EpiGentek launched first-of-its-kind tools to detect SARS-CoV-2-targeted furin activity and screen for inhibitors against COVID-19

EpiGentek | July 10, 2020

New York-based biotechnology firm EpiGentek has released a series of SARS-CoV-2 research assays in combatting the ongoing COVID-19 pandemic. The two kits focus on studies of SARS-CoV-2 targeted furin or proprotein convertase (PC) cleavage activity. These first-of-its-kind tools can be used to rapidly detect SARS-CoV-2 targeted PC and facilitated proteases using biological samples as well as screen for inhibitors of these enzymes that cleave SARS-CoV-2 proteins. Subsequent implications can be the effective development of drug candidates or therapeutic treatments. The SARS-CoV-2 spike glycoprotein harbors a furin/PC cleavage site at the boundary between the S1/S2 subunits, which could be cleaved by furin and/or furin-like PCs secreted from host cells and bacteria in the airway epithelium. Unlike the first SARS-CoV, cell entry of SARS-CoV-2 is pre-activated by furin and/or furin-like PCs, reducing its dependence on target cell proteases for entry. The cleavage activation of S-protein is well demonstrated to be essential for SARS-CoV-2 spike-mediated viral binding to ACE2, cell-to-cell fusion, and viral entry into human lung cells.

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INDUSTRIAL IMPACT

The Bracken Organizations Merge to Create a Global Platform to Support Life Science and Digital Health Teams

The Bracken Group | October 11, 2021

Three unique companies with shared origins have now united to better serve their clients in the life sciences industry. The new entity will be known as The Bracken Group (Bracken) with three divisions of the original three companies. The combined companies' mission continues to be supporting the success of companies that improve health, using an integrated network of clients, consultants, and employees across the globe. I am delighted to bring the companies together under the one outstanding leadership team which further improves the services we provide to our clients. The benefits of the synergy that comes from a closer inter-team relationship will be apparent as the cross communication will be immediate. - Dr Colin G. Miller, CEO of The Bracken Group Bracken has been specializing across the life sciences and digital health arenas since inception, This highly regulated life science industry includes high stakes and complex processes. We have created and continue to cultivate an integrated platform to help organizations in this industry succeed. - Elliot Miller, Chief Growth Officer. About Bracken Data Bracken Data was founded in 2016 to improve how the industry can use public clinical trial data. Bracken Data offers a suite of clinical trial dashboard products, and custom data science and analytics services. For more information, please visit BrackenData.com. About Bracken Marketing Bracken Marketing was founded in 2017 to support the success of digital health and life science teams through marketing services, and custom marketing programs. Services include website design, content development, advertising, sales collateral production, and multi-media production. About The Bracken Group The Bracken Group, founded in 2018, provides highly experienced consultative support for the development of products that are designed to improve life, in an ethical manner, underpinned with integrity and quality. Bracken offers biopharmaceutical consulting in the development of drugs, biologics, and medical devices, as well as in the use of medical imaging in clinical trials. Clients leverage The Bracken Group's team of executive consultants across a range of specialties through Virtual C-Suite services and related offerings.

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RESEARCH

Bio-Techne And Carterra Initiate A Clinical Research Collaboration For COVID-19 Variant Analysis

