1stOncology™: Cancer Intelligence Service – Page 16857 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

TG Therapeutics, Inc. Recaps Schedule of Clinical Data Presentations at the 52nd Annual Meeting of the American Society of Clinical Oncology

On June 02, 2016TG Therapeutics, Inc. (Nasdaq:TGTX) today recapped the schedule of data presentations at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), to be held from June 3 – 7, 2016, at McCormick Place in Chicago, Illinois (Press release, TG Therapeutics, JUN 2, 2016, View Source [SID:1234512960]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Poster Presentation & Discussion Session:

Title: Long-term follow-up of the PI3Kδ inhibitor TGR-1202 demonstrates a differentiated safety profile and high response rates in CLL and NHL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab
Abstract Number: 7512 (Poster Board # 68)
Presentation Date & Time: Monday, June 6, 2016 8:00 AM – 11:30 AM CT
Track: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Presenter: Howard A. Burris MD, Sarah Cannon Research Institute/Tennessee Oncology
Discussion Session:
1:15 PM – 2:45 PM CT, at Room E354b

A copy of the above referenced abstract can be viewed online through the ASCO (Free ASCO Whitepaper) meeting website at www.asco.org. Following the presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com.

TG Therapeutics will also host a reception on Monday, June 6, 2016 beginning at 7:00pm CT, with featured presentations beginning promptly at 7:10pm CT. The event will take place at the Peninsula Chicago Hotel in the Avenues Ballroom. This event will be webcast live and will be available on the Events page, located within the Investors & Media section of the Company’s website at www.tgtherapeutics.com, as well as archived for future review. This event will also be broadcast via conference call. In order to access the conference line, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), and reference Conference Title: TG Therapeutics June 2016 Investor & Analyst Event.

Navidea Announces Data Presentations at 2016 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI)

On June 2, 2016 Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), reported that results from investigator studies using Lymphoseek (technetium Tc 99m tilmanocept) injection are being presented at the 2016 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) to be held June 11-15, 2016 in San Diego, CA (Press release, Navidea Biopharmaceuticals, JUN 2, 2016, View Source;p=RssLanding&cat=news&id=2174435 [SID:1234512958]). The oral and poster presentations highlight the comparative performance of Lymphoseek against commonly-used non-receptor targeted colloidal materials as well as other performance characteristics in breast cancer and melanoma.

Results being presented at SNMMI 2016 include:

Presentation Title: Use of lymphoscintigraphy with Tc-99m tilmanocept does not affect the number of nodes removed during sentinel node biopsy in breast cancer
Author: Jonathan Unkart, Anne Wallace, Surgery, University of California San Diego, San Diego, CA
Date: June 15, 2016
Session Breast, Clinical Applications

Presentation Title: Performance of Tc-99m tilmanocept when used alone is as or more effective in localizing sentinel nodes than sulfur colloid plus blue dye
Author: J. Unkart,1 D. W. King,2 L. A. Christman,2 A. M. Wallace1; 1UCSD, San Diego, CA, 2Statking Consulting, Inc, Fairfield, OH
Date: June 15, 2016
Session Breast, Clinical Applications

Presentation Title: Comparative analysis of 99mTc-Tilmanocept (Lymphoseek) vs. 99mTc-Sulfur Colloid Sentinel Node Lymphoscintigraphy and Biopsy
Author: J. H. Pollard, B. Zaidi, M. Graham; University of Iowa Hospital, Iowa City, IA
Date: June 14, 2016
Session: Sarcoma/Melanoma

Poster Title: Rate of sentinel lymph node visualization in fatty breasts: Tc-99m Tilmanocept versus Tc-99m filtered sulfur colloid
Author: Maryam Shahrzad, Valeria Moncayo, John Malko, and Raghuveer Halkar; Emory University School of Medicine, Atlanta, GA
Date: June 13, 2016
Session Oncology, Clinical Science Track – MTA I: Breast Cancer Posters

About Lymphoseek

Lymphoseek (technetium Tc 99m tilmanocept) injection is the first and only FDA-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek is approved by the U.S. Food and Drug Administration (FDA) for use in solid tumor cancers where lymphatic mapping is a component of surgical management and for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, melanoma or squamous cell carcinoma of the oral cavity. Lymphoseek has also received European approval in imaging and intraoperative detection of sentinel lymph nodes in patients with melanoma, breast cancer or localized squamous cell carcinoma of the oral cavity.

Accurate diagnostic evaluation of cancer is critical, as results guide therapy decisions and determine patient prognosis and risk of recurrence. Overall in the U.S., solid tumor cancers may represent up to 1.2 million cases per year. The sentinel node label in the U.S. and Europe may address approximately 600,000 new cases of breast cancer, 160,000 new cases of melanoma and 100,000 new cases of head and neck/oral cancer diagnosed annually.

