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Andromeda
Andromeda Biotech Ltd. is focused on the development of innovative treatments for autoimmune diabetes. The company's lead product, DiaPep277®, is an unique synthetic peptide of 24 amino acids derived from the sequence of the human heat shock protein 60, representing a novel therapeutic approach to prevent the destruction of insulin producing cells in the pancreas. Treatment of type 1diabetes patients with DiaPep277® may have several medical benefits including prevention of disease deterioration, improved glycemic control, reduction of daily insulin dose requirements, and delay or reduction of diabetic complications.
DiaPep277® is currently in a confirmatory Phase III clinical trial for treating type 1diabetes, which began in the first half of 2010. The global study is being conducted in Europe, USA, Israel, and Latin America with a recruitment of approximately 450 patients at more than 100 clinical study sites.
To date, there is no therapy that can prevent the destruction of insulin secreting beta cells. DiaPep277® is designed to treat type 1 diabetes patients with residual insulin secreting cells in order to preserve their function. Potential target populations include newly diagnosed adult patients with type 1 diabetes, newly diagnosed children or adolescents with type 1 diabetes, people with a high risk of developing type 1diabetes, and type 1 diabetes patients with slow progressing disease. The company has a strategic collaboration agreement with Teva.
CEO: Dr. Shlomo Dagan
Field: Type 1 diabetes
Lead product: DiaPep277®
Stage: Phase III
CBI holding: 84%
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MediWound
MediWound Ltd. is a biotechnology company committed to developing, manufacturing, and commercializing products to address unmet medical needs in the fields of burn and wound management.
MediWound's first investigational medicinal product, NexoBrid™, is designed to provide healthcare professionals and patients with a non-invasive, enzymatic product for selective, swift debridement of the burn eschar. A Marketing Authorization Application was recently submitted for NexoBrid™ to the European Medicine Agency.
MediWound acquired the commercial rights for PolyHeal™, a CE-marked medical device indicated for the treatment of chronic wounds, which is about to be launched in Europe and other regions.
Tevahas acquired an option to market NexoBrid™ in the EU and/or North America and has a license to market NexoBrid™ in the rest of the world. Teva has sub-licensed the worldwide rights for commercializing PolyHeal™.
CEO: Gal Cohen
Field: Burn & wound management
Lead product: NexoBrid™
Stage: Registration
CBI holdings: 52%
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D-Pharm
D-Pharm Ltd. (TASE: DPRM), an integrated drug development company, is focused on the design and development of innovative drugs for the treatment of potentially life-threatening medical conditions that affect the brain. The company has developed two unique platform technologies that generate lipid-like medicines. These technologies use cell-membrane specific mechanisms and influence lipid-related biochemical pathways, for therapeutic effect.
DP-b99 is a first-in-class broad-spectrum neuroprotective drug. The Phase III study (abbreviated to MACSI) of DP-b99 is ongoing in acute ischemic stroke patients. The MACSI protocol was agreed with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) program. The study is being conducted under IND. Additional potential therapeutic applications for DP-b99 include treatment of traumatic brain injury and diminishing the risk of brain damage associated with cardiac surgery. DP-VPA (a derivative of VPA, a leading generic anti-epileptic drug) has completed a Phase I study and a first Phase II study in epilepsy patients. More than 240 healthy volunteers and patients have been exposed to the drug. In addition to epilepsy, DP-VPA is intended for treatment of bipolar disorder and for patients with severe migraine.
CEO: Dr. Alexander Kozak
Field: Ischemic stroke
Lead product: DP-b99
Stage: Phase III
CBI holding: 46%
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CureTech
CureTech Ltd. is focused on the development of novel, broad-spectrum, immune-modulating products for the treatment and control of cancer. The company's lead product, CT-011, is a humanized monoclonal antibody that interacts with PD-1, a B7 receptor-family-associated protein and exhibits efficient anti-cancer immune response against a wide variety of human tumors. CT-011 was shown to effectively attenuate tumor growth and eliminate tumor metastases in a variety of model systems.
CT-011 is currently in several clinical studies including a multi-center Phase II clinical study in the US, Israel and India in patients with diffuse large b-cell lymphoma and another Phase II study in patients with metastatic colorectal cancer that is ongoing in the US, Europe, Asia and South America. CT-011 is also being evaluated in a Phase II study in patients with relapsed follicular lymphoma, where it is given in combination with Rituximab. CT-011 is also being assessed in four additional studies in patients with chronic hepatitis C infection, primary hepatocellular carcinoma, multiple myeloma and acute myeloid leukemia (AML).
