VeriStrat Poor Patients Show Encouraging Overall Survival and Progression Free Survival Signal; Confirmatory Phase 2 Study Planned by Year-End
|
|
- Annabel Alexander
- 5 years ago
- Views:
Transcription
1 AVEO and Biodesix Announce Exploratory Analysis of VeriStrat-Selected Patients with Non-Small Cell Lung Cancer in Phase 2 Study of Ficlatuzumab Presented at ESMO 2014 Congress VeriStrat Poor Patients Show Encouraging Overall Survival and Progression Free Survival Signal; Confirmatory Phase 2 Study Planned by Year-End MADRID Sep. 29, 2014 AVEO Oncology (NASDAQ: AVEO) and Biodesix, Inc. today announced the presentation of results from a retrospective exploratory analysis using VeriStrat, a commercially available serum protein test, to identify patients most likely to benefit from the addition of ficlatuzumab, AVEO s HGF inhibitory antibody, to epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor (TKI) therapy in a randomized Phase 2 study of ficlatuzumab and gefitinib (IRESSA ) in previously untreated Asian subjects with non-small cell lung cancer (NSCLC). The results, presented in a poster session (abstract #8195) at the 2014 Congress of the European Society for Medical Oncology (ESMO), suggest that VeriStrat may be selective of positive clinical response for ficlatuzumab plus gefitinib over gefitinib alone. EGFR TKIs are an important class of therapy for which VeriStrat has potential prognostic and predictive value, said Tony Mok, M.D., Professor, Department of Clinical Oncology, The Chinese University of Hong Kong, and senior investigator of the study. VeriStrat appears to measure a host response in which tumors may become stimulated by alternative pathways, such as HGF/c-MET, leading to resistance to EGFR TKI therapy. In this exploratory analysis, the addition of the HGF-targeted antibody ficlatuzumab to an EGFR TKI therapy has shown encouraging results in this subgroup, including significant improvements in overall survival and progression free survival. Exploratory Analysis Results in Detail A total of 188 patients were enrolled in a randomized Phase 2 study (P6162) designed to compare the combination of ficlatuzumab and gefitinib with gefitinib alone in treatment-naïve Asian patients with non-small cell lung adenocarcinoma. For this retrospective exploratory analysis, 180 serum samples were assigned a VeriStrat label of either Good (VSG) or Poor (VSP) (VSG=145, VSP=35). While the study failed to demonstrate improved overall survival (OS) or progression-free survival (PFS) over gefitinib alone in the intent-to-treat population, the addition of ficlatuzumab to gefitinib provided significant clinical benefit to the VSP subgroup: VSP ficlatuzumab and gefitinib n=18 1 gefitinib alone n=17
2 OS PFS Median 23.9 months 5.8 months Hazard Ratio 0.41 p-value Median 7.4 months 2.3 months Hazard Ratio 0.41 p-value No benefit was observed in the VSG subgroup in either OS (Median 24.7 mo for ficlatuzumab + gefitinib [n=69] vs not reached for gefitinib alone [n=76]; HR 1.18, p=0.492) or PFS (Median 5.6 mo for ficlatuzumab + gefitinib vs 5.6 mo for gefitinib alone; HR 1.06, p=0.753). Despite the small sample sizes, similar patterns in OS and PFS based on VeriStrat stratification were also observed in patients with known EGFR mutations (n=71) and VSP classification (n=11): VSP and EGFRm OS PFS ficlatuzumab and gefitinib n=5 gefitinib alone n=6 Median 17.8 months 10.4 months Hazard Ratio 0.3 p-value 0.09 Median 11.1 months 2.3 months Hazard Ratio <0.01 p-value <0.01 Based on these data, in April 2014, AVEO and Biodesix entered into a worldwide agreement to develop and commercialize ficlatuzumab with a Biodesix companion diagnostic test. As part of this agreement, AVEO and Biodesix plan to conduct a confirmatory Phase 2 study using a Biodesix VeriStrat Poor classification as a selective biomarker for the combination of ficlatuzumab and an EGFR-TKI, versus an EGFR TKI alone, in previously untreated, EGFR mutation-positive patients with advanced non-small-cell lung cancer. The study is expected to initiate before year-end. This analysis suggests that VeriStrat Poor, EGFR TKI-sensitizing mutation-positive patients with NSCLC appear to have limited response to EGFR TKI alone, identifying a significant unmet medical need, stated Tuan Ha-Ngoc, president and chief executive officer of AVEO. Given our scientific hypothesis, and the encouraging results in this well-defined patient subset, we believe further clinical evaluation of ficlatuzumab and an EGFR TKI therapy in this population is warranted. These results suggest that a blood test may be used to more precisely classify the response of a subset of patients who, based on EGFR mutation status, should be candidates for an EGFR inhibitor yet appear not to respond to the mono-therapy without the addition of ficlatuzumab, said David Brunel, chief executive officer of Biodesix. By using biomarkers and Biodesix proprietary predictive intelligence computational approach, we believe we can further identify patient sub-populations with differential predictive and prognostic outcomes to advance
