoint Inhibitor Therapy in a Preclinical Non-Hodgkin Lymphoma Model." Blood 138, Supplement 1 (2021): 4560. http://dx.doi.org/10.1182/blood-2021-148885.

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Abstract NL-201 is a potent, selective, and long-acting computationally designed alpha-independent agonist of the IL-2 and IL-15 receptors that is being developed as an immunotherapy for cancer. NL-201 binds to the beta and gamma subunits, selectively stimulating dose-dependent expansion and tumor infiltration of cytotoxic CD8+ T cells and natural killer (NK) cells, thereby enhancing the immune response to the tumor. Absence of binding to the IL-2 alpha subunit reduces the undesirable effects of traditional IL-2 therapies, such as vascular leak syndrome and expansion of immunosuppressive regul

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Gyurkocza, Boglarka, Rajneesh Nath, Patrick J. Stiff, et al. "Re-Induction and Targeted Conditioning with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Leads to High Rates of Transplantation and Successful Engraftment in Older Patients with Active, Relapsed or Refractory (rel/ref) AML after Failure of Chemotherapy and Targeted Agents: Preliminary Midpoint Results from the Prospective, Randomized Phase 3 Sierra Trial." Blood 134, Supplement_1 (2019): 5642. http://dx.doi.org/10.1182/blood-2019-122776.

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Background: Patients ≥55 years of age with rel/ref AML who have failed to achieve complete remission (CR) after standard induction & salvage therapies do not routinely undergo allogeneic hematopoietic cell transplantation (HCT) due to inability to receive myeloablative conditioning and lack of efficacy. With the advent of recently approved targeted therapies (e.g. venetoclax, IDH inhibitors) more patients achieve CR, however durable responses in heavily pre-treated patient populations remain unsatisfactory with very few patients being transplanted. The SIERRA (Study of Iomab-B in Elderly R

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Rosen, David B., James A. Cordeiro, David M. Soper, et al. "Distinct Signaling Profiles of Gemtuzumab Ozogamicin Responsiveness and Refractoriness in Acute Myeloid Leukemia." Blood 114, no. 22 (2009): 2745. http://dx.doi.org/10.1182/blood.v114.22.2745.2745.

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Abstract Abstract 2745 Poster Board II-721 Background: Gemtuzumab Ozogamicin (GO, Mylotarg), a humanized CD33 monoclonal antibody linked to calicheamicin was approved by the US FDA for use as a monotherapy in patients older than 60 years with relapsed acute myeloid leukemia (AML) unfit to tolerate standard salvage therapy. GO is internalized rapidly after infusion, and calicheamicin, a potent enediyene, is subsequently released and acts as a cytotoxic agent by causing double strand DNA breaks. Currently GO is in multiple clinical trials as a single agent or in combination with other therapies

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Storms, Robert W., Congxiao Liu, Elisabeth T. Tracy, Tracy Gentry, Andrew Balber, and Joanne Kurtzberg. "ALDHbr Hematopoietic Progenitors Promote Short-Term Engraftment in Experimental Models for Cord Blood Transplantation." Blood 114, no. 22 (2009): 2433. http://dx.doi.org/10.1182/blood.v114.22.2433.2433.

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Abstract Abstract 2433 Poster Board II-410 We previously developed robust methods to purify human hematopoietic progenitors based on their high expression of aldehyde dehydrogenase (ALDHbr cells). These cells are enriched with both short- and long-term NOD/SCID repopulating cells. One early clinical trial suggested that augmenting a conventional cord blood transplant (CBT) with ALDHbr cells accelerated both neutrophil and platelet engraftment. We now describe experimental models for these clinical transplants, performed in two immunologically disparate strains of NOD/SCID mice. In the clinical

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Howell, Stephen B., Hongying Zhang, and William G. Rice. "A Phase 1a/b Dose Escalation Study of Apto-253 in Patients with Relapsed or Refractory AML or High-Risk MDS." Blood 134, Supplement_1 (2019): 5148. http://dx.doi.org/10.1182/blood-2019-129685.

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INTRODUCTION: APTO-253 has captured attention because of its distinguishing mechanism of action as the only known a small molecule in clinical development to target a conserved structure in the promoter of the MYC oncogene and interrupt MYC gene expression. In preclinical studies of acute myeloid leukemia (AML) cell lines, APTO-253 was discovered to potently down-regulate MYC gene expression, reduce MYC mRNA and protein level, induce apoptosis, and deplete cells of the MYC oncoprotein. APTO-253 demonstrated broad killing of primary mononuclear cells isolated from the bone marrow of patients wi

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Steen, Chloe B., Bogdan A. Luca, Mohammad Shahrokh Esfahani, et al. "An Atlas of Clinically-Distinct Tumor Cellular Ecosystems in Diffuse Large B Cell Lymphoma." Blood 134, Supplement_1 (2019): 655. http://dx.doi.org/10.1182/blood-2019-129461.