Lymphoseek Indication and Important Safety Information

Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:

• Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.

• Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.

Important Safety Information

In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).

Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.

Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers. In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).

FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND AT:
WWW.LYMPHOSEEK.COM

NanoString Technologies Highlights Advances in Precision Oncology and Immunotherapy at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO)

On June 02, 2016 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported the highlights of numerous advances in precision oncology and immunotherapy using the nCounter platform that will be presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, NanoString Technologies, JUN 2, 2016, View Source [SID:1234512957]).

"For more than 50 years the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) has been pioneering cancer research and advancing the care of patients with cancer around the world," said Brad Gray, president and chief executive officer of NanoString Technologies. "We are proud to participate in the ASCO (Free ASCO Whitepaper) Annual Meeting and to have the opportunity to highlight the groundbreaking cancer research and diagnostic assays that are being enabled through the nCounter platform and our expanding portfolio of 3D Biology products."

More than 30 abstracts will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting, which is being held June 3rd through June 7th, 2016 in Chicago, Illinois, that demonstrate the value of the nCounter Platform. In particular, several abstracts provide additional insights on the development and performance of NanoString’s investigational assays in development for immuno-oncology and lymphoma.

In immuno-oncology, NanoString and collaborators will present new details on nCounter-based assays under development for prediction of response to the checkpoint inhibitor pembrolizumab, including:

An interferon-gamma gene signature was shown to predict response more accurately than PD-L1 IHC in squamous cell carcinoma of the head and neck. This research further demonstrates the power of gene expression profiling on the nCounter Analysis System as a biomarker in immuno-oncology. (Abstract #6010)
An interferon-gamma gene signature and an expanded immune gene signature predicted response in five tumor types from the basket trial KEYNOTE-28, underscoring the potentially broad applicability of gene signatures in assessing patient response (Abstract #1536).
Data on the development and analytical performance of an nCounter-based assay incorporating an immune-related gene signature to predict response to checkpoint inhibition in eleven different tumor types. The data show that this assay is robust and may be well-suited to clinical applications. The signature is being evaluated as a predictive biomarker in multiple indications in several studies (Abstract #3034).
In lymphoma, NanoString and collaborators are presenting results generated using nCounter-based assays, including:

An update on the ongoing ROBUST trial, a global pivotal phase 3 trial evaluating the addition of lenalidomide to R-CHOP therapy in untreated ABC-type Diffuse Large B-cell Lymphoma (DLBCL) selected by NanoString’s investigational Cell-of-Origin assay. The results show that real-time testing of Cell-of-Origin using nCounter is feasible in a multi-center, global study with turnaround time of less than 3 days, demonstrating that a decentralized gene expression test can be used to select patients for a clinical trial where rapid results are critical for enrollment (Abstract #7538).
Independent validation of the nCounter-based Cell-of-Origin assay through comparison to subtyping using DNA microarrays. The assay proved to be highly efficient and reliable in an independent series of samples evaluated by a team of researchers not involved in the development of the assay. This research highlights the high concordance between the NanoString assay and the conventional microarray method as well as the robustness and ease of use of the assay, which can be successfully deployed in laboratories around the world (Abstract #7547).
The 2016 ASCO (Free ASCO Whitepaper) abstracts describe research and clinical applications that underscore the diverse capabilities and robust performance of the nCounter platform. The studies cover a wide range of cancers, tissue types (FFPE, peripheral blood and urine), and treatment modalities.

At the 2016 ASCO (Free ASCO Whitepaper) Annual Meeting, NanoString will showcase its nCounter platform and 3D Biology capabilities at booth #8151.

Abstract # Summary Hyperlink
4525 Subclassification and outcome prediction of patients with muscle invasive urothelial carcinoma (MIUC) treated by radical cystectomy (RC) with a NanoString based molecular screening. View Source

3034 Development and analytical performance of a molecular diagnostic for anti-PD1 response on the nCounter Dx Analysis System. View Source

3008 Epigenetic control of CD4/CD8 lineage commitment and resistance to tumor infiltrating lymphocyte adoptive cell therapy for metastatic melanoma. View Source

6056 Immune-related gene expression signatures as predictive biomarkers for outcome after concurrent chemoradiation in patients with locally advanced oropharyngeal carcinomas. View Source

11522 Derivation of gene expression classifiers for the non-invasive detection of bladder cancer in the hematuria and recurrence surveillance populations. View Source

e16014 Multiplatform comprehensive kinase analysis of muscle-invasive bladder cancer (MIBC) to identify potentially actionable therapeutic targets. View Source

