MEDTECH

CosmosID Launches Accurate and Easy Functional Microbiome Analysis with New Software Platform, CosmosID-HUB: Microbiome

CosmosID | September 27, 2021

A complete analysis of the microbiome should combine taxonomic profiling ("who is there?") with functional characterization ("what are they doing?") to discover the capabilities of an entire community of microorganisms. But research teams often require specialized training and extensive computational infrastructure to establish an in-house suite of tools for processing shotgun metagenomic data – and even with the right know-how, the processing can be both time-consuming and challenging.

CosmosID®, known for the most accurate, multi-kingdom, strain level taxonomic profiling technology, has added a functional analysis module to its popular online user-interface, renamed 'CosmosID-HUB: Microbiome'.

Now, in addition to microbiome sequencing services out of its Germantown, MD, laboratory, its industry-leading team of bioinformaticians and software developers, has unveiled a suite of new features for seamless analysis of the genomic potential of microbial communities:
  • Direct links from the platform to MetaCyc and GO terms databases.
  • Data import via direct upload, Illumina BaseSpace & automated SRA import from NCBI with analysis speeds up to 19X faster than open-source tools.
  • Find your organism or gene/pathway of interest with search functions, exportable charts & visualizations.
  • Comparative analysis software, complete with dynamic charts, graphs, and statistical significance testing.
  • Easy-to-navigate user interface OR command-line access.
  • Applicable to almost any sample type
  • Applicable to both metagenomic and metatranscriptomics data

Knowing the combined genomic potential of a microbial community is proving indispensable for practical applications of translational microbiome science, This cutting edge, accurate, easy and fast functional analysis feature is part of our ongoing mission to provide everything researchers need to complete their end-to-end microbiome analysis and lower the barrier to entry for those interested in the field.

- CosmosID CEO, Manoj Dadlani.

The updated web application is part of CosmosID's microbial genomics platform, CosmosID-HUB, which is continually expanding with various apps and modules for analyzing microbial communities and for inferring translational and actionable microbiome insights. Currently, CosmosID-HUB: Microbiome provides options for discovering antimicrobial resistance and virulence markers, microbial taxa (composition) and function whereas CosmosID-HUB: COVID-19 is a separate module for detecting the presence of COVID-19 and characterizing variants of concern/interest in both clinical and wastewater specimens. Researchers have the flexibility to access and pay for the type of analysis they require. Soon, CosmosID-HUB will include a revolutionary web application for microbiome multi-dimensional feature testing and multi-omics analysis.

In addition to strain-level resolution enabled by its curated databases of over 170,000 genomes and gene sequences, CosmosID® also offers next-generation sequencing services. To date, the company has demonstrated its best-in-class technology and won three different challenges for its detection accuracy, including both PrecisionFDA challenges as well as the Janssen/DNAnexus Mosaic 'Strain' challenge.

About CosmosID®
CosmosID® provides end-to-end solutions unlocking the microbiome. A provider of CLIA-certified & ICH-GCP compliant NGS Services and Bioinformatics Solutions, CosmosID offers a range of validated and optimized workflows for a range of applications including pharmaceutical R&D, infectious disease diagnostics, environmental testing, microbiome research, animal health, cosmetics & personal care as well as many more. CosmosID also offers independently validated, industry-leading pipelines for processing metagenomic data, yielding multi-kingdom, strain-level resolution with leading sensitivity and precision as well as functional characterization

Spotlight

2016 BIO Patient & Health Advocacy Summit Buzz Center Interview with Paul Hastings, Chairman & CEO of OncoMed Pharmaceuticals, Inc.

Spotlight

2016 BIO Patient & Health Advocacy Summit Buzz Center Interview with Paul Hastings, Chairman & CEO of OncoMed Pharmaceuticals, Inc.

Related News

CELL AND GENE THERAPY

Imara Announces Primary Endpoint Change in the Ardent Phase 2b Clinical Trial of Tovinontrine (IMR-687) in Sickle Cell Disease

