On April 16, 2016 Adaptive Biotechnologies, the leader in combining next generation sequencing (NGS) and expert bioinformatics to profile T- and B-cell receptors of the adaptive immune system, along with its collaborators from institutions around the world, will present data demonstrating how Adaptive’s immunosequencing platform can be used as a novel oncology diagnostic to accurately and reliably quantify the density and clonality of Tumor Infiltrating Lymphocytes (TILs) to assess disease prognosis and response to therapy (Press release, Adaptive Biotechnologies, APR 16, 2016, View Source [SID:1234511008]). Two oral presentations and eight posters will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 16-20, 2016, in New Orleans, Louisiana.

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Notably, many of the data to be presented explore the relevance of the immune repertoire in the blood as well as in the tumor tissue. The potential to identify blood-based immune molecular biomarkers of response to the growing class of immunomodulatory drugs may offer clinicians a more accessible sample source for widespread benefit to patients across many tumor types.

Select data presentations of interest include:

Dr. Robert Prins, et al. from UCLA will present data showing that in patients with glioblastoma undergoing immunotherapy, immunosequencing identified a potential biomarker of response and overall survival (Abstract 767).
Dr. Padmanee Sharma, et al. from MD Anderson Cancer Center will present data from a prostate cancer patient cohort receiving ipilumumab and androgen deprivation therapy correlating immune profiling data with adverse events which led to discovery of a potential predictive biomarker of patients who are at risk of grade 3 toxicities. (Abstract 1402).
Dr. Rebecca Gardner, et al. from Seattle Children’s Research Institute will present data on children with acute lymphoblastic leukemia (ALL) treated with a CART-19 therapy showing that high-throughput sequencing of patient samples had significantly greater sensitivity in detecting minimal residual disease (MRD) compared with samples analyzed by flow cytometry. Furthermore, in these patients, monitoring disease status by peripheral blood sampling is often more informative and far less invasive than bone marrow sampling. (Abstract 4893).
"These data being presented at AACR (Free AACR Whitepaper) demonstrate the utility of immunosequencing in both tissue and blood samples as a critical component in guiding clinicians’ approach to managing and treating cancer," said Harlan Robins, Chief Scientific Officer and Co-Founder of Adaptive Biotechnologies. "Ultimately incorporating immunosequencing into a potential blood-based biomarker for use in the clinic may help enhance the diagnosis, prognosis and monitoring of disease in cancer patients."

Representatives from Adaptive Biotechnologies will be exhibiting at AACR (Free AACR Whitepaper) booth #2530 to answer questions about their proprietary, transformative immunosequencing technology.

Oral Presentations:
Abstract #847: Molecular characterization of breast tumor T-cell infiltration in exome datasets
Date and Time: Sunday, Apr 17, 2016, 4:35 PM – 4:50 PM
Location: Room 243, Morial Convention Center
Presenter: Ricardo Armisen, Universidad de Chile, Santiago, Chile

Abstract #4362: T cell repertoire diversification is associated with immune related toxicities following immune checkpoint inhibition in metastatic cancer patients
Date and Time: Tuesday, Apr 19, 2016, 3:50 PM – 4:05 PM
Location: New Orleans Theater C, Morial Convention Center
Presenter: Lawrence Fong, University of California, San Francisco

Posters:

Abstract #767: TCR sequencing can identify and track tumor-specific T cell populations and is a predictive biomarker of response to DC vaccination in glioblastoma patients
Date and Time: Sunday, Apr 17, 2016, 1:00 PM – 5:00 PM
Location: Section 33, Poster Board #26
Author: Robert Prins, et al., University of California, Los Angeles

Abstract #1402: Exploratory biomarkers that predict for clinical outcomes in a Phase II trial with ipilimumab plus finite androgen deprivation therapy for metastatic non-castrate prostate cancer
Date and Time: Monday, Apr 18, 2016, 8:00 AM -12:00 PM
Location: Section 22, Poster Board #3
Author: Padmanee Sharma, et al., The University of Texas MD Anderson Cancer Center

Abstract #1405: Vesigenurtacel-L stimulates tumor infiltration of unique polyclonal T cell clones in non-muscle invasive bladder cancer patients
Date and Time: Monday, Apr 18, 2016, 8:00 AM -12:00 PM
Location: Section 22, Poster Board #6
Author: Melissa Price, et al., Heat Biologics, Inc., Durham, NC

Abstract #2392: Genomic and immune heterogeneity in synchronous melanoma metastases is associated with differential tumor growth and response to therapy
Date and Time: Monday, Apr 18, 2016, 1:00 PM -5:00 PM
Location: Section 28, Poster Board #22
Author: Jennifer A. Wargo, et al., MD Anderson Cancer Center, Houston, TX

Abstract #4159: Characterization of the T-cell receptor (TCR) repertoire in extensive disease small cell lung cancer (ED SCLC)
Date and Time: Tuesday, Apr 19, 2016, 1:00 PM – 5:00 PM
Location: Section 31, Poster board #26
Author: Cory Batenchuk, et al., Bristol-Myers Squibb, NJ

