Prima BioMed Ltd

  Overview

Based in Melbourne, Prima BioMed (ASX: PRR) is a biotechnology company with a focus on developing and commercializing 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 in Melbourne, Australia. Prima BioMed has four distinct projects under management including one in clinical trials.

Since listing on the Australian Stock Exchange in June 2001 the company has raised $A11.7m and secured $A410,000 in industry grant funding.

The company has an intellectual property portfolio that includes 26 granted patents and 46 applications under prosecution.

Vision

To demonstrate excellence in identifying, funding, developing and commercializing biotechnology research to produce products for human and animal health care.

Mission

To drive shareholder value through achievement of successful commercial outcomes yielding significant increases in value of both the Prima structure and its underlying technologies.

Focus

Development of technologies arising from the medical field of immunology and cancer immunotherapy.

Business Strategy

To identify technologies and manage the development of research programs which demonstrate initial proof of safety and efficacy in humans in order to attain commercial success though the licensing of products for global development and marketing to pharmaceutical companies.

Management

  Competitive Advantages

In establishing itself as a strong, tightly managed and commercially-focused biotechnology company, Prima Biomed has developed a business model that applies all of the rigor required for developing a successful biotech business while retaining flexibility to achieve multiple commercial outcomes.

Key features of the model are -

• A portfolio approach which reduces technical risk, but remains centered in the lucrative area of immunology and cancer immunotherapy, ensuring focused research and management skills;
• Flexible investment options to assist capital raising and commercialization activities including the ability to investment in either:
  - Prima Biomed for investment in an R&D portfolio; or
  - project companies for investment into specific technologies
• A milestone driven investment strategy for projects, which provides inventors with equity in the project thus directing investment funds to technology development rather than up-front payment for intellectual property and infrastructure;
• Leverage of the management team within Prima Biomed over the four projects’ R&D activities, intellectual property portfolios and commercialization activities from the time of investment until a project company has the need and capacity to become fully independent;
• Participation of key scientists and management in share and options programs, which provide incentive to achieve commercialization goals;
• Access to biotechnology opportunities from within the Australian medical research community, strengthened through priority access to technology from the Austin Research Institute;
• Benefit of lower cost clinical trials as compared to international markets, while meeting international compliance standards;
• Close linkage with Australian merchant banking groups, to facilitate fundraising, structuring of activities and strategic market advice;
• Listed on the Australian Stock Exchange providing liquidity to investors.

Prima Biomed has not been established as a company that will independently develop new products through to product registration. Rather, the focus is on converting technology with solid intellectual property into real product candidates, which are of significant value to larger global biotechnology and pharmaceutical companies - a focus in adding substantial value to technologies where proof of principle has already been demonstrated.

  Technology

Prima BioMed has four distinct biotechnology projects described below:

1. Cancer Vac Project: cell therapy treatment for cancer. Cancer Vac is focussed on the induction of cytotoxic T cells to the tumour antigen mucin-1 (MUC1) coupled to its proprietary immune stimulant “mannan”. The immune stimulant mannan has been previously demonstrated to be effective at inducing T cell responses as opposed to antibody responses. The MUC1-mannan product is delivered via dendritic cells which have been isolated from the patient and primed in vitro with the tumour antigen. A phase I study has been completed and data indicates that there are no significant therapy related adverse effects and all patients (10/10) demonstrated that the treatment induced a tumour specific T cell response. The trial has been extended to optimise the method of culturing the dendritic cells to both reduce the invasive procedures for patients and reduce overall treatment costs. In addition 2 patients have continued on therapy and their immune responses to their tumour are being routinely monitored. A phase II study is planned for Q4 2003.

2. Arthron Project: development of drugs to inhibit inflammation in autoimmune diseases such as rheumatoid arthritis, SLE. In this project we are developing a technology that we believe offers a “3rd generation” product for the treatment of rheumatoid arthritis. The project is a rationale drug design program designing small organic molecules that inhibit immune complex binding to Fc receptors on the surface of inflammatory white blood cells. We have a range of small chemical entities that in mouse models of rheumatoid arthritis have been demonstrated to inhibit disease. Arthron has also demonstrated that the genetic insertion of the particular Fc receptor of interest, FcÿRIIa, in to a mouse strain results in the induction of spontaneous arthritis as mice age. The Fc receptor of interest, FcÿRIIa, is not found naturally in mice

Arthron has intellectual property covering a soluble form of the FcÿRIIa. This has the potential to be developed as a biological product for the treatment of rheumatoid arthritis. We are currently looking licence this development technology.

