Norwood Immunology Ltd
Strategy Overview
Norwood Immunology (‘NIM’) is developing and commercializing technologies related to stem cells and the immune system. Approximately $40 million has so far been invested by the Norwood group in the development of its technologies. NIM is publicly listed on the AIM of the London stock Exchange and is considering the possibility of seeking either an ASX listing or a dual AIM/ASX listing
The core NIM strategy is to generate revenues and ‘profitability’ via the development and commercialization of technologies and intellectual property associated with:-
- Provision of stem cell services and therapies
- Licensing and partnerships re intellectual property and therapies based on stem cells, the immune system and immune cell targeting of vaccines..
NIM has out-licensing arrangements with Abbott Laboratories (USA) and Solvay Pharmaceuticals BV for two of its core technology platforms.
Aims
The aims of the Board are to substantially increase the value of the Company over the next 2-3 years via the possible development and provision of both veterinary and human stem cell banking and processing services, as well as the possible provision of veterinary and human stem cell (and immunology based) clinical therapies.
Corporate Structure - the Company has two branches:-
- Norwood Stem Cells (Stem Cells and Immunology)
- Norwood Vaccines (including ‘Virosome Biologicals’)
Business Development
NIM is considering the in-licensing or acquisition of revenue producing stem cell technologies.
Revenues
NIM currently earns revenue from licensing and milestone payments. NIM expects to begin earning its first ‘stem cell’ revenues in 2008/2009, with the expectation of progressively increasing revenues from the possible provision of stem processing and banking (veterinary and/or human) from 2009 onwards.
A) Norwood Stem Cells
Background
Norwood Stem Cells Pty Ltd (‘NSC’) is a subsidiary of NIM. NSC is developing all of the groups technology related to stem cells and the core immune system rejuvenation technology/programme. Possible new commercial agendas include the provision of processing and banking services, as well as therapies in both the veterinary and human areas.
Aims
NSC is currently evaluating the commercial opportunities flowing from the potential provision of cell processing and banking services - as well as therapies, in both the veterinary and human settings.
Norwood Stem Cells (‘NSC’) plans to generate revenue and profits from:-
1) The possible commercialization and provision of stem cell processing services in both the veterinary and human setting as well as the provision of immunology based services and therapies.
2) the licensing of existing technology
Stem Cell Therapies
Medicine is on the cusp of a revolution in which the body’s own building blocks, stem cells, are used to repair injuries and cure diseases. Already stem cells are being used to various blood-related cancers especially leukemia, and recent researches have revealed that cord blood stem cells have the ability to reduce disease severity in Type 1 diabetes patients by possibly re-setting the immune system and slowing the destruction of insulin-producing beta cells in the pancreas. Over the next decade, regenerative medicine such as this is expected to transform the way in which disease and injury is treated.
For some regenerative medicine applications stem cells can be extracted from the body at or near the time of their use in therapy, for example, ahead of cancer chemotherapy to be used later to restore the body’s immune system. However, some potentially highly useful types of stem cells can only be obtained from parts of the body’s life support system at the time of birth, for example from umbilical cord blood and amniotic fluid. Such potentially life saving material should be stored until it is needed later in life.
Current Medical Treatment
HSC transplantation is already an accepted curative therapy for many cancers and inherited non-malignant diseases, including bone marrow failure syndromes, haemoglobinopathies, and inborn errors of metabolism (Brien et al., 2006). HSCs have an exact match to the child and have an increased likelihood to match others within the family (Laleman, 2008). Nevertheless, umbilical cord blood has tolerance for a degree of human leukocyte antigen (HLA) incompatibility not possible with adult bone marrow (Brien et al., 2006). In other words, there would be greater likelihood of finding an appropriate match for a patient who requires an allogeneic treatment.
Possible Future treatments
Stem cells have been documented as being used in treatment for over 72 diseases, the most notable one being bone marrow transplantation to treat leukemia and lymphoma.[1] Potential application of human stem cells is the generation of cells and tissues for use in cell-based therapies, thus called Regenerative Medicine. The use of stem cells in regenerative medicine offers a promise to potentially revolutionize the practice of medicine and it has been the focus of immense research projects over the past decade.