Imara | November 22, 2021

Imara Inc. a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin and other serious diseases, today announced a change to the primary endpoint for the Ardent clinical trial, a Phase 2b study of tovinontrine (IMR-687) in patients with sickle cell disease (SCD), based on the recommendation of the U.S. Food and Drug Administration (FDA). Imara requested feedback from the FDA on the draft statistical analysis plan (SAP) for the Ardent trial in which fetal hemoglobin (HbF) response was the primary endpoint and annualized rate of vaso-occlusive crises (VOCs) was the key secondary endpoint. In reviewing the Ardent draft SAP and prior to any database lock for analysis, the FDA recommended that Imara change the primary endpoint to be annualized rate of VOCs. HbF response will continue to be evaluated as a key secondary endpoint. The endpoint revisions do not affect the conduct of the trial or operational aspects of the study. As part of its recommendation, the FDA suggested further interactions regarding the revised SAP and engagement on the potential of the current program for regulatory decision-making. “We welcome the FDA’s recommendations and are in the process of changing the primary endpoint of the Ardent trial to be annualized rate of VOCs and moving HbF response to be a key secondary endpoint. A reduction in VOC rate is an established approval endpoint, and we are engaging the FDA further on this and related topics, including possible streamlined paths to registration.” Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara Dr. Ballal continued, “In light of this endpoint revision, the previously planned fourth quarter interim analysis will no longer occur. That interim analysis had been designed to have a focus on safety and pharmacodynamic biomarkers, including HbF, but did not include a review of VOCs. The first review of data from the Ardent trial, including annualized VOC rate, will be conducted when all subjects have completed assessment at Week 24 or terminated early, and is planned for the first quarter of 2022, subject to our upcoming discussions with the FDA. Final data analysis from the Ardent trial remains on track for the second half of 2022. In June 2021, we reported promising data from our Phase 2a and open label extension clinical trials in SCD that demonstrated reduced annualized rates of VOCs in patients treated with tovinontrine versus placebo. We expect to present updated 12-month VOC data from our ongoing Phase 2a open label extension clinical trial at the American Society of Hematology Annual Meeting in December 2021.” About the Ardent Phase 2b Clinical Trial The Ardent Phase 2b clinical trial is a fully-enrolled, global, randomized, double-blind, placebo-controlled, multicenter study with approximately 115 adult patients with sickle cell disease (SCD) enrolled. The planned primary efficacy objective will be to evaluate the annualized rate of vaso-occlusive crises (VOCs) in patients dosed with tovinontrine (IMR-687) as compared to placebo. A key secondary endpoint will be to evaluate the proportion of all patients with fetal hemoglobin (HbF) response, defined as an absolute increase from baseline of at least 3% in HbF, as compared to placebo. Additional endpoints include the evaluation of the effect of tovinontrine versus placebo on other VOC-related outcome measures, HbF-associated biomarkers, markers of red blood cell hemolysis, white blood cell adhesion markers and quality of life measures over the course of a one-year treatment period. The FDA has granted Orphan Drug, Fast Track and Rare Pediatric Disease designations and the European Commission has granted Orphan Drug designation for tovinontrine for the treatment of SCD. About Tovinontrine (IMR-687) Tovinontrine is a highly selective and potent small molecule inhibitor of phosphodiesterase-9 (PDE9). PDE9 selectively degrades cyclic guanosine monophosphate (cGMP), an active signaling molecule that plays a role in vascular biology and hemoglobin production in red blood cells. Lower levels of cGMP are found in people with sickle cell disease (SCD) and beta-thalassemia and are associated with reduced blood flow, increased inflammation, greater cell adhesion and reduced nitric oxide mediated vasodilation. Blocking PDE9 acts to increase cGMP levels, which is associated with several benefits including the potential reactivation of fetal hemoglobin (HbF), a natural hemoglobin produced during fetal development. Increased levels of HbF in RBCs have been demonstrated to improve symptomology and substantially lower disease burden in both patients with SCD and patients with beta-thalassemia. About Sickle Cell Disease Sickle cell disease (SCD), a hemoglobinopathy, is a rare inherited red blood cell disorder. The disease causes structural abnormalities in hemoglobin that cause red blood cells to become inflexible and elongated, ultimately blocking blood flow to organs, which can lead to vaso-occlusive crises (VOCs). SCD is characterized by debilitating pain, progressive multi-organ damage and early death. The global prevalence of SCD is estimated to be approximately 4.4 million patients, including an estimated 100,000 patients in the United States and 134,000 patients in the European Union. About Imara Imara Inc. is a clinical-stage biotechnology company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin and other serious diseases. Imara is advancing tovinontrine (IMR-687), a highly selective, potent small molecule inhibitor of PDE9 that is an oral, potentially disease-modifying treatment currently in clinical development for sickle cell disease and beta-thalassemia and preclinical development for heart failure with preserved ejection fraction, or HFpEF. Imara is also advancing IMR-261, an oral activator of nuclear factor erythroid 2–related factor 2, or Nrf2. Cautionary Note Regarding Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to (i) the Company’s plans to change the primary and secondary endpoints for the Ardent Phase 2b clinical trial of tovinontrine (IMR-687), (ii) the timing for reporting of additional data from the Ardent Phase 2b and open label extension clinical trials of tovinontrine in patients with sickle cell disease and (iii) the Company’s planned discussions with the FDA regarding the regulatory pathway for tovinontrine. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the impact of extraordinary external events, such as the risks and uncertainties resulting from the impact of the COVID-19 pandemic on the Company’s business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities and ability to readout data from the Ardent Phase 2b and open label extension clinical trials of tovinontrine in sickle cell disease; the Company’s ability to advance the development of tovinontrine under the timelines it projects in current and future clinical trials, demonstrate in any current and future clinical trials the requisite safety and efficacy of tovinontrine; and other factors discussed in the “Risk Factors” section of the Company’s most recent Quarterly Report on Form 10-Q, which is on file with the Securities and Exchange Commission and in other filings that the Company makes with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Read More

