Bioprocessing encompasses many different types of product. Rob Williams, Ph.D., head of development projects at Cancer Research UK, said that cancer is the biggest area for drug discovery and development with potential therapies now including vaccines, targeted small molecules, antibodies, and siRNA—and there is also a huge emphasis on biomarkers.
“Many believe that therapeutic vaccines are the holy grail in cancer,” he said. “This is a huge interest area because of relatively low cost and the specific ability to target a disseminated disease.”
Cancer Research UK spent £333 million ($474.5 million) on research in 2007–2008 and is currently involved in several cancer vaccine projects.
One is a the MFEz T-cell Phase I study that involves the adoptive transfer of autologous tumor antigen specific T cells with preconditioning chemotherapy and intravenous IL-2 in patients with advanced carcinoembryonic antigen positive tumors. In the future, Dr. Williams thinks there will be more patient stratification using biomarkers for both clinical trials and disease management and increased use of flexible trials rather than the conventional Phase I/II/III paradigm.
A key message from the TGN 1412 catastrophic incident that occured in 2006 is that studies in nonhuman primates will not always predict a safe starting dose in man when a novel agent is concerned. Therefore, Cancer Research UK has started various clinical trials on novel agents using different data such as surrogate antibodies, knock in/out animal models, and human cells as a preclinical package.
Duncan Casson, Ph.D., COO of PanGenetics, said that TGN 1412 had been the 9/11 of antibody development; security and regulation have become even more stringent since.
PanGenetics was launched in 2005. PG102, its lead compound, is an anti-CD 40 antibody with a unique mode of action for autoimmune, rheumatoid arthritis, and Crohn’s disease, Dr. Casson noted. The company is also working on PG110 an anti-NGF antibody for chronic pain. “Most antibody companies set up a platform and take everything forward,” he said. “We turned this on its head and went for the low risk ones, PG 102 and PG110.”
Time to clinical proof-of-concept is increasing because of an increase in the regulatory burden and a scarcity of biologics-naive patients and of reliable and competent contractors, Dr. Casson added.