Currently, the donated organs and tissues are the sources of replacement for ailing or destroyed tissue. [2] However, the available supply could not cope with the increasing need for transplantable tissues and organs. Researches have suggested that stem cells offer the possibility of a renewable source of replacement cells and tissues to compensate for the limitation of current clinical treatments. Recently, cord blood stem cells have been shown to demonstrate the ability to reduce disease severity in Type 1 diabetes patients by possibly re-setting the immune system and slowing destruction of insulin-producing beta cells in the pancreas. [3]
Additional potential benefits from potential Stem Cell Treatmentst
The other advantages that stem cells could offer in comparison to current medical treatments are:
1. cheaper alternative to current clinical treatment
2. Less painful than current remedies (eg operations, chemotherapies, etc.)
3. result in less side effects after treatments
4. May serve a larger proportion of patients.
Stem Cells - Veterinary
Overview
Stem cell therapies to regrow damaged bone, tendon, ligament and joint tissue are well advanced in veterinary applications.
NSC has formed a wholly owned subsidiary – Norwood Veterinary (‘NVET ’) to evaluate the development and provision of stem cell treatments in the veterinary setting. NVET believes that the veterinary markets offer the opportunity for the generation of substantial early revenues and profits from the provision of services related to the provision of stem cell based therapies.
The limited initial use of stem cells for the treatment of certain medical conditions in animals has resulted in some outstanding results in both equine and canine species. From evidence in the equine setting, it is believed that the use of mesenchymal stem cells in the treatment of muscle, tendon and ligament injuries is likely to lead to the repaired tissue being identical in all respects to the tissue prior to the injury.
NVET is evaluating the possible generation of revenues from the veterinary industry by providing services to both the canine and equine industries re the extraction, processing and multiplication of canine and equine stem cells. These cells can be then used in the treatment of tendon and ligament injuries as well as arthritic conditions and skin allergies.
The program would possibly initially use autologous MSC’s to treat inflammatory conditions (arthritis and skin) in companion animals as well as joints, tendons and ligaments in horses.. Muscle, tendon and ligament damage are ideal injuries for treatment with stem cell therapies.
NIM is also evaluating the possible development of ‘off the shelf’ allogeneic stem cell products.
Canine
There are over 4 million companion animal dogs in Australia. Dogs are resident in approximately 3.5 million Australian homes. Arthritic conditions and skin allergies are major problems with dogs – particularly ageing dogs. Treatment costs can be very high as the conditions are chronic. From market research, NIM believes that there are a large number of dog owners who would welcome the provision of stem cell therapies in order to improve the health and the lifestyle of their dogs
NIM is evaluating the introduction of stem cell treatments for dogs – initially targeting arthritis and skin conditions (including allergies/inflammation). NIM believes that these are potentially very significant markets for the use of stem cells in a canine setting.
Equine
Stem Cells have already begun to be used for the treatment of horses. Initial treatments have been focused on the treatment of tendon, ligament and muscle injuries in racing thoroughbreds. A large part of the function of tendons is to store energy via its elasticity and return that energy to the horse for the next stride. The downside is injury, when the tendons and ligaments are overstretched.
While many, if not most, of these injuries will ‘repair naturally’, the repaired scarred tendon is less elastic than normal tissue, thus detracting from the performance ability of the horse as well as putting it at risk of re-injury. The need is for regeneration (of normal tissue) rather than repair (scarred tissue).
The use of stem cells in the treatment of these injuries has led to very promising results. Initial treatments of ‘bow-tendon’ have lead to the repaired tissue being ‘virtually identical’ to the original tissue, including having the same strength and elasticity. In the treatment of tendon injuries, ultrasound images have shown a rapid filling of the injured site and elegant tendon regeneration in horses.
Australia is the second largest ‘breeder’ of thoroughbred horses (after the U.S.) and supplies thoroughbred horses to the Australian, Asian, Middle East and European markets.
Veterinary Business Development
NIM is currently evaluating possible commercial arrangements with existing international providers of both canine and equine based stem cell processing and therapy services.
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Human Stem Cell Therapies
Background
The technologies of stem cells and immunology are synergistic. NSC believes that its proprietary technology for inducing thymus – based immune tolerance - to prevent rejection by the patient – will play a major part in allogeneic (‘non self) stem cell therapies.
