ImmunogenX Completes CypCel Trial for Celiac Disease

Further validation of minimally-invasive monitor of celiac villous
intestinal health

NEWPORT BEACH, Calif.–(BUSINESS WIRE)–ImmunogenX and the Mayo Clinic are pleased to announce the completion of
a longitudinal study to further evaluate a disease management tool for
monitoring the intestinal health of recovering celiac disease patients.
The method, which we call CypCelTM is based on a drug
biomarker simvastatin, a cholesterol reducing medication, that has the
unusual property of being highly metabolized in the small intestine by
the enzyme CYP3A4, which is expressed on the villi. The patient ingests
a simvastatin tablet and then provides a blood sample at two later time
points. The concentration of the simvastatin in the blood samples is
directly related to the villous health of the patient; in patients with
healthy villi a high rate of metabolism leads to reduced concentration
of simvastin in the blood samples whereas in patients with damaged
villi, the converse is true. Simvastatin levels measured in individuals
at periodic intervals therefore can monitor progressive changes that are
indicative of whether a treatment, such as a gluten-free diet, is

The Mayo study was conducted on newly diagnosed and long-term healed
celiac disease patients as well as non-celiac healthy control subjects.
The results showed a trend toward systematic improvement in villous
health in newly diagnosed patients adhering to a gluten-free diet
whereas the other cohort groups representing healthy villi showed
negligible further improvement as expected. These results are consistent
with a previous published study (Moron, Am J Gastroenterol 2013). This
work was selected for an oral presentation at the revered Tampere Celiac
Disease Symposium 2018 held in Tampere, Finland from September 13-15,

“We are very excited to be developing this new diagnostic method, which
serves as an alternative to an expensive and invasive biopsy” states Dr.
Jennifer Sealey Voyksner, CSO of ImmunogenX. She further adds “This
method also makes use of a novel mass spectrometry analysis developed in
our laboratories.”

Dr. Joseph Murray of the Mayo Clinic and the principal investigator of
this project remarks “There is a great need to develop a routine
diagnostic to monitor changes in the histology of celiac patients. We
were pleased to lead on this study and look forward to further
development and bringing this diagnostic into clinical practice.”

About ImmunogenX

ImmunogenX (a subsidiary of Immunogenics LLC) is a clinical-stage
biotherapeutics company founded in 2013 and is supported by a team of
world-renowned clinicians, scientists and advisors in celiac disease
research. The company is developing Latiglutenase for celiac disease
therapy. ImmunogenX is also developing a minimally-invasive diagnostic
tool for celiac disease management (CypCelTM) based on a
clinically relevant metabolic marker compound that can assess the state
of recovery of a celiac patient adhering to a gluten-free diet or other
treatment. For food safety, ImmunogenX is pioneering advanced mass
spectrometry methods to identify and measure physiologically relevant
gluten peptide sequences found in wheat, barley, and rye.


Matthew Dickason, COO
949 679-0900