3 decisions for therapeutic guidance. Biomarkers are empowering oncologists and the healthcare community with an evidence-based medical approach that informs more precise decisions on diagnosis, prognosis, therapeutic guidance and quality of patient care. A copy of the poster presentation is available on AVEO s website at About Ficlatuzumab and the HGF/c-Met Pathway HGF is the sole ligand that binds to and activates a receptor called c-met. Activation of the HGF/c-Met pathway is believed to be important in normal processes in embryonic development and wound healing, but its dysregulation is believed to play a role in cancer development, metastasis and drug resistance. HGF/c-Met has also been shown to be one of the most potent drivers of tumor growth in AVEO s Human Response Platform. HGF/c-Met over-expression is observed in many solid tumors including breast, colorectal, gastric, head and neck, lung and prostate, as well as hematologic malignancies. Additionally, c- Met and EGFR are frequently co-amplified and co-expressed in a variety of tumor types; HGF/c- Met pathway upregulation can render resistance to EGFR-targeted therapies, and vice-versa. HGF has also been shown to be one of the most potent growth factors that can drive resistance to a panel of anti-cancer therapies. Ficlatuzumab is a humanized IgG1κ antibody that binds to the HGF ligand with high affinity and specificity to inhibit the biological activities of the HGF/c-Met pathway. Studies have demonstrated that ficlatuzumab is well tolerated as a single agent as well as in combination with EGFR TKIs. About VeriStrat VeriStrat, developed by Biodesix, is a multivariate, blood-based, protein test currently available to help physicians guide treatment decisions for patients with advanced non-small cell lung cancer. The test identifies patients who are likely to have Good or Poor outcomes after treatment with either epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy such as erlotinib or with chemotherapy. VeriStrat is based on Biodesix proprietary proteomics platform which enables the discovery of multivariate classifiers that characterize a patient s condition or likely outcome in response to therapy. About AVEO AVEO Oncology (NASDAQ: AVEO) is a biopharmaceutical company committed to discovering and developing targeted therapies designed to provide substantial impact in the lives of people with cancer by addressing unmet medical needs. AVEO s proprietary Human Response Platform provides the company unique insights into cancer and related disease biology and is being leveraged in the discovery and clinical development of its therapeutic candidates. For more information, please visit the company s website at About Biodesix Biodesix is a molecular diagnostics company advancing the development of innovative products for personalizing medicine. The company provides physicians with diagnostic tests for earlier
4 disease detection, more accurate diagnosis, disease monitoring and better therapeutic guidance, which may lead to improved patient outcomes. Biodesix discovers, develops and commercializes multivariate protein diagnostics based on their proprietary mass spectrometry-based discovery platform. In addition to developing novel diagnostics independently, the company also partners with biotechnology and pharmaceutical companies to develop companion diagnostics to improve utility of therapeutic agents. For more information about Biodesix, please visit Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements of AVEO within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release are forward-looking statements. The words anticipate, believe, estimate, expect, intend, may, plan, target, potential, could, should, seek, or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about AVEO s plans to conduct a Phase 2 study of ficlatuzumab using Biodesix s Veristrat test; the commencement of the Phase 2 study prior to year-end; Veristrat s prognostic value and the ability for VeriStrat to be predictive of positive clinical response for ficlatuzumab plus gefitinib over gefitinib alone. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forwardlooking statements that AVEO makes due to a number of important factors, including risks relating to: AVEO s ability to execute on its business strategy and enter into and maintain new strategic partnerships and collaboration agreements; AVEO s ability to successfully enroll and complete clinical trials and preclinical studies of its product candidates; AVEO s ability to demonstrate to the satisfaction of the FDA, or equivalent foreign regulatory agencies, the safety, efficacy and clinically meaningful benefit of its product candidates; AVEO s ability to achieve and maintain compliance with all regulatory requirements applicable to its product candidates; AVEO s ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates and