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Sunesis Pharmaceuticals Announces Presentations at ASH Annual Meeting

On November 5, 2015 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported one oral presentation and two poster presentations at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held December 5-8 in Orlando, Florida (Press release, Sunesis, NOV 5, 2015, View Source;p=RssLanding&cat=news&id=2107396 [SID:1234507997]).

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The details for the oral presentation are as follows:

Date and Time: Monday, December 7, 2015 at 8:00 a.m. Eastern Time
Abstract Title: Phase I/II Study of Vosaroxin and Decitabine in Newly Diagnosed Older Patients (pts) with Acute Myeloid Leukemia (AML) and High Risk Myelodyplastic Syndrome (MDS)
Session Number: 616
Session Name: Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: New Epigenetic Approaches
Publication Number: 461
Location: Orange County Convention Center, W109

The full abstract can be viewed here.

The details for the poster presentations are as follows:
Date and Time: Saturday, December 5, 2015 from 6:00 p.m. to 8:00 p.m. Eastern Time
Abstract Title: Baseline Predictors of Mortality in Patients with Relapsed or Refractory Acute Myeloid Leukemia Treated with Vosaroxin Plus Cytarabine in the Phase 3 VALOR Study
Session Number: 616
Session Name: Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster II
Publication Number: 2560
Location: Orange County Convention Center, Hall A

The full abstract can be viewed here.

Date and Time: Saturday, December 5, 2015 from 5:30 p.m. to 7:30 p.m. Eastern Time
Abstract Title: A Phase I Study of Vosaroxin Plus Azacitidine for Patients with Myelodysplastic Syndrome
Session Number: 637
Session Name: Myelodysplastic Syndromes – Clinical Studies: Poster I
Publication Number: 1686
Location: Orange County Convention Center, Hall A

The full abstract can be viewed here.

Stemline Therapeutics Announces Five Presentations at the American Society of Hematology (ASH) Annual Meeting; SL-401 Poster Will Include Clinical Data From Lead-In and Ongoing Expansion Stages of BPDCN Pivotal Trial

On November 5, 2015 Stemline Therapeutics, Inc. (Nasdaq:STML) reported that it will present results from clinical and preclinical studies, including updated data from its ongoing SL-401 pivotal trial, at the 2015 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, to be held December 5-8, 2015 at the Orange County Convention Center in Orlando, FL (Press release, Stemline Therapeutics, NOV 5, 2015, View Source [SID:1234507996]).

Five poster presentations, including one covering clinical data updates from the lead-in and ongoing expansion stages of the SL-401 pivotal trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN), will be featured. Three preclinical presentations will highlight data around SL-401’s potential in additional indications as both a single agent as well as in combination. In addition, a poster demonstrating broad preclinical anti-cancer activity will be presented around SL-801, Stemline’s novel oral XPO1 inhibitor being advanced toward the clinic across multiple hematologic and solid tumor indications.

Ivan Bergstein, M.D., Stemline’s CEO, commented, "At the upcoming ASH (Free ASH Whitepaper) meeting, we plan to share updated clinical data from the SL-401 pivotal trial in BPDCN. Data from the abstract demonstrate that SL-401 offers a manageable safety profile over multiple cycles with high response rates. We have also gained important insights into the dosing and administration schedule which has enabled us to improve the safety profile of SL-401 in BPDCN." Dr. Bergstein continued, "We also plan to present additional data on BPDCN patients from both the lead-in as well as initial expansion stage of the ongoing pivotal trial, including patients enrolled since abstract submission." Dr. Bergstein concluded, "In addition, we believe that SL-401’s ability to induce responses quickly coupled with a manageable safety profile following multi-cycle administration may bode well not only for our single agent approach in relapsed/refractory BPDCN but also in future combination studies in larger indications, such as myeloma."

About SL-401 and SL-801

SL-401 is a targeted therapy directed to the interleukin-3 receptor (IL-3R) present on cancer stem cells (CSCs) and tumor bulk of BPDCN, AML, and other hematologic cancers. Stemline is evaluating SL-401 in multiple clinical programs, including an ongoing pivotal trial in BPDCN, as well as trials in additional hematological cancers. SL-801 is a novel oral, small molecule reversible XPO1 inhibitor that is expected to enter clinical development in early 2016 for both solid and hematologic cancers.