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Background: Diffuse large B cell lymphoma (DLBCL) exhibits significant clinical and biological heterogeneity, in part due to cell-of-origin subtypes, somatic alterations, and diverse stromal constituents within the tumor microenvironment (TME). Several immunologically-active lymphoma therapies are known to rely on innate and adaptive anti-tumor responses occurring within this dynamic TME, including agents that are approved (e.g., rituximab, lenalidomide, CART19, ibrutinib) or emerging (e.g., anti-CD47, checkpoint inhibitors). We hypothesized that a large-scale characterization of the cellular

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Stapleton, Ann, Aurelio Silvestroni, Pacita Roberts, et al. "126. Robust and Persistent Vaginal Colonization with LACTIN-V Vaginal Lactobacillus crispatus Probiotic in a Double-Blind, Placebo-Controlled (DBPC) Phase 2b Trial to Prevent Recurrent UTI (rUTI)." Open Forum Infectious Diseases 5, suppl_1 (2018): S8. http://dx.doi.org/10.1093/ofid/ofy209.016.

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Abstract Background We investigated vaginal colonization using repetitive sequence PCR (repPCR) and 16S rRNA sequencing in a Phase 2b DBPC trial of a L. crispatus intravaginal suppository probiotic for prevention of rUTI in premenopausal women. Methods Twenty-four young women with a history of rUTI and current culture-confirmed symptomatic UTI were enrolled and treated (Visit 0), then randomized (Visit 1) to receive an intravaginal suppository containing L. crispatus CTV-05 (LACTIN-V®, Osel, Inc.) or placebo daily for 5 days, then once weekly for 2 months. Participants were followed up during

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Fang, Riguo, Yingchi Zhang, Pengfei Yuan, et al. "Highly Efficient Gene Editing of Human Hematopoietic Stem Cells to Treat X-Linked Sideroblastic Anemia." Blood 136, Supplement 1 (2020): 1. http://dx.doi.org/10.1182/blood-2020-140208.

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X-linked sideroblastic anemia (XLSA) is an anemic disease caused by mutations in the gene encoding 5-aminolevulinate synthase 2 (ALAS2), which catalyzes the rate-limiting step of heme biosynthesis. With current interventions including pyridoxine treatment and allogeneic hematopoietic stem cell transplantation, severe unmet needs remain for patients with XLSA. Here, we used CRISPR/Cas9 technology to efficiently and functionally correct the pathogenic mutation in intron 1 of ALAS2 in CD34+ hematopoietic stem cell and progenitor cells (HSPCs) from two patients. Intriguingly, we found that the gen

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Loveday, Kenneth, Doriana Froim, Anna Pisania, et al. "ACE-536, a Novel GDF-Trap, Increases Hemoglobin, Hematocrit, and Red Blood Cell Levels in Rats and Monkeys." Blood 114, no. 22 (2009): 3603. http://dx.doi.org/10.1182/blood.v114.22.3603.3603.

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Abstract Abstract 3603 Poster Board III-540 Anemia is a common and debilitating complication of several tumor types, especially multiple myeloma and myelodysplastic syndrome, chemotherapy, chronic kidney disease, and many other conditions. The vast majority of therapies approved to treat anemia target the erythropoietin (EPO) pathway; however, recent studies suggest an increased risk of mortality associated with this class of therapy, arising from exposure to high levels of EPO. The TGF-β protein superfamily has been described to play a role in RBC development, but signals through a pathway di

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Srinivasan, Surabhi, Nguyen Tan, Hsin-Yuan Cheng, et al. "Investigation of ALLO-316: A Fratricide-Resistant Allogeneic CAR T Targeting CD70 As a Potential Therapy for the Treatment of AML." Blood 136, Supplement 1 (2020): 23. http://dx.doi.org/10.1182/blood-2020-142161.

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CD70, a member of the TNF superfamily, is a type II transmembrane glycoprotein that interacts with its receptor (CD27) to promote survival of primed T cells and leads to formation of effector and memory T cells. Expression of CD70 in normal tissues is restricted to activated T and B lymphocytes and mature dendritic cells. CD70 is also widely expressed in various malignancies, including renal cell carcinoma (RCC) and acute myeloid leukemia (AML). The restricted expression pattern of CD70 in normal tissues makes it an attractive target for cancer therapeutics. Adoptive transfer of T cells expres

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Smolen, J. S., F. Behrens, S. Liu Leage, et al. "AB0841 TARGET OUTCOMES IN PsA: SIMULTANEOUS ACHIEVEMENT of ACR50-PASI100 AND BEYOND: INSIGHTS FROM SPIRIT-H2H AT WEEK 24." Annals of the Rheumatic Diseases 79, Suppl 1 (2020): 1726.2–1727. http://dx.doi.org/10.1136/annrheumdis-2020-eular.2884.