10561 Patterns of PD-1, PD-L1 and PD-L2 expression in pediatric solid tumors. View Source

TPS3636 The FUNNEL: A molecular multiplex triage for precision medicine in metastatic colorectal cancer. View Source

3038 Association of response to programmed death 1 receptor or ligand (PD1/PDL1) blockade with immune-related gene expression profiling across three cancer-types. View Source

7045 Up-regulation of BAALC/MN1/MLLT11/EVI1 gene cluster in relation to MYC / BCL2 protein co-expression and poor overall survival in acute myeloid leukemia (AML). View Source

e20089 Preliminary analysis of genomic profiling of small cell lung cancer in Chinese population revealed frequent PIK3CA hotspot mutations. View Source

e23235 Analysis of RSPO gene expression in solid tumors. View Source

e14565 Safety and immunologic activity of anakinra in HER2-negative metastatic breast cancer (MBC). View Source

10509 Relationship of BRAF V600E and associated secondary mutations on survival rate and response to conventional therapies in childhood low-grade glioma. View Source

e17103 Genomic profiling of high-intermediate risk endometrial cancer to differentiate recurrence risk. View Source

3570 Influence of mRNA expression of fibroblast growth factor 2 (FGF2) in colorectal cancer (CRC) cell lines and in patients with metastatic colorectal cancer (mCRC) treated with FUFIRI or mIrOx (FIRE1). View Source

7510 Prognostic significance of the proliferation signature in mantle cell lymphoma measured using digital gene expression in formalin-fixed paraffin-embedded tissue biopsies. View Source

TPS7575 Rituximab, lenalidomide, and ibrutinib alone and combined with dose adjusted chemotherapy for patients with high risk diffuse large B-cell lymphoma. View Source

7538 Feasibility of real-time cell-of-origin subtype identification by gene expression profile in the phase 3 trial of lenalidomide plus R-CHOP vs placebo plus R-CHOP in patients with untreated ABC-type diffuse large B-cell lymphoma (ROBUST). View Source

TPS7577 A phase 2 study of PNT2258 in patients with relapsed or refractory (r/r) diffuse large b-cell lymphoma (DLBCL): An initial report from the Wolverine study. View Source

6010 Biomarkers and response to pembrolizumab (pembro) in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). View Source

e20014 The upregulation of FOXA2 transcription factor in RET rearranged lung adenocarcinoma. View Source

e16023 PD1, PDL1, PDL2 tumor tissue (TT) expression as predictors of response to neoadjuvant chemotherapy (NAC) and outcome in bladder cancer (BC). View Source

543 Prospective multicenter study of the impact of the Prosigna assay on adjuvant clinical decision-making in women with early stage breast cancer: which patients are the best candidates? View Source

7547 Classification of diffuse large b-cell lymphoma (DLBCL) FFPE samples of the GELA LNH2003 program, using Lymph2Cx assay on the nCounter analysis system. View Source

1536 T-cell inflamed phenotype gene expression signatures to predict clinical benefit from pembrolizumab across multiple tumor types. View Source

3510 Clinical outcome and benefit of oxaliplatin in colon cancer according to intrinsic subtypes: Results from NRG Oncology/NSABP C-07. View Source

1585 Male breast cancer: correlation between immunohistochemical subtyping and PAM50 intrinsic subtypes. View Source

575 A retrospective study of SPAG5 expression and its clinical implications in > 8,000 patients of ER positive (ER+) breast cancer (BC): Genomic, transcriptomic and protein analysis. View Source

569 Outcomes of single versus double hormone receptor positive breast cancer. View Source

TPS623 OPTIMA (Optimal Personalised Treatment of early breast cancer usIng Multi-parameter Analysis): A prospective trial to validate the predictive utility and cost-effectiveness of gene expression test-directed chemotherapy decisions. View Source

e23143 The genomic profile (GP) of early breast cancer (EBC): Daily practice analysis. View Source

555 A test utilizing diagnostic and on-treatment biomarkers to improve prediction of response to endocrine therapy in breast cancer. View Source

Curis Announces Presentations Related to CUDC-907 and Erivedge® at 2016 ASCO Annual Meeting

On June 02, 2016 Curis, Inc. (Nasdaq:CRIS), a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer, reported that a Phase 2 trials-in-progress poster for CUDC-907, Curis’ proprietary drug candidate in development for treatment of patients with relapsed refractory diffuse large B-cell lymphoma (DLBCL) with MYC gene alterations, will be presented at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held from June 3-7 in Chicago, IL (Press release, Curis, JUN 2, 2016, View Source [SID:1234512953]).

In addition, data will be presented from clinical studies of Erivedge, a first-in-class drug approved for the treatment of patients with advanced basal cell carcinoma (BCC). Roche and Genentech, a member of the Roche Group, develop and commercialize Erivedge under a collaboration agreement with Curis.

