In the vast area of immunotherapies, the development of monoclonal antibodies as a therapeutic concept emerged as a quantum leap out of the area of traditional vaccines (Köhler and Milstein) in vitro selection and optimisation made it possible to elaborate a single biological molecule from the molecular plethora of an individual adaptive immune response and to utilize such a cloned antibody repeatedly in a generalized fashion whenever the therapeutic indication is given to humans. At present, some 25 therapeutic monoclonal antibodies are currently being marketed in oncology, exceeding sales of USD20bn in 2011. A total of about 270 antibodies are currently in Phase II and III clinical development. Working on the assumption of usually lower attrition rates for antibody candidates, we expect approximately 120 of these 270 antibodies to be finally approved. This poses some key questions. What level of differentiation is required so that the coming new antibody drugs can command premium pricing when members of the founding generation become generic and inexpensive? What will global demand for antibody drugs be in view of the rising buying power in emerging pharmaceutical ('pharmerging') markets, but which is still not comparable with that of developed ones? What would the next quantum leaps be that might potentially push antibody technology on to a next level by disruptive innovation? Presentations given at the Phacilitate Immunotherapy Leaders' Forum 2012 (9-11 May in Barcelona) reflected on these questions and provided some stimulating perspectives.
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http://dx.doi.org/10.4161/hv.21413 | DOI Listing |
Hum Vaccin Immunother
September 2013
Consultant on International Public Health Organizations for NURON Biotech; Schaffhausen, Switzerland.
Hum Vaccin Immunother
October 2012
BB Biotech Ventures, Zürich, Switzerland.
How to tap into dilutive and non-dilutive funding sources for immunotherapy projects.
View Article and Find Full Text PDFHum Vaccin Immunother
October 2012
Healthcare Equities, Helvea, Geneva, Switzerland.
In the vast area of immunotherapies, the development of monoclonal antibodies as a therapeutic concept emerged as a quantum leap out of the area of traditional vaccines (Köhler and Milstein) in vitro selection and optimisation made it possible to elaborate a single biological molecule from the molecular plethora of an individual adaptive immune response and to utilize such a cloned antibody repeatedly in a generalized fashion whenever the therapeutic indication is given to humans. At present, some 25 therapeutic monoclonal antibodies are currently being marketed in oncology, exceeding sales of USD20bn in 2011. A total of about 270 antibodies are currently in Phase II and III clinical development.
View Article and Find Full Text PDFImmunotherapy
August 2011
Carolina Urologic Research Center/Atlantic Urology Clinics, Myrtle Beach, SC 29572, USA.
The era of active immunotherapy has now been successfully ushered into the clinical realm of advanced prostate cancer. The successful clinical trial development and US FDA approval of sipuleucel-T (Provenge®) has revamped the therapeutic paradigm for advanced prostate cancer. Nonetheless, physician and patient education as well as regulatory pathways and manufacturing efficiencies are still required in order to optimize patient care.
View Article and Find Full Text PDFHum Vaccin
June 2011
ImmunoSite Technologies, Fort Lauderdale, FL, USA.
The utility of functional cell mediated immune assays in the assessment of immune response or immunogenicity is increasing significantly as we search for surrogates to determine vaccine efficacy or therapeutic response. No definitive reports to date have demonstrated that CMI assays in human clinical trials correlate with clinical outcome, although animal and non human primate studies have reported surrogacy in varying degrees. This report discusses the approaches identified, their advantages and disadvantages, and their justification for inclusion in the clinical trial setting.
View Article and Find Full Text PDFEnter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!