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About ImmusanT Inc.
ImmusanT, Inc. is a privately –held emerging
biotechnology company focused on restoring
tolerance to gluten in celiac disease by harnessing
new discoveries in immunology that improve
diagnosis and treatment and return patients to a
normal diet, good health and improved quality of
life. The Company, that acquired the technology
from Australia based Nexpep Pty. Ltd., has a strong Executive Summary
intellectual property position and foundational
ImmusanT, Inc. is revolutionizing the diagnosis and treatment of celiac disease, which affects
science which provides the basis for their peptide-
based immunotherapy and diagnostics. approximately 1% of the population and currently has no pharmacological treatment. The Company is
harnessing the specificity of the immune reaction to gluten (protein in wheat, rye and barley) to
ImmusanT, Inc. is a Delaware Corporation with develop diagnostics and therapeutics. The Company’s new treatment paradigm for celiac disease
offices in Cambridge, MA.
leverages the immune response to gluten to isolate three toxic peptides responsible for the damage
Mission Statement to the intestinal lining and for the alteration of nutritional absorption. ImmusanT’s Founding Scientist
ImmusanT seeks to restore tolerance to gluten in along with his colleagues at Walter and Eliza Hall Research Institute and Oxford University studied
patients with celiac disease. more than 200 celiac disease patients to elucidate the pathologic peptide epitopes. Nexvax2,
Founders & Team
ImmusanT’s peptide based immunotherapy, is designed to desensitize individuals with celiac disease
Leslie J Williams, BS, RN. MBA to the toxic effects of gluten allowing them to return to a normal diet, good health and improved
President & CEO quality of life.
Bob Anderson, MB, ChB, BmedSc, PhD FRACP Pathogenesis of Celiac Disease – Central role of T-Cell’s
CSO & CMO ImmusanT’s Discovery Platform for Targeted Immunotherapy
Lab Head, Autoimmunity & Transplantation
The Walter and Eliza Hall Institute

Maury Matteodo
CFO

Scientific Advisors/Consultants
Jason Tye Din, MB, BS, PhD FRACP
Scientific Consultant
Walter and Eliza Hall Institute, Melbourne, AU

Bana Jabri, MD, PhD


Senior Scientific Advisor, Chicago, IL

Markku Maki, MD, PhD


Senior Clinical Advisor

Wally Binder, PhD


Senior Scientific/Technical Advisor
ImmusanT’s therapeutic focus - Peptide-based therapy
Scientific Advisory Board
Bob Anderson, MD, PhD T-Cell Mediated Immune Disease
Walter and Eliza Hall Institute, Melbourne, AU Celiac disease is the first human immune disease for which there is comprehensive
Wally Binder, PhD understanding of the pathogenic T-cell response. ImmusanT has translated the
Founder, INOVA Diagnostics (acquired by Werfen scientific discovery of immuno-dominant T-cell stimulatory gluten peptides into
Group) valuable diagnostics and therapeutics for patients with celiac disease. It is believed
that upon repeated Nexvax2 dose administration, the number of gluten-specific T
Peter Green, MD, Professor of Clinical Medicine,
Columbia University, New York, NY 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.
Bana Jabri, MD, PhD
University of Chicago, Chicago, IL Tolerance is non-responsiveness to a specific antigen. Tolerance to an immune-
Ciaran Kelly, MD, Professor of Medicine, dominant gluten epitope is induced by administration of Nexvax2 peptides in the
Beth Israel Hospital; Harvard University, Boston, MA absence of a second, T cell co-stimulatory, signal (“danger signal”). Nexvax2
peptides, delivered intradermally in small doses, re-programs/desensitizes the
Knut Lundin, MD, PhD, FACP (Hon) disease causing T-cells. Because Nexvax2 is delivered in low doses without
Gastroenterologist/Immunologist, Rikshospitalet
University of Oslo 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
Markku Maki, MD, PhD, Professor of Pediatrics, phenotypic change to a suppressor regulatory T cell phenotype.
University of Tempere, Finland
Intellectual Property
Joseph Murray, MD, Professor of Medicine, Mayo ImmusanT owns one and has exclusive licenses to three patents enabling diagnostics and
Clinic, Rochester, MN therapeutics based on the gluten peptides recognized by the disease-causing T cells in celiac disease
in the major global markets. th
Michelle Pietzak, MD, Pediatric Gastroenterologist, One Broadway, 14 Floor
Children’s Hospital Cambridge, MA 02142
Los Angeles, CA 617-401-2154 www.immusant.com
617-515-6755
Market Opportunity
Celiac Disease, also known as celiac sprue, is an inherited
autoimmune disorder triggered by the consumption of foods
containing gluten, a cereal grain protein. It is a lifelong disease with
onset in early childhood. The chronic inflammation of the intestine
in this disease is caused by the immune response to gluten.
Unrecognized, celiac disease is a major contributor to poor
educational performance and failure to thrive in children. Untreated
disease is associated with other health conditions from IBS, bone
loss, anemia, chronic fatigue and diarrhea, to liver disease, infertility
and cancers.

