US biopharmaceutical companies are using biological processes to develop 907 drugs and vaccines targeting more than 100 diseases, according to new industry data.The report, from the Pharmaceutical Research and Manufacturers of America (PhRMA), says that these products, which are all now either in human clinical trials or under review by the Food and Drug Administration (FDA), include the following, by therapeutic category:
- 338 cancer therapeutics that target several different types of solid tumours, leukaemia and lymphoma. Monoclonal antibodies (mAbs) account for 170 of these products;
- 176 candidates in development for a range of infectious diseases, including 134 vaccines;
- 71 medicines for autoimmune diseases including lupus, multiple sclerosis and rheumatoid arthritis;
- 58 treatments for cardiovascular diseases such as congestive heart failure and stroke; and
- other diseases including diabetes, digestive disorders, genetic disorders, neurologic and respiratory conditions.By product type, the 907 products include: antisense - 30; - cell therapy - 69; - gene therapy - 46; - mAbs - 388; - recombinant proteins - 93; - vaccines - 250; and 81 others.
The greatest amount of research currently underway is in mAbs - 338 are in development - and vaccines, with 250 in clinical trials or under review at FDA.
Among the mAb treatments now in the pipeline are:
- a mAb designed to block the IL-13 cytokine, a protein messenger between cells that triggers inflammation. Blockage of IL-13 may reduce the risk of asthma and other respiratory diseases;
- a mAb that targets B-cells that cause the immune system to turn against itself and produce antibodies against the body's own cells and tissue;
- a mAb for the treatment of psoriasis. This is an engineered human antibody to interleukin-17 (IL-17), a key cytokine involved in inducing and mediating inflammation associated with psoriasis;
- a mAb directed against interleukin-6 (IL-6) alpha, a signalling protein involved in the regulation of immune and inflammatory responses associated with rheumatoid arthritis. The mAb interrupts the inflammation signalling cascade of IL-6 by blocking its binding to a certain receptor necessary for inflammatory cascade; and
- a mAb for potential use in the regeneration of corticospinal tract fibres resulting from acute spinal injury. The antibody neutralises a protein that inhibits growth of spinal fibres.
Other advanced products now in the pipeline include:
- a third-generation antisense medicine for the treatment of lymphoma. It inhibits production of a specific protein which regulates many key genes important in cancer growth - angiogenesis, cell metabolism, cell proliferation, cell death and cell invasion;
- a virus-based therapeutic vaccine for the treatment of melanoma. It is genetically-modified to replicate selectively in tumour cells and express a gene for an immune-stimulating protein; and
- an immunotherapeutic designed to train the immune system to recognise and eliminate cancer cells in a highly specific way. The medicine is a combination of tumour antigens, delivered as recombinant proteins, and a proprietary adjuvant to stimulate the immune response to cancer cells.