Therapeutic vaccines promise a new wave of highly potent and highly specific therapeutic agents designed to work in harmony with patients' own immune systems. Recent advances in the understanding of the human immune system and in technical capabilities have allowed vaccines to move beyond pre-emptive (prophylactic) immunization and into treatment of established diseases. In April 2010, Dendreon's Provenge became the first ever cancer vaccine to be approved by the US Food and Drug Administration (FDA), overcoming skepticism in the investment community and paving the way for a new generation of biological therapies.
This report explains what therapeutic vaccines are, how they work, and why drug developers around the world are using this approach to address everything from allergies to literally every kind of cancer. More than 70 new proprietary technologies are named and explained, with details of licensing deals and intellectual property positions.
The newest wave of drug candidates based on these technologies can be seen in more than 130 early pipeline candidates, each based on a commercial company or research institute known to have carried out preclinical and/or Phase I trials of at least one therapeutic vaccine candidate in the past year. By way of background, later stage candidates being developed by the same companies are also discussed. In total, more than 270 therapeutic vaccine candidates are identified in this report. Finally, prospects and challenges for the future of this field are discussed, with opinions from around 20 prominent industry leaders and academic researchers.
Key features of this report
• ‘Beginners guide' to vaccines and the human immune system, illustrated with original full-color diagrams, to show the potential challenges and benefits of therapeutic vaccination.
• More than 70 descriptions of proprietary technologies currently in use around the world to design, produce and administer therapeutic vaccines.
• A comprehensive guide to companies around the world that are currently developing brand new therapeutic vaccines (i.e. candidates in preclinical or Phase I clinical trials).
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• Details of more than 270 specific vaccine candidates, in development by around 120 different companies and research institutes.
• Expert opinions on the opportunities, challenges and future trends in the monoclonal antibody field from around 20 industry leaders and academic researchers, over a dozen of whom were contacted directly and interviewed for this report.
Scope of this report
• Understand the basic qualities of vaccines and how these qualities translate into unique medical and commercial features for therapeutic candidates.
• Appreciate the challenges and risks of therapeutic vaccines, as well as their promise.
• Assess emerging technologies for possible investment or in-licensing.
• Identify which companies are involved in this field, and what they are doing.
• Predict the kinds of drug that may reach the market over the next ten years.
• Tailor your own company's strategies to take advantage of upcoming opportunities, such as the validation of new technologies in human patients.
Key Market Issues
• Therapeutic vaccines hold the potential to address diseases with a high unmet need for effective, i.e. markets that are currently under-penetrated.
• Much like monoclonal antibodies, the inherent specificity of vaccines may shorten drug development times and increase rates of success in preclinical and clinical trials, now that the intricacies of the human immune system are better understood.
• The recent US approval of Dendreon's personalized cancer vaccine Provenge has established a precedent and a recognized path to regulatory approval for therapeutic vaccines.
• Newer technologies target the same basic immune system processes as Provenge, but may result in cheaper and more broadly applicable therapies.
Key findings from this report
• New technical capabilities and better understanding of the human immune system has recently allowed vaccination approaches to be applied to therapeutic settings as well as prophylaxis.
• Demand for therapeutic vaccines is high, and profits from launched drugs are expected to achieve ‘blockbuster' levels (billions of US dollars per annum).
• Treatment of established diseases requires different immune reactions to protective (prophylactic) immunity, to overcome existing disease burdens and immuno-avoidance mechanisms, so immune responses must be ‘modulated' rather than just stimulated.
• Many new candidates use multiple ‘antigen' targets, or multiple variants of a single target, to address heterogeneity in both disease targets and patients' immune systems.
• Vaccine approaches can also be used to inhibit immune responses to specific ‘antigens', making them useful for treating allergies, autoimmune diseases and transplant rejection.
• Various vectors (carriers) and adjuvants (immunostimulators), each with their own benefits and drawbacks, are being used to enhance the delivery of vaccine antigens to target immune cells and to modulate the strength and type of immune responses that result.
