Proprietary Processes Take Center Stage In Therapeutic Vaccine Sector

Main Category: Immune System / Vaccines
Also Included In: Medical Devices
Article Date: 21 Jul 2008 - 1:00 PDT

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Pharmaceutical companies, their investors and their outsource service partners are accustomed to working and thinking in terms of well-defined drugs - APIs or NCEs that can be clearly specified, synthesized, purified and packaged. But as technology advances extend the reach of clinicians, several emerging therapeutic areas are nearing commercial importance - areas that do not fit the traditional 'fire up the pill presses' business model. One of the most colorful, in terms of the wide range of therapeutic approaches, involves therapies that attempt to stimulate the immune system to achieve a positive therapeutic effect against a pre-existing condition using what are known as therapeutic vaccines.

Therapeutic vaccines are currently in clinical development for HIV, Hepatitis and a variety of cancers, as well as other conditions. The major difference among the therapeutic candidates for each indication is the source of the antigen or epitope - that piece of foreign molecule, usually a protein or peptide a few amino acids long, that will allow the patient's immune system to better recognize infected or damaged cells. The processes that create these therapeutic vaccines are usually quite specific, and are critical to the success of the companies that own or license them. In other words, when a drug company partners with, invests in or acquires a therapeutic vaccine maker, the drug company is investing in the process. In essence, for several emerging therapeutic segments the process is becoming the new API.

Of all the activity in therapeutic vaccines, those designed to upregulate the immune system against cancer are the most advanced and diverse. Therapeutic cancer vaccines currently winding their way through the clinical trial process include antigen presenting cells containing patient tumor fragments or RNA, viral vectors modified to express cancer epitopes, fusion proteins, hybridomas, whole tumor cells that are processed in vitro and re-injected into the patient, and at least fifteen other distinct approaches to antigen-specific immune stimulation.

While therapeutic cancer vaccines have historically endured a string of clinical disappointments, participants have gained from their experiences, making meaningful adjustments, particularly in the area of trial and protocol design. The result is an increasing number of vaccines moving into late-stage development. Regulatory attitudes toward therapeutic cancer vaccine clinical trials are also continuing to evolve, as indications surface that traditional trial end points that focus on the vaccine's effects on the tumor are not adequately measuring true patient benefit.

These findings are contained in a new and comprehensive report: Therapeutic Cancer Vaccines: Evolving Strategies & Pipeline Prospects. Researched and written by Immune Science Associates, a premier immunology consultancy, the report is available from Greystone Associates.

More information is available at www.greystoneassociates.org/Cancer_Vaccines.htm

About Immune Science Associates

Immune Science Associates specializes in assisting life science sector participants seeking to commercialize therapeutic and diagnostic products in the areas of immunology, inflammation, infectious diseases, therapeutic vaccines and transplantation. Our practice areas are designed to address the essential business factors and technology risk elements that can determine the successful commercialization of new and emerging products that are based on immune factor components and the immune cascade.

About Greystone

Greystone Associates provides technology and market research publications that are designed, researched and written to provide timely and insightful information and data on focused market segments, with the aim of providing market participants with the essential knowledge to refine and execute their marketing plans and financial targets.

Greystone Associates

www.greystoneassociates.org