Abstract #4903: Multimodal therapy with a potent vaccine, metronomic cyclophosphamide and anti-PD-1 enhances immunotherapy of advanced tumors by increasing activation and clonal expansion of tumor infiltrating T cells
Date and Time: Wednesday, Apr 20, 2016, 7:30 AM – 11:00 AM
Location: Section 23, Poster board #14
Author: Genevieve Weir, et al., Immunovaccine, Inc., Halifax, NS, Canada

Abstract #4893: Molecular detection of ALL in the peripheral blood is more sensitive than flow cytometric analysis of the bone marrow in patients with treatment-related hypocellularity
Date and Time: Wednesday, Apr 20, 2016, 8:00 AM -12:00 PM
Location: Section 23, Poster board #4
Author: Rebecca Gardner, et al., Seattle Children’s Research Institute, Seattle, WA

Abstract #4897: First evidence of changes in the TCRβ repertoire from a cutaneous melanoma patient immunized with the CSF-470 vaccine.
Date and Time: Wednesday, Apr 20, 2016, 8:00 AM -12:00 PM
Location: Section 23, Poster board #8
Author: José Mordoh, et al., Centro de Investigaciones Oncológicas-Fundación Cáncer, Ciudad Autónoma de Buenos Aires, Argentina

About the immunoSEQ Platform
Adaptive’s immunoSEQ Platform helps researchers make discoveries in areas such as oncology, autoimmune disorders, infectious diseases and basic immunology. The immunoSEQ Assays can identify millions of T- and B-cell receptors from a single sample in exquisite detail. Offered as a Service or Kit, immunoSEQ Assays provide quantitative, reproducible sequencing results along with access to powerful, easy-to-use analysis tools. The immunoSEQ Assays are for research use only and are not for use in diagnostic procedures.

About Minimal Residual Disease
Minimal residual disease (MRD) refers to cancer cells that may remain in the body of a person with lymphoid cancer after treatment. These cells are present at levels undetectable by traditional microscopic examination (also called morphologic examination) of blood, bone marrow or a lymph node biopsy. Sensitive molecular technologies, such as the next-generation sequencing utilized by Adaptive’s clonoSEQ MRD Test, are needed for reliable detection of very low levels of MRD. Learn more at knowMRD.com.

About the clonoSEQ Process
Adaptive’s clonoSEQ Process enables physicians to utilize sequencing-based minimal residual disease (MRD) detection as an aid to clinical decision making for patients with lymphoid cancers (blood cancers). With its ability to detect cancer cells at a level as low as one per one million white blood cells, the clonoSEQ MRD Test is one to two orders of magnitude more sensitive than the other methods of MRD detection, such as ASO-PCR and flow cytometry.

The Giens 2015 Workshop Round Table entitled "What specifications for a centre or network of excellence in clinical research?" took a viewpoint distinct from earlier work and studies on changes in clinical research activities in France. The purpose of the present work was to identify, starting from concrete examples, the main strengths and advantages of clinical research activity in France related, in part, to the background environment and also to the specific characteristics of the investigation centres considered to be among the most high-performance units in activity. The criteria retained were grouped into a set of specifications that could be used to establish a "label of excellence" upon which the different teams and clinical research centres could model themselves. It was thus considered that belonging to a centre or structured network with at least a national configuration, when this is possible for the medial topic in question, constitutes a real advantage. Four benchmarks were identified: the scientific and clinical expertise of the head investigator, as well as the qualification and operational capacity of the centre’s team; definition and measurement of performance using clearly displayed indicators and evaluation procedures; the quality of the overall trial "process" and of each of its component steps; communication, because know-how and promotion go hand in hand, with the main objective of informing the professional and general public about the value of the research centre meeting the above-mentioned criteria, about its networks of competencies, and more generally, about the important assets of the background of clinical research in France. This sector of research is funded by the public authorities via calls for public grants, financial aids for structures supporting clinical research in the University Hospital Centres and other healthcare institutions allowing for a professionalization of the research occupations, and the national public health plans (cancer, rare disease, HIV).
Copyright © 2016. Published by Elsevier Masson SAS.

