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Novel Approach Reveals More Diversity in the Human Brain

Publication from the Journal of Science by author Dr. Rizi Ai of Wei Wang’s Lab shows promising new method to classify single neurons.

SAN DIEGO, July 7, 2016 /PRNewswire/ — A collaborative effort from the University of California San Diego, The Scripps Research Institute (TSRI), and Illumina has led to the classification of neuronal single-nuclei transcriptomes from the cerebral cortex of the human brain. The new findings were published on June 23rd in the Journal of Science. http://science.sciencemag.org/content/352/6293/1586.full

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Classification of single neurons into subtypes has often posed a challenge because of the lower signal-to-noise ratio in cell subtypes than other typical single-cell datasets. Dr. Rizi Ai (Wang Lab at University of California, San Diego), the leading researcher and co-first author in the new Journal of Science paper, developed a new bioinformatics algorithm to iteratively classify 3,227 single-cell transcriptome datasets across the six brain regions. Dr. Ai’s algorithm called “Clustering-and-Classification” is able to sensitively measure the most variant gene expressions at each splitting level and determine the cell subtypes based on the active/inactive genes iteratively. The algorithm successfully revealed a lot more diverse in human brain than previously thought by dividing 3,227 individual neurons into 16 neuronal subtypes that are correlated with functions. Besides, Dr. Ai also developed an automatic analysis pipeline to automatically process and analyze large volumes of high-throughput sequencing data such as RNA sequencing data of neuronal cells.

Dr. Rizi Ai had this to say when contacted through email:

“Our research is beyond classifying cells into cell types, we wanted to look more deeply and classify single neurons into cell subtypes. This process is important in further understanding how different brain regions could function differently. With the shortfalls of traditional clustering methods I worked around the clock to create the novel bioinformatics algorithm, Clustering-and-Classification. This new algorithm is sensitive enough to reveal heterogeneity in cell subtypes and capturing transcription variation signals from different neuronal subtypes. “

The Journal of Science article that Dr. Rizi Ai co-first authored is a huge step forward in understanding neuronal subtypes in the human cerebral cortex and provides a framework for comparing individual neurons. This data can also be useful for further research into neurological disorders like dementia, Alzheimer’s, Parkinson’s, schizophrenia, depression and seeing if changes in heterogeneity of neuronal subtypes plays a role in these diseases.

SOURCE Wei Wang’s Lab

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AnaptysBio Initiates Multiple Ascending Dose Cohorts In ANB020 Phase 1 Clinical Trial

SAN DIEGO, July 6, 2016 /PRNewswire/ — AnaptysBio, Inc., a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation and immuno-oncology, today announced the initiation of multiple ascending dose cohorts in an on-going double-blind, placebo-controlled healthy volunteer Phase 1 study of its proprietary anti-interleukin-33 antibody (ANB020). 

During an earlier segment of the aforementioned Phase 1 study, AnaptysBio conducted safety, tolerability, pharmacokinetic and pharmacodynamic assessment of ANB020 in healthy volunteer cohorts administered with single doses of the antibody.  Data generated from single dose cohorts was reviewed by regulatory authorities in Australia prior to the initiation of multiple ascending dose testing.  

ANB020 is a potent inhibitor of interleukin-33 (IL-33) developed by AnaptysBio using its proprietary SHM-XEL antibody discovery platform.  IL-33 is a pro-inflammatory cytokine that multiple studies have indicated is a central mediator of atopic diseases, including atopic dermatitis, food allergies and asthma.  Since ANB020 acts upstream of IL-4, IL-5 and IL-13, AnaptysBio believes ANB020’s IL-33 inhibitory mechanism has potential advantages in human therapy over agents that block only a subset of the cytokines responsible for atopic diseases. In addition, published human genetic analyses have linked down-modulation of IL-33 signaling with protection from asthma.

AnaptysBio plans to conduct future clinical development of ANB020 in patients with atopic dermatitis, peanut allergy and asthma. 