INDUSTRIAL IMPACT

Omega Therapeutics Announces Strategic Research Collaboration with Stanford University School of Medicine

Omega Therapeutics, Inc | October 14, 2021

Omega Therapeutics, Inc. ("Omega"), a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programing™ platform, today announced a strategic research collaboration with researchers at the Stanford University School of Medicine to explore the therapeutic potential of Omega Epigenomic Controllers (OECs) to control ocular disease genes associated with inflammation or regeneration of ocular tissues. Under the terms of the collaboration, Omega and members of the Ophthalmology Department of Stanford University School of Medicine will use the OMEGA Epigenomic Programming platform to discover and research novel ocular targets for potential future OEC development candidates. Albert Wu, M.D., Ph.D., FACS, Associate Professor of Ophthalmology, will serve as principal investigator. Other contributors will include Jeffrey Goldberg, M.D., Ph.D., Professor and Chair of Ophthalmology, and Michael Kapiloff, M.D., Ph.D., Associate Professor (Research) of Ophthalmology. "Through this research collaboration, we aim to expand the reach of our OMEGA platform within regenerative medicine, immunology, and inflammation with ocular disease targets. We will continue exploration of the broad potential of our disruptive platform and OECs, our new class of mRNA therapeutics as programmable epigenetic medicines." Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics About Omega Therapeutics Omega Therapeutics is a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programming™ platform. The OMEGA platform harnesses the power of epigenetics, the mechanism that controls gene expression and every aspect of an organism's life from cell genesis, growth and differentiation to cell death. The OMEGA platform enables control of fundamental epigenetic processes to correct the root cause of disease by returning aberrant gene expression to a normal range without altering native nucleic acid sequences. Omega's engineered, modular, and programmable mRNA-encoded epigenetic medicines, Omega Epigenomic Controllers™, target specific intervention points amongst the thousands of mapped and validated novel DNA-sequence-based epigenomic loci to durably tune single or multiple genes to treat and cure disease through Precision Genomic Control™. Omega is currently advancing a broad pipeline of development candidates spanning a range of disease areas, including oncology, regenerative medicine, multigenic diseases including immunology, and select monogenic diseases.

Read More

MEDICAL

Lilly, Vir Biotechnology and GSK Collaborates to Evaluate a Combination of two COVID-19 Therapies in Low-risk Patients

Lilly | January 28, 2021

Eli Lilly and Company, Vir Biotechnology, Inc. also, GlaxoSmithKline plc declares a collaboration effort to assess a mix of two COVID-19 therapies in low-risk patients with mild to direct COVID-19. Lilly has extended its progressing BLAZE-4 trial to assess the organization of bamlanivimab (LY-CoV555) 700mg with VIR-7831 (otherwise called GSK4182136) 500mg, two killing antibodies that quandary to various epitopes of the SARS-CoV-2 spike protein. This unique collaboration effort denotes the first occasion when that monoclonal antibodies from discrete organizations will be united to explore expected results. Bamlanivimab is a neutralizing antibody coordinated against the spike protein of SARS-CoV-2 designed to obstruct viral connection and entry into human cells, in this manner killing the infection. Bamlanivimab emerged out of the collaboration among Lilly and AbCellera to make antibody therapies for the avoidance and treatment of COVID-19. Bamlanivimab is approved for emergency use for the treatment of mild to direct COVID-19 in patients who are at high risk for progressing to severe COVID-19 and/or hospitalization. "Bamlanivimab is a potent antibody – with data from multiple Phase 2 and 3 clinical trials, which have demonstrated robust evidence for both treating and preventing COVID-19," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories. "With a virus like SARS-CoV-2, it's expected that variants could emerge that require new therapeutic options, which is why Lilly is studying bamlanivimab together with other neutralizing antibodies, including etesevimab. Adding VIR-7831 to our study is an important part of our commitment to develop therapies to treat current and future strains of COVID-19 until vaccines are widely available and utilized."

Read More