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IMMUTEP LIMITED Investor Presentation 2011

Mar 7, 2011

65122_rns_2011-03-07_12dee054-1c00-4b9a-b9e8-a789c072d716.pdf

Investor Presentation

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EDITION 3 EDITION 3 FEBRUARY 2011 MARCH 2011

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PRIMA BIOMED INVESTOR UPDATE

Message from the CEO

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Company prepares for NASDAQ listing

The Company is pleased to report that its expects its planned listing on the NASDAQ Exchange in the USA ������������������������������������������������������������� ��������������������������������������������������������� �������������������������������� ��������������������������������������������������� ����������������������������������������������� ��������������������������������������������������� ������������������������������������������������������� �������

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In this Issue

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Scientific Advice Agreement early termination of spring-tree for Phase iii trial funding facility and additional $2.5m placement

The Company continues to make strong progress on its late stage clinical trials for CVac[TM] .

In January Prima announced that it had reached an agreement with US investment fund SringTree for the early termination of the convertible loan funding facility SpringTree had provided Prima.

The commencement of a Phase III Trial in Europe will be a key focus for Prima in 2011, and preparations for this are well advanced.

Prima entered into the funding agreement with Spring-Tree in July 2009, and since that time they have provided Prima in the order of $12.2 million to continue its work to develop and commercialise the CVac™ immunotherapy ovarian cancer vaccine.

Prima recently completed a key milestone in the trial preparation, with an Agreement being reached for the strategy and design of the Phase III Trial for CVac[TM] .

SpringTree has agreed to waive the termination fee that would have otherwise been due under the funding agreement. The termination will take effect no later than on 29 March 2011.

The Agreement comes after the European regulator, the European Medicines Agency (EMA), advised that Scientific Advice for the Phase III Trial had successfully been completed.

Scientific Advice was completed after the review of extensive data on the trial strategy, design and endpoints was completed.

With Prima’s pending lsiting on the NASDAQ, and the anticipated increase in exposure and interest from US investors it is expected to deliver, both Prima and SpringTree agreed that the early termination was in the best interests of shareholders.

Evaluation of patient needs, the CVac[TM] dosing regimen, plus manufacturing and safety data from past clinical and pre-clinical data was compiled in order to allow the regulator to make a positive determination on the strategy and design of the upcoming trial.

Prima has enjoyed a very strong working relationship with SpringTree, and the funds they have provide have proved invaluable to Prima over a key phase of its development timeline for CVac™.

The Scientific Advice is a significant milestone in the development timeline for CVac™’s global registration. Prima can now move forward and begin preparations for patient enrollment into the trial.

springtree to make additional one-off $2.5m investment in Prima

See page 6 for more details on the CVac™ Phase III Clinical Trial.

In addition, to the agreement on the early termination of the funding facility, SpringTree has agreed to make a further, one-off, $2.5 million investment in Prima. This will be made up of a placement of $1.25 million in Prima (at 20 cents per share) and $1.25 million by way of a convertible security. Full details of this investment was provided in an ASX announcement of 10 January 2011.

experts Conference Call

The Company recently hosted an Expert’s Conference call to provide an update on CVac™’s clinical trials, the unmet medical need of ovarian cancer patients and relevance for the medical oncology profession. The Call featured Dr Jonathan Berek from Stanford Medical Centre, Prima’s chief medical officer Dr Neil Frazer and Jason Kolbert head analyst from National Securities.

The Webcast of the Conference Call is available on the Prima website at the following link; http://www.investorcalendar.com/iC/CePage.asp?id=163542

dr sharron Gargosky’s column

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Prima is delighted to welcome the Company’s Senior Vice President of CVac™ Program, Dr Sharron Gargosky, as a new contributor to your Investor Update.

