Transcript שקופית 1

Berlin Meets Israel
Biotechnology in Israel and Biomed 2007
Dr. Rafi Hofstein, CEO, Hadasit
Israel`s Academic Institutions and their
Technology Transfer Companies (TTC)
Institutions
TTC
Hebrew U. (Jerusalem)
Tel-Aviv U. (TA)
Technoion (Haifa)
Weizmann Inst. (Rehovot)
Ben-Gurion U. (Beer-Sheba)
Hadassah University Hospital (Jerusalem)
Yissum
Ramot
Mosad Technion
Yeda
B.G.Negev
Hadasit
Israel`s Investments at the
Academic Stage
Israel`s GDP
2001
NIS 480B
2004
NIS 520B
2006
NIS 570B
R&D Expenditure (GDP Basis)
Israel
4.6 %
Europe
3.5 %
Japan
3.0 %
R&D Expenditure (2005)
Total R&D
NIS 27.4B
Government
Portion
NIS 4.9B
Israel`s Investments at the
Academic Stage – Cont.
Government Portion (Nis 4.9B)
VATAT
44%
OCS – MOITAL
38%
OCS – Health
0.7%*
*0.7% reflects $8M while NIH is $30B
National Patent Estate
Medical Device Patents per million Capita
Medical Device Patents per million Capita
Number of Patents per Capita
120
100
80
60
40
20
0
United
States
Japan
Source: www.uspto.gov,
Analysis: ILSI ©
Germany
United
Kingdom
Canada
France
Israel
Sw eden
Taiw an
Number of BioPharma
Patents per million Capita
Number of BioPharma Patents per million Capita
Num. of Patents per million Capita
180
160
140
120
100
80
60
40
20
Source: www.uspto.gov,
Analysis: ILSI ©
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Patents Registered
Life Science Patents
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28.3%
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Source: www.uspto.gov,
Analysis: ILSI ©
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% of Total Patents Registered
Significant Outcome
Product
Licensor
Licensee
Copaxone
Rasageline
Exelone
Rebif
Doxil
Yeda
Technion
Yissum
Yeda
Yissum/Hadasit
Teva
Teva
Novartis
Serono
J&J (alza)
StemEx
Hadasit
Gamidacell
HADASIT LTD.
• Technology Transfer Company of Hadassah
Medical Hospitals located in Jerusalem,
Israel.
• Promote and Commercialize IP (270 patent
families) & R&D activity (1000 MDs and
PhDs).
• Develope Therapeutics, Diagnostics &
Devices
• Conduct Clinical trials and offers Pre-clinical
services
Hadasit’s Mission
Promote and commercialize the applied
R&D and innovative discoveries of HMO,
for the purpose of maximizing return on
R&D and increasing the revenue base of
the institute.
Thereby, the institute can further its
investments in technology, medical
infrastructure, research activities, and
education.
Main Bottleneck
Financial Gap Problem
Chasm
Main Bottleneck
Financial Gap Problem
$ 50-500K
Internal
Sources
> $ 5M
Venture funds
- Companies
Chasm
The Classical Commercialization Models
I.
Patent Protection
II.
Licensing to Multinational companies
III. Collecting royalties
New/Additional Commercialization Models
Initiating Start-Up
companies
Hadasit Clusters
ProTab
Inflammatory
Verto
Tolaren
Theravir
PP-14
CancerCure
DMMT
Hadasit
Condrosite
Hapto
APEI
Other
Trombotech
GVT
KAHR
TK Signal
Cancer
Regenerative
Cellcure
Investment in start-up
companies
Hadasit
Bioline Rx
Incubators
HBL
VCs
Start-up companies
Angels
Others
Glioblastoma
•
•
•
•
•
•
•
•
•
Most malignant of cancers
Affects about 17,000 patients
55 weeks median survival from time of Dx
30 weeks median survival after recurrence with
best approved therapeutic agent, temozolomide
Effectiveness measured in weeks added to survival
Only 15% of patients achieve 6-month progression free
survival
Complete radiological tumor responses about 1/200
Often selected as 1st application of new biologic therapies
New therapeutic approaches urgently needed
TheraVir’s Vision
•“Good” viruses can be
developed that will home in
on and kill cancers that are
beyond the range of
current medicine and
•Treatments will emerge
that are effective, free of
side-effects and maintain
the patient’s quality of life
Newcastle
Virus
Glioblastoma
Brain Cancer
The Product – NDV HUJ
• New strain of the avian Newcastle
Disease Virus discovered by Prof.
Zichria Zakay-Rones
• Advantages: Not a human
pathogen, not engineered, not
harmful to poultry (no
environmental impact)
• Acts by causing cancer cells to kill
themselves (apoptosis) and by
activating the immune response
• Administered by intravenous
injection
• Relatively economical to
manufacture
Schematic of a paramyxovirus from University of Warwick
Remarkable Response in Glioblastoma Patient
• Complete
responses are
extremely rare with
best Rx
• No serious sideeffects
• Phase I/II Study of
Intravenous NDV
HUJ published in
leading journal
Complete tumor response: baseline (a), first follow-up
(b), second follow-up (c), 20. 25 and 30 weeks (d, e, f).
Summary
• NDV HUJ is a new
candidate for a the
biologic treatment of
cancer
• Very encouraging early
results for safety and
efficacy in brain cancer
• Probable activity in broad
range of cancers
• Completing negotiations
with a major partner for
continued development
and marketing
• Phase II studies planned
for US
fighting cancer with therapeutic viruses
Hadasit
HBL
Hadasit 67%
Verto
75%
Incure Cellcure
66%
45%
TKS
39%
Protab
100%
Kahr
100%
Public 33%
Ortec
7.7%
Thrombo
27%
Tolarex
94%

