Intellect Neurosciences, Inc, a biopharmaceutical company with an internal preclinical and clinical-stage pipeline and licenses with major pharmaceutical companies covering products in late-stage clinical trials, announced that it has received a Notice of Allowance from the United States Patent and Trademark Office related to RV01 and RV02, the company's two lead vaccine candidates.
The Notice of Allowance is a written communication stating that the patent application has been allowed and will be granted as a new patent. RV01 and RV02, generated using the company's RECALL-VAX technology, have the potential to delay the onset of or prevent Alzheimer's disease in individuals susceptible by age, genetic or other risk factor. Patents previously have been issued in Europe, Australia, New Zealand and South Africa, and patents are pending in Canada and Israel.
Dr Daniel Chain, chairman and chief executive officer of Intellect, commented, "Many view a vaccine of this nature, which is analogous to a flu shot, as the ultimate quest in Alzheimer's research. This new patent should increase interest from potential strategic partners to collaborate Intellect on the RECALL-VAX programme. Alzheimer's disease remains the largest unmet medical need in neurology, with existing Alzheimer's treatments only easing symptoms of the disease. This patent is indicative of the type of innovative research at Intellect aimed at discovering drugs that can fundamentally transform the way Alzheimer's disease is treated and ultimately prevent the onset of the disease. The Notice of Allowance is another important milestone for Intellect. It heralds a bold new approach that may drastically reduce the incidence of Alzheimer's disease for the 115.4 million people who are expected to suffer from the disease by 2050."
Professor Benjamin Chain, Department of Immunology, UCL School of Life and Medical Sciences, London, UK, is the inventor of the RECALL-VAX technology. Professor Chain, brother of Intellect CEO Dr. Daniel Chain, is a member of the Company's scientific advisory board.
Intellect presented the first animal data regarding RECALL-VAX in August 2007 at the 13th International Congress of Immunology in Rio de Janeiro, Brazil. "We demonstrated in preliminary animal studies that we can use this method of vaccination to generate highly specific antibodies in blood that bind A? toxin, which accumulates in the brains of Alzheimer's patients, while avoiding binding to the Amyloid Precursor Protein, which has important physiological functions in the brain and other tissues," added Daniel Chain. "This vaccine could achieve the goal of a safe immunotherapy for Alzheimer's disease, providing prevention in at-risk populations. To the best of our knowledge, no other vaccine in development guarantees specificity for A?, which is necessary to avoid possible toxicities that may manifest over time."
The Alzheimer's toxin A is generated from a much larger protein known as the Amyloid Precursor Protein (APP). APP is widely expressed and especially concentrated in the synapses of CNS neurons and on the surface of blood platelets. Various physiological functions are attributed to APP, including the growth and protection of neurons and wound healing. In 1997, Dr Daniel Chain invented a method, the ANTISENILIN platform, using an administered monoclonal antibody for treating Alzheimer's disease. The goal was to remove A? protein without affecting the normal physiological role of APP.
However, A? is almost identical to APP, making it difficult to achieve the required specificity. Dr Chain overcame this problem by pinpointing the unique molecular signatures at either end of A?, which are not present in APP: the presence of a free amino (NH2) and carboxyl (CO2) group. Major pharmaceutical companies have monoclonal antibodies in phase 2 and Phase 3 clinical trials based on Dr. Chain's invention and have purchased royalty-bearing licenses from the Company. RECALL-VAX is a method to reproduce the same specificity in an active vaccine. The advantage of a vaccine is that it can be administered less frequently and is less expensive than a monoclonal antibody and has the possibility to be used in a larger population than a monoclonal antibody.
Moreover, a vaccine is more easily used as a preventative treatment as well as a therapeutic treatment. After specificity, the primary concern related to using an active vaccine based on an endogenous protein such as A? is the existence of T-cell epitopes that could give rise to an autoimmune response in certain individuals, as occurred previously with the AN1792 vaccine tested by Elan Pharma and Wyeth. Another challenge is overcoming a weak immune system in elderly people. To overcome these issues, RECALL-VAX generates antibodies that are highly specific for A? such that they will not bind to APP, have low potential to stimulate an autoimmune response and stimulate an autoimmune response in elderly patients. The technology utilizes Tetanus Toxoid, previously used in other vaccines in FDA-approved clinical trials, to activate a memory imprint in the immune system, which is expected to overcome the problem of immunizing older people without the need to resort to potentially harmful adjuvants.
Preliminary results demonstrate that mice vaccinated with RECALL-VAX generate antibodies that bind to A?, but not APP. The result could be a safe, efficacious, and cost-effect preventative treatment and therapeutic agent for Alzheimer's disease.
Intellect Neurosciences, Inc. is a Manhattan-based biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic agents for the treatment and prevention of Alzheimer's disease and other disorders.