Two months before the historic climate agreement in Paris, where representatives from nearly 200 countries pledged to reduce greenhouse emissions, a smaller group of climate experts and politicians gathered at UC San Diego’s Scripps Institution of Oceanography.
Physicists understand fairly well what happened after the Big Bang and the laws of physics that govern the universe. It’s what the universe looked like immediately after the event—a trillionth of a trillionth of a trillionth of a second after—that is still a mystery. A new observatory in Chile’s Atacama Desert could be the key to understanding that instance.
Large Clinical Data Set in Lung Cancer Featuring Trovagene’s Precision Cancer Monitoring® Platform Selected for Oral Presentation at the 2016 ASCO Annual Meeting
Results from 213 patient study demonstrates use of urinary ctDNA as a stand-alone test for the highly sensitive detection of EGFR T790M mutations for therapy selection
SAN DIEGO, May 19, 2016 /PRNewswire/ — Trovagene, Inc. (NASDAQ: TROV), a developer of cell-free molecular diagnostics, announced today that diagnostic performance results using the Company’s Precision Cancer Monitoring® platform to detect and monitor EGFR T790M in the urine of non-small cell lung cancer (NSCLC) patients will be the subject of an oral presentation given by Heather Wakelee, M.D., Stanford University Medical Center, at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting. Abstracts for the ASCO meeting were released last night, and can be viewed at http://abstracts.asco.org/
Title: Epidermal growth factor receptor (EGFR) genotyping of matched urine, plasma and tumor tissue from non-small cell lung cancer (NSCLC) patients treated with rociletinib
- Presenter: Heather Wakelee, M.D., Stanford University Medical Center
- Date/Time: Monday, June 6, 2016, 9:57am Central Daylight Time
- Oral Abstracts Session: Lung Cancer–Non-Small Cell Metastatic
- Location: Arie Crown Theater
About Trovagene, Inc.
Headquartered in San Diego, California, Trovagene is leveraging its proprietary technology for the detection and monitoring of cell-free DNA in urine. The Company’s technology detects and quantitates oncogene mutations in cancer patients for improved disease management. Trovagene’s Precision Cancer Monitoring® platform is designed to provide important clinical information beyond the current standard of care, and is protected by significant intellectual property including multiple issued patents and pending patent applications globally.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend,” or other similar terms or expressions that concern Trovagene’s expectations, strategy, plans or intentions. These forward-looking statements are based on Trovagene’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our need for additional financing; uncertainties of patent protection and litigation; clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or fourth party payer reimbursement; limited sales and marketing efforts and dependence upon fourth parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any medical diagnostic tests under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that our Precision Cancer Monitoring® platform will be utilized by oncologists or prove to be commercially successful. Trovagene does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Trovagene’s Form 10-K for the year ended December 31, 2015 and its other periodic reports filed with the Securities and Exchange Commission.
About Trovagene’s Precision Cancer Monitoring platform
Trovagene’s urine and blood-based EGFR, KRAS and BRAF oncogene mutation assays are now available to healthcare providers for detection and/or monitoring of tumor dynamics in their patients before, during and after treatment. Physicians interested in utilizing these tests should contact Client Services at 888-391-7992. For more information, please visit www.trovagene.com/our-tests.
Vice President, Investor Relations
Corporate Practice Counsel
Inventiv Health Public Relations
SOURCE Trovagene, Inc.
MabVax Therapeutics’ Antibody Discovery Platform and HuMab-5B1 Cancer Therapeutic Featured in Presentation at America’s Antibody Congress
SAN DIEGO, May 19, 2016 /PRNewswire/ — MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage immuno-oncology drug development company, announces that Paul Maffuid, PhD, Executive Vice President of Research and Development, will discuss MabVax’s unique approach to the discovery of fully human antibodies to cancer antigens and the resulting lead HuMab-5B1 clinical projects in a presentation at America’s Antibody Congress in San Diego on May 19-20, 2016.
