Promising Bioconjugate Vaccine Against Hypervirulent Superbug Klebsiella

BioTecNika | September 03, 2019

Researchers have now produced and tested a promising bioconjugate vaccine against Klebsiella in mice. This is a vaccine that protects against this worrisome superbug i.e, a hypervirulent form of the bacteria Klebsiella pneumoniae. Researchers, Washington University School of Medicine in St. Louis and VaxNewMo, a St. Louis-based startup., have done this by genetically manipulating a harmless form of E. coli. Klebsiella pneumonia superbug causes a number of variety of infections including the rare but life-threatening liver infections, respiratory tract infections, bloodstream infections, and other infections. Only little is known about how exactly people become infected with these bacteria, and the bacteria are unusually adept at acquiring resistance to the antibiotics. A prototype vaccine against superbug Klebsiella, details of the study which are published online Aug 27 in Proceedings of the National Academy of Sciences, may offer an effective way to protect people against the lethal infection caused by Klebsiella which is hard to prevent and treat generally. David A. Rosen, MD. Ph.D., an assistant professor of pediatrics and of molecular microbiology at Washington University, said that for a long time, Superbug Klebsiella was primarily an issue in the hospital setting, so even though its drug resistance was a real problem in treating these infections, the impact on the public was limited. Rosen who is also the co-author of the study on novel Vaccine against superbug Klebsiella added that now we’re seeing Klebsiella strains that are virulent enough to cause death and severe disease in healthy people in the community. In the past five years, the resistant bugs and the really virulent superbugs that have begun to merge so we are beginning to see drug-resistant and hypervirulent strains which are the very scary factor to be considered.

Spotlight

Process efficiency is a key goal for biopharmaceutical production, focused on increasing the process' speed, keeping costs under control, and building flexibility into the process, all while maintaining the quality of the final product. In this article, several different approaches and technologies will be detailed that can significantly improve the efficiency of upstream processing, including cell line development, process development, and process intensification, real-time analytics, and process integration.

Spotlight

Process efficiency is a key goal for biopharmaceutical production, focused on increasing the process' speed, keeping costs under control, and building flexibility into the process, all while maintaining the quality of the final product. In this article, several different approaches and technologies will be detailed that can significantly improve the efficiency of upstream processing, including cell line development, process development, and process intensification, real-time analytics, and process integration.

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MEDICAL

GT Molecular, Rapidly Expanding Molecular Diagnostics Biotech, Launches Two Highly Sensitive Tests for the Dangerous UK Variant of SARS-CoV-2

GT Molecular | January 13, 2021

GT Molecular, a quickly extending sub-atomic diagnostics biotech, has dispatched two profoundly delicate tests for the risky UK Variant of SARS-CoV-2 (B.1.1.7). These tale examines expand upon GT Molecular's clinical foundation and technology for profoundly exact and solid qPCR and advanced PCR recognition of SARS-CoV-2 virus and are offered in two formats. The fee-for-service testing of wastewater for the presence of SARS-CoV-2 and the variations available for use furnishes networks with a quick, exceptionally savvy technique to comprehend the measure of viral transmission inside a local area. Everybody inside a local area gives an example as a flush to the wastewater treatment office and a solitary wastewater test can cover a large number of individuals for a simple portion of what a clinical test for an individual expenses. Moreover, the presence of the infection in wastewater can go before nearby flare-ups locally by as long as seven days, giving wellbeing authorities time to prepare and increase testing. By applying this technique for local area wastewater checking to the recently coursing UK variation, GT Molecular is the first to go above and beyond and really "genotype the sewer".

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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.

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MEDICAL

CosmosID® Enters Microbiome Partnership with Locus Biosciences

CosmosID | June 22, 2022

CosmosID®, an American provider of end-to-end microbiome platforms and award-winning metagenomics services, announced entering into a microbiome partnership with a clinical-stage biotechnology company developing a new class of precision-engineered bacteriophage treatments, Locus Biosciences, Inc. With this partnership, CosmosID focuses on providing its GCP-compliant and CLIA-certified laboratory services for Locus' clinical trial initiatives in the microbiome field. Locus is developing two innovative biotherapeutics categories to meet significant unaddressed medical needs. First, engineered bacteriophage therapies that use bacteria resident in specific body locations to dispatch therapeutic molecules. Second, precision CRISPR-enhanced bacteriophage (crPhage®) products to combat fatal infections, including the ones caused by multi-drug resistant bacteria. Locus is able to swiftly recognize, distinguish, engineer, and produce bacteriophage products against bacterial targets involved in the pathogenesis of numerous diseases by collaborating discovery automation, industry-leading informatics, synthetic biology, and sophisticated in-house manufacturing. CosmosID's infrastructure for providing access to compliant, higher resolution, and robust microbiome analysis will allow Locus to enhance its capability and add insight into precision therapeutics platforms. With its shotgun metagenomics, the company will assist Locus in understanding its products' effectiveness through CosmosID's robust resolution microbiome analysis, commencing with its urinary tract infection clinical program. We're thrilled to partner with Locus on its groundbreaking clinical pipeline as we help the company better understand the impact of these phages on the microbiome, Locus' robust and diligent approach to this study is much needed in the field and we look forward to helping them build a strong clinical data package." Manoj Dadlani, CEO of CosmosID. This partnership with CosmosID will allow Locus to monitor microbiome changes upon treatment of patients with antibiotics and with crPhage, helping us to evaluate the impact of preserving and protecting their microflora while clearing their infections." Paul Garofolo, CEO of Locus Biosciences.

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