Bio-Rad Laboratories has launched their SARS-CoV-2 Variant RT-PCR Assays for research use only (RUO).
C4Diagnostics, a French biotech, has received CE marking for their C4Covid-19 Human for the rapid diagnosis of Covid-19 from a saliva sample. The performance of the test was calculated upon a clinical trial of 1320 participants, carried out in collaboration with Synlab Provence Laboratories. Sensitivity is 86% and specificity is 97.5%.
A large number of COVID-19 diagnostic tests are reliant on detection of viral RNA from buccal swabs by PCR.
Agena Bioscience, has unveiled their MassARRAY® SARS-CoV-2 Variant Panel for Research Use Only (RUO) for the detection of key SARS-CoV-2 virus strains, including the UK (B.1.1.7), South Africa (B.1.351), Brazil (P.1) and Denmark (Cluster 5) variants.
Paradigm4 has unveiled its scalable solution for efficiently working with the Allotrope Data Format (ADF).
AMSBIO has launched a comprehensive range of cytosections that offer a verified, reproducible and renewable source of positive / negative controls where the expression of the target biomarker is confirmed for accuracy and specificity by an immunoassay.
IONTAS and FairJourney Biologics, leaders in the discovery and optimisation of fully human antibodies, have announced the identification of neutralizing antibodies, which bind to multiple emerging SARS-CoV-2 variants. The results, generated from a combination of phage display technology and B-cell receptor repertoire sequencing of hospitalized COVID-19 patients, have identified potent neutralizing antibodies with distinct mechanisms of action. Based on this approach, the Company has developed a panel of therapeutic candidates.
SARS-CoV-2 virus enters the body as a result of the viral spike protein binding to the ACE2 protein on the surface of lung cells. This interaction is driven by a small region of the spike protein and the majority of antibodies currently undergoing clinical trial bind to this site. However, this site has changed in some of the emerging viral variants, reducing or abolishing the effect of some clinical candidates. Drug candidate antibodies developed by IONTAS to this same site have been shown to retain binding to the emerging variants.
An alternative approach for tackling variants is to target alternative regions of the virus which have a greater degree of conservation, making escape variants less likely. GSK/VIR Biotechnology recently announced a successful Phase 3 trial of such an antibody. VIR-7831 is an antibody which binds to a region of the spike protein which is highly conserved between SARS-CoV-2 and SARS-CoV-1 (A distantly related virus responsible for the outbreak of Severe Acute Respiratory Syndrome in 2003). VIR-7831 has shown an 85% reduction in hospitalisation and death during the COMET-ICE clinical trial.
A sub-set of the IONTAS antibodies, show a similar functionality to VIR-7831, by binding to sites conserved both in the recently emerging SARS-CoV-2 variants as well as to the more distantly related SARS-CoV-1 virus.
Dr John McCafferty, CSO at IONTAS, commented: “The first wave of antibody drugs for treating COVID-19 was focused on achieving maximal neutralization to the original SARS-CoV-2 strain first identified in Wuhan. This led many companies to a target site on the virus which is very effective for neutralization but also prone to genetic change. Second generation drug candidates need to anticipate the emergence of new variants by targeting more conserved sites. IONTAS has identified drug candidates which neutralize by targeting conserved regions of the virus. We now seek partners to help develop these to better position the world in tackling this dreadful disease.”
Berlin-based ProBioGen AG has signed a commercial multi-product license agreement with Sanofi. Under the agreement, Sanofi will integrate ProBioGen’s proprietary GlymaxX technology into their product development strategy for an undisclosed number of antibody candidates across several business units.
GlymaxX enables a boost of antibody-dependent cell-mediated cytotoxicity (ADCC), consequently leading to an elevated NK cell mediated killing activity of its target cells. The GlymaxX technology adds value to the products by significantly improving their potency and potentially reducing the overall clinical doses for patients.
The GlymaxX technology for production of afucosylated proteins is widely applied in the pharma industry and hence used in various numbers of mAb candidates. It is universally applicable, simple and very potent.
The unique advantage of the GlymaxX technology allows a single GlymaxX modified cell line to produce both, completely fucosylated and/or afucosylated antibodies and those with intermediate defined fuscosylation levels.
The technology can be easily integrated in newly developed or already existing cell lines of different host cell origins, which demonstrates its great flexibility.
ProBioGen is a premier CDMO for developing and manufacturing complex therapeutic glycoproteins. The GlymaxX technology, developed by ProBioGen, prevents the addition of the sugar “fucose” to the N-linked antibody carbohydrate part by antibody producing cells. The absence of fucose enhances ADCC (antibody-dependent cell-mediated cytotoxicity) activity for antibodies directed against cancer and infectious diseases. The GlymaxX technology is based on the stable introduction of a gene for an enzyme which deflects the cellular pathway of fucose biosynthesis. ProBioGen offers this technology royalty-free to third parties.
