DRUG DISCOVERY AND DEVELOPMENT 19
prevalence rates, were approximately 160,000 in the USA and roughly 145,000 in the EU.
RPC4046 is a recombinant humanised antiinterleukin-13 (IL-13) monoclonal antibody that is selective with a high affinity. Te antibody binds an IL-13 epitope that prevents its binding with interleukin-13 receptor (IL-13R) (alpha)1 and IL-13R(alpha)2, which could offer advantages in terms of efficacy and/or safety. In a Phase I study of the compound, AbbVie showed that RPC4046 was well tolerated in healthy subjects and patients presenting with mild to moderate persistent asthma. In addition, RPC4046 supports single- dose IV administration as well as multiple subcutaneous doses.
Meanwhile ChromoTek has signed a license agreement granting Bayer Pharma the right to use its proprietary cell cycle Chromobody technology for drug profiling by high-content analysis.
Under the terms of the agreement, Bayer will apply Chromobody technology for real-time monitoring of cell cycle progression in drug discovery (Fig. 1). Tis agreement follows a collaboration in which ChromoTek provided custom cell line development for Bayer.
ChromoTek’s Chromobody technology is a patented, universal live-cell imaging technology for high-content analysis. Te so-called Chromobodies are single-domain
antibodies that have been genetically fused to fluorescent proteins to serve as functional nanoprobes in living cells. According to ChromoTek, the Chromobody technology allows users for the first time to trace endogenous intracellular antigens and to visualise dynamic changes of these targets within living cells.
Currently available Chromobodies trace important cellular processes such as cell cycle, apoptosis, DNA damage and repair, and even allow cytoskeletal analysis. Te cell cycle Chromobody cell line that has been licensed by Bayer traces the complete cell cycle in real-time in live cells in a non-invasive manner while providing full flexibility to multiplex with other procedures, according to ChromoTek’s R&D head Kourosh Zolghadr.
“We are pleased to offer our customers efficient tools for achieving more detailed and physiologically relevant information on the effects of drug candidates on cell cycle progression,” he added.
Established in 2008 as a spin- off from Munich’s Ludwig Maximilian University and located in Martinsried, which is Germany’s leading biotech hub, ChromoTek develops and markets Chromobody-based live-cell assays for drug screening and target validation. Other products include immunological and bioimaging reagents, such as the GFP-Trap for the rapid pull-down of GFP fusion proteins, GFP and RFP Booster to
amplify fluorescence signals of GFP or RFP fusion proteins.
Te company’s newly-developed fluorescence-based protein-protein interaction assay called Fluorescent- 2-Hybrid (F2H) is also available as a development service.
Early clinical platforms Xceleron, a leader in the design and use of ultra-sensitive accelerator mass spectrometry (AMS) in novel clinical investigations, has announced a partnership with JCL Bioassay, a leader in the use of highly sensitive LC-MS/MS and proprietary methodologies. Te new partnership will offer drug developers access to the broadest range of sensitive and robust analytical platforms in early clinical development across Asia, Europe and North America.
Phase 0 and enriched Phase 1 studies have been used successfully in recent years to investigate a range of developmental endpoints including drug presence at the tissue or cells of interest, absolute bioavailability and human metabolism.
Investigations of this type conducted early in drug development allow confident critical decision-making that offers a very cost-effective alternative when compared to later stages of clinical development.
Te partnership between Xceleron and JCL Bioassay will provide access to clinical design expertise and the most appropriate analytical platform for the purpose of early
clinical investigation. Xceleron and JCL Bioassay have between them developed over 100 analytical methods for Phase 0 and enriched Phase 1 investigations and both companies have recently built, equipped and staffed laboratories specifically for the purpose of ultra- low level analyses under GLP and GCP conditions.
“Tis partnership emphasises the critical role of contemporary analytical platforms in driving down the cost of drug development. Whether in Phase 0 or enriched Phase I, we can confidently provide critical pharmacokinetic and pharmacodynamic information before Phase II,” said Michael Butler, ceo of Xceleron.
Finally, Blueprint Medicines, a company that focuses on the molecular blueprint of cancer as the basis for developing highly selective therapies, has announced the establishment of its first collaboration with the Massachusetts General Hospital Cancer Centre and Wellcome Trust Sanger Institute, a genomic research centre located in the UK and primarily funded by the Wellcome Trust. Under this collaboration, the partners will focus on a collection of Blueprint Medicines’ next-generation, highly selective kinase inhibitor compounds and will use the extensive human cancer cell line panel developed by the Sanger Institute and Massachusetts General in hopes of facilitating the discovery of novel cancer targets.
EMD Millipore expands flow cytometry services for biomarker testing E
MD Millipore, the life science division of Merck, Darmstadt, Germany, has announced the expansion of its biomarker testing service
capabilities with the launch of flow cytometry services at its North America facility. The service supports exploratory and GLP-
requiring studies, and includes full and flexible assay development, validation and sample testing services using clinically established flow cytometry instrumentation. The launch completes the significant investment
EMD Millipore has made over the past two years to develop flow cytometry services globally, building on what it describes as the existing industry-leading flow cytometry capabilities of the company’s European testing site in Oxford, UK. At the St Charles, Missouri, facility in the USA, EMD
Millipore provides a wide range of quantitative analyses for drug development including pharmacodynamic, immunophenotyping, receptor assays, antibody- dependent cellular cytotoxicity, cell proliferation and genomic biomarker testing. The site also offers
cell-based assay options for immunogenicity testing, monoclonal antibody assays and characterisation services for biosimilars. “Flow cytometry technologies have become
increasingly sophisticated and valuable for biomarker evaluation,” notes James Hulse, North America managing scientific director for EMD Millipore discovery and development. “Adding this service to our drug development services offering allows customers to gain greater insight into relevant biomarkers and make pipeline decisions in confidence.”
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