prima newsletter

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COMPANY ANNOUNCEMENT
Prima Newsletter
1 June 2004
The following June 2004 Milestone newsletter is being despatched to all shareholders.
Richard Revelins
Director
• Mr Eugene
Kopp—Nonexecutive
Director
• Dr Emma Ball —
Project Manager
• Panvax focuses on
oncology
• Deal with Biomira
for CancerVac
• Oncomab tumour
studies
• Arthron presented
to US pharmas
Highlights
Welcome to the seventh edition of Milestone. Our primary purpose with this newsletter is to
update shareholders on recent events at Prima Biomed including high profile board and
management appointments and scientific developments at our four project companies, Arthron,
Panvax, CancerVac and Oncomab.
Our secondary purpose in this edition is to not only demonstrate the dedicated and focused
hard work behind the development of our technologies but also to demonstrate the enormous
potential that Prima holds.
We appreciate that biotech is a significant challenge for investors not only in terms of valuation
and understanding but also the patience required through the long periods of scientific
development and consolidation.
In our last newsletter we discussed Prima BioMed being in a period with long term commercial
and strategic implications. Since then we have increased our shareholding position to 85%
(from our initial equity of 65%) in recognition of second round funding in all four project
companies. By consolidating our management and majority ownership we are well positioned
to benefit from their successful development. This represents a clear signal of the Board’s
confidence in the potential of all projects under development.
We believe the company is well positioned to generate significant shareholder value over the
coming months as many of our commercialization and corporate strategies achieve their
designed endpoints.
Option holders have recently been notified that the closing date for the exercise of their listed
options is 15 June 2004. If option holders are unsure whether or not to exercise their options
they should seek advice from their broker or financial adviser.
More than ever we believe that we are on course to provide significant and ongoing benefits to
shareholders and thank you for your ongoing support of Prima BioMed. Should you have any
queries related to this newsletter or Prima BioMed, please don't hesitate to call me on
+61 3 9854 5700.
Marcus Clark
Chief Executive Officer
Milestone
The Prima BioMed Limited Newsletter for Shareholders ( A SX:PRR ) • Number 7 / June 2004
Bio2004 1
New Appointments 2
Panvax 2
CancerVac 3
Oncomab 3
Inside this issue
Arthron 4
BIO 2004
Prima’s management team will be attending BIO2004, the annual international conference of the Biotechnology
Industry Organisation in the US, in San Francisco, 6 to 9 June.
The annual BIO conference is the largest biotechnology event in the world. It is expected that more than 20,000
biotech executives, investors, journalists, policymakers and scientists from more than 55 countries will attend. With
estimates that 85% of attendees are the key decision makers of their organisations, this meeting has high potential
for progressing commercial opportunities and developing strategic alliances.
2
In recent months, we have seen an increase of interest in
Arthron's Fc receptor as a target for drug development
in autoimmune disease. Professor Mark Hogarth, the
lead inventor of Arthron's technology and a director of
Prima Biomed, was recently invited to present Arthron’s
technology to a major pharmaceutical company in the
US and discuss the role of Fc receptors in autoimmunity.
We utilized his presence in the USA by arranging visits
to the other groups we see as key in this area and
Professor Hogarth conducted an extensive road show to
assist the business development executives with the
ongoing process of securing licensing and development
partners and collaborators for the Arthron program by
giving presentations on the role of Fc receptors in
autoimmune diseases such as rheumatoid arthritis.
Further, Arthron has received a Notice of Allowance in
the USA to a new patent application on small drug
molecules that block the function of the Fc Receptor. It
is anticipated that the patent will issue in Q3 of 2004.
As a result of specific requirements of potential licensing
partners, Arthron has extended its intellectual property
licence from the Austin Research Institute (ARI) to
include "all therapeutic indications" rather than just
"autoimmune diseases". This extension will facilitate
securing a licensing agreement favourable to Arthron,
Prima BioMed and the ARI.
Arthron: Patents and Licensing update
New Appointments
Part of our strategy for increasing the value of our
technology and thus the value of the company is
recognizing the importance of engaging high quality
personnel. We take this opportunity to welcome two
newcomers to the company. Dr Emma Ball will take up
the position of Project Manager and Mr Eugene Kopp
has been appointed to the Board as Non-Executive
Director.
Eugene is Managing Director of a highly successful and
well funded private equity company, Bluscan Pty Ltd
which invests in private and listed companies, focusing
on emerging technologies and turnaround opportunities.
He has 20 years’ experience in merchant banking and
four years of direct relevance to the biotechnology
sector. Eugene followed Prima Biomed closely and holds
both the company and technology emanating from the
Austin Research Institute (ARI) in high regard. Eugene
currently holds non-executive directorships in Convé
Limited, an Australian biotechnology firm developing
antifungal treatments and Sonnet Ltd a software
integration company listed on the ASX of which he is the
non-executive Chairman.
Eugene's appointment is one key element in a wider
range of corporate activities with a view to advancing
the global commercialisation of the company’s products.
Dr Emma Ball joins us from the Institute of
Reproduction and Development at Monash University
where she gained experience in developing and managing
biotechnology projects. She is a recognised achiever,
having received from the Faculty of Medicine at Monash
an Exceptional Achievement award. Emma completed
her PhD on enzymes involved in the regulation of
prostate cancer in 1999 and is an inventor on a patented
technology. Her project management experience at the
Institute will be of great benefit to the efficient progress
of our plans.
Arthron technology at a glance
Arthron's proprietary technology centres on a protein called 'the Fc receptor' or ‘FcR’, found on the surface of white blood cells. It is a
component of the immune system and functions in the processes that cause painful and often debilitating inflammation such as in
rheumatoid arthritis. Arthron has shown that the FcR is a valid target for the treatment of rheumatoid arthritis and is likely to be involved in
other diseases involving inflammatory responses. The characteristics of this protein form the basis of an expanding portfolio of intellectual
property owned by Arthron.