Vision – Cure neurodegenerative diseases
using human embryonic stem cell based cell
replacement therapies

1st Product – Committed dopaminergic neural
progenitor cells for Parkinson’s disease

Status – Pre-clinical testing in animal models

Team – leading scientific group in the field
headed by Benjamin Reubinoff

IP – key patents in the field in-licensed from
ES Cell International

Investment - $3 M in addition to $3M from
Hadasit Bio-Holding to reach clinical trials

Jointly owned with ES Cell Int. from
Singapore. Part of “Genesis” Consortium.
Hapto Biotech – Ortec International
During April 2006, Hapto Merged with ORTN (NASDAQ)
 Key Platform Technologies:
The product: GMP produced
Haptized-collagen sponge
Haptides™ (~20 amino acids) synthetic peptides
Synthetic peptides, Non-toxic up to high concentrations
Enabling technology:
1. Coat biological materials to produce “smart dressings”.
Wound healing product
2. Augment penetration of drugs and gene delivery into cell. Proof of concept
Fibrin Micro Beads (FMB) (50-300 m)
Fabricated fibrin beads to attach and grow cells in suspension, able to
bind different cell types, well tolerated in vivo, biodegradable
Enabling technology. Proof of concept
1. Non cellular tissue regeneration matrix – tissue filling
2. Cellular – Grow cells in suspension; select stem cells for expansion &
implantation
 Major IP Estate in place, Fully Operative Team
 R&D collaboration agreements with TEVA & Major US Pharma Co.
TK Signal - Profile
• Development and commercialization of targeted
EGFR radiopharmaceuticals for application in cancer
diagnostics and cancer therapy using PET imaging.
• Radiopharmaceutical market estimated at $ 2 B at
2005 and growing at 10% per year.
• Key personnel - 2 world renowned cancer and
imaging researchers from Hadassah and Hebrew U.
(A. Levitzki, E. Mishani)
• Multi disciplinary team (chemists, radiochemists, nuclear-engineers, biologists)
• Strong IP position (2 approved, 1 pending)
• Feasibility demonstrated in vitro and in vivo
• Wide collaboration metwork
• Completed UK funding of $ 1.6 M
ThromboTech Ltd.
Novel Thrombolytic Agents
• Thrombotech has discovered the use of a specific hexa-peptide
having a sequence that is used for the docking of tPA to PAI-1.
• Thrombotech has demonstrated that utilizing this peptide in
conjunction with tPA increases the safety profile of these thrombolytic
therapeutics and offers key advantages: Expanded treatment window,
PAI-1 resistance & Fibrin specificity.
• Market: All thrombolytic agents existing today cause severe side
effects as they damage blood vessels, increasing internal hemorrhage.
Presently, only 3% of the patients receive tPA after stroke due to the
adverse side-effects. The annual targeted USA market for a
thrombolytic product is over 3 million patients per year.
• IP: Wide claims covering the use of urokinase derived peptide for
dissolving of blood clots.
• The peptide production is manufactured in GMP conditions, Tox. And
pre-clinical testing to be completed during 2006.Initial clinical
indications to be tested: Myocardial Infarction.

Vision – Treat autoimmune diseases by highly
selective removal of the damaging antibodies
from circulation

1st Product – Revolutionary treatment of Lupus
(SLE) using the Lupusorb plasmapheresis
immunoabsorption column

Status – Clinical studies to start within 4
months

Team –Scientific group led by leading
authority in the field, Prof. Yaakov Naparstek

IP – Therapeutic and diagnostic patents issued

Business Model – Alliance with major US
supplier of plasmapheresis equipment

Investment - $1 M to extend clinical studies
Systemic Lupus Erythematosus (SLE)
US Prevalence 500K, Cost of Severe
Patients $20K/yr, No specific drug
Market $500M
Protab Developing new therapies for autoimmunity

Vision –Autoimmune diseases will be treated
with a new type of drug that activates antiinflammatory agents to supplement or
replace current blockbusters

1st Product – anti-peptide 6 monoclonal
antibody for RA arthritis and diabetes

Status – Animal studies completed; awaiting
production of humanized monoclonal
antibody

Team –Scientific group led by leading
authority in the field: Prof. Y. Naparstek

IP – Strong core patent on HSP65 peptides,
antibodies and use in inflammatory diseases

Business Model – Out-licensing to pharma
/biotechs after demonstration of efficacy