technologies; developments and expenses related to AVEO s ongoing shareholder litigation and SEC inquiry; AVEO s ability to raise the substantial additional funds required to achieve its goals; adverse general economic and industry conditions; competitive factors; and those risks discussed in the section titled Risk Factors included in AVEO s most recent Quarterly Report on Form 10-Q and in its other filings with the SEC. The forward-looking statements in this press release represent AVEO s views as of the date of this press release. AVEO anticipates that subsequent events and developments will cause its views to change. However, while AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO s views as of any date subsequent to the date of this press release. AVEO Contact: David Pitts, Argot Partners (212) aveo@argotpartners.com
5 Biodesix Contacts: Kena Hudson or Kelly Quigley, ###
AVEO Oncology Announces Strategic Restructuring. AVEO to Host Conference Call Wednesday, June 5 at 8:30 a.m. ET
NEWS RELEASE FOR IMMEDIATE RELEASE AVEO Oncology Announces Strategic Restructuring AVEO to Host Conference Call Wednesday, June 5 at 8:30 a.m. ET CAMBRIDGE, Mass., June 4, 2013 AVEO Oncology (NASDAQ: AVEO)
More informationAnnounce Expected Initiation of an Investigator-Initiated, Randomized, Phase 2, Multicenter Trial of Ficlatuzumab and Cetuximab in HNSCC in 2H 2017
AVEO Oncology and Biodesix Announce Results from Two Investigator-Sponsored Phase 1 Studies of HGF Targeted Antibody Ficlatuzumab at the 2017 ASCO Annual Meeting Announce Expected Initiation of an Investigator-Initiated,
More informationAVEO and Astellas Announce Positive Findings from TIVO-1 Superiority Study of Tivozanib in First-Line Advanced RCC
FOR IMMEDIATE RELEASE AVEO and Astellas Announce Positive Findings from TIVO-1 Superiority Study of Tivozanib in First-Line Advanced RCC - Tivozanib is the First Agent to Demonstrate Greater than One Year
More informationAVEO and Astellas Report Final Overall Survival Results from TIVO-1
AVEO and Astellas Report Final Overall Survival Results from TIVO-1 - Median Overall Survival of 28.8 Months Reported for Tivozanib in Patients with Advanced Kidney Cancer - CAMBRIDGE, Mass. and TOKYO,
More informationAVEO and Astellas Announce TAURUS Patient Preference Clinical Study Comparing Tivozanib with Sunitinib in First-Line Kidney Cancer
FOR IMMEDIATE RELEASE AVEO and Astellas Announce TAURUS Patient Preference Clinical Study Comparing Tivozanib with Sunitinib in First-Line Kidney Cancer Study designed to build upon safety profile demonstrated
More informationOncology Therapeutics without Compromise APRIL 2011
Oncology Therapeutics without Compromise APRIL 2011 Forward Looking Statements This presentation contains forward-looking statements that involve substantial risks and uncertainties, including among other
More informationJefferies 2015 Global Healthcare Conference. June 2015 CORP OVERVIEW
Jefferies 2015 Global Healthcare Conference June 2015 CORP OVERVIEW Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation
More informationMyeloid Differentiation Observed, Including Induction of CD38 in 85% of Evaluable Patients
December 10, 2017 Syros Announces Initial Clinical Data from Ongoing Phase 2 Trial of SY-1425 Showing Biological and Clinical Activity as Single Agent in Genomically Defined AML and MDS Patients Clinical
More informationSavolitinib Global Phase II Trial Initiated in EGFR Mutant Non-Small Cell Lung Cancer
Savolitinib Global Phase II Trial Initiated in EGFR Mutant Non-Small Cell Lung Cancer Initiation of expanded Phase II trials in NSCLC triggers US$10 million milestone from AstraZeneca to Chi-Med New study
More informationSyndax Announces Updated Results from Phase 2 ENCORE 601 Trial of Entinostat in Combination with KEYTRUDA (pembrolizumab)
Syndax Announces Updated Results from Phase 2 ENCORE 601 Trial of Entinostat in Combination with KEYTRUDA (pembrolizumab) Ongoing ENCORE 601 biomarker analyses suggest enhanced clinical benefit in subpopulation
More informationNewLink Genetics Corporation Provides Operational Update and Reports Second Quarter 2015 Financial Results
July 31, 2015 NewLink Genetics Corporation Provides Operational Update and Reports Second Quarter 2015 Financial Results -Management to Host Conference Call Today at 8:30 a.m. ET- AMES, Iowa, July 31,
More informationUnder the terms of the agreement, AVEO will receive an initial cash payment of $125 million, composed of a $75 million license fee and $50 million in
Astellas Pharma Inc. AVEO Pharmaceuticals Corporate Communications Investor Contact: Astellas Pharma Inc. Monique Allaire AVEO Pharmaceuticals +81(3)-3244-3201 (617) 299-5810 Media Contact: Dan Budwick
More informationArQule Jefferies Global Healthcare Conference June 2015
ArQule Jefferies Global Healthcare Conference June 2015 1 ArQule Corporate Update Safe Harbor This presentation and other statements by ArQule may contain forward-looking statements within the meaning
More informationJuly, ArQule, Inc.
