Immune pharma presentationapril2010

Immune Pharma Targeted Medicine

Immune Pharmaceuticals Corporation

Developing the Next Generation Monoclonal Antibody Therapeutics

Corporate PresentationApril 2010

Immune Pharma Targeted Medicine A Development Stage Monoclonal Antibody Company

IMMUNE Pharmaceuticals is a New York based biopharmaceutical company focused on First-in-Class Therapeutics addressing significant unmet medical needs in Oncology, Immunology and Infectious Diseases.

IMMUNE is building a portfolio of Clinical and Pre-Clinical MAbs with multiple shots on goal for $ 1 billion drugs based on novel targets and proprietary best in class antibody technologies.

IMMUNE is establishing a Research Center in Israel to capitalize on its academic relationships with Weizmann Institute and Hebrew University.

Immune Pharma Targeted Medicine Investing in a MAbs company is highly attractive

1. Large and Growing Market Monoclonal Antibody Market $ 40 B in 2009 to reach $ 60 B by 2014 5 of top 10 drugs are MAbs and 8 have already reached $ 1 B in sales

2. Higher Development Success Rate 50% higher success rate with MAbs compared to small molecules (Tufts CSDD) Faster clinical development and regulatory review ( IND to BLA in 6years)

3. Longer Commercial exclusivity with reduced Generic Threats US Healthcare Law provides for at least 12 Years Marketing Exclusivity Antibody Complexity and lack of Regulatory consensus to delay Biosimilars

4. Improved Engineering and Decreasing Manufacturing Costs Novel Antibody Engineering delivers improved performance Manufacturing Costs have decreased 50% in the last 10 years

5. Rich Partnering OpportunitiesPartnering for innovative phase 2 MAb exceeds $ 500 M per deal value

6. Higher Market and M&A Exit Valuations Many company valuations range from $ 500 M to $ 2+ B

Immune Pharma Targeted Medicine A Portfolio with multiple shots on goal for $ 1 B drugs

.

Multiple value creating milestones in next 3 years:

1. First-in Class Highly Specific Rheumatoid Arthritis MAb to reach phase II a ready for Corporate Partnering

2. In Licensed MAb for orphan indication to progress to phase II/ III

3. Two INDs for novel MAbs

4. Three MAbs promoted to Early Development Candidates ( pre-clinical POC)

5. Validated Fully Human and Bi-Specific Antibody technology platforms


IN PARTNERSHIP WITH

Beyond TNFalpha inhibitorsThe first highly specific MAb for Rheumatoid Arthritis


Significant Unmet Medical Need for new Rheumatoid Arthritis Treatment

Only 30% of Rheumatoid Arthritis (RA) patients are treated with TNF-alpha blockers (Enbrel $8B, Remicade $6.9B, Humira $ 5.5B)

1. Unspecific immuno-suppression is responsible for severe and occasionally lethal infections, including Tuberculosis,

2. 2/3 of treated patients have Partial Response with TNF-alpha Blockers and still experience daily pain, stiffness and fatigue

3. 25-40% patients do not respond to TNF-apha blockers even at the lowest efficacy level (ACR 20)

4. 20% of patients experience diminishing response with TNF-alpha blockers over the course of the first year

High Unmet Medical Need for a Highly Specific RA treatment with improved efficacy and limited off target safety concerns


First in Class CD44vRA MAbHighly Specific for Rheumatoid Arthritis

CD44vRA MAb recognizes and targetsspecific protein expressed on thesurface of pathological inflammatorycells but not expressed on normal cells,so healthy cells remain undamaged:

RA Specific: binds to 75% of synovial fluid cells from RA patients,

Target Selective: not active in Peripheral white blood cells from

the same patients, Keratinocytes from normal donors, Synovial fluid cells from

osteoarthritis patients

Site of actionof antihCD44vRA MAb

Golan, Naor & all, Journal of Autoimmunity vol 28 issue 2-3 March-May 2007, Pages 99-113


