Feb2011ImmusanTexexecsummary
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8/6/2019 Feb2011ImmusanTexexecsummary
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Intellectual PropertyImmusanT owns one and has exclusive licenses to three patents enabling diagnost
therapeutics based on the gluten peptides recognized by the disease-causing T cells in celiac
in the major global markets.
Executive SummaryImmusanT, Inc. is revolutionizing the diagnosis and treatment of celiac disease, which
approximately 1% of the population and currently has no pharmacological treatment. The Comharnessing the specificity of the immune reaction to gluten (protein in wheat, rye and ba
develop diagnostics and therapeutics. The Companys new treatment paradigm for celiac
leverages the immune response to gluten to isolate three toxic peptides responsible for the d
to the intestinal lining and for the alteration of nutritional absorption. ImmusanTs Founding S
along with his colleagues at Walter and Eliza Hall Research Institute and Oxford University
more than 200 celiac disease patients to elucidate the pathologic peptide epitopes. N
ImmusanTs peptide based immunotherapy, is designed to desensitize individuals with celiac
to the toxic effects of gluten allowing them to return to a normal diet, good health and im
quality of life.
ImmusanT Inc.
sanT, Inc. is a privately held emerging
chnology company focused on restoring
nce to gluten in celiac disease by harnessing
discoveries in immunology that improve
osis and treatment and return patients to a
al diet, good health and improved quality of
The Company, that acquired the technology
Australia based Nexpep Pty. Ltd., has a strong
ectual property position and foundational
e which provides the basis for their peptide-
immunotherapy and diagnostics.
sanT, Inc. is a Delaware Corporation with
s in Cambridge, MA.
on Statement
sanT seeks to restore tolerance to gluten in
nts with celiac disease.
ders & Team
J Williams, BS, RN. MBA
dent & CEO
nderson, MB, ChB, BmedSc, PhD FRACP
& CMO
ead, Autoimmunity & Transplantation
Walter and Eliza Hall Institute
y Matteodo
tific Advisors/Consultants
Tye Din, MB, BS, PhD FRACP
ific Consultant
r and Eliza Hall Institute, Melbourne, AU
Jabri, MD, PhD
r Scientific Advisor, Chicago, IL
ku Maki, MD, PhD
r Clinical Advisor
Binder, PhD
r Scientific/Technical Advisor
tific Advisory Board
nderson, MD, PhD
r and Eliza Hall Institute, Melbourne, AU
Binder, PhD
der, INOVA Diagnostics (acquired by Werfen
p)
Green, MD, Professor of Clinical Medicine,
mbia University, New York, NY
Jabri, MD, PhD
rsity of Chicago, Chicago, IL
n Kelly, MD, Professor of Medicine,
srael Hospital; Harvard University, Boston, MA
Lundin, MD, PhD, FACP (Hon)
oenterologist/Immunologist, Rikshospitalet
rsity of Oslo
ku Maki, MD, PhD, Professor of Pediatrics,
rsity of Tempere, Finland
h Murray, MD, Professor of Medicine, Mayo
Rochester, MN
elle Pietzak, MD, Pediatric Gastroenterologist,
ens Hospital
ngeles, CA
DDDOOOMMMIIINNNAAANNNCCCEEEIIINNNIIIMMMMMMUUUNNNOOOTTTHHHEEERRRAAAPPPYYY
One Broadway, 14th
Floor
Cambridge, MA 02142
617-401-2154 www.immusan
617-515-6755
Pathogenesis of Celiac Disease Central role of T-Cells
T-Cell Mediated Immune DiseaseCeliac disease is the first human immune disease for which there is comprehensive
understanding of the pathogenic T-cell response. ImmusanT has translated the
scientific discovery of immuno-dominant T-cell stimulatory gluten peptides into
valuable diagnostics and therapeutics for patients with celiac disease. It is believed
that upon repeated Nexvax2 dose administration, the number of gluten-specific T
cells capable of triggering a pro-inflammatory response will subside and regulatory
suppressor T cells will increase in number to establish tolerance to dietary gluten.
