Imugene Market Update Quarterly Report to 31 December 2006
Highlights:
Efficacy trial success of Imugene's new avian influenza vaccine candidates. Potentially the world's first easy-to-administer bird flu vaccines for poultry. Awarded $882,000 Commercial Ready Grant for the development of avian influenza vaccines as well as diagnostic tests Milestone payment from licensee Merial Ltd for progress of the Poultry Productivity Enhancer. PPE is Imugene's lead product improves health and growth of poultry Approval of pig vaccine patent in Europe Coccidiosis poultry vaccine candidates finalised US Pig trials for PRRS vaccine to begin Bioshares report on Imugene 31 January 2007
Avian Influenza—Protecting Poultry
In November 2006 Imugene's new bird flu vaccines started trials in a high security bio-containment facility in Nebraska USA. These vaccines developed earlier last year by Imugene are designed to protect chickens and to be orally administered in drinking water to large populations of birds. This was a proof-of-concept efficacy trial using the H5N1 strain bird flu for broilers (meat producing) and layer/broiler breeder poultry.
Benchmark Biolabs undertook the trial at its approved Animal and Laboratory Biosafety Level 3 (BSL-3) laboratory and trial facility. It is one of the few locations worldwide authorized to conduct animal trials with infectious agents such as avian influenza.
Earlier this week Imugene announced positive preliminary results for the lead broiler vaccine candidate. This vaccine has achieved proof of concept and will progress to product development.
The broiler vaccine stimulated the required immune response to protect two thirds of vaccinated birds against a very high dose of a highly pathogenic Asian strain of the H5N1 avian influenza virus. All control birds (not vaccinated) died. The challenge dose ultimately used in this trial was many times more severe than bird flu outbreaks in the field.
These results are the first indication of protection for birds with oral administration of a bird flu vaccine. The Company expects to achieve higher levels of protection with refinement of the vaccine candidates and adjustments to the dose and timing of administration. These optimisation procedures will occur after the full trial report has been received and analysed. Future challenge trials will use lower virus challenges to simulate the naturally occurring bird flu outbreaks in the field.
About the Imugene avian influenza vaccines
Imugene is developing two vaccines one for broiler (meat producing) birds and the other for breeding and egg layer birds. The commercial requirements for broilers and breeders or layers vary. The main aim for a commercial bird flu vaccine for broilers is to provide immunity early in a bird's life as broilers reach market weight by 42-49 days of age. Layer birds and birds used for broiler breeding need longer lasting immunity.
An effective orally administered vaccine could protect the world's poultry industry from avian influenza outbreaks and halt the spread to Australia, Europe and the US.
A commercially viable vaccine to control outbreaks must be safe, effective and able to be quickly and easily administered on a large scale.
Imugene's vaccine under development:
allows authorities to differentiate between infected and vaccinated birds delivers only a portion of flu genetic material ensuring the vaccines are safe by preventing mutations or recombination is cost effective for mass administration to entire poultry sheds probably as a drinking water additive is specific to the H5N1 avian influenza but can be readily be adapted to protect against other bird flu virus strains does not require the injection to be injected as does most exiting treatments Commercial Ready Grant
In November 2006 Imugene won an Australian Federal Government grant to develop the two bird flu vaccines as well as diagnostics for poultry. The Commercial Ready Grant of $880,000 will be drawn over two years starting on 1 October 2006. Imugene is matching the grant dollar-for-dollar.
Industry Minister Ian Macfarlane congratulated Imugene and said, "bird flu is deadly and unpredictable and a project to test vaccines to protect chickens from the virus will be an enormous breakthrough."
Poultry Productivity Enhancer (PPE)
Imugene's PPE licence to Merial is an important external validation of the technology by one of the major international animal health pharmaceutical companies. Merial is managing development of the PPE..
During the quarter Dr Bob Nordgren, Vice President Biologics, Research, Development & Technology Acquisition at Merial stated, "key regulatory elements of the product development program were satisfied with the positive results from the safety trials conducted in Australia and the previously agreed milestones remain in place."
Merial has remitted a milestone payment and Imugene will earn further milestone payments throughout the product development. Imugene will also receive royalty payments on product sales.
As previously reported Imugene has completed the final safety trials requested by the Office of Gene Technology Regulator (OGTR). The results re-confirmed the PPE's safety with all regulatory trial endpoints being easily satisfied. The final OGTR dossier will soon be submitted seeking 'intentional release' for the PPE in Australia. This is a major step toward commercialising the product.
The PPE remains on track to become Imugene's first vaccine product in the market.
About Merial
Merial is a world-leading, innovation-driven animal health company producing pharmaceutical products and vaccines for livestock, pets and wildlife. Millions of doses of Merial products are administered each year to keep livestock and pets healthy.
Merial employs about 5,000 people and operates in more than 150 countries. Its 2004 sales were over $1.8 billion. Merial is a joint venture of Merck & Co. and sanofi-aventis. www.merial.com: .
Pig Vaccines—Approval of European Patent
During the quarter Imugene's Porcine Adenoviral Delivery Vector technology patent was approved in Europe. The Porcine Adenoviral Delivery Vector is the base technology behind all Imugene's pig vaccines.
With official grant of the European patent, Imugene will have patent protection for the Porcine Adenoviral Delivery Vector technology in Europe and the US in addition to other major pig producing countries.
The new provisional patent lodged in 2006 covers improvements in the effectiveness of vaccines and further commercial advantages such as possible dose reduction and reduced frequency of administration. The new patents prolong commercial protection and extend the duration of future royalty income for all the pig vaccine products.
Poultry Coccidiosis Vaccines
Most of the required versions of the coccidiosis vaccine candidates have been constructed and are ready for animal trialing. These have been prepared for Abic Biological Laboratories Teva Ltd, (Abic) the animal health division of Israeli-based Teva Pharmaceutical Industries Ltd.
Imugene constructed the vaccines for trial based on its patented Adenoviral Vector Delivery System using patented coccidia genes supplied and owned by Abic. Imugene has provided input into the proposed trial design and the candidates will be shipped to Abic for poultry trials.
Coccidiosis is one of the most common and costly diseases in poultry and is prevalent worldwide. Apart from causing weight loss and poor feed conversion, the death rate in chicks and adult birds can be high. Coccidia is the second biggest poultry health product, second to in-feed antibiotics currently fed to poultry.
Pig PRRS Vaccine Trial to Begin in US by June 07
As reported last quarter Imugene had successfully completed optimisation work with the PAV vectored PRRS (Porcine Reproductive and Respiratory Syndrome) vaccine candidates. Planning is nearly complete for the US-based trial scheduled for the first half of 2007.
The trial planning including protocol and trial facility have been finalised and we anticipate this trial should commence during the June 07 quarter.
PRRS is one of the most economically damaging diseases of pigs worldwide causing industry losses of up to $1 billion each year. Initially recognised in the US in 1987 the disease spread to Europe in 1990 and subsequently across most of the rest of the world. Australia is one of three countries to be considered PRRS-free.
Positive results from this trial will assist Imugene's licensing negotiations with major international animal health companies.
Bioshares report
Independent Australian life sciences analysts at Bioshares have reported positively on Imugene in a recently published report. In a feature report on Imugene's progress in its 17 January edition Bioshares cited: "Imugene has traveled through the latest downturn in the biotech sector remarkably well." The company was praised for the way it has raised funds, prioritised products with the strongest commercial prospects, its business model of contracting-out research and its low cash-burn. Imugene also received high favour for its technology.
IMU Price at posting:
0.0¢ Sentiment: Buy Disclosure: Held
(20min delay)