Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that can affect various parts of the body including blood, kidneys, skin, and joints. Approximately one-third of SLE patients will develop lupus nephritis.

With approximately 16,000 new cases of lupus diagnosed each year, it affects a total of 1.4 million people in the United States.   Currently there is no cure for SLE.  In more than 30 years, no new therapy has been approved.  Rituxan^®(rituximab) failed to meet all primary and secondary endpoints in two separate Phase II/III and Phase III clinical trials in SLE and lupus nephritis, respectively.

FcGR polymorphisms are directly involved in the development of SLE and lupus nephritis. The susceptibility of patients to these diseases, as well as their progression and severity, are correlated to these polymorphisms. By leveraging our unique proprietary position in the FcGR polymorphisms landscape, PIKAMAB is well positioned to develop both theragnostic tests and customized antibody therapies to treat SLE and lupus nephritis.

Strategy

Initially, Lupus Therasight will be made available to PIKAMAB partners in conjunction with their product development programs. By partnering with biopharma companies, our theragnostic test will be co-developed with MAb candidates as combination products (Drug + Theragnostic Test). We are also entering into collaborations with both academic groups and others to make available this theragnostic product in conjunction with currently marketed therapies.

Based on systematic retrospective and prospective analysis of clinical trials, our tests are being developed as stand-alone products to be incorporated into drug treatment protocols for already approved MAb therapies.

The severity of the lupus disease can be mild, moderate, severe, or life threatening.  Immune complexes are deposited in nearly every organ in the body including heart, lungs, blood vessels, joints, kidney, skin, liver, nervous system, and brain.

Some of the more serious complications involving major organ systems include:

• Inflammation of the kidneys (lupus nephritis), which can affect the body’s ability to filter waste from the blood and can be so damaging that dialysis or kidney transplant may be needed;
• An increase in blood pressure in the lungs (pulmonary hypertension);
• Inflammation of the nervous system and brain, which can cause memory problems and strokes;
• Inflammation in the brain’s blood vessels, which can cause high fevers, seizures, behavioral changes; and
• Hardening of the arteries (coronary artery disease), which is a buildup of immune complex deposits on coronary artery walls that can lead to heart attack.

Lupus Therasight is used to determine Lupus Severity Index. Based on a series of assays, a Lupus Severity Index is generated for a given patient. This index provides biopharma companies, payers, and physicians the critical guidance as to how well each patient will respond to a therapy, as well as the progression and severity patterns of lupus and lupus nephritis over years.