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Onconova to Host Myelodysplastic Syndromes (MDS) Key Opinion Leader Meeting on Tuesday, June 30 in New York City

On June 23, 2015 Onconova reported that it will host a Key Opinion Leader breakfast focused on the treatment landscape for myelodysplastic syndromes (MDS), including the Company’s late-stage drug candidate, rigosertib, a small molecule RAS mimetic that inhibits cellular signaling (Press release, Onconova, JUN 23, 2015, View Source [SID:1234505792]). MDS is a heterogeneous group of bone marrow disorders characterized by ineffective hematopoiesis and increased risk of developing acute myeloid leukemia (AML). The event and live webcast will take place on Tuesday, June 30 from 8:00-9:30 AM Eastern Time in New York City.

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The meeting will feature presentations by Guillermo Garcia-Manero, M.D., Chief of the Section of Myelodysplastic Syndromes, Deputy Chair of Translational Research, Co-Director of the DNA Methylation Core, and Professor in the Department of Leukemia at the University of Texas MD Anderson Cancer Center, and Lewis R. Silverman, M.D., Associate Professor of Medicine in Hematology and Medical Oncology and Assistant Professor of Oncological Sciences at the Icahn School of Medicine at Mount Sinai. The Onconova management team will also provide an overview of the Company’s clinical development work with rigosertib, including a discussion of the design of a planned global Phase 3 trial in higher-risk myelodysplastic syndromes (HR-MDS) and ongoing Phase 2 trials utilizing combination therapy with rigosertib and azacitidine. A Q&A session with the featured experts and management will follow the presentations.

This event is intended for institutional investors and sell-side analysts. To reserve a place, please contact Mac MacDonald at 212-915-2567 or via e-mail at [email protected]. A live webcast and subsequent replay of the event will be available at View Source

Guillermo Garcia-Manero, M.D., serves as Chief of the Section of Myelodysplastic Syndromes, Deputy Chair of Translational Research, Co-Director of the DNA Methylation Core, and Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center. He is also on the faculty of The University of Texas Graduate School of Biomedical Sciences at Houston. Dr. Garcia-Manero previously served as Co-Chair of the MDS Clinical Research Consortium. The focus of his academic and clinical efforts have been to improve outcomes for patients with MDS.

Lewis R. Silverman, M.D., is Associate Professor of Medicine in Hematology and Medical Oncology and Assistant Professor of Oncological Sciences at the Icahn School of Medicine at Mount Sinai (ISMMS). He leads the Myelodysplastic Syndrome and Myeloproliferative Disease Program at ISMMS, where he has served as the Principal Investigator for several national clinical trials exploring treatments for patients with MDS. Dr. Silverman played an important role in the completion of the AZA-001 trial, which led to the approval of the first drug for the treatment of MDS, azacitidine (VIDAZA).

Synta Announces Journal Publication Describing Complementary Activity of Hsp90 Inhibition and Immune Checkpoint Blockade for Cancer Therapy

On June 23, 2015 Synta Pharmaceuticals reported the publication in this month’s issue of Cancer Immunology Research of an in-depth review describing the rationale for pursuing the combination of Hsp90 and immune checkpoint inhibition for cancer therapy (Press release, Synta Pharmaceuticals, JUN 23, 2015, View Source [SID:1234505793]).

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The review article, titled "Targeting Heat-Shock Protein 90 (Hsp90) as a Complementary Strategy to Immune Checkpoint Blockade for Cancer Therapy," is available online at View Source Synta is currently studying the Hsp90 inhibitor ganetespib in several randomized studies, including the GALAXY-2 trial, a global, randomized, multi-center Phase 3 study of ganetespib and docetaxel for the second-line treatment of advanced non-small cell lung adenocarcinoma.