“We are pleased to continue clinical development of ANB020, which to our knowledge is the first anti-IL-33 antibody to be tested in humans,” said Hamza Suria, President & CEO of AnaptysBio.  “ANB020 is a potential therapeutic option for patients suffering from debilitating IL-33 mediated atopic disorders. We look forward to initiating proof-of-concept patient studies later this year.”

About AnaptysBio

AnaptysBio is a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation and immuno-oncology.  The Company’s proprietary anti-inflammatory pipeline includes its anti-IL-33 antibody (ANB020) for the treatment of atopic dermatitis, asthma and peanut allergy, its anti-IL-36R antibody (ANB019) for the treatment of generalized pustular psoriasis and palmo-plantar pustulosis, and a portfolio of checkpoint agonist antibodies for the treatment of severe T-cell driven inflammatory conditions. AnaptysBio’s antibody pipeline has been developed using its proprietary SHM-XEL platform, which has pioneered the use of in vitro somatic hypermutation for antibody discovery and is designed to replicate key features of the human immune system to overcome the limitations of prior antibody technologies.  AnaptysBio has also developed multiple therapeutic antibodies in partnership with Celgene and TESARO, including an anti-PD-1 antibody (TSR-042) currently under clinical development.   

Contacts:

Julie Rathbun
Rathbun Communications
julie@rathbuncomm.com
206-769-9219

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SOURCE AnaptysBio, Inc.

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RiboMed and Tocagen Collaborate to Analyze Epigenetic Prognostic Markers, Including MGMT, in Recurrent Brain Tumors

SAN DIEGO, July 6, 2016 /PRNewswire/ — RiboMed Biotechnologies, Inc. and Tocagen Inc., today announced a collaboration to analyze potential epigenetic prognostic and predictive markers, including the gene for the DNA repair enzyme O-6-Methylguanine-DNA Methyltransferase (MGMT), in Tocagen’s clinical trials evaluating the investigational treatment Toca 511 & Toca FC in patients with recurrent high grade gliomas (HGGs).

HGGs, including glioblastoma, are the most aggressive primary malignant brain tumors and are treated initially with surgery, radiation and chemotherapy, including temozolomide (TMZ, Temodar®). Response to TMZ treatment is variable and almost all tumors ultimately recur. Tumor sensitivity to TMZ correlates with the inactivation of MGMT and longer overall survival in patients with glioblastoma. Inactivation of MGMT is primarily caused by DNA methylation in the MGMT gene’s control region.

Given the prognostic and predictive value of MGMT methylation status, this test has become an informative tool in the management of glioblastoma. RiboMed has developed a new validated test, which improves the reliability and accuracy of MGMT testing. A full description and validation of this technology and comparison to other commonly used DNA methylation methods was recently published in Epigenomics (http://www.futuremedicine.com/doi/pdf/10.2217/epi-2016-0004).

“Accurate diagnostics information is critical to help inform treatment decisions and expectations for outcomes,” said David Piccioni, M.D., Ph.D., neuro-oncologist at UC San Diego’s Moores Cancer Center. “Having a test that can produce accurate and reliable MGMT promoter methylation data with minimal sample is an important advance for patients and their caregivers.”

Favorable safety and promising survival data from Tocagen’s Phase 1, open-label, ascending dose, multicenter trial, that included analysis of epigenetic markers of tumors by RiboMed were published in the cover article of the June 1, 2016 issue of Science Translational Medicine (http://stm.sciencemag.org/content/8/341/341ra75). Based on the positive results reported in this study, Tocagen is now conducting an international Phase 2/3 trial, Toca 5; more information can be found by searching www.clinicaltrials.gov using the clinical trial identifier NCT 02414165). In collaboration with RiboMed, the assay will be utilized to analyze MGMT status in tumors resected during the trial and evaluate association with potential treatment activity.

