On April 15, 2016 Kite Pharma, Inc., (Nasdaq:KITE) ("Kite") a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT) products for the treatment of cancer, reported the schedule of presentations and addresses related to its engineered cell therapy programs at the upcoming AACR (Free AACR Whitepaper) Annual Meeting in New Orleans, Louisiana (Press release, Kite Pharma, APR 15, 2016, View Source [SID:1234510955]). Topics will include KTE-C19, Kite’s lead chimeric antigen receptor (CAR) product candidate, as well as engineered T cell receptor (TCR) product candidates targeting solid tumors that express the MAGE-A3 and KRAS cancer proteins. KTE-C19 is currently being studied in four pivotal clinical trials. Clinical study of the MAGE-A3 TCR and pre-clinical study of KRAS TCRs are being advanced as part of a Cooperative Research and Development Agreement (CRADA) between Kite and the National Cancer Institute.

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Oral Presentations

Updated Phase 1 Results from ZUMA-1: A Phase 1-2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-C19 (Anti-CD19 CAR T Cells) in Subjects with Refractory Aggressive Non-Hodgkin Lymphoma (NHL)
Date: April 19, 2016, 4:00 – 4:15PM Central Time
Session: Early Clinical Trials Evaluating Cell-based, Checkpoint Inhibitors, and Novel Immunotherapeutics
Abstract Number: CT135
Location: Room 343, Morial Convention Center
Presenter: Armin Ghobadi, M.D., Washington University, St. Louis, MO

A Phase 1 Study of an HLA-DPB1*0401-restricted T Cell Receptor Targeting MAGE-A3 for Patients with Metastatic Cancer
Date: April 17, 2016, 3:15 – 3:35PM Central Time
Session: Immuno-Oncology Clinical Trials I
Abstract Number: CT003
Location: La Nouvelle Orleans Ballroom, Morial Convention Center
Presenter: Yong-Chen W. Lu, Ph.D., Surgery Branch, National Cancer Institute

Session Presentations

Plenary Session: T Cell Recognition of Human Cancer
Date: April 17, 2016, 11:00 – 11:30AM Central Time
Session: PL01 Opening Plenary – Breakthroughs in Cancer Research: Genomics, Epigenetics, and Immunomodulation
Location: Hall F, Morial Convention Center
Speaker: Ton Schumacher, Ph.D., Netherlands Cancer Institute

Targeting Cancers with Engineered T Cells or BiTES: Towards Broader Application
Date: April 18, 2016, 5:00 – 6:30PM Central Time
Session: Forum FO09
Location: La Nouvelle Orleans Ballroom, Morial Convention Center
Invited Speaker: David Chang, M.D., Ph.D., Kite Pharma

Poster Presentations

Manufacturing and Characterization of KTE-C19 in a Multicenter Trial of Subjects with Refractory Aggressive Non-Hodgkin’s Lymphoma (NHL) (ZUMA-1)
Date: April 18, 2016, 1:00 – 5:00PM Central Time
Session: Adoptive Cell Therapy
Abstract Number: 2308
Location: Poster Hall, Section 25, Poster Board 20
Presenter: John M. Rossi, Kite Pharma

Comparative Evaluation of Peripheral Blood T Cells and Resultant Engineered Anti-CD19 CAR T Cell Products from Relapsed/Refractory Non-Hodgkin’s Lymphoma (NHL) Patients
Date: April 18, 2016, 1:00 – 5:00PM Central Time
Session: Adoptive Cell Therapy
Abstract Number: 2305
Location: Poster Hall, Section 25, Poster Board 17
Presenter: Timothy J. Langer, Kite Pharma

Identification of T-cell Receptors Targeting KRAS-mutated Human Tumors
Date: April 19, 2016, 8:00AM – 12:00PM Central Time
Session: Late-Breaking Research: Experimental and Molecular Therapeutics 3
Abstract Number: LB-242
Location: Poster Hall, Section 11, Poster Board 22
Presenters: James C. Yang, M.D., National Cancer Institute, National Institutes of Health

On April 15, 2016 Lytix Biopharma reported that Lytix Biopharma presented 4 posters at AACR (Free AACR Whitepaper) in New Oreleans April 2016 (Press release, Lytix Biopharma, APR 15, 2016, View Source [SID:1234514845]).

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Andrew Saunders (CMO), Øystein Rekdal (CSO), Baldur Sveinbjørnsson (Senior researcher), Ketil Camilio (Senior researcher) and Brynjar Mauseth (PhD Student) represented Lytix Biopharma at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in New Orleans April 16-21, 2016. Leading scientists and a large number of pharmaceutical companies attends the conference, and the mission is to prevent and cure cancer through research, education, communication and collaboration.

