Businessweek

TNI BioTech, Inc. operates as a specialty pharmaceutical company. The company’s products, technologies and patents are designed to harness the power of the immune system to improve the treatment of cancer, and autoimmune diseases. The company’s clinical programs involve immunotherapy using Met-enkephalin (MENK) and low dose naltrexone (LDN). Both immunotherapies work by triggering opioid receptors on immune cells leading to an activation and expansion of various cells of the immune system. Patents and Licenses The company has been developing active and adoptive forms of immunotherapies through the acquisition of patents, Investigational New Drugs (INDs), clinical data and all proprietary technical information, know-how, procedures, protocols, methods, prototypes, designs, data and reports which are not readily available to others through public means. The company’s patents and intellectual property includes the specific application of Met-enkephalin (MENK) as a treatment for cancer, HIV/AIDS, and infectious diseases. MENK is a member of the body of hormones known as cytokines which are produced by the immune system. MENK plays an essential role in influencing all components of the immune system. The most important participant in the immune response is a class of white blood cells known as lymphocytes. These cells develop in the bone marrow and are released into general circulation. The company also holds patents granted for cancer treatments and an adjunct to patents for autoimmune diseases including: European Patents in the United Kingdom, Germany, France, and Ireland covering an enkephalin peptide composition; a Russian Federation Patent covering BI Methods for inducing sustained immune response; and Government of India Paten for an enkephalin peptide composition. The company also signed an exclusive licensing agreement for all of the intellectual property developed at Pennsylvania State University for the treatment of cancer. The patents cover methods and formulations related to the treatment and prevention of cancers, particularly gastrointestinal cancer. The company also acquired the licensing rights to the patent portfolio and intellectual property relating to treatments with drugs that interact with opioid receptors such as low-dose naltrexone (LDN) and MENK for a variety of diseases and conditions, including malignant lymphoma, chronic lymphocyctic leukemia, Hodgkin’s lymphoma, and non-Hodgkin’s lymphoma, chronic herpes virus infections, and chronic infections due to the Epstein-Barr virus and a treatment method for humans infected with HTLV-III (AIDS) virus, including patients clinically diagnosed as suffering from HIV/AIDS and those suffering from HIV/AIDS-related complex (ARC). Products IRT-101 is an active immunotherapy systemic administration of MENK that works by activating a patient’s immune system against infectious diseases and tumor cells. This is accomplished by increasing the number of T-cells and NK cells, NKT and gamma/delta T-cells that destroy infective organisms and tumor cells, while simultaneously inhibiting T regulatory cells. IRT-102 is an adaptive immunotherapy that works by isolating and elevating a patient’s own immune cells and following an enriching external incubation, transfusing them back into the patient. This provides the patient with a passive immunity containing large amounts of auto-amplified immune cells that combat cancer cells. TNIB is advancing LDN as an active immunotherapy that works by modulating a patient’s immune system. For treatment against HIV/AIDS or tumor cells, LDN appears to increase enkephalin receptors on immune cells and also increases endogenous levels of enkephalins and endorphins, resulting in an increased number of T cells and NK cells, which are then mobilized to destroy infectious organisms and tumor cells. LDN also modulates the immune system in patients with various autoimmune diseases, such as Crohn’s disease and multiple sclerosis, by reducing pro-inflammatory cells and cytokines in the areas of active disease. Strategy The company’s business strategy focuses on four areas: the establishment of treatment facilities throughout Africa, the Caribbean and South America for cancer, HIV/AIDS and other autoimmune diseases that can benefit from IRT-101, IRT-102 and IRT-103 patented technology and therapies; the large scale treatment of HIV/AIDS and immune-enhancing therapy using IRT-103; the large scale manufacturing and distribution of IRT-103 LDN, either in pill form, or cream for those unable to handle the medication in pill form, throughout Africa and expanding to other developing nations; and the Joint Venture with the Hubei Qianjiang Pharmaceutical Company that would provide the funding required for the phase III trials in China in exchange for TNIB providing exclusive licensing rights in China. Competition The company’s competitors include Abbott Laboratories; Amgen; AstraZeneca; Biogen Idec; Bayer; Elan; Johnson & Johnson; Merck; Merck Serono; Takeda; Novartis; Pfizer; Reata; Sanofi-Aventis; and Teva.