PIKAMAB obtains U.S. patent rights to develop theragnostic product

Oct 15 2009

PIKAMAB, a stratified medicine biopharmaceutical company, announced today that it has secured exclusive rights to two issued U.S. patents from Hospital for Special Surgery, New York. PIKAMAB is developing Lupus Therasight^TM, a novel theragnostic product that will eventually help guide the drug development process and patient treatment protocols in the areas of lupus and lupus nephritis.

“We are incredibly pleased to secure these rights from HSS, a global leader in the areas of rheumatology and lupus research. Some of the seminal contributions such as the first demonstration of impaired clearance of immune complexes in SLE patients, the identification of the role of Fc receptors in phagocytosis, and the identification of FcGR-2A as the first human lupus gene were made by HSS investigators,” said Vijay Ramakrishnan, Ph.D., Founder and CEO of PIKAMAB.

The U.S. patent 5,830,652 provides methods for determining severity of lupus and lupus nephritis by correlating to the functional polymorphisms in FcGR genes. The U.S. patent 7,022,476 provides the use of FcGR-2B promoter polymorphisms to assess the occurrence and susceptibility patterns of lupus in humans. One of the polymorphisms (-343 C/C) in FcGR-2B is enriched in lupus patients of European descent.

“Lupus Therasight is a proprietary approach to stratify patients based on the FcGR-3A, 2A, 3B, and 2B polymorphisms. These polymorphisms, when collectively correlated, should provide a deeper understanding on the mechanism of onset and progression of lupus and lupus nephritis, and can determine the severity of these diseases in patients irrespective of their ethnicity. The test, which includes a functional assay, can provide significant clues with regard to the progression and severity of these diseases in these patients over a period of time. We intend to quickly validate the test for the commercial launch,” explained Ramakrishnan.

“Lupus Therasight is an important step forward in pharmacogenetics and the application of human genetic variation to personalized medicine,” said Robert P. Kimberly, M.D., Professor of Medicine at the University of Alabama at Birmingham and Director of the UAB Comprehensive Arthritis, Musculoskeletal and Autoimmunity Center. Dr. Kimberly is a co-inventor of the U.S. Patent 5,830,652 that was developed while he was a Professor of Medicine at HSS. He is also a member of the Advisory Board of PIKAMAB, and has an equity stake in the Company.

Jane E. Salmon, M.D., Co-Director of the Mary Kirkland Center for Lupus Research at Hospital for Special Surgery, is also a co-inventor of the U.S. Patent 5,830,652.

For more than 30 years, no new therapy has been approved to treat these disorders. Although several antibodies (and biologics) and small molecule drug candidates are at various stages in clinical trials, the attrition rate is extremely high. “Lupus Therasight is a simple and yet transformative framework to better understand a complex disease such as lupus,” noted Ramakrishnan. The test is expected to have immediate applications in drug development, and can provide qualitative and quantitative aspects of lupus/lupus nephritis in a given patient: the number, severity, progression, and duration of symptoms.

“We need to know why a patient responds (or does not respond) to a lupus therapy,” said Ramakrishnan. For instance, rituximab (trade names: Rituxan and MabThera) failed in two separate Phase II/III and Phase III clinical trials in lupus and lupus nephritis, respectively. With antibody therapies (and Fc-fusion proteins), a one-size-fits-all approach may not work in these indications. Lupus Therasight potentially can explain why a monoclonal antibody-based lupus drug works in some subsets of patients and not in others.

“By partnering with biopharma companies that are involved in lupus drug development, PIKAMAB intends to develop combination products by integrating Lupus Therasight. This theragnostics-guided stratified medicine approach provides significant benefits to all the stakeholders: patients, physicians, payers, regulatory agencies, and biopharma companies. The Company is also developing a CLIA-certifiable test, which will be available next year to enable physicians and payers to incorporate Lupus Therasight as part of routine patient treatment protocols,” commented Ramakrishnan.