Op-T-Mune, Inc — Department of Health and Human Services STTR Phase I: NIAID

Description

Multiple Sclerosis is an inflammatory neurodegenerative disease with autoimmune components that exacerbate and potentially initiate the disease Diagnosis is invasive time consuming relatively expensive and extremely difficult In fact no clear diagnostic test yet exist A major concern is that MS symptoms are identical to the symptoms of numerous other neurologic diseases OND as well as some infectious diseases thus making diagnosis particularly tricky The disease occurs in different courses including relapsing remitting and progressive forms The etiologies of disease and progression are unclear Autoimmune components define MS from OND and became better understood through the EAE mouse model The central problem has been defining a reliable biomarker for pathogenic cells We described a unique T cell subset Th cells CD CD T cells that are highly auto aggressive We compared Th levels in peripheral blood of patients with clinically isolated syndrome CIS relapsing remitting RRMS secondary progressive SPMS and primary progressive PPMS disease to non autoimmune controls MS subjects demonstrate significantly increased percentages of Th cells In reverse translation studies we confirmed the role of Th cells as disease causing in EAE The role of CD is well established in MS We are proposing that a screening platform for MS can be generated based on CD and CD co staining Using antibodies for those molecules we can show that CD CD cells are significant in MS compared to non autoimmune controls Antibody staining is problematic requiring consistent compensations during detection We created a series of peptides based on the CD the major ligand for CD sequence We determined that some of those peptides bind directly to CD and importantly when the antibodies are fluorescently tagged the peptides discern CD cells From that data we propose that these peptides can be used to create a screening platform for the autoimmune component of MS This technology would create not only a new test to distinguish MS from OND and infectious disease but a new way to stain cells Therefore the commercial opportunity is high for neurology and for staining product development If successful this screening platform could distinguish MS This product has high significance given the high possibility for misdiagnosing MS Extension of the product may be a means to predict MS progression and to confirm disease modulating therapy efficacy Narrative An efficient effective screen for MS does not exist We propose that by staining CD and CD as an autoimmune biomarker we can discern MS from other neurologic disease and infectious disease this would drastically improve MS diagnosis including improving false positive and false negative diagnoses We also have created a completely novel approach to cell stains using specially targeted peptides