July, 2012 Safe Harbor This presentation and other statements by ArQule may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to clinical
More informationTwo-stage study designed to evaluate tolerability and efficacy of pracinostat combined with azacitidine in patients with high and very high risk MDS
Helsinn Group and MEI Pharma Announce First Patient Dosed in Phase 2 Dose-Optimization Study of Pracinostat and Azacitidine in Myelodysplastic Syndrome Two-stage study designed to evaluate tolerability
More information-- Edasalonexent Substantially Slowed Duchenne Muscular Dystrophy Disease Progression through 36 Weeks --
Catabasis Pharmaceuticals Reports Positive Results from Open-Label Extension of Phase 2 MoveDMD Trial Evaluating Edasalonexent in Duchenne Muscular Dystrophy and Plans to Initiate Phase 3 Clinical Trial
More informationTheravance Announces Positive Results from Phase 1 and Phase 2 Clinical Studies with TD-1211 in Development for Opioid-Induced Constipation
Theravance Announces Positive Results from Phase 1 and Phase 2 Clinical Studies with TD-1211 in Development for Opioid-Induced Constipation TD-1211 Achieves Primary and Secondary Endpoints SOUTH SAN FRANCISCO,
More informationBuilding a Premier Oncology Biotech
Corporate Deck Building a Premier Oncology Biotech Dr. Helen Torley, President and CEO November 2018 Forward-Looking Statements All of the statements in this presentation that are not statements of historical
More informationCombining HS-110 and anti-pd-1 in NSCLC. September 1, 2015
Combining HS-110 and anti-pd-1 in NSCLC September 1, 2015 Forward Looking Statements This presentation includes statements that are, or may be deemed, forward-looking statements. In some cases, these forward-looking
More informationMemory Pharmaceuticals Establishes Plans for Clinical Program for MEM 3454 in Schizophrenia. -Broadens Roche Nicotinic Alpha-7 Alliance-
Memory Pharmaceuticals Establishes Plans for Clinical Program for MEM 3454 in Schizophrenia -Broadens Roche Nicotinic Alpha-7 Alliance- -Secures Additional $5M Debt Financing to Support Phase 2a Trial-
More informationImmunocore and MedImmune announce new collaboration to conduct immuno-oncology combination trials in melanoma
PRESS RELEASE IMMUNOCORE LIMITED Immunocore and MedImmune announce new collaboration to conduct immuno-oncology combination trials in melanoma (Oxford, UK, 16 April 2015) Immunocore Limited, a world-leading
More informationFirst Phase 3 Results Presented for a PD-1 Immune Checkpoint Inhibitor
September 30, 2014 Positive Phase 3 Data for Opdivo (nivolumab) in Advanced Melanoma Patients Previously Treated with Yervoy @ (ipilimumab) Presented at the ESMO 2014 Congress First Phase 3 Results Presented
More informationSpectrum Pharmaceuticals
Spectrum Pharmaceuticals Joe Turgeon President and CEO June 2018 Investor Presentation 1 Safe Harbor Statement This presentation contains forward looking statements regarding future events and the future
More informationMore cancer patients are being treated with immunotherapy, but
Bristol-Myers Squibb and Five Prime Present Phase 1a/1b Data Evaluating Cabiralizumab (anti-csf-1 receptor antibody) with Opdivo (nivolumab) in Patients with Advanced Solid Tumors PRINCETON, N.J. & SOUTH
More informationADAPTIMMUNE INVESTOR PRESENTATION. August 2016
ADAPTIMMUNE INVESTOR PRESENTATION August 2016 DISCLAIMER This presentation contains forward-looking statements, as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA),
More informationCytoDyn Announces Initiation of Metastatic Triple Negative Breast Cancer Trial and Reiterates Phase 3 Goal in Cancer
November 26, 2018 CytoDyn Announces Initiation of Metastatic Triple Negative Breast Cancer Trial and Reiterates Phase 3 Goal in Cancer VANCOUVER, Washington, Nov. 26, 2018 (GLOBE NEWSWIRE) -- CytoDyn Inc.
More informationBuilding a Premier Oncology Biotech
Wells Fargo Securities Healthcare Conference Building a Premier Oncology Biotech Dr. Helen Torley, President and CEO September 2018 Forward-Looking Statements All of the statements in this presentation
More informationYour contact. Merck and Pfizer to Present Data at ASCO for Avelumab, an Investigational Anti-PD-L1 Antibody
Your contact Merck Media: Gangolf Schrimpf +49 6151 72 9591 Investor Relations: +49 6151 72 3321 News Release Pfizer Media: Sally Beatty +1 212 733 6566 Investor Relations: Ryan Crowe +1 212 733 8160 May
More informationIMMUNOMEDICS, INC. Advanced Antibody-Based Therapeutics
IMMUNOMEDICS, INC. Advanced Antibody-Based Therapeutics Oncology Autoimmune Diseases Rodman & Renshaw 19 th Annual Global Investment Conference Michael R. Garone, Principal Executive Officer and CFO Forward-Looking
More informationZynerba Pharmaceuticals Announces New FAB-C Phase 2 Open-Label Data in Patients with Fragile X Syndrome
Zynerba Pharmaceuticals Announces New FAB-C Phase 2 Open-Label Data in Patients with Fragile X Syndrome - Significant Improvements in Behavioral Symptoms Observed in Patients and Sustained through 38 Weeks
More information-- Single Global Phase 3 Trial Expected to Begin in First Half of
Catabasis Pharmaceuticals Reports Edasalonexent Preserved Muscle Function and Substantially Slowed Duchenne Muscular Dystrophy Disease Progression Through More Than One Year of Treatment -- Consistent