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Background:Psoriatic Arthritis (PsA) treatment should aim to achieve robust improvement of arthritis as well as control of extra-articular manifestations like the skin. SPIRIT-H2H evaluated the efficacy of ixekizumab (IXE) and adalimumab (ADA) in patients with active PsA and psoriasis, and naïve to biologic Disease-Modifying Anti-Rheumatic Drugs (bDMARDs). At week 24 (W24), IXE showed superiority to ADA in simultaneous achievement of ACR50 and PASI100 as well as significant improvement of treat-to-target and other extra-articular outcomes.Objectives:To examine and to compare PsA efficacy outco

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Lawrence, Jody, Nicholas Kitchin, Annaliesa S. Anderson, et al. "12. Randomized Studies of Two Clostridioides (Clostridium) difficile Vaccine Formulations." Open Forum Infectious Diseases 7, Supplement_1 (2020): S29. http://dx.doi.org/10.1093/ofid/ofaa439.057.

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Abstract Background Two formulations of investigational bivalent Clostridioides (Clostridium) difficile vaccine (QS-21 adjuvanted toxoid and toxoid-alone) were assessed for safety and immunogenicity in randomized studies in healthy adults 50–85 years of age. Methods The Phase 1 study of QS-21 adjuvanted toxoid vaccine randomized subjects 3:1 to 100 μg QS-21-containing C difficile vaccine or placebo; 3 doses were given according to 2 different schedules: a shortened month (Months 0, 1, 3) or day (Days 1, 8, 30) regimen. The Phase 2 toxoid-alone vaccine study randomized subjects 3:3:1 to receive

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Peterson, James, Daniel Drazan, Hanna Czajka, et al. "6. Pentavalent Meningococcal (MenABCWY) Vaccine is Safe and Well Tolerated With Immunogenicity Noninferior to Coadministered MenB-FHbp and MenACWY-CRM in a Phase 2 Study of Healthy Adolescents and Young Adults." Open Forum Infectious Diseases 7, Supplement_1 (2020): S25—S26. http://dx.doi.org/10.1093/ofid/ofaa439.051.

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Abstract Background Meningococcal serogroups A, B, C, W and Y cause nearly all meningococcal disease globally. Vaccination is complicated by different dosing recommendations for serogroup B (MenB) and quadrivalent (MenACWY) vaccines, which could be solved with a single pentavalent vaccine. This study in adolescents and young adults evaluated a new pentavalent MenABCWY vaccine that combines 2 licensed vaccines, MenB-FHbp (Trumenba®; bivalent rLP2086) and MenACWY-TT (Nimenrix®), into a single vaccine. Methods In this ongoing, randomized, controlled, observer-blinded, multicenter study (NCT031358

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Cichocki, Frank, Ryan Bjordahl, Svetlana Gaidarova, et al. "iPSC-Derived NK Cells and Anti-PD-1 Antibody Synergize to Enhance T Cell Cytokine and Cytolytic Responses Against Multiple Tumors." Blood 132, Supplement 1 (2018): 730. http://dx.doi.org/10.1182/blood-2018-99-114893.

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Abstract The development of immunotherapeutic monoclonal antibodies targeting checkpoint inhibitory receptors (CIR), such as programmed death 1 (PD-1), has transformed the oncology landscape. However, many tumor subtypes are resistant to CIR-targeted therapy, and relapse remains a significant concern. Therefore, combination of novel immunotherapies with CIR targeting remains a promising and widely investigated approach to bolster anti-tumor responses and to overcome tumor resistance to CIR therapy. Natural killer (NK) cells mediate direct tumor cell lysis and are key regulators of T cell respo

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Smith, Pascal, Evelyn Teh, Ken Chisholm, et al. "Proteomic analysis of plasma exosomes as biomarkers of response to MVP-S based immunotherapy." Journal of Immunology 208, no. 1_Supplement (2022): 66.09. http://dx.doi.org/10.4049/jimmunol.208.supp.66.09.

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Abstract Ovarian cancer is a deadly gynaecological disease owing to its late-stage diagnosis. Recurrence and chemo-resistance develop despite initial treatment success. Maveropepimut-S (MVP-S), formerly DPX-Survivac, is a DPX-based immune educating therapy that elicits robust, targeted and, sustained specific anti-tumor T- and B-cell responses in advanced ovarian cancer patients. Exosomes are a subtype of extracellular vesicles (EVs) secreted by cells involved in intercellular communication. They contain bioactive molecules that can influence the tumor, the immune system, and the extracellular

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Zinzani, Pier Luigi, Vladimir Melnichenko, Krimo Bouabdallah, et al. "Pembrolizumab Monotherapy in Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma (PMBCL): 3-Year Follow-up of the Keynote-170 Study." Blood 136, Supplement 1 (2020): 42–43. http://dx.doi.org/10.1182/blood-2020-137080.