The company has a strategic collaboration agreement with Teva Pharmaceutical Industries for the development of CT- 011.
CEO: Dr. Michael Schickler
Field: Cancer
Lead product: CT-011
Stage: Phase II
CBI holding: 37%
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Gamida Cell
A world leader in stem cell expansion technologies and therapeutic products, Gamida Cell is developing a pipeline of cell therapeutics in the areas of bone marrow transplantation and regenerative medicine. The company's therapeutic products are allogeneic and contain adult stem cells selected from non-controversial sources, such as umbilical cord blood. These stem cells are then enriched in culture using the company's proprietary expansion technologies. The company has successfully translated these technologies into cost effective commercial GMP manufacturing processes.
The company's lead product, StemEx®, is now being tested in an advanced, Phase III, international clinical trial for hematological malignancies. This is an open study, approved by the FDA under Special Protocol Assessment (SPA), with a historical control cohort and with completion expected in 2011. StemEx®, scheduled for market launch in 2013, has orphan drug designation both in the US and in Europe and is being developed by the Gamida Cell – Teva Joint Venture, which owns all global commercialization rights. The company has a 50% stake in the Joint Venture.
In addition, the company is developing NiCord™, the first of several therapeutics derived from the company's second platform technology, for stem cell expansion for the treatment of autoimmune and hematological diseases. Gamida Cell has initiated a pilot clinical study for NiCord™ in the USA, under IND. Additional development projects include allogeneic products for regenerative medicine and adoptive immune therapy.
CEO: Dr. Yael Margolin
Field: Cancer
Lead product: StemEx®
Stage: Phase III
CBI holding: 20%
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BioCancell
BioCancell Therapeutics, Inc. (TASE: BICL) is focused on the development of targeted cancer therapy for the treatment of numerous types of cancer by utilizing the H19 gene, an important oncofetal gene, expressed at high levels in over 40 types of human cancer tissues. The company's proprietary technology constitutes a novel paradigm for the targeted destruction of cancer cells, with no effect on normal surrounding tissue and no observed severe adverse events, allowing for long-term, safe treatment and prevention of cancer recurrence.
The company's lead product, BC-819 is currently in a Phase IIb clinical trial for patients suffering from superficial bladder carcinoma. A Phase I/IIa clinical trial for treatment of ovarian cancer is on-going in Israel. A Phase I/IIa clinical trial for treatment of pancreatic cancer demonstrated an excellent safety profile and preliminary efficacy. The FDA has granted orphan drug status for BC-819 as a treatment for both pancreatic and ovarian cancer.
BioCancell was founded in 2004 by Professor Avraham Hochberg, a professor of molecular biology at the Hebrew University of Jerusalem, based on technology developed by him over the past 20 years.
CEO: Uri Danon
Field: Cancer
Lead product: BC-819
Stage: Phase II
CBI holding:15%
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Polyheal Ltd.
Polyheal Ltd. has pioneered a revolutionary wound management approach using charged polysterene microspheres to stimulate the healing process of acute and chronic wounds through generation of granulation tissue.
The company's lead product, PolyHeal™, rapidly stimulates granulation coverage of chronic wounds and helps health professionals take control of stubborn wounds. PolyHeal™ will initially target hard-to-treat, deep wounds with exposed bones and tendons and long-standing venous ulcers.
PolyHeal™ has consistently demonstrated strong clinical outcomes of high rates of complete healing or wound improvement for skin grafts in wounds which were recalcitrant to other treatments. The company has completed four clinical studies including a double blind randomized controlled clinical trial.
PolyHeal™ recently received marketing approval in Europe (CE mark) and the company is currently in discussion with the FDA to obtain US approval. The company has signed a worldwide development, marketing and distribution agreement with MediWound and Teva.
Field: Wound management
Lead product: PolyHeal™
Stage: Market approved
CBI holding: 38%
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Avraham
Avraham Pharmaceuticals Ltd. is focused on developing novel products for treatment and/or prevention of neurodegenerative disorders. The company's lead product, Ladostigil, is a novel cholinesterase and brain-selective monoamine oxidase inhibitor and neuroprotective agent designed to provide comprehensive medical treatment for Alzheimer's disease and other neurodegenerative diseases. Ladostigil is the first multi-functional drug to reach clinical trials, acting via additional novel mechanisms of action and providing potential to improve the behavioral and psychological symptoms of dementia, such as depression and anxiety. Moreover, Ladostigil has the potential to slow the progression of clinical symptoms of Alzheimer's disease for sustained periods of time and to modify the pathology associated with the disease.
