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Immune Pharma Targeted Medicine
Immune Pharmaceuticals CorporationDeveloping the Next Generation Monoclonal Antibody Therapeutics
New York Biotechnology Association
Corporate Showcase
April 19, 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 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
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
Immune Pharma Targeted Medicine
IN PARTNERSHIP WITH
Beyond TNFalpha inhibitorsThe first highly specific MAb for Rheumatoid Arthritis
Immune Pharma Targeted Medicine
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
Immune Pharma Targeted Medicine
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
Immune Pharma Targeted Medicine
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
Immune Pharma Targeted Medicine
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
Immune Pharma Targeted Medicine
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
Immune Pharma Targeted Medicine
Targeting Cancer Stem Cellswith Fully Human Antibodies (cellular engineering)
Immune Pharma Targeted Medicine
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
Immune Pharma Targeted Medicine
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
Immune Pharma Targeted Medicine
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
Immune Pharma Targeted Medicine
Bi-specific AntibodiesEnhanced Targeted Efficacy against Hematological and Solid Tumors
Immune Pharma Targeted Medicine
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
Immune Pharma Targeted Medicine
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
Immune Pharma Targeted Medicine
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
Immune Pharma Targeted Medicine
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 Pharma Targeted Medicine
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: d.teper@immunepharma.com
Jean Kadouche
President, Research
Email: j.kadouche@immunepharma.com
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