Based in Melbourne, Prima BioMed (ASX: PRR) is a biotechnology company with a focus in 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 $A27m and secured $A900,000 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 efficacy and safety in humans in order to attain commercial success though the licensing of products for global development and marketing to pharmaceutical companies.
Management Mr Marcus Clark...Chief Executive Officer Ms Vanessa Waddell...Business Development Manager Dr Emma Ball...Project Manager
Number of employees 7
Specific focus of company Cancer immunotherapy.
Core Business Definition Biotechnology Business Development.
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 centred 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 invest 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 focus in adding substantial value to technologies where proof of principle has already been demonstrated.
Partners
BIOMIRA Inc. (Canada): CancerVac has secured exclusive world wide rights t the use of mucin-1 in Dendritic Cell therapy for the treatment of cancer. Biomira has first rights to commercialise the CancerVac technology post completion of a phase IIa clinical trial.
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.
PRANA BIOTECHNOLOGY (AUSTRALIA): Prima is collaborating with Prana through its subsidiary Panvax in an attempt to produce immunotherapies in Alzheimer?s Disease.
CENTRE FOR ANIMAL BIOTECHNOLOGY: Prima is investigating the effect of its adjuvant, DCtag to produce an effective vaccine in foot and mouth disease.
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 centred 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 invest 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 focus in adding substantial value to technologies where proof of principle has already been demonstrated.
Technology/IP
Prima BioMed has four distinct biotechnology projects described below:
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 (14/14) demonstrated that the treatment induced a tumour specific T cell response.
The trial was extended to test the effect of freezing dendritic cells to both reduce the invasive procedures for patients and reduce overall treatment costs. In addition 2 patients were continued on therapy and their immune responses were maintained.
A phase IIa trial commenced in June 2004 and will investigate the activity of the treatment in ovarian cancer. Cancer Vac signed a license agreement in March 2004 with Biomira Inc. whereby Cancer Vac received the world rights to Mucin-1 in dendritic cell therapy for the treatment of cancer and Biomira took a first right on pre-negotiated terms for world-wide rights to Cancer Vac?s technology post the outcome of the Phase IIa results.
Arthron Project: development of drugs to inhibit inflammation in autoimmune diseases such as rheumatoid arthritis, SLE. This project has developed a technology that may potentially offer a ?3rd generation? product for the treatment of rheumatoid arthritis. The project was a rationale drug design program designing small 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 release of TNFa and disease progression. Arthron has also demonstrated that the genetic insertion of the particular Fc receptor of interest, FcgRIIa, in to a mouse strain results in the induction of spontaneous arthritis as mice age.
Arthron has intellectual property covering a soluble form of the FcgRIIa. This has the potential to be developed as a biological product for the treatment of autoimmune diseases.
Arthron has an extensive package of intellectual property that encompasses the gene, protein, 3D structure of the FcgRIIa, the drug molecules and the animal model for screening compounds. Arthron has validated the role of FcgRIIa in disease and demonstrated that the receptor can be targeted with small drug like molecules.
Arthron has signed commercial agreements with AstraZeneca (AZ) and Zymogenetics. The agreement with AZ is a research/license agreement. The R&D is in progress and Arthron anticipates entering into license negotiations in the middle of 2005 after AZ has an opportunity to evaluate the data generated. The Zymogenectics agreement is an option/licence agreement in which Zymogenetics are initially developing FcReceptor recombinant proteins for use as a biological therapeutic.
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. Studies conducted so far demonstrate that DCtag 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 demonstrated 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 tumour growth in mouse models of the disease.
The technology has recently been tested for its ability to prevent viral infections and the ability to induce immune responses in larger animals. Results from these studies demonstrated protection from RSV (respiratory synctial virus) in a mouse model and strong cellular immune responses in sheep. The company will now progress this technology through product formulation/optimization and pre-clinicals to a Phase I clinical trial during 2005.
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, cripto -1. 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 associated with the 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 has generated fully human antibodies to the tumour antigen and expects to progress their evaluation in animals in 2005.
Partnering Opportunities
Arthron Project Prima is currently seeking licensees and partners for this program for both the biological product and the small drug molecule program.
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
Partners with expertise in the following disciplines are currently being sought:
Immunology Vaccine development Chemistry Cell based delivery of tumour vaccines
PRR Price at posting:
12.3¢ Sentiment: None Disclosure: Not Held
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