In Phase I and Phase IIa clinical trials, the drug was shown to be pharmacologically active, safe and well tolerated.
The company has exclusively licensed the commercial rights to Ladostigil from the Hebrew University of Jerusalem and the Technion Research and Development Foundation.
CEO: Dr. Vincent Zurawski
Field: Alzheimer's disease
Lead product: Ladostigil
Stage: Phase II
CBI holding: 16%
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Aposense
Aposense Ltd. (TASE: APOS) focuses on developing innovative products, diagnostics and therapies based on the detection and targeting of cells undergoing apoptosis (programmed cell death). ApoSense™, the company's proprietary technology, based on a set of original, small, rationally-designed proprietary compounds, has demonstrated ability to identify, bind and accumulate within apoptotic cells in-vivo.
The company's lead compound, the ML-10 agent for PET imaging of apoptosis, is in Phase II clinical trials for early visualization of effect of anticancer therapy. In addition, the company is developing anticancer therapeutics based on ApoSense™. The company has signed collaboration agreements with Teva, GSK, Roche, IBA (Ion Beam Applications) S.A, Sigma-Aldrich Co. and others.
CEO: Yoram Ashery
Field: Cancer
Lead product: ML-10
Stage: Phase II
CBI holdings: 4%
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Biokine
Biokine Therapeutics Ltd. is focused on developing novel anti-cancer and stem cells mobilization drugs to treat cancer patients. Biokine targets CXCR4 chemokine receptor, which is critical to the development and progression of cancer and metastasis, chemo-resistance of blood cancers as well as to regulating stem cell mobilization and the recovery of bone marrow following chemotherapy and inflammation.
Biokine's lead molecule, BKT140, a CXCR4 antagonist, recently finalized a Phase I/IIa, non-randomized, open label, single dose, dose escalation, safety and efficacy clinical trial in 16 multiple myeloma patients. In the trial, BKT140 demonstrated an excellent safety profile and was well tolerated at all doses tested. To validate the safety and efficacy of BKT140 as a mobilizer of stem cells and an anti multiple myeloma agent, the company is planning to initiate a Phase II clinical study in multiple myeloma patients.
CEO: Yossi Riback
Field: Cancer
Lead product: BKT140
Stage: Phase II
CBI holding: 31%
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BioControl
BioControl Medical Ltd. develops advanced active implantable medical devices for the treatment of autonomic disorders, conditions whereby the autonomic nervous system ceases to function properly, resulting in a disruption to the control of involuntary body processes. The devices enable controlled electrical stimulation of various nerves to achieve therapeutic results.
The company's lead product, CardioFit™ System, is intended to effectively treat heart failure via vagus nerve stimulation. The company is now initiating an international, multi-center, pivotal study of CardioFit™ at prestigious clinical sites in the U.S. and in Europe. This follows a multi-center European pilot study, data from which was published in September 2008 by the European Journal of Heart Failure.
The CardioFit™ System received the CE mark in 2008 and it not available yet in the US.
CEO: Dr. Ehud Cohen
Field: Cardiology
Lead product: CardioFit™
Stage: Pivotal studies
CBI holdings: 3%
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TransPharma
TransPharma Medical Ltd. is a specialty pharmaceutical company focused on the development and commercialization of drug-products utilizing RF-MicroChannel™ technology, an innovative active transdermal drug delivery technology. The company implements RF-MicroChannel™ Technology through the ViaDerm™ delivery system, intended for home use, consisting of a reusable, handheld, low-cost device and a disposable patch containing a drug.
Current drug-product development programs include ViaDerm-hPTH (1-34), to treat osteoporosis, developed in collaboration with Eli Lilly and undergoing Phase IIb clinical trials. Two additional products have completed Phase I testing, one of which is ViaDerm-GLP 1 agonist for the treatment of type 2 diabetes.
TransPharma and Lilly have entered into a licensing agreement for the development and commercialization of ViaDerm-hPTH (1-34). Under the terms of the agreement, Lilly was granted exclusive worldwide rights to develop and market ViaDerm- hPTH (1-34). TransPharma received a $35 million upfront payment and will be entitled to development and sales milestones as well as royalties.
