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16 January, 2006: Antibody therapeutics company, EvoGenix Ltd (ASX: EGX), has released results on the successful scientific development of its product for the treatment of bone loss, called OVP (OPG Variant Protein).
EvoGenix has successfully applied its optimisation technology, called EvoGeneTM, to produce a variant of a naturally occurring regulator protein, Osteoprotegerin (OPG). The OPG variant (previously described by the company under its internal number EGX-010) retains all of OPG's ability to stop abnormal bone erosion and loss, but now lacks a secondary activity of OPG which was the potential to increase cancer incidence in treated patients.
The results were presented at the annual CHI conference on Protein Engineering, held in San Diego, California on Friday 13 January, 2006.
At the conference, CEO of EvoGenix, Dr Merilyn Sleigh, described OVP as an effective, but safer version of OPG, a natural protein that has been shown in animal testing and early patient studies to be very effective in stopping excessive bone loss, which occurs in diseases such as osteoporosis and bone cancer. However, she commented that as a potential therapeutic, OPG has been clouded by uncertainties on its possible interference in systems used by the body to target and eliminate cancer cells.
"The success of the project is a powerful demonstration of the effectiveness of our proprietary EvoGeneTM technology for optimising proteins," Dr Sleigh reported.
"Slight modification of the OPG protein using our EvoGene technology has proved to be highly effective in identifying active variants, which retain the ability to block bone loss but have at least a 200-fold drop in the ability to interfere in cancer surveillance," she said.
With an ageing population, the incidence of osteoporosis is rising, with several million patients needing treatment worldwide. OVP may also be applied in other conditions where bone is weakened, including arthritis, Paget's disease, bone cancer and myeloma. Industry reports estimate that therapeutics of this class have blockbuster drug potential (sales of more than US$1 billion annually).
OVP is currently completing testing to confirm its activity in appropriate disease-related systems, through company collaborators in Melbourne and Adelaide. A patent application has recently been filed by the company to protect a range of different OVPs and their application in diseases such as osteoporosis.
For further information:
Company inquiries:
Media and investor inquiries:
Dr Merilyn Sleigh
Chief Executive Officer
EvoGenix Ltd
Mob: 0412 766 790
Rebecca Piercy
Buchan Consulting
Ph: 03 9866 4722
Mob: 0422 916 422
rpiercy@bcg.com.au
OPG facts
A natural regulator of bone turnover
OPG is a protein with a central role in the normal processes of bone formation and turnover. Breakdown and erosion of bone in diseases such as arthritis, osteoporosis and bone cancer results from the activity of cells called osteoclasts. Osteoclasts are formed from white blood cells that receive appropriate activation signals, which are delivered by interaction between a protein RANK, on the surface of the osteoclasts, and a complementary protein RANKL on the surface of the activating cells. OPG blocks this activation process by binding to and blocking the activity of RANKL. Balancing of the relative levels and actions of RANK, RANKL and OPG is the natural process by which the body maintains healthy bone.
Successful clinical testing
Because of its ability to inhibit osteoclast activation and block excessive bone loss, the parent OPG protein has undergone extensive testing in animals and patients and has shown an impressive ability to suppress bone loss in both osteoporosis and bone cancer.
Potential side effects
Unmodified OPG interacts with a second target in addition to RANKL. This second target is a protein called TRAIL, which specifically recognises cancer cells and induces their death. TRAIL action is an important part of the body’s surveillance system that monitors and controls the appearance of abnormal cells which can go on to form tumours. It is possible that the effects of OPG in blocking TRAIL could result in an increased risk of cancer in patients receiving OPG therapy.
Target market for OPG/OVP-like drugs
OPG/OVP may also be applied in a range of conditions where bone is weakened, including osteoporosis, arthritis, Paget’s disease, bone cancer and myeloma. The total market for all drugs used to treat such bone loss conditions is estimated at more than $8 billion worldwide.
Interest in the market potential of OVP-like drugs has been boosted as a result of recent clinical results with an antibody, (Denusomab), under development by US company Amgen. This antibody selectively attaches to and blocks RANKL action, a similar profile of properties to OVP now developed by EvoGenix. Industry reports have estimated that therapeutics of this type have blockbuster drug potential (sales of more than US$1 billion annually).
EvoGeneTM Technology
EvoGenix has established a proprietary technology platform to facilitate the development of antibodies and other protein therapeutics of high potency, suitable for long term administration to patients. . Antibodies are natural proteins designed to attack, block and remove unwanted materials from the body. The components of the platform are
· SuperhumanisationTM, an approach for modifying antibodies generated in animals, so that they appear “human-like” and will not be rejected by the immune system of patients receiving them.
· EvoGeneTM Optimisation, a highly efficient and novel process for fine tuning antibodies and other proteins, to increase their activity or specificity. The process involves making billions of copies of the protein, each with one or two small changes compared with the original. The copies are then tested to find ones with improved properties, for example more powerful attachment to a target to improve potency, or loss of attachment to a target to improve specificity and reduce side effects.
About EvoGenix
EvoGenix was incorporated in August 2001 and listed on the ASX in August 2005, under the code EGX. The company has established proprietary technology and industry expertise in the identification and development of protein and antibody-based drugs
The company is exploiting this know-how through technology collaborations with partner companies and the development in-house of wholly-owned products. EvoGenix recently entered a significant technology collaboration with pharmaceutical company GlaxoSmithKline and expects to form further such technology alliances over the next 12 months. OVP (EGX-010) is the first internal product to be developed. Two antibody products, targeting viral disease and liver cancer respectively, are at an earlier stage of development, while a third antibody, directed at the treatment of leukaemia, is under evaluation.
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