Tolerance is non-responsiveness to a specific antigen. Tolerance to an immune-
dominant gluten epitope is induced by administration of Nexvax2 peptides in the
absence of a second, T cell co-stimulatory, signal (danger signal). Nexvax2
peptides, delivered intradermally in small doses, re-programs/desensitizes the
disease causing T-cells. Because Nexvax2 is delivered in low doses without
adjuvant, T cell recognition will occur in a non-inflammatory environment and
responding CD4 T cells in celiac disease patients will be suppressed or undergo a
phenotypic change to a suppressor regulatory T cell phenotype.
ImmusanTs therapeutic focus - Peptide-based therapy
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8/6/2019 Feb2011ImmusanTexexecsummary
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arket Opportunityac Disease, also known as celiac sprue, is an inherited
oimmune disorder triggered by the consumption of foods
taining gluten, a cereal grain protein. It is a lifelong disease with
et in early childhood. The chronic inflammation of the intestine
this disease is caused by the immune response to gluten.
ecognized, celiac disease is a major contributor to poor
cational performance and failure to thrive in children. Untreated
ease is associated with other health conditions from IBS, bone
, anemia, chronic fatigue and diarrhea, to liver disease, infertility
cancers.
ac disease affects about 1% of the population globally (25.5M
ple; 7.5M in developed countries) and has historically been
er-diagnosed with no available drug therapy. The only option
most celiac patients is to eliminate gluten from their diet.
wever, that is not easy given that it is found in many foods. It has
n predicted that 50-60% of affected patients will be diagnosed in
eloped countries by 2019, creating a potential pharmaceutical
rket worth US$8 billion.
chnology Opportunity and Company Vision
celiac disease market is untapped and has significant growthential due to the high level unmet need. The recognition that
ac disease is an autoimmune disease (effect of gluten on the
stine is akin to what type 1, autoimmune, diabetes is to the
creas) that has serious long term complications if untreated, has
to increased awareness of this pathology.
musanT has a three prong strategy: increase awareness through
reach programs, enhanced diagnostics and biomarkers that
rove diagnosis and management of the disease, and a therapy
t directly targets the immunologic cause of this condition.
musanTs lead therapeutic vaccine, Nexvax2, is a combination of
ee proprietary peptides. ImmusanT has a commercial agreement
h INOVA Diagnostics to fund research aimed at discovering and
eloping new serology diagnostic screening tests for celiac
ease. In parallel ImmusanT is developing a novel functional T-cell
to diagnose and monitor optimal maintenance of immune
rance with peptide based therapy (Nexvax2).
musanTs lead product, Nexvax2, a therapeutic vaccine, is in
elopment and ready to advance to a Phase IIa clinical trial
ing completed:
Pre-clinical program
GMP drug manufacture
Pharmacokinetics and Toxicology conducted in rats Preclinical proof-of-concept in transgenic mouse model
Phase I First in human study: safety, tolerability & bioactivity
musanT will continue to advance their pipeline and expand the
ent portfolio internally and with academic collaborators. The
gress made in understanding, treating, preventing, and
gnosing celiac disease with peptides has major implications for
er autoimmune diseases and allergies. The Company intends to
tegically collaborate with leading pharmaceutical companies to
ance and expand their product portfolio.
Product Pipeline
ImmusanT Value Proposition:
Proprietary discovery platform for targetedimmunotherapy
Therapeutic and companion diagnostic andmonitoring tool
o Nexvax2 Phase I clinical trial completed Untapped growing market & high unmet need
o Potential market worth US $8 billion by2019
o No pharmacologic treatment currentlyavailable
Experienced management and scientific team Robust, blocking intellectual property estate Demonstrated manufacturability with two year
stability in cGMP facility
Demonstrated scalable formulation Seminal publications
One Broadway, 14th
Floor
Cambridge, MA 02142
617-515-6755
www.immusant.com