Intravenous Immune Globulin (IVIG) Currently, very large doses of human antibody are used to treat patients when the immune system stops protecting against pathogens, a condition called Primary Immune Deficiency (PID). In this treatment, the patient’s working immune system is augmented/replaced by giving a large infusion of intravenous immune globulin (“IVIG). This treatment is also called Immune Replacement Therapy.
This mainline product, (IVIG), is derived by pooling donations from thousands of people. IVIG, which constitutes roughly 50% of the approximately $25 billion plasma protein worldwide revenue, is primarily utilized to protect people who cannot mount an immune defense against infections. IVIG is also used to treat a number of Auto-Immune, Inflammatory and Neuropathic conditions and is believed to function by effectively “resetting” imbalances in the immune system. In many of these conditions immune globulin is the only product that is known to work and collectively these applications account for over 50% of all the IVIG used.
Hyperimmune Globulin Other immunoglobulin products include Hyperimmune Globulins, which are antibody products intended for a specific immune function or control. Examples of hyper-immune globulin products include snake anti-venom and anti-viral products like hepatitis B HBIG. Further applications are immune control products such as Anti-D (RhoGAM), the product that saved more than 60 million babies. Quotient is fundamentally a Hyperimmune Globulin human antibody company, with the goal of bringing to market a series of totally new products targeting mainline conditions with millions of sufferers.
Natural human antibodies have been given safely and effectively for more than 50 years. These antibodies are approved through a different regulatory pathway than conventional small molecule and manufactured biologic drugs. This is important because natural human antibody-based products (IVIG and Hyperimmune Globulins), which represent more than $25 billion in revenue annually, are known by the FDA and other regulatory authorities to be safe, and therefore can enjoy a more rapid, less costly clinical approval pathway.
Similar to the success of RhoGAM and HBIG, Quotient’s product platform is based on the ability to transfer immediate immunity to patients through administration of a specific blend of antibodies sourced from human donors. This so-called “passive” immune approach is distinct from active immune therapy, which relies on immunizing patients in the hope that their own immune systems will develop the needed immunity over time. Passive immune therapy also differs significantly from the use of monoclonal antibodies, which are engineered molecules produced by fermentation that have limited functionality and potentially serious side effects.