Feb2011ImmusanTexexecsummary

download Feb2011ImmusanTexexecsummary

of 2

Transcript of Feb2011ImmusanTexexecsummary

  • 8/6/2019 Feb2011ImmusanTexexecsummary

    1/2

    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

  • 8/6/2019 Feb2011ImmusanTexexecsummary

    2/2

    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