Five abstracts were accepted for the 2015 ASH (Free ASH Whitepaper) meeting, and the details on the presentations are listed below and available on the ASH (Free ASH Whitepaper) conference website:

Lead-in Stage Results of a Pivotal Trial of SL-401, an Interleukin-3 Receptor (IL-3R) Targeting Biologic, in Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) or Acute Myeloid Leukemia (AML)
Lead Author: Marina Konopleva, MD, PhD
Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX

A Novel Agent SL-401 Triggers Anti-Myeloma Activity by Targeting Plasmacytoid Dendritic Cells: Implications for a Novel Immune-associated Mechanism
Lead Author: Arghya Ray, Ph.D.
The LeBow Institute for Myeloma Therapeutics and Jerome Lipper Myeloma Center, Department of Medical Oncology, Dana Farber Cancer Institute, Harvard Medical School, Boston, MA

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Patient-Derived Xenografts Are Faithful Genomic and Phenotypic Models of Primary Leukemia and Respond to the IL-3R targeting agent SL-401 In Vivo
Lead Author: Amanda Christie, B.A.
Department of Hematologic Oncology, Dana Farber Cancer Institute, Harvard Medical School, Boston, MA

CD123 immunostaining in systemic mastocytosis: differential expression in disease subgroups and potential prognostic value
Lead Author: Animesh Pardanani, MBBS, Ph.D.
Department of Hematology, Mayo Clinic College of Medicine, Rochester, MN

SL-801, a novel, reversible inhibitor of Exportin-1 (XPO1) / Chromosome Region Maintenance-1 (CRM1) with broad and potent anti-cancer activity
Lead Author: Janice Chen, Ph.D.
Stemline Therapeutics, Inc., New York, NY

NanoString Technologies Expands 3D Biology Portfolio With the Commercial Launch of Seven New nCounter PanCancer Profiles to Deeply Probe Cancer Biology

On November 5, 2015 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported the expansion of its 3D Biology portfolio with the commercial launch of the nCounter PanCancer Profiles, seven new gene expression panels each designed to interrogate a focused area of cancer biology including immuno-oncology (Press release, NanoString Technologies, NOV 5, 2015, View Source [SID:1234507995]). The panels are focused on Adaptive Immunity, Cancer Metabolism, Intracellular Signaling, Cellular Profiling, Wnt Pathway, Innate Immunity, and DNA Damage & Repair. Each 192-gene panel includes 180 topic-specific probes and twelve universal housekeeping genes. These panels may be combined with nCounter protein expression modules to enable a deeper view of biology through simultaneous analysis of gene and protein expression in key areas of interest to cancer biologists including immuno-oncology researchers.

"NanoString is excited to offer the power of 3D Biology technology in a series of focused PanCancer Profiles that enable our customers to measure gene and protein expression simultaneously," said Joseph M. Beechem, Ph.D., Senior Vice President of Research & Development at NanoString Technologies. "We believe the power of 3D Biology technology will drive a new frontier of immuno-oncology biomarker discovery and utilization, enabling our customers to become leaders in developing a deeper understanding of the underlying biology and its relevance to cancer immunology."

The new PanCancer Profiles leverage NanoString’s new 3D Biology technology, enabling multiplexed digital assays that provide a deeper view of biology through the analysis of multiple analytes at once. Designed for flexibility, these panels can be used as assay development building blocks and may be combined with nCounter protein assays, creating new possibilities for researchers to interrogate both protein and RNA in a single experiment. By providing a menu of focused RNA profiling options, researchers can tailor their assay to meet the needs of their experiments. For example, the 30 protein targets from the Protein Immune Profiling Panel may be added to the nCounter PanCancer Profiles Cancer Metabolism Panel to investigate how the blockade of a growth factor receptor (e.g., anti-HER2/neu) alters tumor cell metabolism while simultaneously measuring downstream activation of innate and adaptive immune cell populations in response to dying tumor cells. Also, the new panels may be customized with up to 24 additional gene expression targets defined by the user. Visit www.nanostring.com/pancancer_profiles to learn more.

At the 2015 Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in National Harbor, Maryland, NanoString will be hosting a luncheon seminar entitled "Bringing the next-generation of immuno-oncology biomarkers to the clinic." Dr. Beechem will provide an introduction to NanoString’s 3D Biology technology and the new PanCancer Profiles, and Alessandra Cesano, M.D., Ph.D., Chief Medical Officer at NanoString Technologies, will moderate a panel discussion featuring presentations by key opinion leaders from academia and the pharmaceutical industry. The seminar begins Friday, November 6 at 12:30pm ET.

The new PanCancer Profiles build on the success of the company’s existing nCounter PanCancer Immune Profiling Panel for gene expression analysis and the recently introduced nCounter PanCancer RNA:Protein Immune Profiling Panel for multi-analyte analysis. Gene expression targets selected for these panels include genes which are representative of topics indicated in the Hallmarks of Cancer, first described in seminal papers by Hanahan and Weinberg (Hanahan, D., and Weinberg, R.A. (2000). Cell 100, 57-70 and Hanahan, D., and Weinberg, R.A. (2011). Cell 144, 646-674). The nCounter Protein Immune Profiling Panel measures immune cell types, cancer antigens, checkpoint blockades and key immune pathway genes for both innate adaptive and humoral immune targets as indicated in the Cancer Immunity Cycle, first described by Chen and Mellman (Chen DS, Mellman I. Immunity. 2013;39:1-10).