The collaborative research also includes evaluation of RiboMed’s GliomaSTRAT assay initially in tumor samples from earlier clinical trials. GliomaSTRAT is designed to stratify gliomas by both tumor aggressiveness and potential for drug activity. In addition to MGMT methylation, GliomaSTRAT includes a DNA methylation biomarker panel to determine the tumor’s CpG Island Methylator Phenotype (CIMP) and detection of the IDH1 R132H mutation known to cause CIMP. These prognostic biomarkers identify two distinct tumor subtypes that show significant differences in overall survival, independent of initial tumor grade classification.

The ability to reliably analyze HGGs for multiple DNA methylation biomarkers, particularly with minimal material from FFPE tumor samples, has only recently become possible through the development of RiboMed’s extremely sensitive detection method for measuring both DNA methylation and point mutations using its core technology, Abscription®.

About RiboMed
RiboMed Biotechnologies, Inc. is a CLIA-certified molecular diagnostic clinical laboratory and Contract Research Organization offering ultra-sensitive DNA methylation based tests for cancer and drug response related biomarkers to physicians and for use in clinical trials. RiboMed’s test for stratifying glioma brain tumors, GliomaSTRAT™, uses a combination of DNA methylation profiling and mutation analysis to both determine glioma grade (LGG vs HGG) and has been reported to predict response to first line chemotherapy with temozolomide.  Research Use Only (RUO) kits, reagents, and technology licensing are also available. For more information go to www.RiboMed.com or follow @RiboMed.

About Tocagen
Tocagen is a clinical-stage, cancer-selective gene therapy company focused on developing first-in-class, broadly applicable product candidates designed to activate a patient’s immune system against their own cancer from within. The company is developing its lead investigational product candidate, Toca 511 (vocimagene amiretrorepvec) & Toca FC (extended-release 5-fluorocytosine), initially for the treatment of recurrent high grade glioma (HGG), a disease with significant unmet medical need. Tocagen has initiated the Phase 2 portion of a randomized, controlled Phase 2/3 clinical trial of Toca 511 & Toca FC in patients with recurrent HGG, which is designed to serve as a potential registrational trial. More information about the clinical trial can be found at www.tocagen.com/toca5. Tocagen plans to initiate clinical trials of Toca 511 & Toca FC in newly diagnosed HGG and metastatic cancer, including colorectal, pancreatic, lung, breast, renal and melanoma. Tocagen obtained Fast Track designation from the U.S. Food and Drug Administration for Toca 511 & Toca FC as a treatment of recurrent HGG and Orphan drug designation for the treatment of glioblastoma (GBM), a subset of HGG. Tocagen has received grant support from leading brain cancer foundations, including Accelerate Brain Cancer Cure (ABC2), National Brain Tumor Society (NBTS), American Brain Tumor Association (ABTA), Musella Foundation and Voices Against Brain Cancer (VABC). For more information, visit www.tocagen.com or follow @Tocagen.

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SOURCE RiboMed Biotechnologies, Inc.

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Trovagene to Present at the 2nd Annual Cantor Fitzgerald Healthcare Conference

SAN DIEGO, July 5, 2016 /PRNewswire/ — Trovagene, Inc. (NASDAQ: TROV), a developer of circulating tumor DNA (ctDNA) molecular diagnostics, today announced that its Chief Executive Officer, Bill Welch, will present a corporate overview at the 2nd Annual Cantor Fitzgerald Healthcare Conference taking place July 12-13, 2016 at Le Parker Meridian Hotel, NY.

Trovagene is scheduled to present on Wednesday, July 13, 2016 at 1:30 pm EDT. The Company’s Chief Executive Officer, Bill Welch, and Chief Scientific Officer, Mark Erlander, Ph.D., will be available for one-on-one meetings during the conference. The presentation will be webcast live at http://wsw.com/webcast/cantor4/trov and can also be accessed through the investor relations web page at www.trovagene.com. A replay of the presentation will be available at www.trovagene.com and will be archived for 90 days. 

