immune pharma nyba april2010

Immune Pharma Targeted Medicine

Immune Pharmaceuticals CorporationDeveloping the Next Generation Monoclonal Antibody Therapeutics

New York Biotechnology Association

Corporate Showcase

April 19, 2010


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.


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 Opportunities

Partnering 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


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 MAb

Highly Specific for Rheumatoid Arthritis

CD44vRA MAb recognizes and targets

specific protein expressed on the

surface of pathological inflammatory

cells 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

action

of anti

hCD44vRA

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 Inflammation

Golan, 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

(m

m)

Negative Control

F8:33 200 ug

F8:33 Time 200 ug

F8:33 70 ug

anti-TNF


Attractive Target Product Profile

for First in Class Anti-Human CD44vRA MAb

Anti-Human

CD44vRA MAb

Anti-TNFalpha

MAb

Oral

Kinase Inhibitor

Selectivity High Average Average

Non specific

immunosuppression

Risk of severe

infections and TB

Low Moderate to High Moderate to High

Risk of High Blood

PressureNo No Yes

Treatment

Responders

(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 Hybridomas

Fusion

Splenocytes

Hetero-Myeloma

+

IMPH Novel “Fully Human” MAbs

Initial 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

So

rting

Tra

nsp

lan

t

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 Science

Publication 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 Officer

Dr 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 Officer

Mr 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 Officer

Dr. 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 Technology

Platform Partnering

2011 2012 2013

Phase I

Phase I Phase II

Phase II

Immune Pharma Targeted Medicine Contact Details

Daniel Teper

CEO

Email: [email protected]

Jean Kadouche

President, Research

Email: [email protected]

22

immune pharma nyba april2010

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