More informationDetermined to realize a future in which people with cancer live longer and better than ever before
Determined to realize a future in which people with cancer live longer and better than ever before 3Q 2018 EARNINGS PRESENTATION NOVEMBER 2018 1 Forward-looking statements disclosure This presentation
More informationInfinity Highlights Promising Preclinical Hedgehog Data and Announces First Quarter Financial Results
Infinity Highlights Promising Preclinical Hedgehog Data and Announces First Quarter Financial Results Heat Shock Protein 90 Program Continues to Advance Toward Potential Registration Trial CAMBRIDGE, Mass.,
More informationARQ 087 Overview. FGFR Inhibitor. March 2017
ARQ 087 Overview FGFR Inhibitor March 2017 Safe Harbor This presentation and other statements by ArQule contain forward-looking statements within the meaning of the Private Securities Litigation Reform
More informationPfizer Presents Final Phase 2 Data on Investigational PARP Inhibitor Talazoparib in Patients with Germline BRCA-Positive Advanced Breast Cancer
For immediate release June 3, 2017 Media Contact: Sally Beatty (212) 733-6566 Investor Contact: Ryan Crowe (212) 733-8160 Pfizer Presents Final Phase 2 Data on Investigational PARP Inhibitor Talazoparib
More informationNewLink Genetics Corporation
Cantor Fitzgerald 2018 Global Healthcare Conference NewLink Genetics Corporation NASDAQ: NLNK October 3, 2018 Cautionary Note Regarding Forward-Looking Statements This presentation contains forward-looking
More informationLeerink Immuno-Oncology Roundtable Conference
Leerink Immuno-Oncology Roundtable Conference September 28, 2017 NASDAQ:FPRX Forward-Looking Statements Disclaimer This presentation contains forward-looking statements within the meaning of the Private
More informationResults Confirm and Extend 40-Week Findings that Treatment with Crysvita is Superior to Conventional Therapy
Ultragenyx and Kyowa Kirin Announce Positive 64-Week Results for Crysvita (burosumab) from Phase 3 Study in Children with X-linked Hypophosphatemia (XLH) Results Confirm and Extend 40-Week Findings that
More informationDeveloping & Commercializing Targeted Small Molecule Drugs in Cancer
Developing & Commercializing Targeted Small Molecule Drugs in Cancer SAFE HARBOR STATEMENT 2 Forward-looking statements made in the course of this presentation are made pursuant to the safe harbor provisions
More informationHR 95% Confidence Interval. *no DFS events occurred in AJCC 7 stage I/II TNBC patients treated with NPS plus trastuzumab.
NEWS RELEASE SELLAS Life Sciences Announces Additional Positive Triple Negative Breast Cancer (TNBC) Subgroup Data from Phase 2b Study of Nelipepimut-S Plus Trastuzumab at the 2018 San Antonio Breast Cancer
More informationBayer and Loxo Oncology to develop and commercialize two novel oncology therapies selectively targeting genetic drivers of cancer
Investor News Not intended for U.S. and UK Media Bayer AG Investor Relations 51368 Leverkusen Germany www.investor.bayer.com Bayer and Loxo Oncology to develop and commercialize two novel oncology therapies
More informationBusiness Update & Financial Results for Q1 2018
Business Update & Financial Results for Q1 2018 May 15, 2018 Disclaimer The statements made in this presentation may include forward-looking statements regarding the future operations of ERYTECH Pharma
More informationJanuary 30, 2018 Dow Wilson President and Chief Executive Officer
Acquisition of SIRTeX January 30, 2018 Dow Wilson President and Chief Executive Officer This presentation is intended exclusively for investors. It is not intended for use in Sales or Marketing. Forward-Looking
More informationEvofem Biosciences Reports Second Quarter 2018 Financial Results and Provides Corporate Update
Evofem Biosciences Reports Second Quarter 2018 Financial Results and Provides Corporate Update Phase 3 Trial of Amphora for Hormone-free Contraception Continues to Move Ahead of Schedule; Top Line Data
More informationB I ABOUT BI DISEASE AREA & MECHANISM OF ACTION. For journalists outside UK/US/Canada only B A C K G R O U N D E R
For journalists outside UK/US/Canada only B I 1 4 8 2 6 9 4 1. About BI 1482694 2. Disease area & mechanism of action 3. Development status 4. Data overview 1. ABOUT BI 1482694 BI 1482694* (HM61713**)
More information8 of 21 (38.1%) Achieved RECIST v1.1 Durable Complete Response (CR) in Predicted Anti-PD-1 Non-Responder Melanoma Patients at 24 Weeks
October 19, 2017 OncoSec Presents Positive Phase 2 Data for ImmunoPulse IL-12 in Combination with Pembrolizumab Demonstrating a Best Overall Response Rate (BORR) of 50% in Predicted Anti-PD-1 Non- Responder
More informationBio-Path Announces Clinical Update to Interim Analysis of Phase 2 Prexigebersen Trial in Acute Myeloid Leukemia
Bio-Path Announces Clinical Update to Interim Analysis of Phase 2 Prexigebersen Trial in Acute Myeloid Leukemia Interim Data Update from Phase 2 Study Demonstrates Meaningful Clinical Improvement with
More informationSunesis Pharmaceuticals Reports Third Quarter 2014 Financial Results and Recent Highlights
Sunesis Pharmaceuticals Reports Third Quarter 2014 Financial Results and Recent Highlights November 10, 2014 7:00 AM ET Announces Submission of Letter of Intent to File MAA for Vosaroxin in Relapsed or
More informationAbout X-Linked Hypophosphatemia (XLH)