CD44vRA MAb binds to Gal-8 and induces Apoptosis of Inflammatory Synovial Cells

The involvement of CD44 and its novel ligand Galectin-8 in the regulation of Auto-Immune InflammationGolan, Naor & all, J.Immunol. 2007;179;1225-1235


CD44vRA MAb equal or better than anti-TNFalpha in Ex Vivo and In Vivo models

Proof of Concept studies in Collagen Induced Arthritis standard In Vivo model

Histo-pathology shows:– Reduction in cell inflammation – Reduction in fibro-vascular

proliferatiion– Reduction in cartilage

destruction and improved repair Anti-Human CD44vRA MAb

induces resistance to Collagen induces Arthritis in DBA/1 mouse model because of the homology between mouse CD44 v4/v5 and human CD44vRA

Confirms ex vivo apoptotic activity of inflammatory synovial cells from RA patients1.5

1.7

1.9

2.1

2.3

2.5

2.7

2.9

1 2 3 4 5 6 7

Days

Paw

(mm

)

Negative ControlF8:33 200 ugF8:33 Time 200 ugF8:33 70 uganti-TNF


Attractive Target Product Profile for First in Class Anti-Human CD44vRA MAb

Anti-HumanCD44vRA MAb

Anti-TNFalphaMAb

Oral Kinase Inhibitor

Selectivity High Average Average

Non specific immunosuppressionRisk of severe infections and TB

Low Moderate to High Moderate to High

Risk of High Blood Pressure

No No Yes

TreatmentResponders(ACR 20)

Biomarker for responders

> 75%up to 100% in

CD44vRA positive patients

Yes

50%

No

60%

No


Targeting Cancer Stem Cellswith Fully Human Antibodies (cellular engineering)


Treatment of cancer stem cells one step towards the cure*

1. Next paradigm in cancer treatment

2. Significant data published and acknowledged

3. Cancer stem cells resist current treatments

4. Cancer stem cells lead to relapsing cancer

5. Targeted therapeutics of cancer stem cells can lead to full cancer cure

*According to the American Society of Clinical Oncology, Journal of Clinical Oncology, June 2008


First in Class Anti-CD44 MAb targeting Cancer Stem Cells

1. IMP 111 is a novel Anti-CD44 MAb with the following activity: Targets specific epitope on

constant part of CD44 on AML cells,

Survival benefit in knock out mice grafted with human leukemia cells

No hemagglutination

2. Antibody Dependant Cellular Phagocytosis (ADCP) is a novel mechanism of action demonstrated with IMP-111

3. Follow on screening of CD44 variant targets specific to Stem Cells in various malignancies and development of a library of fully human antibodies


Selected Antigen

Human HybridomasFusion

Splenocytes

Hetero-Myeloma

+

IMPH Novel “Fully Human” MAbsInitial application for anti CD44 MAbs in AML

Mouse Myeloma Cells

Human Lymphoma B Cells

+Human Cord Blood

CD34+ sorted cells

Mouse with human immune system

SortingTransplant

Spleen extraction

14

Fully Human MAbs

A Cellular Engineering Approach


Bi-specific AntibodiesEnhanced Targeted Efficacy against Hematological and Solid Tumors


1. Quadrivalent bi-specific antibodies• 3 Year EC financed pan-European academic research coordinated by

IMPH co-founder• Patent License from CNRS-France

2. Bi-Specific Immuno-NanoParticules• Scientific collaboration between IMPH co-founder and Hebrew

University (Prof. Benita)• One or two antibodies grafted on a NanoParticule• Ability to co-deliver a chemotherapeutic

• Patent License from Yissum-Hebrew University

3. Dual Soluble Receptor Fusion Protein• Developed by IMPH

Developing three novel Bi-Specific MAbs approaches


Combinations of two anti-ErbB antibodies targeting different epitopes may increase therapeutic efficacy through enhanced endocytosis

IMPH to develop bi-specific anti-ErbB/ HER2 antibodies in partnership with Weizmann Institute

