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HOUSTON--(BUSINESS WIRE)--Aravive Biologics today announced the appointment of Stephen L. Eck, M.D., Ph.D. as President and Chief Executive Officer. Dr. Eck was formerly Vice President of Oncology Medical Sciences at Astellas Pharma Global Development, Inc. Ray Tabibiazar, M.D., founding President and CEO of Aravive, remains as Chairman of the company’s Board of Directors. “Stephen has an impressive track-record of oncology drug and biomarker development at prominent pharmaceutical companies, as well as a close relationship to Houston’s M.D. Anderson Cancer Center as a member of the Advisory Board for their oncology Moonshot Program,” said Dr. Tabibiazar. “We welcome his expertise and leadership to the Aravive team as we prepare to advance our lead drug candidate, Aravive-S6, into human clinical testing in 2018.” “I am very excited to be joining Aravive at this point in the company’s development,” said Dr. Eck. “Aravive-S6 is a novel and promising agent that has shown in preclinical trials the potential to improve the treatment of cancer in combination with a wide range of other approaches, including chemotherapeutic drugs, radiation, PARP inhibitors and checkpoint inhibitors. I look forward to helping Aravive realize the full potential that I believe Gas6/AXL inhibition can bring to the treatment of cancer.” Prior to joining Astellas Pharma, Stephen Eck served as Vice President, Translational Medicine & Pharmacogenomics at Eli Lilly and Company, where his group developed the biomarkers and companion diagnostics needed for study-specific decision making and for tailoring biotherapeutics to unique patient populations. Prior to joining Lilly, he served in a variety of oncology and neuroscience drug development leadership roles at Pfizer, Inc. Dr. Eck is a board-certified hematologist, who holds a Ph.D. in chemistry from Harvard University and received his M.D. degree from the University of Mississippi School of Medicine. He serves on the Board of Directors of Luminex Corporation, a Texas-based life sciences company, is a Fellow of the American Association for the Advancement of Science, and is Chairman of the Board of Directors of the Personalized Medicine Coalition. Aravive Biologics is a privately held, late pre-clinical stage biopharmaceutical company developing novel, highly selective cancer therapies that treat serious malignancies while sparing normal healthy cells. The company’s lead program is focused on the GAS6/AXL pathway, where activation appears to play a critical role in multiple types of cancer malignancies by promoting tumor metastasis and cell survival. Aravive Biologics has generated strong preclinical data for its lead drug candidate, Aravive-S6, in both acute myeloid leukemia (AML) and solid tumors including ovarian, pancreatic, and breast cancers. The company is based in Houston, Texas, and receives support from the Cancer Prevention & Research Institute of Texas (CPRIT). For more information, please visit our website at http://www.aravive.com. This press release contains forward-looking statements. Forward-looking statements contained in this press release include, without limitation, statements regarding the expected contribution of Dr. Eck, and Aravive-S6’s potential to improve the treatment of cancer in combination with a wide range of other approaches, including chemotherapeutic drugs, radiation, PARP inhibitors and checkpoint inhibitors. These forward-looking statements are not guarantees of future performance and involve a number of unknown risks, assumptions, uncertainties and factors that are beyond Aravive Biologics' control including the ability to successfully integrate Dr. Eck into the Aravive management, and the ability of Aravive-S6 to treat cancer, the ability of Aravive-S6 to demonstrate safety and efficacy, as well as clinical results that are consistent with prior in vitro results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, the company’s ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to the company’s ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, the company’s ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, and its ability to retain its key scientists or management personnel. All forward-looking statements are based on Aravive Biologics' expectations and assumptions as of the date of this press release. Actual results may differ materially from these forward-looking statements. Except as required by law, Aravive Biologics expressly disclaims any responsibility to update any forward-looking statement contained herein, whether as a result of new information, future events or otherwise.