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Short intensive chemotherapy is the standard of care for adult patients with Burkitt’s leukaemia or lymphoma. Findings from single-arm studies suggest that addition of rituximab to these regimens could improve patient outcomes. Our objective was to test this possibility in a randomised trial.
In this randomised, controlled, open-label, phase 3 trial, we recruited patients older than 18 years with untreated HIV-negative Burkitt’s lymphoma (including Burkitt’s leukaemia) from 45 haematological centres in France. Exclusion criteria were contraindications to any drug included in the chemotherapy regimens, any serious comorbidity, poor renal (creatinine concentration >150 μmol/L) or hepatic (cirrhosis or previous hepatitis B or C) function, pregnancy, and any history of cancer except for non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma. Patients were stratified into two groups based on disease extension (absence [group B] or presence [group C] of bone marrow or central nervous system involvement). Patients were further stratified in group C according to age (<40 years, 40-60 years, and >60 years) and central nervous system involvement. Participants were randomly assigned in each group to either intravenous rituximab injections and chemotherapy (lymphome malin B [LMB]) or chemotherapy alone by the Groupe d’Etude des Lymphomes de l’Adulte datacentre. Randomisation was stratified by treatment group and centre using computer-assisted permuted-block randomisation (block size of four; allocation ratio 1:1). We gave rituximab (375 mg/m(2)) on day 1 and day 6 during the first two courses of chemotherapy (total of four infusions). The primary endpoint is 3 year event-free survival (EFS). We analysed all patients who had data available according to their originally assigned group. This trial is registered with ClinicalTrials.gov, number NCT00180882.
Between Oct 14, 2004, and Sept 7, 2010, we randomly allocated 260 patients to rituximab or no rituximab (group B 124 patients [64 no rituximab; 60 rituximab]; group C 136 patients [66 no rituximab; 70 rituximab]). With a median follow-up of 38 months (IQR 24-59), patients in the rituximab group achieved better 3 year EFS (75% [95% CI 66-82]) than did those in the no rituximab group (62% [53-70]; log-rank p stratified by treatment group=0·024). The hazard ratio estimated with a Cox model stratified by treatment group, assuming proportionality, was 0·59 for EFS (95% CI 0·38-0·94; p=0·025). Adverse events did not differ between the two treatment groups. The most common adverse events were infectious (grade 3-4 in 137 [17%] treatment cycles in the rituximab group vs 115 [15%] in the no rituximab group) and haematological (mean duration of grade 4 neutropenia of 3·31 days per cycle [95% CI 3·01-3·61] vs 3·38 days per cycle [3·05-3·70]) events.
Addition of rituximab to a short intensive chemotherapy programme improves EFS in adults with Burkitt’s leukaemia or lymphoma.
Gustave Roussy Cancer Campus, Roche, Chugai, Sanofi.
Copyright © 2016 Elsevier Ltd. All rights reserved.

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On April 16, 2016 Abpro, an integrated life science company at the forefront of synthetic biology, reported a partnership with Essex Bio, a China-based biopharmaceutical company (Press release, abpro therapeutics, APR 16, 2016, View Source [SID1234525612]). Abpro and Essex will co-develop multiple monoclonal antibodies in immuno-oncology and ophthalmology by leveraging Abpro’s DiversImmune platform. Abpro received a $3.5M equity investment from Essex Bio and an undisclosed amount from affiliates, as part of the agreement.

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"This partnership with Essex Bio adds further validation to our discovery platform and provides an opportunity to advance novel therapeutics with one of the largest ophthalmology companies in China, which is the second largest pharmaceutical market in the world," said Ian Chan, CEO of Abpro. "This agreement results in a strong partnership with R&D efforts and significant capabilities both in the United States and China."

"Abpro’s unique proprietary platform has proven to be successful against traditionally difficult targets for antibodies and offers significant potential for us to co-develop novel therapeutic treatments for immuno-oncology and ophthalmic diseases," said Patrick Ngiam, Founder and Chairman of Essex Bio. "We look forward to leveraging this platform to advance monoclonal assets into the clinic and onto commercialization."

According to the agreement, Abpro will receive an upfront equity investment from Essex Bio and affiliates. The companies will advance multiple assets through pre-clinical and clinical development and seek commercial authorizations. Essex Bio holds commercial rights to these assets in China, and Abpro retains commercialization rights in the U.S. and rest of world, excluding China, with cross-royalties from each region. Through its DiversImmune platform, Abpro generates antibodies with high sensitivity and specificity for advancing human health.

Abpro’s products and discovery services are used by leading academic labs and companies around the world for life science research purposes, such as therapeutics, diagnostics and research products. Abpro has formed multiple partnerships around novel biomolecules with leading biotechnology and international pharmaceutical companies including Amgen, Eli Lilly, Genzyme, MedImmune, Merck, Novartis, Pfizer, and others. In addition, Abpro has collaborated with several academic research centers, including Harvard University, Massachusetts Institute of Technology and Stanford University.

Bioorthogonal turn-on probes have been widely utilized in visualizing various biological processes. Most of the currently available bioorthogonal turn-on probes are blue or green emissive fluorophores with azide or tetrazine as functional groups. Herein, we present an alternative strategy of designing bioorthogonal turn-on probes based on red-emissive fluorogens with aggregation-induced emission characteristics (AIEgens). The probe is water soluble and non-fluorescent due to the dissipation of energy through free molecular motion of the AIEgen, but the fluorescence is immediately turned on upon click reaction with azide-functionalized glycans on cancer cell surface. The fluorescence turn-on is ascribed to the restriction of molecular motion of AIEgen, which populates the radiative decay channel. Moreover, the AIEgen can generate reactive oxygen species (ROS) upon visible light (λ=400-700 nm) irradiation, demonstrating its dual role as an imaging and phototherapeutic agent.
© 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

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