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Introduction: No standard of care exists for patients (pts) with relapsed or refractory primary mediastinal B-cell lymphoma (rrPMBCL). As such, pts typically receive therapies recommended for diffuse large B-cell lymphoma, with poor prognosis. Similar to classical Hodgkin lymphoma, rrPMBCL tumors often overexpress the programmed death 1 (PD-1) ligands, PD-L1 and PD-L2. Data from the first full analysis of the phase 2 KEYNOTE (KN)-170 (NCT02576990) study showed that pembrolizumab provided effective and durable antitumor activity with a manageable safety profile in patients with rrPMBCL. These d

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Minson, Katherine A., Madeline G. Huey, Amanda A. Hill, et al. "Bone Marrow Stromal Cell Mediated Resistance to Mertk Inhibition in Acute Leukemia." Blood 128, no. 22 (2016): 2819. http://dx.doi.org/10.1182/blood.v128.22.2819.2819.

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Abstract MERTK is a receptor tyrosine kinase of the TAM family (TYRO-3, AXL, MERTK) that is ectopically expressed in 30-50% of newly diagnosed pediatric acute lymphoblastic leukemia (ALL) patient samples and aberrantly expressed in 80-100% of pediatric and adult primary acute myeloid leukemia (AML) samples. MERTK inhibition mediated by shRNA or a small molecule inhibitor, MRX-2843, decreased colony-forming potential and induced apoptosis in leukemia cell cultures. Moreover, MERTK inhibition prolonged survival in mouse xenograft models of acute leukemia, but was not curative. In these models, t

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Martinowitz, Uri, Amy D. Shapiro, Doris V. Quon, et al. "Pharmacokinetic Behavior of IB1001, An Investigational Recombinant Factor IX, in Patients with Hemophilia B: Repeat Pharmacokinetic Study and Subgroup Analysis." Blood 118, no. 21 (2011): 2267. http://dx.doi.org/10.1182/blood.v118.21.2267.2267.

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Abstract Abstract 2267 Introduction IB1001 is an investigational recombinant factor IX for the treatment and prevention of bleeding in individuals with hemophilia B. A randomized cross-over pharmacokinetic (PK) study demonstrated that IB1001 (75 IU/kg) compared with nonacog alfa (BeneFIX®). was non-inferior (lower bound of the 1-sided 95% confidence interval for the area under the concentration curve [AUC0–∞] was 90%) and was well tolerated. Here we report the findings from a repeat PK assessment, in which a subset of patients underwent a second PK evaluation with IB1001 only. In addition, we

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Kirsch, Ilan, Zijun Yidan Xu-Monette, Thomas Snyder, and Ken H. Young. "Defining Immunoglobulin Somatic Hypermutation in De Novo Diffuse Large B-Cell Lymphoma Patients: Potential Application for Prognosis and Risk Stratification." Blood 124, no. 21 (2014): 1669. http://dx.doi.org/10.1182/blood.v124.21.1669.1669.

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Abstract Context Diffuse large B cell lymphoma (DLBCL) is a heterogeneous group of diseases with variable clinical presentation, morphologic features, genomics, gene expression signature and prognosis. Some of the variability in patient course and response to therapy is likely to represent a function of developmental stage and/or specific pathway of transformation. We have been engaged in a detailed investigation of the molecular and clinical features of a large cohort of patients with DLBCL at the MD Anderson Cancer Center. Through these analyses we have begun to subcategorize this patient po

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Best, Scott R., Taylor Rowland, Cody Paiva, et al. "TAK-243, a Small Molecule Inhibitor of Ubiquitin-Activating Enzyme (UAE), Induces ER Stress and Apoptosis in CLL Cells." Blood 132, Supplement 1 (2018): 1867. http://dx.doi.org/10.1182/blood-2018-99-114964.

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Abstract Introduction: Despite the promise of B-cell receptor-associated kinase inhibitors (BCRi) in CLL, resistance to these agents is inevitable. Ubiquitin-proteasome systems are altered in cancer, leading to destabilization of tumor suppressors, overexpression of proto-oncogenes (e.g., MYC), and impaired DNA repair. Neoplastic B cells exhibit a state of heightened cellular stress and are thereby susceptible to endoplasmic reticulum (ER) stress and the unfolded protein response (UPR). The UPR is activated in CLL cells upon sIgM signaling and inhibited by ibrutinib. Proteasome inhibitors demo

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