Table of Contents
Advances in monoclonal antibody therapeutics
Monoclonal antibody therapeutics are being used for treatment of a wide array of diseases, specially in therapeutic areas such as oncology, immunology (including autoimmune and inflammatory diseases, as well as, transplant rejection) and neuroscience. The development of these new molecular agents, successfully directed to specific cellular targets, is playing a crucial role in the pharmaceutical industry. This trend shows the strong focus of top biopharmaceutical companies in biologics, including monoclonal antibody therapeutics. This research service discusses the emerging trends in monoclonal antibody therapeutics on a global scale, through a detailed strategic assessment of the industry environment.
Next-generation products are expected to be superior to first-generation products, in terms of potency against disease targets, ability to treat more than one aspect of a disease simultaneously, better and cheaper production processes and fewer side effects.
Big Pharma companies (Amgen, Novartis, Pfizer, Roche), are advancing through deals with potentially very large payoffs to acquire antibody technologies, compensating some patent losses in more traditional molecules and making easier to afford the advent of biosimilars.
Nanobodies (Ablynx), stapled peptides (Aileron), single-gene mutation gene therapy (BlueBird Bio), neurotrophic factor gene therapy (Sangamo BioSciences), Dicer-substrate short interfering RNAs (Dicerna), therapeutic vaccines (Galena), dual-affinity re-targeting (MacroGenics), bispecific T-cell engaging antibodies (Amgen), locked nucleic acids (Roche), and XmAbs (Xencor), are highlighted.
Although immuno-modulatory antibodies have also recently achieved remarkable clinical success, regulatory issues in biologics plays a crucial role in the development of monoclonal antibody therapeutics.
A profound knowledge of the molecular basis of the disease, as well as, outstanding protein-engineering techniques, mechanisms of action and resistance, including the behavior exhibited by the immune system and the targeted cells is essential. In terms of therapeutic areas, the use of monoclonal antibodies in immuno-oncology has achieved considerable success in recent years. Antibody–drug conjugates are powerful new treatment options for lymphomas and solid tumors. Principal deals are strongly correlated to immuno-oncology areas.
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