Arthron has an extensive package of intellectual property that encompasses the gene, protein, 3D structure of the FcÿRIIa, the drug molecules and the animal model for screening compounds. Arthron has validated the role of Fc?RIIa in disease and demonstrated that the receptor can be targeted with small drug like molecules.

Arthron’s focus for 2003 is on securing licensees and/or partners for further development.

3. Panvax Project: developing an immune stimulant known as DCtag which is a targeting system for vaccines and immunotherapy, targeting antigens to dendritic cells. The technology involves the coupling of a nanoparticle to a disease antigen and the subsequent delivery of that conjugate to dendritic cells through DCtag’s unique targeting approach. Studies conducted so far demonstrate that DCtag targeting is very effective at delivering antigen to dendritic cells, leading to the effective induction of both humoral (antibody) and cell-mediated (T cell) immunity.

The technology has been demonstrated to offer 100% protection against a lethal infection of malaria in mice. Furthermore, this protection can be induced with both crude cell lysate preparations or with purified antigens. The technology has also been demonstrated to both prevent and treat tumours in mouse models of disease.

The technology is currently being tested for its ability to prevent viral infections and the ability to induce immune responses in larger animals. Results from these studies are expected in April-May 2003.

4. Oncomab Project: developing antibody based therapies for the treatment of cancer in collaboration with Medarex Inc. The tumour antigen that is targeted in this project is a protein found on the surface of cancer cells. It appears to be an important regulator of tumour cell survival and interfering with the tumour antigen's activity results in the death of cancer cells. Its preferential expression by cancer tissues makes it an ideal target for antibody therapy, as the antibodies are unlikely to bind to and destroy normal tissues. This tumour antigen is expressed on a wide variety of solid tumours (breast, lung, colon, ovarian, prostate) as well as on lymphomas.

Oncomab has demonstrated that rat antibodies that bind to the tumour antigen protein associated with cancer inhibit the survival of tumour cells as well as inducing apoptosis (a form of cell death) in tumour cells. Studies conducted in mice have shown that the antibodies are effective at both preventing the formation of tumours and also at eradicating existing tumours.

US based biotechnology company, Medarex and Oncomab are now collaborating to develop a series of fully human antibodies using the Medarex technology. These antibodies are expected to improve the effectiveness of the potential product and reduce the risk of adverse effects associated with rodent derived antibodies. The collaboration aims to generate fully human antibodies to the tumour antigen and expects to analyse those antibodies during 2003.

  Corporate Alliances/Partnerships

Partners

MEDAREX INC (USA): In March 2003 Prima BioMed announced a commercial partnership between Oncomab and Medarex Inc (USA) to co-develop and commercialize anti-cancer antibodies. Under the terms of the agreement, Oncomab and Medarex expect to share equally the costs of, and future revenues arising from, the development of any antibody products.

PASTEUR INSTITUT (FRANCE): Prima is collaborating with the Pasteur Institut in the development of a human malaria vaccine using antigens identified at the Pasteur Institut in conjunction with the DCtag immune stimulant being developed in the Panvax project.

Partnering Opportunities

Cancer Vac Project

The immune stimulant “mannan” is proprietary technology of the company. In the Cancer Vac project we have successfully demonstrated a 100% success rate at inducing T cell responses using “mannan” conjugated to an antigen, mucin-1. The company continues to pursue mucin-1 as a target antigen and plans to undertake a phase II study prior to seeking licensing opportunities. Licensing options are available to companies interested in utilising mannan with other tumour antigens.

Arthron Project

Prima is currently seeking licensees and partners for this program for both the biological product and the small drug molecule program. The company’s preference is to licence rights to the biological product to a third party and enter into collaboration with a company with extensive chemistry capacity to complete the design of small drug molecules to inhibit autoimmune disease.

Panvax Project

Opportunities exist for companies interested in testing the DCtag immune stimulant in either vaccine development programs or cancer immunotherapy to secure access to the technology under an option to licence agreement or a direct licence on specific disease indications.

Partnering Needs

Prima is actively seeking both collaboration based partnership arrangements as well as license opportunities for all technologies currently under development. Partners with expertise in the following disciplines are currently being sought:

• Immunology
• Vaccine development
• Chemistry
• Cell based delivery of tumour vaccines

Contact Person	Mr Marcus Clark
Job Title	Chief Executive Officer
Address	Unit 7, 79-83 High St
City/Suburb	Kew Victoria 3101 Australia
Email	mclark@primabiomed.com.au
Phone	+61 3 9854 5700
Fax	+61 3 9854 5777
Website Address	www.primabiomed.com.au

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