About Trovagene, Inc.

Headquartered in San Diego, California, Trovagene is leveraging its proprietary Precision Cancer Monitoring® (PCM) technology for the detection and monitoring of circulating tumor DNA (ctDNA) in urine. The Company’s technology detects and quantitates oncogene mutations in cancer patients for improved disease management. Trovagene’s PCM technology 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.

Trovagene Contacts

Beth Anderson

VP, Finance & Administration

Vicki Kelemen

Sr. Director, Marketing Communications

858-952-7593

858-952-7652

ir@trovagene.com

vkelemen@trovagene.com

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SOURCE Trovagene, Inc.

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Natera Announces that the U.S. Supreme Court Denies Petition to Review ‘540 Patent Invalidation

SAN CARLOS, Calif., June 30, 2016 /PRNewswire/ — Natera (NASDAQ: NTRA), a leader in non-invasive genetic testing and the analysis of circulating cell-free DNA, announced that the U.S. Supreme Court declined to review the Federal Circuit’s determination that U.S. Patent 6,258,540 is invalid. The patent had broadly claimed the use of cell-free fetal DNA for genetic testing. Natera filed briefs supporting the Federal Circuit’s determination and opposing Supreme Court review.

“We are pleased with the court decisions and the ultimate outcome in this case,” said Matthew Rabinowitz, Ph.D. and Chief Executive Officer of Natera. “In prenatal testing, our massively multiplexed polymerase chain reaction (mmPCR) technology and proprietary bioinformatics are fundamentally distinct from the approach employed in other commercially available non-invasive prenatal tests (NIPTs). We believe Panorama, our NIPT, is the most accurate NIPT commercially available in the United States. As expected, the Supreme Court’s order affirms our freedom to offer this technology to patients.”

About Natera

Natera is a genetic testing company that develops and commercializes non-invasive methods for analyzing DNA. The mission of the company is to transform the diagnosis and management of genetic disease. In pursuit of that mission, Natera operates a CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, CA, and it currently offers a host of proprietary genetic testing services primarily to OB/GYN physicians and fertility centers, as well as to genetic laboratories through its cloud-based Constellation™ software system. Tests include the Spectrum® pre-implantation genetic test for embryo selection during IVF; the Anora® miscarriage test to understand the genetic causes of a pregnancy loss; the Horizon™ carrier screen to detect inherited mutations; and the Panorama® non-invasive prenatal test (NIPT) to screen for common chromosomal anomalies in a fetus as early as nine weeks of gestation.

Natera is also applying its unique technologies to develop non-invasive screening and diagnostic tools for earlier detection and improved treatment of cancer. These tests have not been cleared or approved by the U.S. Food and Drug Administration. For more information, visit http://www.natera.com and connect on Twitter and Facebook.

Forward-looking statements

This release contains forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. Any forward-looking statements contained in this press release are based upon Natera’s historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release. Subsequent events may cause these expectations to change, and Natera disclaims any obligation to update the forward-looking statements for any reason after the date of this press release. These forward-looking statements are subject to a number of known and unknown risks and uncertainties that may cause actual results to differ materially, including uncertainty in the development and commercialization of Natera’s planned future cancer products or other new products or if the results of its clinical studies do not support the use of its tests, or cannot be replicated in later studies required for regulatory approvals or clearances. Additional risks and uncertainties are discussed in greater detail in the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Natera’s Form 10-Q for the quarter ended March 31, 2016. Further information on potential risks that could affect actual results will be included in other filings Natera makes with the SEC from time to time. These documents are available for free on the company’s website at www.natera.com under the Investor Relations section, and on the SEC’s website at www.sec.gov.

Contacts:

Natera, Inc.
Mike Brophy, Investor Relations, 650-249-9091 x1471
mbrophy@natera.com

Laura Zobkiw, Corporate and Media Relations, 650-249-9091 x1649
Lzobkiw@natera.com

 

SOURCE Natera, Inc.

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