NSC is currently evaluating the possible provision of stem cell services and therapies in the human setting.
NSC has identified a number of clinical contexts in which the use of stem cells (possibly in conjunction with immune system rejuvenation) has significant potential clinical benefits in respect to therapies in the fields of respiratory, cardiovascular, oncology, auto-immune and inflammatory conditions.
The immune system deteriorates with age (from puberty onwards). NIM has been developing technologies to promote restoration of the immune system caused by natural aging, but also chemotherapy, radiation therapy and infections such as HIV/AIDS NIM owns a portfolio of patents that cover technology involving the rejuvenation of the immune system (including increasing the functionality and output of stem cells from the bone marrow), as well as increasing the output of T cells from a rejuvenated thymus. NIM has already licensed the technology and intellectual property to Abbott Laboratories (formerly ‘TAP’) with respect to North America.
Therapies
NSC is evaluating the progressive introduction of autologous stem cell therapies into clinical settings.
The international development of stem cell therapies is being driven by the largely unmet clinical needs of millions of patients suffering from debilitating, and life threatening, degenerative diseases of the heart, lung, liver, kidney, spine, and nervous system as well as medical conditions related to bone, muscle, nerve and cartilage damage. Many patients also suffer from severe autoimmune diseases such as diabetes and rheumatoid arthritis. There are significant clinical and hence commercial opportunities for stem cell-based therapies. It is expected that over the next several years revenues related to stem cell therapies will increase dramatically.
Adult stem cells were initially thought to be multipotent but recent research projects have shown that they are pluripotent (Wikipedia, 2008). They are no longer restricted to their lineage-linked groups of cells; some of them are now able to be triggered and directed to differentiate into more diverse families of specialized cells. Based on this cutting edge discovery, many scientists and researchers strongly believe that stem cells offer the promise of future treatments and potential cures for many debilitating diseases through Regenerative Medicine.
Some of the life-threatening diseases which are bounded with unmet clinical needs that can potentially be cured by stem cells are:-
:
1. Parkinson’s disease
2. Alzheimer’s disease
3. Brain damage
4. Cancers
5. Haematopoisis
6. spinal cord injury
7. stroke
8. organ repair (eg. Liver, kidney)
9. cardiovascular diseases
10. auto-immune diseases
11. physical trauma
12. burns
13. diabetes
14. digestive tracts corrosion
15. osteoarthritis
16. rheumatoid arthritis
17. muscle damage
18. baldness
19. deafness
20. blindness and vision impairment
21. Lou Gehrig’s Disease
22. cystic fibrosis
23. inflammatory bowel disease
The major human therapeutic ‘target markets’ initially being evaluated by NSC in respect to the provision of stem cell therapies include respiratory conditions such as COPD, arthritis, diabetes, burns, inflamed bowel syndrome, auto-immune disorders (such as multiple sclerosis and rheumatoid arthritis) and cancer (immuno-suppression).
NSC would expect to initially concentrate on autologous stem cell treatments (using stem cells from the patient being treated). It is expected that autologous mesenchymal stem cells would be collected from either the bone marrow or adipose (fatty) tissue.
It is possible that into the future, NSC may examine the possibility of extending the provision of stem cell services and therapies to international markets, via joint ventures with leading hospitals and clinicians. It is envisaged that the primary contribution of NSC will be via the provision of intellectual property, knowledge and ‘expertise’.
Norwood Vaccines
The Norwood Vaccine group (‘NV’) holds all of NIM’s virosomal vaccine delivery technology as well as having a license from NIM covering all of the vaccine and viral aspects of the immune system rejuvenation technology (with the exception of vaccines related to cancer and auto-immune disorders)
Virosome Biologicals (‘VB’), a wholly owned subsidiary, is developing and commercialising a proprietary platform ‘delivery’ technology for the delivery of vaccines and DNA/RNAi. VB has entered into an out-licensing agreement with a European group – Solvay Pharmaceuticals B.V. (‘Solvay’) in the field of intranasal influenza vaccines.
Norwood vaccines plans to endeavour to expand its out-licensing programme by licensing its virosome based delivery technology to pharmaceutical companies for a range of vaccines as well as the delivery of RNAi. VB currently expects to generate substantial licensing, milestone and royalty income.