Ultragenyx and Kyowa Kirin Announce Publication of Phase 2 Study Results Demonstrating that Crysvita (burosumab) Improved Outcomes in Children with X-linked Hypophosphatemia in the New England Journal
More informationASTELLAS AND MEDIVATION INITIATE PHASE III TRIAL OF ENZALUTAMIDE IN PATIENTS WITH TRIPLE-NEGATIVE BREAST CANCER
Astellas Contact: Medivation Contacts: For Media For Media Tyler Marciniak Samina Bari Director, Communications Vice President, Corporate (847) 736-7145 Communications tyler.marciniak@astellas.com (415)
More informationZIOPHARM / Intrexon Graft-Versus-Host Disease Exclusive Channel Collaboration SEPTEMBER 28, 2015
ZIOPHARM / Intrexon Graft-Versus-Host Disease Exclusive Channel Collaboration SEPTEMBER 28, 2015 1 Forward-looking Statements This presentation contains certain forward-looking information about ZIOPHARM
More information(212) Investors Contact: Ryan Crowe (212)
For immediate release: February 5, 2014 Media Contact: Sally Beatty (212) 733-6566 Investors Contact: Ryan Crowe (212) 733-8160 Pfizer And Merck To Collaborate On Innovative Anti-Cancer Combination Studies
More informationPhase 3 Top-Line Results Show IBRANCE in Combination with Fulvestrant Meets Progression-Free Survival (PFS) Primary Endpoint
For immediate release: April 15, 2015 Media Contact: Sally Beatty (212) 733-6566 Investor Contact: Ryan Crowe (212) 733-8160 Pfizer Announces PALOMA-3 Trial for IBRANCE (Palbociclib) Stopped Early Due
More informationSavient's Pegloticase Data in Treatment-Failure Gout Patients Presented at 72nd Annual Meeting of the American College of Rheumatology Conference
Savient's Pegloticase Data in Treatment-Failure Gout Patients Presented at 72nd Annual Meeting of the American College of Rheumatology Conference EAST BRUNSWICK, N.J., Oct 27, 2008 /PRNewswire-FirstCall
More informationGenomic Health. Kim Popovits, Chairman, CEO and President
Genomic Health Kim Popovits, Chairman, CEO and President Safe Harbor Statement Various remarks that we make in this presentation that are not historical, including those about our future financial and
More informationIRESSA (Gefitinib) The Journey. Anne De Bock Portfolio Leader, Oncology/Infection European Regulatory Affairs AstraZeneca
IRESSA (Gefitinib) The Journey Anne De Bock Portfolio Leader, Oncology/Infection European Regulatory Affairs AstraZeneca Overview The Drug The Biomarker and Clinical Trials Sampling Lessons Learned The
More informationMedia Contact: Ron Rogers Investor Contact: Scott Gleason (801) (801)
News Release Media Contact: Ron Rogers Investor Contact: Scott Gleason (801) 584-3065 (801) 584-1143 rrogers@myriad.com sgleason@myriad.com Myriad Receives FDA Approval of BRACAnalysis CDx as Companion
More informationONO PHARMACEUTICAL CO., LTD. and Bristol-Myers Squibb Announce Strategic Immuno-Oncology Collaboration in Japan, South Korea and Taiwan
ONO PHARMACEUTICAL CO., LTD. and Bristol-Myers Squibb Announce Strategic Immuno-Oncology Collaboration in Japan, South Korea and Taiwan Companies to develop and commercialize Opdivo (nivolumab), ipilimumab,
More informationINTERIM MANAGEMENT STATEMENT Q3 2017
INTERIM MANAGEMENT STATEMENT Q3 2017 Significant progress across all clinical programs New pre-clinical immunooncology data to be presented during R&D Day in New York Research & Development highlights:
More informationM (SAPPHIRE-II)
PRESS RELEASE AbbVie Demonstrates 96 percent SVR 12 in its Phase III Study of Treatment- Experienced Patients with Genotype 1 Hepatitis C Results further confirm phase II studies, with consistent virologic
More informationInvestor Presentation
Investor Presentation June 2017 Joe Turgeon President and Chief Operating Officer Safe Harbor Statement This presentation contains forward-looking statements regarding future events and the future performance
More informationSunesis Pharmaceuticals Reports Second Quarter 2011 Financial Results
Investor and Media Inquiries: David Pitts Argot Partners 212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc. 650-266-3717 Sunesis Pharmaceuticals Reports Second Quarter 2011 Financial Results SOUTH
More informationBuilding a Premier Oncology Biotech
Building a Premier Oncology Biotech August 208 Forward-Looking Statements All of the statements in this presentation that are not statements of historical facts constitute forward-looking statements within
More informationBuilding a Fully Integrated Biopharmaceutical Company. June 2014
Building a Fully Integrated Biopharmaceutical Company June 2014 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of The Private Securities Litigation
More informationJefferies 2014 Global Healthcare Conference. June 5, 2014
Jefferies 2014 Global Healthcare Conference June 5, 2014 ArQule, Inc. Safe Harbor This presentation and other statements by ArQule may contain forwardlooking statements within the meaning of the Private
More informationCelldex Therapeutics' Rindopepimut Demonstrates Promising Clinical Activity in Patients with EGFRvIII-positive Recurrent Glioblastoma at SNO
November 24, 2013 Celldex Therapeutics' Rindopepimut Demonstrates Promising Clinical Activity in Patients with EGFRvIII-positive Recurrent Glioblastoma at SNO Strong interim survival trend (12.0 vs 7.9
More informationIMMUNOMEDICS, INC. November Advanced Antibody-Based Therapeutics. Oncology Autoimmune Diseases
