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prima’s dctag technology confirmed as broad spectr

  1. 355 Posts.
    here is the whole announcement. i dont think people read it or if it has sunk in

    Prima’s DCtag Technology Confirmed as Broad Spectrum Vaccine Technology Against Cancer, Parasitic and Viral Diseases

    28th August 2003

    · Prima Biomed announces excellent results from DCtag technology, which is being developed to boost immune response to cancer, viral and parasitic diseases. All previously established objectives and milestones have been achieved.

    · DCtag showed superior induction to immune responses compared to leading experimental vaccine adjuvants in side by side comparisons in mice.

    · Results show DCtag, coupled with cancer proteins, converts them into potent stimulators of immune response. Experiments also show DCtag can be linked to viral proteins to provide effective immunisation against viral infections.

    · Results from an independent safety study have proven favourable and enable the company to progress DCtag to human clinical trials.

    · Stage 2 now planned to demonstrate DCtag enhances effect of marketed vaccine in humans.

    · Specific vaccine applications in malaria and livestock disease being progressed in partnered deals.

    · Potential to pursue immediate term licensing deals.

    Melbourne - August 2003: Prima Biomed Limited (ASX: PRR) today announced the final and excellent results from the first stage of the development of its DCtag vaccine technology, being developed by subsidiary Panvax Ltd.

    DCtag is a unique nanoparticle with demonstrated ability to protect animals against lethal malaria parasites and to provide an effective immunotherapy treatment against established tumours in mice, leading to eradication of the tumours.

    In addition to results previously announced, over the last 18 months, experiments have been performed to ascertain if DCtag could be coupled to a range of proteins found in human cancers and to viral proteins from a respiratory virus and similarly stimulate strong immune responses and prevent such diseases in mice.

    Independent toxicology experiments were performed to also demonstrate whether DCtag would be suitable for administration to humans and the results confirm it does not cause tissue or organ pathology or inflammatory reactions at the injection site which means DCtag is potentially suitable for administration in a human clinical trial.

    In addition, side-by-side comparative studies with other leading adjuvants and vaccine protocols have been performed to assess DCtag's competitive placement as a vaccine able to induce both antibodies and killer T cells. These studies showed that DCtag achieved superior results to a range of adjuvants currently being marketed or in development for use in humans. (Detailed results of the development program are attached in Appendix 1).

    Marcus Clark, said, “These results establish the technology as a potential platform for vaccine adjuvant technology. They build on the results reported earlier this year, which demonstrated that DCtag produced strong cellular immunity in large animals and was able to eradicate the malaria parasite from mice that had the disease in their blood.

    “The technology can achieve these effects with 1-2 doses which would be a major advantage if this translates into humans. The particle is very stable and the process of coupling to proteins very simple, albeit this is for small groups of animals.

    “All these features add up to make a very attractive profile for a vaccine adjuvant. As there are many vaccines providing sub optimal preventative cover in infectious diseases we see a significant opportunity and will now be targeting existing vaccines with a view to enhancing their efficacy.

    "We are also pleased to report that other highly positive results have emerged from Professor Magdalena Plebanski’s work at the Austin Research Institute that we had not anticipated. The mechanism of action of DCtag has been further elucidated and this will enhance our patents which have now moved into national phase in the major countries.”

    Mr Clark said other groups are showing interest in the DCtag technology and it’s incorporation into their vaccine programs.

    We are also very excited by the collaboration into the new therapeutic area of Alzheimer’s disease. The collaboration with the Institute Pasteur in malaria continues and we anticipate developing our collaborations in the Oncology area commenced last year into commercial arrangements this financial year, as well as progressing collaborative Foot and Mouth Virus vaccines in sheep in the veterinary field supported by the Australian Government.

    Our strategy for stage 2 is three fold:

    - Complete a collaboration agreement with a manufacturer of a marketed vaccine to undertake a Phase 1 trial to demonstrate enhanced immunogenicity in humans

    - Secure licenses for specific indications in oncology and malaria and

    - Maintain existing collaborations and development of a cancer immunotherapy program.

