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Bio-ADM, the very first blood biomarker capable to diagnose when blood vessels become leaky (endothelial dysfunction), is set to make a rapid carrier at intensive care units (ICUs) and emergency departments (EDs) of hospitals. Data from pilot clinical routine testing presented at the 2nd Scientific Symposium on Endothelial Disruption (18. December 2018) in Berlin impressively confirmed results from previous tests on 30,000 patients with acute heart failure (AHF) and severe sepsis indicating that bio-ADM testing improves medical decision making to prevent mortality, organ damage and rehospitalisation. An automated point-of-care (POC) test measuring bio-ADM both as a biomarker and as a companion diagnostic to a therapeutic antibody (adrecizumab) that repairs endothelial dysfunction, will be launched by H1/2019 by Sphingotec GmbH. However, bio-ADM is just the first representative of a full pipeline of diagnostic blood proteins reflecting disturbed signalling pathways underlying disorders of unmet medical need.
In autumn, stakeholders across the globe pledged to take more action in the fight against antimicrobial resistance (AMR). Whereas from the push side new public and private initiatives appeared on the screen, discussion about which pull mechanism should be started first is in full swing. Meanwhile, small and medium-sized companies combine forces aiming to propel preclinical and early clinical R&D.
Diagnostic results must be readily available to diagnose critically ill patients in emergency settings and at ICUs. So far, diagnostic blood tests, which demonstrably could help emergency meds recognise residual congestion in heart failure, septic shock, or acute kidney injury before patients reach critical condition, have not been available in the automated format required at ICUs. After Sphingotec acquired Nexus IB-10 POC testing platform in May, investors wait in line.
Financial pressure on Big Pharma and biotechs increases the need for drug developers to outsource their development and manufacturing capabilities. The CDMO and CRO sector, which is further consolidating through M&A, looks well set for continued growth. As developers have to balance the need to reduce their development risk with time to market or – for biotechs – time to next financing, contract manufacturing and contract research companies clearly favour offering fully integrated services.
Since reports that blood cancer response rates to T cells carrying chimeric antigen receptors (CARs) exceed 80%, investors have been laying bets on CAR-T cell approaches. In August, the first two therapies hit European markets in a head-to-head race to be the number one next-gen cancer therapy. So will CAR-T cell treatment really take pole position? Or will alternatives like TCR-based cell therapy or multivalent antibody-T cell engagers leave them in the dust?
Answering the increasing demand for novel fully human antibodies in immunotherapy, German biotech pioneer YUMAB GmbH accelerates drug discovery and development with a comprehensive and versatile technology platform.
Up to now, researchers believed that lung remodeling follows an autoimmune inflammation triggered by components of the extracellular matrix. In August, British scientists provided a more accurate view of the processes in the lung tissue, opening up a way to optimise failed mid-stage clinical candidates.
As the global demand for injectables grows, so does the demand for innovative delivery systems. For lyophilised forms, dual-chamber systems offer advantages. They have been on the market since the mid-1980s, mainly for emergency or chronic medication. The systems have been developed for the convenience of the patients/caregivers, but they also offer benefits for the pharma/biotech companies in regards to low residual volume and increased API yield.
Is synthetic biology on the cusp of unlocking the next industrial revolution? A major roadblock is the ability to synthesise DNA for R&D in ways that are both cheap and efficient. Established players in the field believe the answer lies in miniaturising standard chemical processes and running them in parallel systems. But the new kids on the block are betting on a completely new process that involves enzymes.