Shares in Oxford Biomedica showed a sudden burst of excitement this week, capping off a strong rally that started in November 2006 when the share price was hovering around 25 pence. The company has a range of interesting prospects in the pipeline, but scouring around looking for reasons to explain the sudden interest at first looks difficult. At first.
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Oxford Biomedica's most advanced drug is Trovax®, a cancer immunotherapy product. Trovax® is a cancer vaccine that targets the antigen 5T4. 5T4 is distributed through a range of solid cancers and its presence often correlates with poor prognosis. I
n laymen's terms, Oxford Biomedica (OXB) has shown that in some solid tumours, the 5T4 antigen is present. When it is present, the outcome for the patient is below average. By administering a vaccine which targets 5T4, it in effect targets the cancerous cells. Trovax® is under clinical trials for a number of types of cancer, including colorectal cancer, prostate cancer, renal cell carcinoma and breast cancer. The most advanced trials at Phase III are for renal cancer a market estimated to be worth US$600 million a year.
The worldwide cancer vaccine market is expected to be worth US$6 billion by 2010. Previous trials for Trovax® have shown the drug to be safe and well tolerated with no serious side affects for the patients. In 95% of evaluable patients the 5T4 tumour antigen induced an anti-tumour response, with tendency for the strongest response to show the greatest clinical benefit. So what does this all mean? If Trovax® Phase III trials for renal cancer are positive, the company will be in a position to register the product for use in the United States by 2009. Once Trovax® reaches this milestone, multiple Phase III trials for other cancers will be coming through the development pipeline and the company should have the Trovax® family of cancer vaccines in the market by 2015. I
t also goes without saying that along the path to product launch, OXB will entertain many discussions on the commercial development of the products with larger drug companies who can market it globally.
The company also has other cancer therapies in the pipeline, the other notable candidate being MetXia® which turns a tumour into a small-scale drug factory, increasing the production of the anti-tumour cytotozic derivative of cyclophosphamide. MetXia® is envisaged to be used in conjunction with chemotherapy and could potentially be used in all treatments of solid tumours. MetXia® is currently in Phase II trials for pancreatic cancer and has completed Phase I/II trials for breast cancer and melanoma.
Despite the obvious potential of OXB?s cancer vaccines, house broker Evolution Securities dedicated its most recent research note on the company's gene delivery platform, LentiVector. Evolution is encouraged by recent deals in the sector including SR Pharma?s joint venture with Pfizer and AstraZeneca's takeover of Cambridge Antibody for £702 million.
There is nothing new in big fish gobbling up smaller fish, but what is interesting is the type of drug companies being gobbled up; Cambridge Antibody was best known for its expertise in antibodies, Kudus, was private company bought for £125 million for a skill set in DNA repair research, and SR Pharma's JV covered a drug based on RNi interference. The commonality is that all three companies were involved in new drug platforms that for many years have been on the fringe of the pharmaceutical sector. The large pharmaceutical companies have a veracious appetite for development pipelines, so pretty much any company that has developed and patented a novel drug development platform is fair game.
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LentiVector is a platform for gene therapy. This is the process of adding genetic material to cells to change the course of a disease. A gene is simply a piece of DNA code which carries the instructions to build a protein. When genes introduced to a cell, they are incorporated into the DNA, and are then used by the cell. Proteins come in many forms and in essence control the cells and many functions in the body. Gene therapy seems to work in two ways. First by adding a missing gene that produces an otherwise missing protein, and this absence causing a disease. Second by adding a gene that produces a protein that inhibits other proteins, which are causing a disease.
One of the major hurdles for gene therapy has been ensuring the uptake of a gene by the targeted cell. Viruses are often used as the vehicle to transport the gene, after being genetically modified to infect a cell with the gene. OXB's platform is based on the Lentivirus which has shown to have strong qualities including high gene transfer ability, adequate capacity, genetic stability, non toxicity, simplicity of production, ability to infect non-dividing cells and allow for the long-term expression of a gene. In other words, Lentivirus is very good at delivering a gene into a target cell ? particularly in neurological diseases where a combination of long-term expression in non-dividing cells and high gene transfer efficiency are the most important characteristics.
It is for these reasons that OXB are focusing the LentiVector platform's attention on disorders of the nervous system including Parkinson?s disease, age related macular degeneration, motor neuron disease, spinal muscular atrophy and spinal cord injury. ProSavin®, targeting the treatment of Parkinson's disease, is expected to enter its first clinical trial before the end of 2007. ProSavin® has a novel approach as it actually delivers three genes that produce enzymes involved in the dopamine production pathway (Parkinson's is a result of the degeneration of neurons which in turn reduce levels of dopamine, which affects voluntary movement)
Twelve patients will be involved in the trail and, as usual, the primary goals of the trial is to test safety and tolerability, however, changes in patients? symptoms and levels of dopamine will be observed too, to see if a preliminary gauge on the effectiveness can be attained. OXB are hoping to move ProSavin® straight into Phase III trials in 2009 if the initial study is positive and the relevant regulatory authorities approve. Pre-clinical tests of ProSavin® have shown extremely encouraging results.
OXB has a plethora of early stage drugs also under development that take advantage of the LentiVector Platform.
So why have shares in OXB suddenly perked up? Clearly there are a few takeover rumours doing the rounds, and in the case of this company, the rumours appear to have some justification as this company does have some exciting products in the pipeline and controls a new gene delivery platform - OXB should be tempting to a bigger fish.