Firm hopes to have CLIA-certified Lupus Therasight test available in 2010.

Pikamab negotiated exclusive rights to two U.S. patents held by New York’s Hospital for Special Surgery relating to technologies for determining the occurrence, susceptibility patterns, and severity of lupus and lupus nephritis. The patents are relevant to Pikamab’s theranostic product, Lupus Therasight™, which is being designed to help guide drug development and patient treatment protocols.

One of the two acquired patents covers methods for determining the severity of lupus and lupus nephritis through correlation with FcGR gene polymorphisms. The other patent relates to the use of FcGR-2B promoter polymorphisms to assess the occurrence and susceptibility patterns of lupus in humans.

The Lupus Therasight test will allow the stratification of patients according to their FcGR-3A, 2A, 3B, and 2B polymorphisms, according to Vijay Ramakrishnan, Ph.D., Pikamab founder and CEO. “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. Lupus Therasight potentially can explain why a monoclonal antibody-based lupus drug works in some subsets of patients and not in others.”
Pikamab is now working to validate the Lupus Therasight test for commercial launch, and Dr. Ramakrishnan suggests a CLIA-certifiable test will be available next year for use by physicians as part of routine patient treatment protocols. 

Pikamab also aims to partner with companies involved in the lupus therapeutics field, for the development of new products with the integration of the Lupus Therasight test. “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,” comments Dr. Ramakrishnan.

According to the Lupus Research Institute, estimates indicate that over 1.5 million people suffer from lupus in the U.S. alone. However, there hasn’t been a new drug approved for the chronic autoimmune disease in nearly 50 years.

Hopes for a near-term breakthrough this year were not helped when in February BioMarin Pharmaceutical and La Jolla Pharmaceutical stopped their ongoing Phase III trial with the lupus candidate Riquent® after an interim analysis of efficacy data led the trial’s independent data monitoring board to state that continuing the study would be futile. 

Then in March Genentech and Biogen Idec confirmed that a Phase III trial combining Rituxan® with mycophenolate mofetil (MMF) and corticosteroids in lupus nephritis patients failed to significantly reduce disease activity at 52 weeks.

Within the last few months things have started looking up, however. In July Human Genome Sciences and GlaxoSmithKline reported positive results from the first of two Phase III trials with Benlysta in patients with serologically active systemic lupus erythematosus (SLE). Results from the second Phase III trial are expected in November. The companies say that if this trial is also positive, they project submitting marketing applications in the U.S., Europe, and other regions during the first half of 2010.

In August Immunomedics and Belgium-based UCB also announced positive results from UCB’s Phase IIb study comparing epratuzumab (a humanized anti-CD22 mAb) to placebo in patients with SLE. Epratuzumab was developed by Immunomedics and licensed to UCB in 2006 for all autoimmune disease indications.

The current lupus clinical pipeline also includes Trubion Pharmaceuticals’ SBI-087, a next-generation CD20-targeting drug, developed using the company’s Small Modular Immunopharmaceutical technology. Trubion’s partner, Wyeth Pharmaceuticals, started a Phase I trial with SB1-087 during March in patients with SLE. The drug is also being evaluated in a Phase I study for rheumatoid arthritis (RA).

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