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The review article describes preclinical findings that suggest that proteasomal degradation of cellular client proteins associated with Hsp90 inhibition may augment antitumor immune response through increased cellular antigen expression and subsequent enhanced T-cell recruitment and tumor-cell recognition. The review article also explains that client proteins affected by Hsp90 inhibition include oncogenes that may drive expression of Programmed Death-Ligand 1 (PD-L1), a key immune checkpoint. The resulting reduction of PD-L1 expression on tumor cells may increase T-cell mediated cytotoxic activity and complement the activity of selective anti-PD-1 or anti-PD-L1 antibody therapies. This is supported by in vivo study results, where ganetespib was found to potentiate the antitumor efficacy of anti-PD-L1 antibody treatment. In these studies, the combination of ganetespib and an anti-PD-L1 antibody displayed significantly greater antitumor activity than either individual agent, in mouse models of both colon carcinoma and melanoma.

"While there is still more to learn regarding the mechanistic basis for combining Hsp90 and immune checkpoint inhibitors, and the role of Hsp90 in antitumor immunity, the findings in this review suggest that this approach may be complementary and therapeutically advantageous. We look forward to exploring the combination of immune checkpoint inhibitors and ganetespib in future clinical studies," said Chen Schor, President and Chief Executive Officer of Synta. "Our team and collaborators are also conducting preclinical studies investigating potential combinations of ganetespib and other emerging forms of immunotherapy for cancer, including T-cell therapy. We are encouraged by our progress thus far and will look to present and publish results of these studies in the future."

BIND Therapeutics Announces FDA Authorization of First-in-Human Clinical Trial with AstraZeneca’s Aurora B Kinase Inhibitor Accurin AZD2811

On June 23, 2015 BIND Therapeutics reported that the U.S. Food and Drug Administration (FDA) has authorized the use of AstraZeneca’s Accurin AZD2811 in clinical trials under an investigational new drug (IND) application (Press release, BIND Therapeutics, JUN 23, 2015, View Source [SID:1234505791]).

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BIND is collaborating with AstraZeneca on the development of AZD2811, an Aurora B Kinase inhibitor that has been shown to be active in both solid and hematological tumors in preclinical models, and the companies anticipate enrolling patients in a phase 1 clinical trial with AZD2811 in the fourth quarter of this year. BIND will earn a $4 million milestone payment upon first dosing a patient in a phase 1 clinical trial with AZD2811.

Preclinical data on AZD2811 were presented at the 2015 American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April 2015, including data demonstrating promising in vivo and in vitro tumor growth inhibition as monotherapy in models of diffuse large B-cell lymphomas (DLBCL) and small cell lung cancer (SCLC). Additional data showed that AZD2811 delivers prolonged exposure to active drug while having the potential to adapt the dosing regimen, potentially achieving an improved therapeutic index. In addition, using mass spectrometric imaging, AZD2811 was shown to accumulate in tumors and achieve prolonged tumor drug exposure. This represents the first time distribution of nanoparticles in tumors has been demonstrated. Previously, preclinical tumor model data were presented showing that AZD2811 minimizes the bone marrow toxicity seen with the parent compound, which has limited the clinical utility of Aurora B kinase inhibitors as a class.

"We have worked diligently with our collaborators at AstraZeneca to quickly advance the Aurora B kinase inhibitor program, AZD2811, through preclinical development," said Andrew Hirsch, president and chief executive officer of BIND Therapeutics. "The data recently presented at AACR (Free AACR Whitepaper) describing the optimized pharmacological properties of AZD2811 further demonstrate the unique attributes of Accurins as a new treatment modality with the potential to produce therapeutics with best-in-class profiles. With AZD2811 now cleared to begin a phase 1 study, we are positioned to have two Accurins in clinical development, with our lead Accurin BIND-014 currently in phase 2 studies."

BIND and AstraZeneca expect to enroll the first patient in a phase 1 clinical trial with AZD2811 in the fourth quarter of 2015. Under terms of the collaboration, AstraZeneca is responsible for clinical development and commercialization and BIND is responsible for conducting clinical manufacturing through at least the end of phase 2 clinical trials.