In this issue she provides some of her insights into ovarian cancer and the need for new treatment options.

ovarian cancer facts

Ovarian cancer is one of the most insidious cancers, and has a high morbidity rate. In Australia, three women are diagnosed with ovarian cancer every day, and there is no early detection test. This means that when most patients are diagnosed, the cancer is already

at an advanced stage. More than 1200 women are diagnosed with ovarian cancer in Australia each year and 800 women will die from the disease. At the moment, only 40% of women with ovarian cancer will be alive five years later.

treatment

Current treatment usually involves surgery and chemotherapy, and, less often, radiotherapy. The first treatment is usually surgery ,called a laparotomy. This is also the main way a diagnosis of ovarian cancer is confirmed. In a laparotomy, as much of the tumour as possible is found and removed. Most patients will also require chemotherapy . This aims to attack cancer cells and slow or stop their growth. Chemotherapy works best when the tumour is small and the cancer cells are actively growing. Chemotherapy can also damage some healthy cells in the body and cause a range of side effects. Radiotherapy is also occasionally used as a treatment option. Special x-rays are aimed at the site of the cancer, which damage the DNA in the cancer cells and kills them. Radiotherapy also has side effects.

alternative treatment options

The high morbidity rate of ovarian cancer, coupled with a limited range of treatment options and associated side effects, makes finding viable alternative treatment options a high priority.

Work in the field of immunotherapy treatments – using the body’s own cells to provide a defense mechanism – has made strong progress in recent years. Prima BioMed is to be commended for its work in developing an immunotherapy vaccine for ovarian cancer.

Typically, such treatments won’t offer a cure for a cancer, but provide a complementary treatment option to mainline treatments (like surgery and chemotherapy) to delay the spread of the cancer and improve patients’ quality of life.

There is a clear medical need for viable, widely available such treatments for ovarian cancer.

Statistics and information for this article have been gathered from Ovarian Cancer Australia.

A word from Prima’s Scientific advisory Board Chairman, Professor ian Frazer

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‘I continue to be excited and encouraged by the outstanding work being done by the Prima team in developing this immunotherapy technology for ovarian cancer and its work on other major diseases. Their commitment to providing a commercially available, alternative treatment option for ovarian cancer patients is highly commendable.’

Professor Ian Frazer, Australian of the Year 2006 Prima BioMed Scientific Advisory Board Chairman

Cvac[tm] - a ‘Focused Cancer Killer’

This issue of your Investor Update has been

expanded to include a double-page centrepiece, titled ‘Focused Cancer Killer’, which provides an excellent graphical representation of how the CVac[TM] ovarian cancer vaccine actually works.

It shows a roadmap of the vaccine in action; >> from the body’s own key cells being engaged,

to the cells being selectively harvested from the patient’s blood to make the vaccine, and finally

to the vaccine being administered to the patient and the activated cells targeting the tumour cells

The centre-piece also provides answers to a number of frequently asked questions on CVac[TM] , and provides some key statistics on ovarian cancer, which help highlight the need for new, alternative treatment options.

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Ovarian cancer Ever since the days of William Coley in represents New York, who pioneered in the year the 1893 the use bacterial injections in an attempt to stimulate the immune system 6th to fi ght cancer, physicians have attempmost ted to harness the awesome power of the commonly human immune system to fi ght tumours. diagnosed Dr. Coley’s patient lived for an additional cancer twenty six years, and his tumour vanished. Such a success should have led to more among and more sophisticated cancer immune women therapies, but physicians chose the route worldwide. of toxic chemotherapy, and harmful radiation to destroy rampaging tumours. Killing fast dividing cells by damaging their DNA seemed swifter than waiting for the body It causes to mount a massive immune system attack more deaths per year than any other cancer of the female reproductive Mucin-1 system Dendritic Cell It is the 5th leading cause of cancer death among women globally Only 3 THE KEY CELLS out of The immune system is primed to fi nd “foreign” proteins and to send killer cells 10 to destroy them. The cells that fi nd the women with foreign protein are antigen presenting ovarian cells, and dendritic cells are a key antigen cancer live presenting cell. The antigen presenting more than cell then picks up some of the bad profi ve years tein, and shows it to T cells. The T cells then know what protein to fi nd, and they kill any cell carrying that protein.

STATISTICS

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FOCUSED CANCER KILLER

Dying Cancer Cell

on the tumour. In April of 2010, Dendreon Corporation became the fi rst company in history to get Food and Drug Administration approval in the United States for Provenge, a product consisting of patients own cells, primed to target PAP a protein found in high quantities in prostate tumour cells. Giving patients their own cells to boost the immune system proved an effective therapy, and patients lived on average 4.1 months longer than those given a sham treatment. Many new therapies are in development to target tumours, and an Australian company Prima Biomed Ltd is in the lead to develop a therapy for ovarian cancer that uses the patient’s own cells to tackle their tumours.