Additional information on the presentations can be found below and abstracts can be accessed at www.asco.org.

CUDC-907 Poster Presentation:

Date/Time: Monday, June 6, 8 AM — 11:30 AM CDT
Abstract Number: TPS7579
Presentation Title: Phase 2, open-label study of CUDC-907 with and without rituximab
in patients with relapsed/refractory MYC-altered diffuse large B cell
lymphoma

Erivedge Poster Presentations:

Date/Time: Poster Session: Saturday, June 4, 1 PM — 4:30 PM CDT
Poster Discussion Session: Saturday, June 4, 4:45 PM — 6 PM CDT
Abstract Number: 9509
Presentation Title: Mikie: A randomized, double-blinded, regimen-controlled, phase 2
study to assess the efficacy and safety of two different vismodegib
(VISMO) regimens in patients (pts) with multiple basal cell
carcinomas (BCCs)

Date/Time: Saturday, June 4, 1 PM — 4:30 PM CDT
Abstract Number: 9532
Presentation Title: Vismodegib (VISMO), a hedgehog pathway inhibitor (HPI), in
advanced basal cell carcinoma (aBCC): STEVIE study primary
analysis in 1215 patients (pts)

ARIAD Completes the Sale of Its European Operations and Out-License of European Rights to Iclusig®

On June 2, 2016 ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) reported that it has completed the sale of its European operations to Incyte Corporation and entered into the previously announced license agreement for Incyte to exclusively license Iclusig (ponatinib) in Europe and other select countries (Press release, Ariad, JUN 2, 2016, View Source;p=RssLanding&cat=news&id=2174467 [SID:1234512951]).

ARIAD transferred all rights to its EU operations to Incyte, which has acquired all shares of ARIAD Pharmaceuticals (Luxembourg) S.a.r.l., the parent company of ARIAD’s European subsidiaries responsible for the commercialization of Iclusig in the licensed territory, for a payment to ARIAD at the closing of approximately $140 million (subject to customary post-closing adjustments). In addition, Incyte has now been granted an exclusive license to develop and commercialize Iclusig in the European Union and 22 other countries, including Switzerland, Norway, Turkey, Israel and Russia.

"With the closing of this transaction, we have completed a key outcome from our strategic review," stated Paris Panayiotopoulos, president and chief executive officer of ARIAD. "This agreement puts ARIAD in a strong financial position. It will allow us to focus our resources on our promising R&D initiatives and our efforts to achieve the full commercial potential of Iclusig and brigatinib, if approved, in the highly valuable U.S. market, while also maintaining future strategic flexibility through the buy-back provision for the licensed Iclusig rights."

In connection with the closing of the Incyte transaction, the previously disclosed amendments to ARIAD’s royalty financing agreement with PDL BioPharma, Inc. (PDL), entered into on May 9, 2016, became effective. ARIAD and PDL agreed to amend the agreement to, among other things, include net sales of Iclusig made by Incyte in the calculation of net sales under the PDL agreement and to restructure ARIAD’s option to receive additional funding so that ARIAD may require PDL to fund up to an additional $40 million (instead of the original $100 million) in July 2017, rather than between January and July 2016.

Baker & McKenzie LLP represented ARIAD in the Incyte transaction, and Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C. represented ARIAD in the PDL transaction.

About Iclusig (ponatinib) tablets

Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug-design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.

Iclusig is approved in the U.S., EU, Australia, Switzerland, Israel and Canada.

In the U.S., Iclusig is a kinase inhibitor indicated for the:

Treatment of adult patients with T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.
These indications are based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Iclusig.

IMPORTANT SAFETY INFORMATION, INCLUDING THE BOXED WARNING

WARNING: VASCULAR OCCLUSION, HEART FAILURE, and HEPATOTOXICITY

See full prescribing information for complete boxed warning

Vascular Occlusion: Arterial and venous thrombosis and occlusions have occurred in at least 27% of Iclusig treated patients, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and without cardiovascular risk factors, including patients less than 50 years old, experienced these events. Monitor for evidence of thromboembolism and vascular occlusion. Interrupt or stop Iclusig immediately for vascular occlusion. A benefit risk consideration should guide a decision to restart Iclusig therapy.
Heart Failure, including fatalities, occurred in 8% of Iclusig-treated patients. Monitor cardiac function. Interrupt or stop Iclusig for new or worsening heart failure.
Hepatotoxicity, liver failure and death have occurred in Iclusig-treated patients. Monitor hepatic function. Interrupt Iclusig if hepatotoxicity is suspected.
Please see the full U.S. Prescribing Information for Iclusig, including the Boxed Warning, for additional important safety information.

In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.