CEO: Dr. Dafna Heffetz
Field: Osteoporosis
Lead product: ViaDerm-hPTH (1-34)
Stage: Phase II
CBI holding: 12%
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Thrombotech
Thrombotech Ltd. is developing a drug to make the treatment of stroke both radically safer and far more effective. The company has developed THR-18, a peptide administered alongside existing stroke treatments. THR-18's unique mechanism of action and experimental evidence suggest that it may also be effective against heart attacks, traumatic brain injury, lung embolisms, and occluded arteries and veins in the legs and arms. Furthermore, recent experimental findings suggest that THR-18 may have additional clinical indications such as treatment of asthma and hypertension.
The company has completed pre-clinical studies at independent sites exploring THR-18's unique mechanism of action. Thrombotech's animal studies exhibited high efficacy and safety in two major clinical indications (stroke and traumatic brain injury). Thrombotech completed a successful pre-IND meeting with the FDA and a first-in-man clinical study that included 40 healthy volunteers was successfully completed in September 2010.
CEO: Dr. Itschak Lamensdorf
Field: Ischemic stroke
Lead product: THR-18
Stage: Phase II
CBI holding: 42%
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Braintact
Braintact Ltd. is developing an innovative, proprietary blood glutamate scavenging platform for the treatment of acute and chronic neurodegenerative diseases. This approach is based on a peripheral mode of action whereby drugs are administered into the blood circulation in order to boost a natural brain defense mechanism - the brain-to-blood efflux of excess glutamate.
Braintact has successfully accomplished proof of concept in numerous animal models, including head trauma, stroke, brain cancer (glioma) and Amyotrophic Lateral Sclerosis (ALS). Blood glutamate scavenging is a novel approach representing a paradigm shift in the treatment of these severely disabling and often fatal diseases, causing the beneficial effects without damaging normal glutamate function.
CEO: Dr. Noa Shelach
Field: CNS
Stage: Pre-clinical
CBI holding: 38%
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ProtAb
ProtAb Ltd. is focused on the development of novel therapeutic agents that modulate cytokine regulation, tipping the balance toward anti-inflammatory signaling pathways in the treatment of autoimmune and inflammatory diseases. ProtAb's therapeutic approach is based on stimulating a molecule that suppresses inflammation, unlike current drugs on the market which are designed to suppress molecules that stimulate inflammation.
ProtAb's first product – Proximab - is a promising monoclonal antibody with a unique mechanism of action currently in late-stage preclinical development for the treatment of Rheumatoid Arthritis (RA), Inflammatory Bowel Disease (IBD) and other autoimmune diseases. The company has successfully completed the humanization of Proximab and established pre-clinical proof-of-concept in experimental disease models of the two major clinical indications - RA and IBD. Late-stage development is ongoing, including GMP manufacturing and toxicology experiments, whereby initiation of a Phase I/IIa clinical trial in RA is scheduled for Q3 2011.
Based on its unique mechanism of action, Proximab has the potential for treating a wide span of additional autoimmune diseases, including psoriasis and others.
CEO: Shira Yair
Field: Autoimmune
Lead product: Proximab
Stage: Pre-clinical
CBI holding: 15%
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Campus Bio
Campus Bio focuses on the development of biopharmaceuticals and medical devices licensed from academic institutions, with the aim of advancing compounds and technologies from early stages of discovery to clinical trials, regulatory approval and marketing.
Campus Bio's concept is novel, combining the expertise of CBI in drug development with the research excellence of academia. CBI has created collaborations with leading academic institutes such as the Weizmann Institute of Science by establishing an investment fund for technological innovation from early stage of proof of concept through all advanced stages of drug development.
CEO: Dr. Noa Shelach
Field: Drug development
CBI holding: 100%
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Clal Life Sciences
Clal Life Sciences (CLS) is a research and development center established to provide optimal conditions for the growth of emerging life science companies.
CLS' state of the art research and development laboratories include a GMP manufacturing pilot plant and a central clean room facility.
Five CBI portfolio companies have already established operations at CLS: CureTech, MediWound, Polyheal, Avraham and Andromeda.
Located in Yavne and wholly owned by CBI, CLS is Israel's only privately-held life science research and development center.
CEO: Moti Hacham
Field: GMP facility
CBI holding: 100%
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