Report on immunotherapies and vaccines for nontraditional indications

December 02, 2015

Immunotherapies (including antibodies and vaccines) are also being developed for treatment of different cardiovascular disorders. These are discussed in Chapter 5. The targeted cardiovascular disorders include angina, atherosclerosis, dyslipidemia, hypertension, venous thromboembolism, and digoxin toxicity. Chapter 6 discusses the development and use of immunotherapies for hematological disorders including idiopathic (immune) thrombocytopenic purpura (ITP), paroxysmal nocturnal hemoglobinuria (PNH), and Rh incompatibility and hemolytic disease of the newborn (HDN).

Antibodies can also be used for treatment of ophthalmic diseases. As discussed in Chapter 7, Lucentis (ranibizumab) is an antibody fragment that binds to and inhibits VEGF. It is FDA approved for treatment of neovascular (wet) age-related macular degeneration. It is also in late-stage clinical development for additional ophthalmic indications. A human monoclonal antibody against VEGF, Genentech's/Roche's Avastin (bevacizumab), is FDA approved for treatment of colorectal cancer, non-small cell lung cancer, breast cancer, and glioblastoma. While Avastin is not approved for treatment of wet AMD, it is also used for this indication. Other examples of ophthalmic diseases for which antibodies are being developed include diabetic retinopathy and diabetic macular edema, retinal vein occlusion, and uveitis. Chapter 8 discusses the development of antibodies for treatment of osteoporosis and other bone metabolism disorders. The most advanced of these is Amgen's denosumab, which is a human monoclonal antibody that targets the receptor activator of nuclear factor kappa beta ligand (RANKL). Denosumab has been submitted to the FDA. Ablynx (Belgium) is developing nanobodies that target RANKL. These are in preclinical development. In addition, Amgen (with UCB Pharma) is also developing Sclerostin Ab, a humanized antibody that targets the protein sclerostin.

In addition, multiple monoclonal antibodies are being developed for treatment of type 2 diabetes. Three companies are developing antibodies that target IL-1 beta, a pro-inflammatory cytokine that stimulates the immune response. The second molecule being targeted by a monoclonal antibody in development for type 2 diabetes is the glucagon receptor. These are discussed in Chapter 9. In addition to all of these activities in neurology, cardiovascular disease, hematology, ophthalmology, osteoporosis, and type 2 diabetes, many additional antibodies, antibody-based drugs, and other immunotherapies/anti-inflammatory drugs are being developed to treat a wide range of indications. Several examples of those that have reached clinical development are discussed in Chapter 10, and even more are included in the table that accompanies Chapter 10. This report also includes seven interviews with experts in the application of antibodies, antibody-derived therapies, and vaccines to the treatment of various diseases included in this study. These experts discuss the progress, challenges, and hurdles faced by researchers and companies working in this field.

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