Celiac disease affects about 1% of the population globally (25.5M


people; 7.5M in developed countries) and has historically been
under-diagnosed with no available drug therapy. The only option
for most celiac patients is to eliminate gluten from their diet.
However, that is not easy given that it is found in many foods. It has
been predicted that 50-60% of affected patients will be diagnosed in
developed countries by 2019, creating a potential pharmaceutical Product Pipeline
market worth US$8 billion.

Technology Opportunity and Company Vision


The celiac disease market is untapped and has significant growth
potential due to the high level unmet need. The recognition that
celiac disease is an autoimmune disease (effect of gluten on the
intestine is akin to what type 1, autoimmune, diabetes is to the
pancreas) that has serious long term complications if untreated, has
led to increased awareness of this pathology.

ImmusanT has a three prong strategy: increase awareness through


outreach programs, enhanced diagnostics and biomarkers that
improve diagnosis and management of the disease, and a therapy
that directly targets the immunologic cause of this condition.
ImmusanT’s lead therapeutic vaccine, Nexvax2, is a combination of
three proprietary peptides. ImmusanT has a commercial agreement
with INOVA Diagnostics to fund research aimed at discovering and
developing new serology diagnostic screening tests for celiac
disease. In parallel ImmusanT is developing a novel functional T-cell
ImmusanT Value Proposition:
test to diagnose and monitor optimal maintenance of immune
tolerance with peptide based therapy (Nexvax2).  Proprietary discovery platform for targeted
immunotherapy
ImmusanT’s lead product, Nexvax2, a therapeutic vaccine, is in  Therapeutic and companion diagnostic and
development and ready to advance to a Phase IIa clinical trial monitoring tool
having completed: o Nexvax2 Phase I clinical trial completed
 Untapped growing market & high unmet need
√ Pre-clinical program o Potential market worth US $8 billion by
√ cGMP drug manufacture
2019
√ Pharmacokinetics and Toxicology conducted in rats
√ Preclinical proof-of-concept in transgenic mouse model
o No pharmacologic treatment currently
√ Phase I First in human study: safety, tolerability & bioactivity available
 Experienced management and scientific team
ImmusanT will continue to advance their pipeline and expand the  Robust, blocking intellectual property estate
patent portfolio internally and with academic collaborators. The  Demonstrated manufacturability with two year
progress made in understanding, treating, preventing, and stability in cGMP facility
diagnosing celiac disease with peptides has major implications for  Demonstrated scalable formulation
other autoimmune diseases and allergies. The Company intends to  Seminal publications
strategically collaborate with leading pharmaceutical companies to
advance and expand their product portfolio.
One Broadway, 14th Floor
Cambridge, MA 02142
617-515-6755
www.immusant.com
Nexpep addresses

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