IMMUNOMEDICS, INC. Advanced Antibody-Based Therapeutics Oncology Autoimmune Diseases November 2017 Forward-Looking Statements This presentation, in addition to historical information, contains certain
More informationCorporate Presentation May Transforming Immuno-Oncology Using Next-Generation Immune Cell Engagers
Corporate Presentation May 2016 Transforming Immuno-Oncology Using Next-Generation Immune Cell Engagers Forward-looking statements / safe harbor This presentation and the accompanying oral commentary contain
More informationMANIFEST Phase 2 Enhancement / Expansion
MANIFEST Phase 2 Enhancement / Expansion Investor Conference Call Stellar Science, Breakthrough Medicine October 11, 2018 Forward-Looking Statements This presentation contains forward-looking statements
More informationActinium Pharmaceuticals Highlights Analysis of Pivotal Iomab-B Phase 3 SIERRA Trial Presented in Oral Session at ASH Annual Meeting
December 4, 2018 Actinium Pharmaceuticals Highlights Analysis of Pivotal Iomab-B Phase 3 SIERRA Trial Presented in Oral Session at ASH Annual Meeting - Key highlights include near universal engraftment
More informationThird Quarter 2015 Earnings Call. November 9, 2015
Third Quarter 2015 Earnings Call November 9, 2015 Forward-Looking Statements All of the statements in this presentation that are not statements of historical facts constitute forward-looking statements
More informationNews Release. December 9, Not intended for UK-based media
Your Contacts News Release Merck Media: Gangolf Schrimpf +49 6151 72-9591 Investor Relations: +49 6151 72-3321 Pfizer Media: Sally Beatty +1 212 733 6566 Investor Relations: Ryan Crowe +1 212 733 8160
More informationDetermined to realize a future in which people with cancer live longer and better than ever before Q Conference Call
Reimagining Cancer Treatment Determined to realize a future in which people with cancer live longer and better than ever before Q1 2016 Conference Call 1 Forward-Looking Statements Disclosure This presentation
More informationU.S. FDA Approves New Indication for the Use of XTANDI (enzalutamide) Capsules for Patients with Metastatic Castration-Resistant Prostate Cancer
Astellas Contact: Medivation Contact: Tyler Marciniak Rick Bierly Director, Communications and Advocacy Chief Financial Officer (847) 736-7145 (415) 543-3470 tyler.marciniak@astellas.com Anne Bowdidge
More informationMerrimack Pharmaceuticals: A Refocused R&D Company January 2017
Merrimack Pharmaceuticals: A Refocused R&D Company January 2017 Forward Looking Statements This presentation contains forward-looking statements of the Company that involve substantial risks and uncertainties.
More informationObsEva Reports First Quarter 2018 Financial Results and Provides Business Update
ObsEva Reports First Quarter 2018 Financial Results and Provides Business Update -Key First Quarter 2018 Clinical Milestones Achieved Patient randomization completed in Phase 2b EDELWEISS trial of OBE2109
More informationFive Prime Therapeutics, Inc. Corporate Overview
Five Prime Therapeutics, Inc. Corporate Overview June 2015 NASDAQ:FPRX Forward-Looking Statements Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities
More informationNews Release. Merck and Pfizer Advance Clinical Development Program with Two Additional Phase III Trials of Avelumab.
Your Contacts News Release Merck Media: Gangolf Schrimpf +49 6151 72 9591 Investor Relations: +49 6151 72 3321 Pfizer Media: Sally Beatty +1 212 733 6566 Investor Relations: Ryan Crowe +1 212 733 8160
More informationCAELUM BIOSCIENCES. Corporate Overview May, 2017
CAELUM BIOSCIENCES Corporate Overview May, 2017 Forward Looking Statements Statements in this presentation that are not descriptions of historical facts are forward looking statements within the meaning
More informationFull Year 2017 Financial Results. February 14, 2018
Full Year 2017 Financial Results February 14, 2018 Agios Conference Call Participants Prepared Remarks Introduction KENDRA ADAMS, Sr. Director, Investor Relations 2018 Vision & Key Milestones DAVID SCHENKEIN,
More informationFebruary 23, Q4 and Year-End 2016 Financial Results
February 23, 2017 Q4 and Year-End 2016 Financial Results 2 RETHINKING CNS Agenda Today s Speakers Paul Cox, Senior Director, Investor Relations Jeff Jonas, M.D., Chief Executive Officer Jim Doherty, Ph.D.,
More informationArgos Therapeutics Reports Fourth Quarter and Year-End 2013 Financial Results
March 27, 2014 Argos Therapeutics Reports Fourth Quarter and Year-End 2013 Financial Results - AGS-003 Phase 3 ADAPT Trial on Track to Complete Enrollment This Year - - AGS-004-Induced Immune Responses
More informationNEWS RELEASE Media Contact: Megan Pace Investor Contact: Kathee Littrell Patient Inquiries: Ajanta Horan
NEWS RELEASE Media Contact: Megan Pace 650-467-7334 Investor Contact: Kathee Littrell 650-225-1034 Patient Inquiries: Ajanta Horan 650-467-1741 GENENTECH RECEIVES COMPLETE RESPONSE LETTER FROM FDA FOR
More informationObsEva Reports Third Quarter 2017 Financial Results and Provides Business Update
ObsEva Reports Third Quarter 2017 Financial Results and Provides Business Update - All Three Development Compounds Progressing with Key Clinical Milestones Over the Next 12 Months - Geneva, Switzerland
More informationConventional therapy n=32. RGI-C Score (Primary Endpoint) LS Mean* (0.83, 1.45) P< Substantial healing, % patients (RGI-C +2.