Dr. Maffuid will outline the unique approach that MabVax has taken to the discovery of novel fully human antibodies from cancer patients vaccinated against their cancers. The discovery platform surveys the immune response of many patients by interrogating single B-cells from these patients who are producing antibodies against the intended target. These antibodies are then cloned, retaining the natively paired heavy and light chains of the antibody, and produced recombinantly. To date, MabVax has identified multiple antibodies with the selectivity, affinity, and cytotoxicity necessary to make them clinical development candidates. MVT-5873 is the company’s lead clinical development product and currently in a Phase I clinical trial in patients with metastatic pancreatic cancer. MVT-5873 (HuMab-5B1) is currently being evaluated at three centers in an open-label, multicenter, dose-escalation Phase I clinical trial as a single agent and in combination with gemcitabine/nab-paclitaxel in patients with metastatic pancreatic cancer. MVT-2163 (89Zr-DFO-HuMab-5B) is the company’s lead immuno-PET imaging agent that utilizes the targeting specificity of MVT-5873. MVT-2163 will open as an open-label, multicenter, dose-escalation Phase I clinical trial early in June. MVT-1075 (177Lu-DTPA-HuMab-5B) is the company’s radioimmunotherapy agent and third clinical program from this platform. The radioimmunotherapy product is planned for introduction into the clinic early in 2017.
The MVT-5873 Phase I trial is designed to evaluate the safety, tolerability and pharmacokinetics of MVT-5873 as a single agent or in combination with the current standard of care chemotherapy regimen in subjects with metastatic pancreatic cancer. The first cohort of patients is being enrolled in a traditional dose escalation regimen to assess safety and determine the optimal dose of the antibody. A second patient cohort will establish the safety and optimized dose of the antibody when administered with standard of care chemotherapy and a third patient cohort will be administered the optimized dose of antibody as a single agent for the treatment of patients with advanced cancer.
Dr. Maffuid will also present information regarding a second Phase I trial scheduled to begin in the next few weeks. This trial will evaluate MVT-2163, also based on HuMab-5B1 antibody, as a next-generation PET imaging agent for the diagnosis and management of patients with pancreatic cancer. When the antibody is combined with a radio-label as a novel PET imaging agent, the 89Zr-HuMab-5B1 product has demonstrated high-image resolution of tumors in established xenograft animal models, making it attractive diagnostic agent for detection of metastatic pancreatic cancer and for use in combination with the HuMab-5B1 therapeutic product.
The company is currently completing preclinical development activities to support filing an Investigative New Drug Application (IND) for MVT-1075 with the FDA later this year. A summary of preclinical data will be presented which demonstrated effectiveness in established xenograft animal models demonstrating potential as an therapeutic agent.
MabVax anticipates discussing preliminary results from both Phase I trials during the third quarter of this year.
MabVax Therapeutics Holdings, Inc. is a clinical-stage biotechnology company focused on the development of antibody-based products to address unmet medical needs in the treatment of cancer. MabVax has discovered a pipeline of human monoclonal antibody products based on the protective immune responses generated by patients who have been immunized against targeted cancers with the Company’s proprietary vaccines. MabVax has the exclusive license to the therapeutic vaccines from Memorial Sloan Kettering Cancer Center. MabVax is currently engaged in two Phase I clinical trials of fully human monoclonal antibody HuMab 5B1, both as a therapeutic agent (MVT-5873) and later this quarter as a next-generation PET imaging agent (MVT-2163). MabVax also has two cancer vaccines targeting recurrent sarcoma and ovarian cancer in proof-of-concept Phase II multicenter clinical trials. Additional information is available at www.mabvax.com.
Forward Looking Statements:
This press release contains “forward-looking statements” regarding matters that are not historical facts, including statements relating to presentations at the AACR Annual Meeting. We have no assurance that all of the product development pipeline will be fully developed by the Company. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipates,” “plans,” “expects,” “intends,” “will,” “potential,” “hope” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon current expectations of the Company and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release relating to the Company may be found in the Company’s periodic filings with the Securities and Exchange Commission, including the factors described in the section entitled “Risk Factors” in its annual report on Form 10-K for the fiscal year ended December 31, 2015, as amended and supplemented from time to time and the Company’s Quarter Reports on Form 10-Q and other filings submitted by the Company to the SEC, copies of which may be obtained from the SEC’s website at www.sec.gov. The parties do not undertake any obligation to update forward-looking statements contained in this press release.
Jody Cain, Senior Vice President
SOURCE MabVax Therapeutics Holdings, Inc.
Study Published in Prostate Cancer and Prostatic Diseases
SAN DIEGO, May 19, 2016 /PRNewswire/ — GenomeDx Biosciences today announced the publication of a multi-institution validation study of the Decipher® Prostate Cancer Classifier, a genomic test for prostate cancer used to improve clinical decision-making following diagnostic biopsy or radical prostatectomy (RP). This study further validated the impact of clinico-genomic risk assessment by Decipher and CAPRA-S on metastasis outcomes for patients treated with three different postoperative radiation therapy modalities, as compared to observation alone, following RP. The data demonstrate that patients with low clinico-genomic risk, as assessed by CAPRA-S and Decipher scores, have excellent survival without any postoperative therapy and those at highest clinico-genomic risk have the best metastasis-free outcomes when treated early with adjuvant radiation therapy (ART).