- For more information, see: http://www.glymaxx.com/
Researchers from Chalmers University of Technology, Sweden have developed Artificial Intelligence that is capable of generating novel, functionally active proteins. The research represents a significant breakthrough in the field of synthetic protein development.
“What we are now able to demonstrate offers fantastic potential for a number of future applications, such as faster and more cost-efficient development of protein-based drugs,” said Aleksej Zelezniak, Associate Professor at the Department of Biology and Biological Engineering at Chalmers.
Martin Engqvist, Assistant Professor, also of the Department of Biology and Biological Engineering, who was involved in designing the experiments to test the AI synthesised proteins, commented on the development, saying that “accelerating the rate at which we engineer proteins is very important for driving down development costs for enzyme catalysts. This is the key for realising environmentally sustainable industrial processes and consumer products, and our AI model, as well as future models, will enable that. Our work is a vital contribution in that context.”
Protein-based drugs are very common – the diabetes drug insulin is one of the most prescribed. Some of the most expensive and effective cancer medicines are also protein-based, as well as the antibody formulas currently being used to treat COVID-19.
From digital design to working proteins in just a few weeks
Current methods used for protein engineering rely on introducing random mutations to protein sequences. However, with each additional random mutation introduced, the protein activity declines.
“Consequently, one must perform multiple rounds of very expensive and time-consuming experiments, screening millions of variants, to engineer proteins and enzymes that end up being significantly different from those found in nature,” explained Zelezniak, who lead the research.
“This engineering process is very slow, but now we have an AI-based method where we can go from computer design to working protein in just a few weeks.”
The researchers recently published their findings in the journal Nature Machine Intelligence.
The AI-based approach is called ProteinGAN and uses a generative deep learning approach.
In essence, the AI is provided with a large amount of data from well-studied proteins; it studies this data and attempts to create new proteins based on it. At the same time, another part of the AI tries to figure out if the synthetic proteins are fake or not. The proteins are sent back and forth in the system until the AI can no longer not tell apart natural and synthetic proteins. This method is well known for creating photos and videos of fictitious people, but in this study, it was used for producing highly diverse protein variants with naturalistic-like physical properties that could be tested for their functions.
The proteins widely used in everyday products are not always entirely natural but are made through synthetic biology and protein engineering techniques. Using these techniques, the original protein sequences are modified in the hope of creating synthetic novel protein variants that are more efficient, stable, and tailored towards particular applications. The new AI-based approach is of importance for developing efficient industrial enzymes as well as new protein-based therapies, such as antibodies and vaccines.
The next step for the researchers is to explore how the technology could be used for specific improvements to protein properties, such as increased stability, something which could have great benefit for proteins used in industrial technology.
“Expanding functional protein sequence spaces using generative adversarial networks” in Nature Machine Intelligence.
Axol Bioscience, an established provider of iPSC-derived cells, media, and characterization services, has merged with CENSO Biotechnologies, a cell biology CRO with focused expertise in iPSC-related technologies.
The new entity will become a leading provider of product and service solutions in the iPSC-based neuroscience, immune cell, and cardiac modeling for drug discovery and screening markets. It will offer customers validated ready-to-use cell lines and a suite of services with broader expertise, robust functional data, and customization capabilities, all with shorter lead times.
Axol Bioscience’s investors include Dr Jonathan Milner and award-winning EIS fund manager, Calculus Capital. CENSO Biotechnologies’ major investor is leading Edinburgh-based EIS fund manager, Par Equity. The transaction is accompanied by a fundraising round in excess £3.8m, led by Calculus Capital and Par Equity. The investment will be used to enable growth of the business and acquisition of talent.
“Axol has experienced a rapid increase in demand for their iPSC-based products and services over the last three years. Merging with CENSO immediately and significantly grows our scientific team and breadth of expertise. That, and the addition of two sites for iPSC-derived cell line manufacturing and custom service work, will increase our production capacity and future-proof our organization to ensure demand can continue to be met with the short lead times and quality that our customers depend on,” said Liam Taylor, CEO Axol.
Under the terms of the agreement, Taylor, and the Axol senior leadership team will take over the management of the combined entity, with the intent to migrate the brand to Axol Bioscience. The agreement sees CENSO’s interim CEO, Dr Tom Stratford, appointed non-executive director of the combined board, on behalf of Par Equity.
Dr Stratford commented: “CENSO’s strength is our scientific team, as trusted partners in designing, executing, and managing custom project work. The combined entity will now be able to leverage Axol’s strength in iPSC-derived cells as well as complementary services such as electrophysiology to further our ability and efficiency to serve customers. We bring to bear capabilities, bandwidth, and expertise to scale the manufacturing of those tools in a way that benefits both customer bases and the wider market.”