CAMBRIDGE, Mass. and EXTON, Pa., Nov. 09, 2016 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company developing toll-like receptor and RNA therapeutics for patients with cancer and rare diseases, today announced that new data from the Phase 1/2 clinical trial for intratumoral IMO-2125, a TLR9 agonist, being evaluated for the treatment of late-stage metastatic melanoma, will be presented at the 2016 Society for Immunotherapy of Cancer (SITC) Annual Meeting in National Harbor, MD, November 9-13, 2016. Date: Wednesday, November 9, 2016, Presentation Time: 11:15 AM E.T. Session Title: Clinical New Agents in Development Presentation Title:  IMO-2125, An Investigational Intratumoral Toll-Like Receptor 9 Agonist, Modulates the Tumor Microenvironment to Enhance Anti-Tumor Activity Presenter: Mark J. Cornfeld, M.D. M.P.H., Vice President, Oncology Medical Lead, Idera Pharmaceuticals Location: Gaylord National Hotel & Convention Center, Cherry Blossom Ballroom Date: Friday, November 11, 2016, Presentation Time: 3:15 PM E.T. Session Title: State of the Art Immunotherapies: Challenges and Opportunities Presentation Title: Reactivating the anti-tumor immune response by targeting innate and adaptive immunity in a phase I/II study of intratumoral IMO-2125 in combination with systemic ipilimumab in patients with anti-PD-1 refractory metastatic melanoma Presenter: Presenter: Cara Haymaker, Ph.D., Instructor, The University of Texas MD Anderson Cancer Center Location: Gaylord National Hotel & Convention Center, Maryland Ballroom Poster Presentation Date: Saturday, November 12, 2016: Presentation Time: 11:45 AM E.T. – 1:00 PM E.T. Session Title:  Immunotherapy Poster Number: 216 Presentation Title: Reactivating the anti-tumor immune response by targeting innate and adaptive immunity in a phase I/II study of intratumoral IMO-2125 in combination with systemic ipilimumab in patients with anti-PD-1 refractory metastatic melanoma Presenter: Cara Haymaker, Ph.D., Instructor, The University of Texas MD Anderson Cancer Center Location: Gaylord National Hotel & Convention Center, Prince George’s Exhibition Hall AB A copy of the slides from Dr. Cornfeld’s presentation will be made available on Idera’s corporate website at http://www.iderapharma.com/our-approach/key-publications/ on Wednesday, November 9 at 11:15 AM E.T.  Copies of Dr. Haymaker’s presentation and related poster will be also be made available on Idera’s corporate website on Friday, November 11 at 3:15 PM E.T., in accordance with the embargo policies set forth by SITC. “As we noted in late September, we are extremely excited by the initial clinical outcomes we have generated with intratumoral IMO-2125, in combination with ipilimumab,” stated Joanna Horobin, M.B., Ch.B., Idera’s Chief Medical Officer.  “The translational data from this trial is adding to our understanding of how IMO-2125 positively modulates the tumor microenvironment and enabling previously cold tumors an opportunity for regression and ultimately successful outcomes for patients.  The translational research from this trial is critical to further this understanding as well as to help guide the direction of IMO-2125’s development.” These early results are from the phase 1 portion of study IMO-2125-204 (NCT02644967) in which cohorts of patients with metastatic melanoma unresponsive to PD-1 inhibitor therapy are being administered escalating doses of IMO-2125 ranging from 4 mg/kg through 32 mg/kg. IMO-2125 is injected intra-tumorally into a designated tumor lesion together with a standard dosing regimen of ipilimumab. The trial has recently been amended to also study the combination of IMO-2125 and pembrolizumab given intravenously. Following determination of the recommended phase 2 doses (RP2D) additional patients will be treated in an expansion phase 2 portion of the study. The primary objective of the phase 1 portion of the trial is to characterize the safety and determine a RP2D of IMO-2125 when administered intra-tumorally in combination with ipilimumab or pembrolizumab.  The primary objective of the phase 2 portion is to assess the clinical activity of IMO-2125 in each combination at the respective RP2Ds.  Assessment will be based on the immune-related response criteria (irRC) and additionally the traditional RECIST criteria.  Serial biopsies are being taken of selected injected and non-injected tumor lesions to assess immune changes and correlate with clinical response assessments.  The trial will enroll approximately 60 patients.  The study is being conducted at The University of Texas MD Anderson Cancer Center and is being led by Adi Diab, MD, Assistant Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, MD Anderson as part of a strategic research alliance announced by Idera and MD Anderson in 2015. Toll-like receptors (TLRs) play a central role in the innate immune system, the body's first line of defense against invading pathogens, as well as damaged or dysfunctional cells including cancer cells. The innate immune system is also involved in activating the adaptive immune system, which marshals highly specific immune responses to target pathogens or tissue. Cancer cells may exploit regulatory checkpoint pathways to avoid being recognized by the immune system, thereby shielding the tumor from immune attack. Checkpoint inhibitors such as agents targeting CTLA4 or programmed cell death protein 1 (PD1) are designed to enable the immune system to recognize tumor cells. In this setting, intra-tumoral TLR9 agonist administration may increase the tumor-infiltrating lymphocytes (TILs), and thereby potentiate anti-cancer activity of checkpoint inhibitors in the injected tumor as well as systemically. Idera’s TLR9 agonists, IMO-2125 and IMO-2055, have been created using the company's proprietary chemistry-based discovery platform.  IMO-2125 has been shown in various scientific presentations and publications to activate dendritic cells and induce interferon. Idera selected IMO-2125 to advance into clinical development in combination with checkpoint inhibitors based on this immunological profile.  In previously completed clinical trials, subcutaneous administration of IMO-2125 was generally well tolerated in about 80 patients with hepatitis C.  Idera has conducted further preclinical research evaluating the potential of IMO-2125 to enhance the anti-tumor activity of other checkpoint inhibitors in cancer immunotherapy with data being presented at several medical conferences during the past twelve months.  The posters from these presentations can be found at http://www.iderapharma.com/our-approach/key-publications. About Metastatic Melanoma Melanoma is a type of skin cancer that begins in a type of skin cell called melanocytes.  As is the case in many forms of cancer, melanoma becomes more difficult to treat once the disease has spread beyond the skin to other parts of the body such as by through the lymphatic system (metastatic disease).  Melanoma accounts for only one percent of skin cancer cases, but causes a large majority of skin cancer deaths.  The American Cancer Society estimates that in 2016, there will be 76,380 new cases of melanoma in the U.S., and about 10,130 will die of this disease. About Idera Pharmaceuticals            Idera Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel nucleic acid-based therapies for the treatment of certain cancers and rare diseases. Idera’s proprietary technology involves designing synthetic oligonucleotide-based drug candidates to modulate the activity of specific TLRs. In addition to its TLR programs, Idera has used its proprietary knowledge to create a third generation antisense technology platform which inhibits the production of disease-associated proteins by targeting RNA. To learn more about Idera, visit www.iderapharma.com. Forward Looking Statements            This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical fact, included or incorporated in this press release, including statements regarding the Company's strategy, future operations, collaborations, intellectual property, cash resources, financial position, future revenues, projected costs, prospects, plans, and objectives of management, are forward-looking statements. The words "believes," "anticipates," "estimates," "plans," "expects," "intends," "may," "could," "should," "potential," "likely," "projects," "continue," "will," and "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Idera cannot guarantee that it will actually achieve the plans, intentions or expectations disclosed in its forward-looking statements and you should not place undue reliance on the Company's forward-looking statements. There are a number of important factors that could cause Idera's actual results to differ materially from those indicated or implied by its forward-looking statements. Factors that may cause such a difference include: whether interim results from a clinical trial, such as preliminary results reported in this release, will be predictive of the final results of the trial, whether results obtained in preclinical studies and clinical trials such as the preclinical data described in this release will be indicative of the results that will be generated in future clinical trials, including in clinical trials in different disease indications; whether products based on Idera's technology will advance into or through the clinical trial process on a timely basis or at all and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if the Company's products receive approval, they will be successfully distributed and marketed; and such other important factors as are set forth under the caption "Risk Factors" in the Company's Annual Report and on Form 10-Q for the period ended September 30, 2016. Although Idera may elect to do so at some point in the future, the Company does not assume any obligation to update any forward-looking statements and it disclaims any intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