Synergistic Tumor Inhibition by anti-HER2 Antibody combinationsT. Ben-Kasus, Bilha Schechter, Yossi Yarden & Michael Sela, Weizmann Institute ,of SciencePublication in Proceedings of National Academy of Sciences, March 2009


R&D Investments supported by strong Intellectual Property

Exclusive worldwide license from Maimonidex -Yissum/ Hebrew University Patents on CD44vRA

Patents filed by IMPH for CD44 target and antibody against Leukemia Stem Cells

Patents filed by IMPH on Fully Human Antibodies (Cellular Engineering)

Option to exclusive license from Weizmann Institute on HER2 combinations

Option to exclusive license from Feinstein Institute on CLL targets

Option to exclusive license on Quadrivalent Bi-Specific Antibodies from European Academic Consortium

Option to license on ImmunoNanoParticules from Yissum-Hebrew University


IMPH Academic and Industry Network generates a Pipeline of Opportunities

IMPH Management has extensive global relationships with leading Academic Institutions and with Bio-Pharmaceutical companies, creating opportunities for rewarding partnerships such as:

1. In licensing or co-development opportunity of First-in-class novel anti-angiogenic target and antibody for the treatment of Age-Related Macular Degeneration

2. Development of Bi-Specific Antibodies against Specific targets in Chronic Lymphocytic Leukemia ( Collaboration with Prof. Nick Chiorazzi-Feinstein Institute-New York)

3. Development of Antibodies and Novel Delivery forms against anti-infective targets (Collaboration with Professor Pothier- France)

4. Development of MAbs against specific novel targets for a mid-size Biotech company

Immune Pharma Targeted Medicine A Strong Management Team

Daniel Teper, PharmD, MBA, Chief Executive Officer and Co-founder Dr Teper has been a Partner at Strategy Consulting firms, ISO Healthcare (now part of Monitor), Bionest , and 21 West, advising leading pharma and biotech companies. He has previously held sales, marketing, new product development and general management positions at Novartis, GSK, Sanofi-Aventis. Daniel holds an MBA from INSEAD and a Doctor of Pharmacy (PharmD) degree.

J.E. Kadouche, PhD, Co-founder, President and Chief Scientific OfficerDr Kadouche has 25 years experience in the development of MAbs in both Academia and Industry. He was until recently the CEO of MAT an Antibody company where he built and partnered a clinical and pre-clinical portfolio. He is the founder of Clonatec and was an advisor to Sangstat, Roche, Merck AG and J&J. He holds PhD in Immunology from the Pasteur Institute and was an Assistant Professor at St Louis Hospital.

John Mohr, CPA, Chief Financial Officer and Chief Business OfficerMr Mohr is a seasoned Business Development executive with over 20 years industry experience. He was until recently the SVP, Business Development at CV Therapeutics which was acquired by Gilead for $ 1.4 billion. As President of Fournier USA, he partnered with Abbott and launched Tricor, now a $1 billion drug. John is a CPA and started his career in Finance at Merck & Co..

Mitchell Glass, MD, Senior Vice President, Chief Medical OfficerDr. Glass brings leadership experience in drug development at GSK and AstraZeneca as well as emerging Biotech companies and Academia. Mitchell is strong relationships with the FDA and the NIH. received his MD from the University of Chicago and is a member of the American Thoracic Society and American Academy of Asthma, Allergy & Immunology.

Eli Eldan, MBA, Vice-President, General Manager, Israel Operations


IMMUNE aims to deliver Multiple Value Creating Milestones over the next 3 years

First In Class RA MAb

In Licensed Orphan MAb

INDs Novel MAbs

Early Dev. Candidates

Antibody TechnologyPlatform Partnering

2011 2012 2013

Phase I

Phase I Phase II

Phase II

Immune Pharma Targeted Medicine Contact Details

Daniel TeperCEOEmail: [email protected]

Jean KadouchePresident, Research Email: [email protected]

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Immune pharma presentationapril2010

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