Ultragenyx and Kyowa Kirin Announce Topline Phase 3 Study Results Demonstrating Superiority of Crysvita (burosumab) Treatment to Oral Phosphate and Active Vitamin D in Children with X-Linked Hypophosphatemia
More informationFORWARD II PROGRAM UPDATE
FORWARD II PROGRAM UPDATE NASDAQ: IMGN May 17, 2018 FORWARD-LOOKING STATEMENTS This presentation includes forward-looking statements based on management's current expectations. These statements include,
More informationCorporate Presentation October 2018 Nasdaq: ADXS
Innovations in Immuno-Oncology Corporate Presentation October 2018 Nasdaq: ADXS Forward-Looking Statements This presentation contains forward-looking statements, including, but not limited to, statements
More informationCorporate Presentation September Nasdaq: ADXS
Corporate Presentation September 2018 Nasdaq: ADXS Forward-Looking Statements This presentation contains forward-looking statements, including, but not limited to, statements regarding the ability and
More informationPSMA-617 License Transaction. October 2, 2017
PSMA-617 License Transaction October 2, 2017 Forward Looking Statements Certain of the statements made in this presentation are forward looking, such as those, among others, relating to future spending,
More informationU.S. Food and Drug Administration Accepts Supplemental Biologics License Application for Opdivo
U.S. Food and Drug Administration Accepts Supplemental Biologics License Application for Opdivo (nivolumab) in Patients with Previously Untreated Advanced Melanoma Application includes CheckMate -066,
More informationREWRITING CANCER TREATMENT THROUGH EPIGENETIC MEDICINES
REWRITING CANCER TREATMENT THROUGH EPIGENETIC MEDICINES May 18, 2017 Molecularly Defined Solid Tumor Program Update FORWARD-LOOKING STATEMENTS Any statements in this press release about future expectations,
More informationOragenics Shareholder Update
January 4, 2017 Oragenics Shareholder Update Advances Drug Development Programs Focused on Conditions with Significant Unmet Medical Needs TAMPA, Fla.--(BUSINESS WIRE)-- Oragenics, Inc. (NYSE MKT:OGEN.BC),
More informationIRONWOOD AND FOREST ANNOUNCE POSITIVE LINACLOTIDE RESULTS FROM PHASE 3 TRIAL IN PATIENTS WITH IRRITABLE BOWEL SYNDROME WITH CONSTIPATION
FOR IMMEDIATE RELEASE Ironwood Contact: Forest Contact: Susan Brady Frank J. Murdolo Corporate Communications Vice President, Investor Relations 617.621.8304 212.224.6714 sbrady@ironwoodpharma.com frank.murdolo@frx.com
More information33 rd Annual J.P. Morgan Healthcare Conference. January 2015
33 rd Annual J.P. Morgan Healthcare Conference January 2015 Forward-looking Statements This presentation contains forward-looking statements, which express the current beliefs and expectations of management.
More informationErlotinib (Tarceva) for non small cell lung cancer advanced or metastatic maintenance monotherapy
Erlotinib (Tarceva) for non small cell lung cancer advanced or metastatic maintenance monotherapy September 2008 This technology summary is based on information available at the time of research and a
More information37 th ANNUAL JP MORGAN HEALTHCARE CONFERENCE
37 th ANNUAL JP MORGAN HEALTHCARE CONFERENCE January 2019 Safe Harbor Statement This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as
More informationARISTOTLE Demonstrated that ELIQUIS is the First Oral Anticoagulant to Significantly Reduce All-Cause Death
ELIQUIS (apixaban) was Superior to Warfarin for the Reduction of Stroke or Systemic Embolism with Significantly Less Major Bleeding in Patients with Atrial Fibrillation in Phase 3 ARISTOTLE Trial ARISTOTLE
More information(direct) (609) (mobile)
MEDIA Sanofi-aventis Bristol-Myers Squibb Ingrid Görg-Armbrecht Laura Hortas + 33 153-774-625 (direct) (609) 252-4587 +33 686-056-688 (mobile) laura.hortas@bms.com ingrid.goerg-armbrecht@sanofi-aventis.com
More informationBayer and Regeneron start additional Phase 3 Study for VEGF Trap-Eye in Wet Age-related Macular Degeneration
Investor News Bayer AG Investor Relations 51368 Leverkusen Germany www.investor.bayer.com Bayer and Regeneron start additional Phase 3 Study for VEGF Trap-Eye in Wet Age-related Macular Degeneration International
More informationAttached from the following page is the press release made by BMS for your information.
June 2, 2015 Opdivo (nivolumab) Demonstrates Superior Survival Compared to Standard of Care (docetaxel) for Previously-Treated Squamous Non-Small Cell Lung Cancer in Phase III Trial (PRINCETON, NJ, May
More information