About Accurins
Accurins, a new class of targeted therapeutics developed using BIND’s Medicinal Nanoengineering platform, are nanoparticles engineered to have a profound impact on the treatment of disease. The elegant and novel design of Accurins allow for prolonged circulation, controlled and tunable release and selective targeting of a therapeutic payload to diseased tissue or cells while avoiding immune surveillance detection and systemic toxicities.

Accurins can be engineered for multiple therapeutic applications and have the potential to integrate numerous payloads, including highly potent drugs with mechanism-based toxicities that limit therapeutic benefit, DNA, RNA, proteins and immunotherapy agents. This attribute enables Accurins to target multiple diseases, including cancer, inflammatory, vascular, and infectious disease.

6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On June 22, 2015 Aptose Biosciences reported that William G. Rice, Ph.D., Chairman, President and Chief Executive Officer, will present at the upcoming 10th Annual JMP Securities Life Sciences Conference on Wednesday, June 24th at 10:30 a.m. ET at the St. Regis New York (Filing, 6-K, Aptose Biosciences, JUN 22, 2015, View Source [SID:1234505790]). Dr. Rice will provide a corporate overview of the Company’s recent activities and strategic direction, including the development of Aptose’s lead clinical agent, APTO-253, for acute myeloid leukemia (AML), high risk myelodysplastic syndromes (MDS) and other hematologic malignancies.

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A live audio webcast of the Aptose presentation will be accessible by visiting:

View Source

The audio webcast will be archived shortly after the live event and will be available for 90 days through the Aptose website at www.aptose.com.

IMS Health and Foundation Medicine Announce Collaboration to Optimize Targeting of Precision Therapies in Oncology

On June 22, 2015 IMS Health and Foundation Medicine reported a collaboration to advance the understanding and effectiveness of precision medicines for treating cancer (Press release, Foundation Medicine, JUN 22, 2015, View Source [SID:1234505788]). Commercial, medical and outcomes research teams in biopharma and life sciences companies will now be able to leverage an offering that combines IMS Health’s powerful Real-World Evidence (RWE) platform providing clinical and cost-of-care insights with Foundation Medicine’s dynamic knowledgebase of comprehensive cancer genomic profiles, all at the patient-anonymous level.

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Through the collaboration, IMS Health’s clients will gain unprecedented insights to rapidly assess health outcomes and effectiveness, and to improve cancer care by better connecting patients to the right targeted therapies at the right time.

"As life sciences companies look to deploy new, targeted therapies that address the unique molecular drivers of specific cancers, it has become increasingly important for them to better understand unmet needs, treatment decisions and outcomes for patient populations living with those cancers," said Jon Resnick, IMS Health vice president and general manager of Real-World Evidence Solutions. "This collaboration with Foundation Medicine extends our Real-World Evidence platform – uniquely linking claims, EMR and biomarker data at the anonymous patient level to drive a complete understanding of the oncology patient journey and improve clinical development and commercialization strategies."

These enhanced oncologic insights will be powered by Evidence 360 and FoundationCORE. Evidence 360 is IMS Health’s scalable and secure RWE platform that helps clients extract, analyze and visualize real-world data to better understand and measure healthcare outcomes. It brings together IMS Health’s vast library of patient-anonymous data with other patient-anonymous sources of health information to help life sciences companies interpret real-world outcomes and better target their commercial efforts. FoundationCORE is a molecular information knowledgebase containing comprehensive cancer genomic information and insights from more than 43,000 clinical cases profiled by Foundation Medicine. FoundationCORE evolves in real-time, informed by every new cancer patient tested with the company’s commercial assays, FoundationOne and FoundationOne Heme.

"There is recognition within the healthcare industry that rich and highly credible information will be the primary catalyst for the broad adoption of precision medicine, particularly in oncology," said Michael J. Pellini, M.D., chief executive officer of Foundation Medicine. "As the leader in molecular information solutions, Foundation Medicine’s collaboration with IMS Health expands existing relationships with our biopharma partners, further underscoring the value of FoundationCORE and its impact on informing physicians and patients, and transforming clinical practice."