“Treating prostate cancer patients according to a uniform strategy is inadequate, and can result in over- or under-treatment for many men,” said lead study author Ashley Ross, M.D., Ph.D., assistant professor of urology, Johns Hopkins Medical Center. “This can result in exposing the patient to unnecessary toxicity, missing the opportunity to achieve cure as well as overburdening of the healthcare system. The findings of this study may provide patients and physicians with improved tools with which decisions could be made regarding further treatment, if any, after surgery.”
The study, published this month online ahead of print in the latest issue of Prostate Cancer and Prostatic Diseases, included 422 prostate cancer patients identified from the Decipher GRID® database. These patients underwent RP between 1990-2010 at Mayo Clinic, Durham VA, Johns Hopkins Medical Institution and Thomas Jefferson University. All patients reached an undetectable prostate-specific antigen (PSA) level following surgery and either received no postoperative treatment prior to developing metastasis (n=158), or were treated with ART (n=111), minimal residual disease salvage radiotherapy (MRD-SRT, n=70), or salvage radiotherapy (SRT, n=83), defined by initiation of therapy at PSA levels of <0.2, 0.2 to 0.49 and ≥0.5 ng/mL, respectively. The men who did not receive additional therapy (including hormonal suppression) prior to metastasis formed the no radiation therapy (RT) or observation arm.
Multivariable analysis demonstrated that after adjusting for clinico-genomic risk, patients treated with SRT or who were observed with no RT had a nearly fivefold higher rate of metastasis when compared to patients that underwent ART or MRD-SRT. This suggests that delaying postoperative radiation in men with adverse pathological features and high genomic risk is unlikely to be curative and strong consideration should be given to the earlier use of postoperative radiation and the addition of systemic therapy through participation in clinical trials. Furthermore, the study showed that for men with lower clinico-genomic risk, the survival benefits from earlier radiation were modest, and that these men may be optimally managed using an active surveillance approach. Finally, these results provide Decipher users with metastasis risk estimates for postoperative ART, MRD-SRT, SRT and observation that may be of further use to guide decision-making in this setting.
“The imprecise identification of patients at highest risk of metastatic disease and death from prostate cancer highlights the need for additional risk stratification beyond the clinical features,” said Doug Dolginow, M.D., chief executive officer of GenomeDx. “This study further supports the use of clinical and genomic information together to provide a more comprehensive assessment of metastatic risk. Further, it demonstrates how incorporation of the Decipher test into patient treatment plans allows for an individualized approach to the care of men with prostate cancer, which we believe results in improved patient quality of life and efficient use of healthcare resources.”
About Decipher® Prostate Cancer Classifier Tests
Our Decipher prostate cancer classifier tests are currently comprised of Decipher Biopsy and Decipher Post-Op. These commercially available genomic tests provide an assessment of tumor aggressiveness based on the patient’s unique genomic profile. Decipher Biopsy is indicated for men after biopsy diagnosis and Decipher Post-Op is indicated for men after prostate removal surgery. The Decipher tests are used by physicians to stratify patients into more accurate risk groups to better determine which patients will likely benefit from additional treatment and which will not, thereby enabling improved decision-making and helping low-risk patients avoid unnecessary treatments that have serious adverse side effects and result in unnecessary costs to the healthcare system. Studies of thousands of patients from leading cancer centers, published in multiple peer-reviewed journals, demonstrate that the Decipher tests can more accurately predict disease aggressiveness than traditional clinical measures, such as PSA and Gleason score. Decipher Post-Op is covered by Medicare and by a number of private payors and preferred provider organizations representing, together with Medicare, about 70% of the approximately 66 million adult men in the United States age 40 or older who are at increased risk of being diagnosed with prostate cancer.
Learn more at www.DecipherTest.com
About Decipher GRID®
Our Decipher Genomics Resource Information Database (Decipher GRID) is a genomic expression database that provides a foundation for open and interactive research collaboration and knowledge creation. Decipher GRID is a rapidly growing database that contains genomic profiles of thousands of patient tumors, and constitutes what we believe to be the world’s largest shared, clinically-annotated genomic expression database in urologic cancer as well as one of the world’s largest global RNA expression databases utilizing cloud-based analytics. We believe Decipher GRID gives rise to new opportunities for information technology-enabled genomic solutions and enables us to more rapidly discover, develop, commercialize and drive the adoption of our existing and new genomic tests. Through Decipher GRID, GenomeDx is building a suite of genomic tests in urologic cancer that we believe will allow us to achieve our goals of reducing costs to the healthcare system and improving patient lives, from screening through late-stage therapy.