Together with scientific collaborators at Institut Gustav Roussy, Oslo University Hospital and University of Tromsø Lytix Biopharma presented 4 posters at the conference:

Sunday April 17, 2016:
Enhanced antitumor activity achieved by combining the oncolytic peptide LTX-315 with anti-PD-L1 antibody
Monday April 18, 2016:
LTX-315, an oncolytic peptide, increases anticancer immunity mediated by CTLA4 blockade in an interleukin-2 receptor beta-chain-dependent manner
The amphiphatic ß(2,2)-amino acid LTX-401 induces complete regression of experimental hepatocellular carcinoma
Wednesday April 20, 2016:
The oncolytic peptide LTX-315 enhances tumor-specific immune responses and tumor regression in murine 4T1 breast cancer when combined with doxorubicin

There is lack of substantial Indian data on venous thromboembolism (VTE). The aim of this study was to provide real-world information on patient characteristics, management strategies, clinical outcomes, and temporal trends in VTE.
Multicentre retrospective registry involving 549 medical records of patients with confirmed diagnosis of VTE (deep vein thrombosis [DVT] confirmed by Doppler ultrasonography; pulmonary embolism [PE] by computed tomography, pulmonary angiography and/or V/Q scan) from 2006 to 2010 at three Indian tertiary care hospitals.
Acute DVT without PE, acute DVT with PE, and PE alone were reported in 64% (352/549), 23% (124/549), and 13% (73/549) patients, respectively. Mean age was 47 (±16) years, and 70% were males. H/o DVT (34%), surgery including orthopedic surgery (28%), trauma (16%), and immobilization >3 days (14%) were the most common risk factors for VTE. Hypertension (25%), diabetes (19%), and neurological disease (other than stroke) (8%) were the most common co-morbidities. Most (94%) were treated with heparin alone (82%) or fondaparinux (2%) for initial anticoagulation; low molecular weight heparin alone (5%) or warfarin/acenocoumarol (76%) for long-term anticoagulation. Anticoagulant treatment was stopped because of bleeding in 2% (9/515) patients. Mortality was 7% among patients diagnosed with VTE during hospital stay versus 1% in those hospitalized with diagnosed VTE. The annual incidence of DVT (±PE) increased from 2006 to 2010.
Acute DVT alone was responsible for the substantial burden of VTE in Indian patients. Bleeding was not the limiting factor for anticoagulant treatment in most patients.

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GlobeImmune’s Tarmogen() immunotherapy platform utilizes recombinant Saccharomyces cerevisiae yeast as a vaccine vector to deliver heterologous antigens for activation of disease-specific, targeted cellular immunity. The vaccines elicit immune-mediated killing of target cells expressing viral and cancer antigens in vivo via a CD8(+) CTL-mediated mechanism. Tarmogens are not neutralized by host immune responses and can be administered repeatedly to boost antigen-specific immunity. Production of the vaccines yields stable off-the-shelf products that avoid the need for patient-specific manufacturing found with other immunotherapeutic approaches. Tarmogens for the treatment of chronic hepatitis B and C and various cancers were well tolerated and immunogenic in phase 1 and 2 clinical trials encompassing >600 subjects. The platform is being widely utilized in basic vaccine research and the most rapid path to success in these endeavors follows from optimal immunoassay selection and execution. This chapter provides detailed methods for the construction and preclinical immunogenicity testing of yeast-based immunotherapeutic products to support the rapid and efficient use of this versatile technology.

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In the phase III axitinib second-line (AXIS) trial, axitinib significantly prolonged progression-free survival (PFS) versus sorafenib in patients with previously treated metastatic renal cell carcinoma (mRCC). Analyses of associations between germline single-nucleotide polymorphisms (SNPs) and outcomes are reported.
DNA samples from blood were genotyped using TaqMan allelic discrimination. Logistic/Cox regression analyses were used to evaluate association of 15 SNPs in vascular endothelial growth factor (VEGF)-A, VEGF receptor (VEGFR)1, VEGFR2, or hypoxia-inducible factor (HIF)-1α with outcomes for blood pressure (BP; Grade ≥ 3 hypertension, diastolic BP > 90 mm Hg, and increase ≥ 15 mm Hg from baseline) and efficacy (independent review committee-assessed objective response rate and PFS, and overall survival [OS]). Multivariate analyses assessed SNPs and baseline characteristics as potential predictors of PFS and OS.
Genotype data were available for 305 (42.7%) of 714 patients; 159 received axitinib and 146 sorafenib. After Bonferroni adjustment, no SNP was associated with BP outcomes. In axitinib-treated patients, VEGF-A rs699947 (A/A vs. C/C) and rs833061 (C/C vs. T/T) were associated with longer OS (27.0 vs. 13.4 months; hazard ratio [HR], 0.39; Padjusted = .015). In sorafenib-treated patients, VEGFR2 rs2071559 (G/G vs. A/A) was associated with longer OS (26.8 vs. 13.8 months; HR, 0.41; Padjusted = .030). In multivariate analyses, no SNP predicted axitinib efficacy; VEGFR2 rs2071559 predicted PFS (P = .0053) and OS (P = .0027) for sorafenib. Sensitivity/specificity of VEGFR2 rs2071559 for OS was < 80%.
No SNP predicted axitinib outcomes. Although VEGFR2 rs2071559 predicted sorafenib efficacy in patients with mRCC, sensitivity/specificity limitations preclude its use for selecting individual patients for sorafenib treatment.
Copyright © 2015 Elsevier Inc. All rights reserved.

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