Lupus
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.