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ImmunogenX Receives Major Grant from the National Institutes of Health (NIH) to Conduct a Clinical Trial for Latiglutenase

April 9, 2019 Off By BusinessWire

The study will further advance an unmet therapeutic need for celiac
disease

NEWPORT BEACH, Calif.–(BUSINESS WIRE)–The NIH’s National Institute of Allergy and Infectious Diseases (NIAID)
has awarded a grant to ImmunogenX to conduct a Phase 2 trial for
latiglutenase, an investigational drug for celiac disease (CD). The
study will be conducted at multiple study centers including the Mayo
Clinic (Rochester, MN) and Columbia University (New York, NY). The main
focus will be symptom relief in CD patients who continue to exhibit high
gluten-induced antibody levels (seropositive) despite strict adherence
to a gluten-free diet (GFD). The primary outcome measure will be the
FDA-reviewed and trial-tested Celiac Disease Symptom Diary^©
(CDSD^©)patient-reported outcome (PRO) instrument
for CD symptoms.

This NIH grant was awarded as part of the Small Business Innovation
Research (SBIR) program and is notable for being a Fast-track
application in which both the Phase I and II work is approved and at the
highest funding level allowable due to an application addressing a
critical topic area.

The Co-Principle Investigators on the project are Joseph A. Murray MD of
the Mayo Clinic and Jack A. Syage PhD of ImmunogenX. These individuals
have jointly conducted trials in the past and present for an ImmunogenX
diagnostic technology for monitoring intestinal health (CypCel™) as well
as for latiglutenase.

“We are very excited that NIAID recognizes the importance of this work
by awarding a very competitive Fast-track grant. We hope to be a beacon
for the positive use of public funds for society’s benefit by conducting
this therapeutic trial to address a critical unmet need for the
management of celiac disease,” remarks Jack Syage PhD, CEO of ImmunogenX.

Dr. Peter H.R. Green, MD of the Columbia University Celiac Disease
Center adds, “So much is needed to relieve the pain and misery of celiac
disease patients. We are gratified to be working with ImmunogenX to
further develop this promising therapeutic candidate that is critically
needed for these long-suffering patients.”

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
(CypCel™) 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.

www.immunogenx.com