3
In March we announced a
significant licensing deal with
Canadian based company, Biomira,
for the development and
commercialization of CancerVac’s
most advanced therapeutic cancer
vaccine product - mannan-MUC1
fusion protein (MFP).
Biomira is an international company
with its headquarters in Edmonton,
Alberta, Canada and subsidiary
operations in the U.S. and Europe.
The company is a world leader in
therapeutic cancer vaccines and has
several compounds in advanced
stages of development. Biomira
has a significant global development
and a collaborative agreement with
Merck KGaA. This partner gives
Biomira market reach into Europe
and thus in turn provides Cancer
Vac with a very strong international
partner.
Biomira licensed CancerVac the
world rights to MUC1, the tumour
protein already used in
CancerVac’s successful Phase Ib
trials, and to be used in the Phase
IIa trial for ovarian cancer
scheduled to commence this
month. To gain access to MUC1
CancerVac has negotiated a sublicense
from Biomira where by
Biomira has elected to acquire 10%
of CancerVac in lieu of an upfront
cash fee for the MUC1 license.
Importantly we negotiated an
agreement whereby Biomira has
taken the first rights to sublicense
CancerVac’s technology worldwide
or North America post the
evaluation of the Phase IIa clinical
trial. This now gives CancerVac a
clear to path to international
markets through a partner that has
the resources to oversee such
development. CancerVac retained
the rights to Australia and New
Zealand, which provides the
opportunity for the company to
take the product to market, sharing
in the direct marketing profits.
Biomira’s CEO Dr Alex McPherson
will join the board of CancerVac
and will appoint two of Biomira’s
senior clinical development
executives to the joint steering
committee to oversee the ongoing
product development program.
The terms of the agreement with
Biomira are confidential however in
the event of successful Phase IIa
clinical trial results will provide
significant upfront miletone and
royalty payments to CancerVac.
CancerVac: Biomira Announcement Update
Technology at a glance
CancerVac is developing new cancer therapies via enhancing aspects of the immune system. The company’s IP covers stimulation of
immune responses by components of the immune system called dendritic cells.
Oncomab: Scientific advances to be published
Oncomab has recently completed studies to determine how widespread its target
cancer protein is among different tumour types. In a positive outcome for
Oncomab, the target was found to be present at high levels in most of the solid
tumours tested. This finding indicates the existence of a large market potential for
this product under development. Since last reporting we have encountered some
production issues with control reagents, which have now been overcome. We
anticipate reporting outcomes in the 3rd quarter of this calendar year.
The joint venture with Medarex Inc has produced scientific developments advanced
through regular contact between scientists from the ARI and the Californian-based
Medarex. Details of the characterisation of the antibodies licensed from the ARI to
Oncomab have recently been submitted as a paper to a major scientific journal and
we will continue to inform shareholders when the peer review process is
completed and details become available.
Technology at a glance
Oncomab, with Medarex Inc of the
US, is developing therapies for
cancer based on antibodies to a
cancer protein which is found on
the surface of cancer cells and is
involved with cell survival.
Interaction of the surface protein
with the antibody leads to cell
death. This protein is found on a
number of solid tumours, including
those of the breast, lung, colon,
ovary and prostate gland.
Unit 7, 79-83 High St
Kew Victoria 3101
Australia
Ph: 613 9854 5700
Fax: 613 9854 5777
www.primabiomed.com.au
Company Inquiries: Marcus Clark, Chief Executive Officer
Media Inquiries: Kate Mazoudier Buchan Consulting +61 3 98664722
Based in Melbourne, Prima BioMed (ASX: PRR) is a
biotechnology organisation with first and last rights over
technologies from the Austin Research Institute.
Prima BioMed specialises in immunology and cancer
immunotherapy and adopts technology development that
shows potential for commercial returns within three years.
Following recent progress with the company’s
research in oncology, the Panvax management
team of Andrew Batty and Professor Magda
Plebanski have prioritised the company’s
development program on the application of DCtag
technology in therapeutic vaccines for
cancer. Panvax is currently beginning a pre-clinical
development program to produce a candidate for
Phase I human trials mid next
year. This focus ensures early
entry into clinical trials.
The DCtag technology received
a boost recently with the
acceptance of a scientific paper
for publication by the journal
Vaccine, indicating successful passage through the
peer review process. The paper describes
experiments showing that very small regions of
cancer proteins (peptides) are capable of
protecting mice from tumours when combined
with DCtag technology in a vaccine preparation.
The results constitute an important step toward
the development of a peptide-based vaccine for the
treatment of cancer.
Our collaboration with Prana Biotechnology is on
track and very promising. Our objective here is to
demonstrate that immunization with DCtag in an
animal model of Alzheimer’s disease (AD) can
reduce the physiological effects of AD. This
project is currently at an early technical
development phase and while it is too early to
make comments about the activity
we expect to be able to report at
the start of 2005.
Similarly our other collaboration
with the Centre for Animal
Biotechnology is using DCtag as one
component to develop a vaccine
against foot and mouth virus in animals. Again it is
very early in the process, but we are able to report
that we are on track and on budget.
We are currently progressing discussion with an
overseas partner regarding the manufacture of our
DCtag vaccines for testing in malaria and other
infectious diseases.
Technology at a glance
Panvax is developing a nanoparticle technology
called 'DCTag', capable of boosting immune
responses to improve disease treatment based
on vaccines and other therapeutics that use the
immune system.
Panvax: focus on oncology program