PubMed | Eli Lilly and Company, Bioproduct Research and Development., Oncology Medical., Oncology Discovery Research and 5 more.
Type: Journal Article | Journal: Clinical cancer research : an official journal of the American Association for Cancer Research | Year: 2014

MET, the receptor for hepatocyte growth factor (HGF), has been implicated in driving tumor proliferation and metastasis. High MET expression is correlated with poor prognosis in multiple cancers. Activation of MET can be induced either by HGF-independent mechanisms such as gene amplification, specific genetic mutations, and transcriptional upregulation or by HGF-dependent autocrine or paracrine mechanisms.Here, we report on LY2875358, a novel humanized bivalent anti-MET antibody that has high neutralization and internalization activities, resulting in inhibition of both HGF-dependent and HGF-independent MET pathway activation and tumor growth. In contrast to other bivalent MET antibodies, LY2875358 exhibits no functional agonist activity and does not stimulate biologic activities such as cell proliferation, scattering, invasion, tubulogenesis, or apoptosis protection in various HGF-responsive cells and no evidence of inducing proliferation in vivo in a monkey toxicity study. LY2875358 blocks HGF binding to MET and HGF-induced MET phosphorylation and cell proliferation. In contrast to the humanized one-armed 5D5 anti-MET antibody, LY2875358 induces internalization and degradation of MET that inhibits cell proliferation and tumor growth in models where MET is constitutively activated. Moreover, LY2875358 has potent antitumor activity in both HGF-dependent and HGF-independent (MET-amplified) xenograft tumor models. Together, these findings indicate that the mechanism of action of LY2875358 is different from that of the one-armed MET antibody.LY2875358 may provide a promising therapeutic strategy for patients whose tumors are driven by both HGF-dependent and HGF-independent MET activation. LY2875358 is currently being investigated in multiple clinical studies.

Balmanoukian A.,Oncology Medical | Ettinger D.S.,Sidney Kimmel Comprehensive Cancer Center
ONCOLOGY | Year: 2010

Locally advanced nonsmall-cell lung cancer is a heterogeneous group of diseases encompassing both stage IIIA and IIIB disease. The treatment options vary, including surgery, chemotherapy, neoadjuvant concurrent chemoradiation, definitive chemoradiation, radiation, and various combinations of the above. Optimal therapy for each patient group is controversial; however, previous trials have shown efficacy of various treatments for different stages. Surgery as initial therapy is beneficial for patients with stage T3, N1 or T3-4, N0-1 disease due to satellite lesions within the same lung. Chemotherapy should be used for diseases minimally involving the mediastinal lymph nodes, whereas concurrent induction chemoradiation is a good option for bulky nodal disease prior to planning a resection. Concurrent definitive chemoradiation or definitive radiation should be reserved for patients who are not candidates for a surgical resection. Most importantly, the treatment strategy for stage IIIA/IIIB disease should involve a multimodality approach individualized to the patients disease stage, age, underlying medical conditions, and performance status.

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