Bio-Techne Corporation | September 08, 2021

Bio-Techne, a leading supplier of high-quality and innovative tools for life science research, therapeutic manufacturing and clinical diagnostics and Carterra Inc., the world leader in high-throughput antibody screening and characterization, today announced a clinical research collaboration studying COVID-19 variants. New variants, such as Delta, can be more easily transmitted and more likely to evade the immune response of vaccinated or previously infected people. To assess immune responses to new variants and to plan for intervention mechanisms that avoid vaccine escape, scientists and epidemiologists need a fast and effective assay. The partnership leverages Carterra's flagship analytical platform - the LSA® - to characterize panels of SARS-CoV-2 spike and receptor-binding domain (RBD) variants in an information-rich assay. The SARS-CoV-2 variants were developed by Bio-Techne and used to fast-track the new, scalable assay for measuring the potential risks that new variants may evade the ability of the immune system to block the virus. Bio-Techne has been leading the way in COVID-19 research reagent and immunoassay development enabling scientists to make discoveries leading to effective diagnoses, therapies and vaccines. The company was first to market with COVID-19 research protein variants and has significant expertise with SARS-CoV-2 antibody quantitation. Bio-Techne and Carterra will focus this collaboration on more than 40 variants, including the Delta variant that is prevalent today, and emerging variants as they are discovered. The Carterra LSA will be used to generate high-definition insights with over 120 data points from patient serum samples, including a variant profile, ACE-2 blocking potential, and isotyping profiles of immunoglobin response. The LSA's hands-free, high-throughput setup requires only 2 µL of patient serum and provides for the analysis of new and emerging variants in the ever-evolving field of COVID-19 research. Carterra's LSA instrument is the fastest, most sensitive and flexible biosensor platform on the market. Combining proprietary flow printing microfluidics with High Throughput Surface Plasmon Resonance (HT-SPR) technology, the LSA enables detailed screening and characterization of vast antibody or variant libraries, including full kinetic profiles. With the ability to generate real-time binding data for 384 proteins on one chip and assay up to 1152 patient samples in a single unattended run, the LSA significantly improves efficiency and speed in both drug discovery and clinical research. About Bio-Techne Bio-Techne Corporation is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne products assist scientific investigations into biological processes and the nature and progress of specific diseases. They aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses. With thousands of products in its portfolio, Bio-Techne generated approximately $931 million in net sales in fiscal 2021 and has approximately 2,700 employees worldwide. About Carterra, Inc. Carterra® is the leading provider of high throughput technologies designed to accelerate and improve the discovery of novel therapeutic candidates. Carterra's LSA™ instrument, software, and consumables for monoclonal antibody (mAb) characterization deliver up to 100 times the throughput of existing platforms in 10% of the time while using only 1% of the sample required by other systems. The LSA combines patented microfluidics technology with real-time high throughput Surface Plasmon Resonance (HT-SPR) and industry-leading data analysis and visualization software to revolutionize mAb screening. Carterra, Inc. is based in Salt Lake City, Utah, and has Customer Experience Centers in San Francisco, Salt Lake City, Boston, and Munich, Germany.

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INDUSTRIAL IMPACT

Inhibrx Receives FDA Orphan-Drug Designation for INBRX-101 for the Treatment of Alpha-1 Antitrypsin Deficiency

Inhibrx, Inc. | March 04, 2022

Inhibrx, Inc. a biotechnology company with four clinical programs in development and a strong emerging pipeline, announced that the U.S. Food and Drug Administration, or FDA, has granted orphan-drug designation for INBRX-101 for the treatment of alpha-1 antitrypsin deficiency, or AATD. "We believe this designation from the FDA acknowledges the significant unmet need for novel therapeutic options in a patient community where the standard of care has not seen an improvement in many decades. We believe INBRX-101 can greatly improve the quality of life for AAT patients and look forward to working closely with regulators, key opinion leaders, patients and their families to achieve this." Inhibrx Chief Executive Officer, Mark Lappe The FDA's Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan-drug designation provides certain benefits, including financial incentives to support clinical development and the potential for up to seven years of market exclusivity in the U.S. upon regulatory approval. About AATD and INBRX-101 Alpha-1 antitrypsin deficiency, or AATD, is an inherited orphan disease affecting an estimated 100,000 patients in the United States. AATD is characterized by deficient levels of the AAT protein, which causes loss of lung tissue and function and decreased life expectancy. Plasma-derived AAT is the current standard of care but does not maintain patients in the normal AAT range, and requires frequent and inconvenient once-weekly IV dosing, while relying on plasma collection practices that might not be sustainable. INBRX-101 is a precisely engineered recombinant human AAT-Fc fusion protein designed to safely achieve and maintain levels of AAT found in healthy individuals with a favorable safety profile and the potential for once-monthly dosing. In October 2021, the Company announced interim functional PK data from 21 AATD patients in the Phase 1 study. Dose related increases in maximal and total INBRX-101 exposure occurred across the entirety of the tested single ascending dose range of 10 to 120 mg/kg. Data from the first multiple ascending dose cohort of INBRX-101 at 40 mg/kg IV every three weeks showed the expected accumulation of functional AAT levels with observed trough levels exceeding the goal of the current standard augmentation therapy with plasma-derived AAT. Interim safety data from 24 patients with AATD showed no drug-related severe or serious adverse events at doses up to and including 120 mg/kg single dose and 80 mg/kg multiple dose. Drug-related adverse events were predominantly mild with a few moderate events, and all were transient and reversible. No signs of neutralizing anti-drug antibodies have been observed. About Inhibrx, Inc. Inhibrx is a clinical-stage biotechnology company focused on developing a broad pipeline of novel biologic therapeutic candidates in oncology and orphan diseases. Inhibrx utilizes diverse methods of protein engineering to address the specific requirements of complex target and disease biology, including its proprietary sdAb platform. Inhibrx has collaborations with 2seventy bio Bristol-Myers Squibb and Chiesi, among others.

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