Learn more at www.DecipherGRID.com
About GenomeDx Biosciences
GenomeDx Biosciences uses the power of collaborative genomics to transform the management and treatment of cancer patients. GenomeDx has built Decipher GRID, a large genomics database in urologic cancer that provides a foundation for open and interactive research collaboration and knowledge creation. Using Decipher GRID to analyze vast amounts of genomic data, GenomeDx develops and commercializes proprietary clinical tests that are intended to provide more accurate and useful diagnostic information than both traditional diagnostic tools and existing genomic tests. GenomeDx’s Decipher Biopsy and Decipher Post-Op are commercially available prostate cancer genomic tests that provide an assessment of tumor aggressiveness based on a patient’s unique genomic profile. GenomeDx is headquartered in Vancouver, British Columbia and has offices in San Diego, California.
Learn more at www.GenomeDx.com
SOURCE GenomeDx Biosciences
SAN DIEGO, May 19, 2016 /PRNewswire/ — Edico Genome, creator of the world’s first bio-IT processor designed to analyze next-generation sequencing (NGS) data, today announced a third, foundational patent issued by the United States Patent and Trademark Office. U.S. patent number 14/948372, entitled “Bioinformatics Systems, Apparatuses, And Methods Executed On An Integrated Circuit Processing Platform,” broadly covers the technology and methods of use that are core to the DRAGEN™ Bio-IT Processor, including the hardware processing platform and its use for executing a sequence analysis pipeline on genomic data for both onsite and cloud deployment. The patent will provide protection until 2032.
“The innovation of our DRAGEN Bio-IT Processor is reflected in our growing patent estate and, most importantly, brisk customer adoption seen in our first year of commercialization,” said Pieter van Rooyen, Ph.D., chief executive officer of Edico Genome. “Our IP position provides customers as well as collaborators assurance that they’re engaging with best-in-class genomic data analysis technologies and can confidently explore with us additional applications and partnerships that leverage DRAGEN’s unique data-crunching capabilities for onsite and cloud deployment. Our solution provides the most efficient and cost-effective way to analyze genomic data.”
The DRAGEN ultra-rapid bioinformatics processor accelerates the secondary analysis of NGS data, reducing the time required for analyzing a genome at 30x coverage from hours to minutes. DRAGEN uses a field-programmable gate array (FPGA) to implement genome pipeline algorithms, including BCL conversion, compression, mapping, alignment, sorting, duplicate marking and haplotype variant calling. Pipelines available on the DRAGEN platform include Whole Genome or Exome, Transcriptome/RNAseq, Metagenome/Microbiome, Epigenome/Methylome and Joint Genotyping. The highly reconfigurable DRAGEN platform allows for custom algorithm development as well as refinement and improvement of existing pipelines.
About Edico Genome
Edico Genome has created the world’s first bioinformatics processor designed to analyze next-generation sequencing data, DRAGEN™. The use of next-generation sequencing is growing at an unprecedented pace, creating a need for a technology that can process this big data rapidly and accurately. Edico Genome’s computing platform has been shown to speed whole genome data analysis from hours to minutes, while maintaining high accuracy and reducing costs, enabling clinicians and researchers to reveal answers more quickly. For more information, visit www.EdicoGenome.com or follow @EdicoGenome.
SOURCE Edico Genome
Global Blood Therapeutics Announces Presentation of New GBT440 Data in Sickle Cell Disease at the European Hematology Association’s 21st Congress
— Presentations to Include Additional and Longer-Term Data from Ongoing Phase 1/2 Trial —- Company to Host Investor Webcast to Review the Data on Saturday, June 11 —
SOUTH SAN FRANCISCO, Calif., May 19, 2016 /PRNewswire/ — Global Blood Therapeutics, Inc. (GBT) (NASDAQ: GBT), a biopharmaceutical company developing novel therapeutics for the treatment of grievous blood-based disorders with significant unmet needs, today announced that new GBT440 data will be presented in a poster session at the European Hematology Association’s (EHA) 21st Congress in Copenhagen. The presentations will include additional data from the ongoing Phase 1/2 GBT440-001 study in sickle cell disease (SCD), including 90-day data from a cohort of patients taking 700 mg of GBT440, 28-day results from three dosing cohorts of GBT440 and additional data on the pharmacokinetics and pharmacodynamics of GBT440.