Investment - $5 M to produce humanized
mAB
Rheumatoid Arthritis, affects 2.1M
Americans, $5B/yr spent on
antiarhritic drugs, Blockbuster
inbibitors of anti-inflammatory
agents, Enbrel, Remicade,
Humira, reduce scores 50% in
50% of patients.
InCure
 Incure is developing a patent protected diagnostic kit
based on PAR1-released peptide, for the detection and
treatment of tumor metastatic spread in blood samples
 PAR1 (Protease Activated Receptor 1- an oncogene)
plays a central role in the malignant tumor invasion
process
 Initial indications to be explored: Breast, Ovary, Colon,
Prostate
 Metastatic cancers are particularly difficult to treat Therapeutic intervention could be:
 Too aggressive – deleterious side-effects
 Insufficiently aggressive – no cure
 Early detection of potential tumor invasion is critical for
determining the appropriate treatment strategies and
improving recovery prospects
 Development status: In vitro assay using polyclonal
antibodies – established, Optimization assay for peptide
detection in patients – in progress, Collection of breast
cancer patients blood samples (various stages) – in
progress
KAHR Medical Ltd.
PP14 Based Immuno-Therapeutic Proteins
• Essential functional features of PP14 : directly inhibits T cells, targets an
early stage of T cell activation via a unique mechanism, binds to T cell
surfaces in a carbohydrate-dependent fashion.
• In- Vivo Results: Ectopically expressed PP14 inhibits the activation and
proliferation of Human peripheral blood mononuclear cells (PBMC) in SCID
mice.
• KAHR is now positioned to move forward with preclinical studies on the
use of PP14 to treat Psoriasis, Multiple Sclerosis, Rheumatoid arthritis,
Organ Transplant Rejection and Graft-versus-Host Disease.
• During pregnancy auto-immune diseases undergo remarkable remissions
- KAHR has discovered this is probably due, at least in part, to the
production of a unique immuno-regulatory protein - PP14
• The value of biological drugs indicated for autoimmune diseases was
roughly $6.8 billion in 2003 and is predicted to triple by 2008.
• IP: KAHR’s IP covers the use of PP14 and its therapeutic derivatives for
treatment of auto-immune diseases.
•
A Treatment Device For
Recipients of Transplanted
Organs and for Other AutoImmune Diseases

Self material does not normally trigger an immune response due
to a conditioning of the immune system. This conditioning is called
tolerance. An important mechanism of creating tolerance is the
sampling of apoptotic cells that die daily in the body.
 The anti-inflammatory properties of self apoptotic cells can be
used in a variety of clinical conditions including in GVHD.
The use of autologous apoptotic cells ensures a high safety
profile. The repeated “pulses” of treatment maintain peripheral
tolerance.
 Potential Indications: GVHD, Auto-immune Disorders,
Inflammatory Conditions
 Milestones expected: Q1 2007: Completion of human in-vitro
studies. Completion of validation of the final mode of delivery of
autologous cells, Q3 2007: Phase I clinical trial Acute GVHD.
Tradition
• Biomed 2006 already indicated to us that a
tradition has been established and that
members of the international life science
community cannot afford to not attend
Tradition
• Indeed we were proud to host official
delegations from: Belgium, Canada, France,
Germany, India, Ireland, Italy, Singapore, South Korea,
Switzerland, The Netherlands, UK, USA
• along to visitors from: Australia, Austria, Brazil,
Czech Republic, China, Denmark, Egypt, Greece, New
Zealand, Nigeria, Senegal, Sierra Leone, Spain,
Sweden, Taiwan, Turkey and Ukraine.
One-on-One
Meetings
• During the three days of the event, we
could sense the highly positive energy in
the air and the best indication is that many
one-on-one sessions took place between
Israeli delegates and those from the
international venture capital and
production/sales industries.
BioTech
• The 2006 program already took into
consideration the assimilation of biotech
and medical device (Biomed – being our
brand name) and in each of the sessions
(cardiology, orthopedics, nervestimulation) the combination of the two
disciplines has been emphasized.
BioTech
• Biomed 2007 will be a natural extension of
the same approach of converging medical
device, diagnostics and biotechnology.
• Just as a catalyst of attraction.
Highlights
• Stem Cell Research
Together with the Weizmann Institute of
Science we will revisit the whole area of
stem cell research including review of the
basics, analysis of the IP / patent policy,
trends in the industrialization process and
convergence with medical device
approaches
Highlights
• Biomarkers-a tool in personalized medicine
A topic that was placed on the international agenda
several years ago and needs to be addressed once
more within the realms of Biomed 2007. Keynote
speakers from industry and academic arena, will
share with us their views on how to adopt modern
technologies into a better design of therapeutics and
their adjustment into patient special requirement
(personalized medicine).
Highlights
• Medical Device
The program of this year will address the
topic of monitoring and treatment of
chronic diseases, mainly in areas of
Cardiology, metabolic disorders and Nero
stimulation.
Highlights
• BioBusiness: From a scientific
discovery to a profitable industryopportunities and hurdles.
A series of panel discussions will address
the crossroad and meeting site between
tech-transfer, regulation, investment at
various stages and marketing strategies.