Geron Announces Presentations at American Society of Hematology Annual Meeting

On November 05, 2015 Geron Corporation (Nasdaq:GERN) reported that three abstracts describing clinical and non-clinical data on imetelstat have been accepted for presentation at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition to be held in Orlando, Florida from December 5-8, 2015 (Press release, Geron, NOV 5, 2015, View Source;p=RssLanding&cat=news&id=2107371 [SID:1234507994]). The abstracts were published today on the ASH (Free ASH Whitepaper) website at www.hematology.org.

Oral Presentations

Two abstracts containing clinical data on imetelstat were selected for oral presentation. One abstract contains an analysis of preliminary safety and efficacy data from a pilot study of patients with a subtype of myelodysplastic syndromes known as refractory anemia with ring sideroblasts. The second abstract contains an analysis of mutations detected in essential thrombocythemia patients treated with imetelstat. The abstract supplements a prior analysis of JAK2V617F and CALR mutations presented at the ASH (Free ASH Whitepaper) Annual Meeting in December 2014.

Title: Telomerase Inhibitor Imetelstat Therapy in Refractory Anemia with Ring Sideroblasts with or without Thrombocytosis (Abstract #55)
Session Name: 634. Myeloproliferative Syndromes: Clinical: Early and Late Stage Trials in MPN
Session Date: Saturday, December 5, 2015
Session Time: 9:30 a.m. ET – 11:00 a.m. ET
Presentation Time: 9:30 a.m. ET

Title: Dynamics of Mutations in Patients with ET Treated with Imetelstat (Abstract #57)
Session Name: 634. Myeloproliferative Syndromes: Clinical: Early and Late Stage Trials in MPN
Session Date: Saturday, December 5, 2015
Session Time: 9:30 a.m. ET – 11:00 a.m. ET
Presentation Time: 10:00 a.m. ET

Poster Presentation

One abstract containing non-clinical data on imetelstat was selected for presentation as a poster. In this study, the investigators evaluated the activity of imetelstat in a non-clinical model of acute myeloid leukemia, to potentially support broader clinical development of the drug.

Title: Activity of the Telomerase Inhibitor GRN163L (Imetelstat) on Acute Myeloblastic Leukemia Blasts Is Enhanced by DNA Methyltransferase Inhibitors Irrespective of TERT Promoter Methylation Status (Abstract #1267)
Session Name: 604. Molecular Pharmacology and Drug Resistance in Myeloid Diseases: Poster I
Session Date: Saturday, December 5, 2015
Session Time: 5:30 p.m. – 7:30 p.m. ET

In accordance with ASH (Free ASH Whitepaper) policies, abstracts submitted to the ASH (Free ASH Whitepaper) Annual Meeting are embargoed from the time of submission. To be eligible for presentation at the ASH (Free ASH Whitepaper) Annual Meeting, information contained in the abstract, as well as additional data and information to be presented at the Annual Meeting, may not be made public before the abstract has been presented in connection with the ASH (Free ASH Whitepaper) Annual Meeting.

Genocea Announces Immuno-Oncology Research Collaboration with Memorial Sloan Kettering Cancer Center

On November 5, 2015 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, reported a collaboration with Memorial Sloan Kettering Cancer Center to screen the T cell responses of melanoma and non-small cell lung cancer patients treated with checkpoint inhibitors (CPI) against the complete repertoire of patient-specific putative cancer neoantigens (Press release, Genocea Biosciences, NOV 5, 2015, View Source [SID:1234507993]).

The goals of the collaboration are to identify signatures of T cell response in cancer patients associated with response or non-response to CPI therapy and to discover new T cell cancer vaccine antigens. ATLAS will be used in conjunction with Memorial Sloan Kettering’s patient-specific cancer neoantigen sequences and blood samples from the same cancer patients. This new collaborative work will be led by investigators Timothy A. Chan, M.D., Ph.D., Vice Chair, Department of Radiation Oncology, and Jedd D. Wolchok, M.D., Ph.D., Chief of Melanoma and Immunotherapeutics Service, Department of Medicine and Ludwig Center.

"ATLAS is unique in that it makes no assumptions about which cancer antigens are meaningful and which are not. It instead takes a panoramic view of all the mutations that may yield novel targets and reveals clinically relevant T cell antigens that associate with protective immunity," said Jessica Baker Flechtner, Ph.D., senior vice president of research at Genocea. "We believe that ATLAS is a powerful platform that enables the identification of T cell responses that must be present to see an effective response to therapy. This can ultimately lead to the discovery of T cell antigens that may drive cancer vaccine development."

About ATLAS
ATLAS is a first of its kind proprietary rapid antigen identification screening system that finds targets of protective T cell responses. The technology solves challenges to date associated with finding targets of T cell responses. ATLAS can examine T cell responses from large, diverse human populations, and comprehensively screen every potential antigen from a pathogen or target indication in a rapid, high throughput manner, taking weeks versus years to find relevant antigens. Because targets identified by ATLAS are based on actual human immune responses to all potential antigens, with no guesswork or predictions, by the time these candidates reach clinical trials there may be a greater likelihood of success in clinical development. This approach provides the ability to identify smarter targets for use in developing vaccines and immunotherapies to treat infectious disease, cancer and autoimmunity.