GBT440 is being developed as an oral, once-daily therapy for patients with SCD. GBT440 works by increasing hemoglobin’s affinity for oxygen. Since oxygenated sickle hemoglobin does not polymerize, GBT believes GBT440 blocks polymerization and the resultant sickling of red blood cells (RBCs). With the potential to restore normal hemoglobin function, GBT440 may be capable of modifying the progression of SCD.
The EHA abstracts are now available at www.ehaweb.org. The poster presentations will include additional data not available in the abstracts. Presentation details are as follows:
Poster Session: Red blood cells and iron — Clinical 1
Abstract #P371: GBT440, A Novel HbS Polymerization Inhibitor, Increases Hb Oxygen Affinity And Results In A Rapid Improvement In Hemolysis And Anemia
Presenter: Dr. Paul Telfer, Barts Health NHS Trust and Queen Mary, University of London
Date: Friday, June 10, 2016
Time: 5:15-6:45 p.m. CEST/11:15 a.m.-12:45 p.m. ET
Location: Poster area (Hall H)
Poster Session: Red blood cells and iron — Clinical 1
Abstract #P370: Pharmacokinetics (PK) and Pharmacodynamics (PD) Of GBT440, A Novel Hemoglobin S (HbS) Polymerization Inhibitor for the Treatment Of Sickle Cell Disease (SCD), In Healthy Volunteers and SCD Patients
Presenter: Mira Patel, Global Blood Therapeutics
Date: Friday, June 10, 2016
Time: 5:15-6:45 p.m. CEST/11:15 a.m.-12:45 p.m. ET
Location: Poster area (Hall H)
Investor Event Webcast Details
GBT will host an investor webcast on Saturday, June 11, 2016, at 6:30 a.m. CEST/12:30 a.m. ET, during which members of GBT’s management team and distinguished experts Dr. H. Franklin Bunn of Harvard Medical School and Brigham and Women’s Hospital, Dr. Paul Telfer of Barts Health NHS Trust and Queen Mary, University of London, and Dr. Wally R. Smith of Virginia Commonwealth University will review the GBT440 data presented at EHA.
About Sickle Cell Disease (SCD)
Sickle cell disease (SCD) is an inherited blood disorder caused by a genetic mutation in the beta-chain of hemoglobin, leading to formation of abnormal hemoglobin known as sickle hemoglobin, or HbS. In its deoxygenated state, HbS has a propensity to polymerize, or bind together forming long, rigid rods within a red blood cell (RBC). The polymer rods deform RBCs to assume a sickled shape and to become inflexible, which can cause blockage in small blood vessels. Beginning in childhood, SCD patients suffer unpredictable and recurrent episodes or crises of severe pain due to blocked blood flow to organs, which often lead to psychosocial and physical disabilities. This blocked blood flow, combined with hemolytic anemia (the destruction of RBCs), can eventually lead to multi-organ damage and early death.
About Global Blood Therapeutics
Global Blood Therapeutics, Inc. (GBT) is a clinical-stage biopharmaceutical company dedicated to discovering, developing and commercializing novel therapeutics to treat grievous blood-based disorders with significant unmet need. GBT is developing its lead product candidate, GBT440, as an oral, anti-polymerization therapy for sickle cell disease (SCD) and is currently evaluating GBT440 in SCD patients in an ongoing Phase 1/2 clinical trial. GBT is also evaluating GBT440 for the treatment of hypoxemic pulmonary disorders, including idiopathic pulmonary fibrosis, and is engaged in other research and development activities targeted toward hereditary angioedema (HAE). To learn more, please visit www.globalbloodtx.com.
Statements we make in this press release may include statements that are not historical facts and are considered forward-looking 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. We intend these forward-looking statements, including statements regarding the therapeutic potential and safety profile of GBT440, our ability to receive data from our ongoing Phase 1/2 clinical study of GBT440, and our ability to initiate our pivotal program for GBT440 in SCD, and the timing of these events, to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. We can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved, and furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, the risks that our clinical and preclinical development activities may be delayed or terminated for a variety of reasons, that regulatory authorities may disagree with our clinical development plans or require additional studies or data to support further clinical investigation of our product candidate, and that drug-related adverse events may be observed in later stages of clinical development, along with those set forth in our Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, as well as discussions of potential risks, uncertainties and other important factors in our subsequent filings with the U.S. Securities and Exchange Commission. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE Global Blood Therapeutics, Inc.
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