    We expect these strategies to produce near term revenues and significantly add value to the Intellectual Property following the completion of the human trial, after which we will be in a position to pursue multiple licensing strategies.

    About Panvax Limited

    Panvax is a subsidiary of Prima BioMed Limited (65% owned). It is focussed on immunotherapy and is developing a platform technology with the potential to boost the immune responses to vaccine and immunotherapy products being developed for both human and animal health. The company is progressing programs in malaria, viral diseases and cancer in order to demonstrate that the DCtag technology is able to induce effective immune responses, protection and therapy against disease.

    About Prima Biomed

    Based in Melbourne, Prima Biomed (ASX: PRR) is a biotechnology company with a focus in developing and commercialising technology arising from the field of immunology and cancer immunotherapy that shows potential for commercial returns within three to four years. Prima Biomed holds first and last rights over such technologies from the Austin Research Institute.

    Inquiries: Marcus Clark, Chief Executive Officer, 03 9854 5700

    Rudi Michelson, (Monsoon Communications), 03 9620 3333


    Detailed Results of development of the DCtag vaccine technology program by Panvax Ltd

    CANCER - The results obtained demonstrated that DCtag can be coupled to a range of diverse human cancer proteins converting them into potent stimulators of the immune response. Importantly, DCtag coupled to human recombinant colon cancer antigen, carcinoembryonic antigen (rhCEA), with a history of use in human trials, prevents completely the growth of the cancer cells. This result confirms earlier experiments demonstrating DCtag is an effective immuno-therapeutic cancer agent in mice.

    VIRUS - DCtag was coupled to proteins from the Respiratory Syncytial Virus (RSV), a virus responsible for serious respiratory infections in children. Mice were vaccinated with the DCtag linked to viral protein and then challenged with the virus. In 12/16 immunised mice no virus was detected whereas all 8 controls developed viremia. Further experiments have demonstrated DCtag immunisation can prevent RSV infection associated weight loss, and that the effects with DCtag linked to a viral protein are better than protein alone. The protective DCtag effect was established after a single dose.

    Importantly these findings also extend the potential of DCtag as a vaccine for pathogens and diseases attacking the body at mucosal surfaces, such as the lung and the gut.

    MALARIA - 0.5 Billion people each year are infected with malaria leading to 1-3 million deaths. As previously announced DCtag vaccination can protect mice from a lethal malaria injection. In addition, in mice already infected with malaria, DCtag has been shown to eradicate the infection. These results open up the possibility for a combined preventative and therapeutic vaccine. National and international collaborations are in place to progress the development of a human malaria vaccine.

    SAFETY - An acute toxicity study was performed over 28 days and then 56 days to check for any significant toxicity in organs or cells in the tissues, as well as the injection site, in rats. The report indicates no DCtag related side effects in any organs or cells in tissues. There was no inflammatory reaction at the injection site and no damage to tissues or cells. The only difference with control animals was the appearance of antigen presenting cells that appear to have taken up the DCtag locally. The latter is consistent with the mode of action of DCtag, efficient uptake by antigen presenting cells such as dendritic cells.

    This formal pre-clinical study in rats was conducted according to Uniform Regulatory Guidelines and confirms previous findings in mice which were (followed for a year) showing that DCtag does not cause tissue or organ pathology or inflammatory reactions at the injection site. The lack of inflammatory site reactions is an unusual bonus feature for a powerful adjuvant, and was further observed in sheep studies over a 3 month follow up.

    COMPARISONS - DCtag was compared side-by-side to a range of leading immune-stimulators, adjuvants and vaccine protocols for ability to induce antibodies and killer T cells. It showed comparable activity to leading experimental protocols (live dendritic cells) and benchmark adjuvants (Freunds-not available for human use), and superiority to currently marketed adjuvants in use (Alum) or in development for use in humans (MPL, QuilA), for both indications: antibodies and killer T cells. This contrasts the leading protocol for antibody induction (Freunds) which failed to induce high levels of CD8 T cells, and the leading protocol for CD8 T cell induction, peptide-pulsed live dendritic cells, which failed to induce significant antibody titres. These results support previous data indicating DCtag's potential as a powerful and broad immuno-stimulant technology.

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