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Fighting Cancer with a Vaccine Cancer Cell Mucin-1 Customised Dendritic cells targeted to Mucin-1 Dendritic Cell Activated T-Cells Inactive T-Cells Illustration by

TARGETING THE TUMOUR

VACCINE THERAPY

Therapy involves selectively harvesting cells from the patient‘s blood that can be matured into dendritic cells. These dendritic cells are then customised to the foreign protein or cancer antigen called mucin-1. The mucin-1 targeted dendritic cells are the treatment or in the case of PrimaBioMed, CVac™.

When the cells are injected back into the patient’s skin, they fi nd T cells and show them the antigen. Activated T cells then hunt down tumour cells displaying Mucin-1 and destroy them.

FREQUENTLY ASKED QUESTIONS

HOW IS CVAC ™ DIFFERENT FROM OTHER IMMUNE THERAPIES FOR CANCER?

In the case of Provenge ®, the vaccine targets prostate cancer only. The cells are injected into a vein, whereas CVac ™ is injected under the skin where it fi nds T cells in large numbers. Other immune therapies may take a sample of the patients tumour, killing it and returning it the patient in the hopes that the body will start treating the tumour as an invader, and attack it. Yet other therapies simply boost the whole immune system, running the risk that other tissues will be damaged by attack by T cells.

WHAT OTHER TUMOURS ARE BEING TARGETED BY VACCINE THERAPY? There are many immune therapies in development for cancers, and many have shown promise during early development. Another company, Merck KgA, is developing a vaccine against Mucin-1, but in their case, they target lung and breast cancer. The vaccine is called Stimuvax ™ and in early studies, patients lived 17 months longer on average than patients receiving a placebo.

WHY DOES THE BODY NOT RECOGNIZE TUMOUR CELLS AS ABNORMAL BEFORE IT GETS THE VACCINE?

Tumour cells have escaped the normal patrolling T cells and hide in the background. It is only when the vaccine is given, and many new T cells are recruited to hunt down the tumour, then it can no longer remain undetected with such a focused attack.

DO VACCINES WORK TO PREVENT CANCER?

They may do in the future. However, each vaccine tends to be targeted at one tumour type, and we would all have to receive thousands of vaccines to try to prevent any type of tumour from developing.

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about the Phase iii trial

The patient population will be randomised to the CVac™ treatment arm vs a standard of care observation arm.

The Phase III Trial for CVac[TM] will be conducted on a 750 patient population in a double-blind, placebo-controlled study (randomized 1:1) of CVac™ vs Standard of Care.

The objective of the trial is to further confirm the ability of CVac™ to reduce the instance of relapse in ovarian cancer patients, control the metastases of the cancer and increase the life expectancy of patients. Patient quality of life and patient immunological markers will also be measured.

It will be conducted across multiple sites in Europe, US and Australia. This will include the world renowned Charite University Hospital in Berlin, Bonn University, both in Germany, Stanford Medical Centre in the United States and the Austin Hospital in Melbourne, Australia.

If statistical endpoints are successfully reached it is the Company’s hope that CVac™ would become the world’s first ovarian cancer immunotherapy treatment and, in so doing, provide a new paradigm for patients and oncologists globally.

The trial will run concurrently with the Phase IIb Clinical Trial, which is currently underway, under the authority of US Food and Drug Administration.

The CVac[TM] Phase III Trial is designed to deliver statistically powered endpoints for progression free survival, and also for overall survival.

‘… it is the Company’s hope that Cvac™ would become the world’s first ovarian cancer immunotherapy treatment and, in so doing, provide a new paradigm for patients and oncologists globally’.

initial Phase iib trial patient group successfully completes vaccine treatment first CVac[tm]

ents. This patient cohort will be tracked on either standard of care versus treatment with CVac[TM] (CAN-003 is versus standard of care. CAN-004 is versus placebo.)

The initial patient group, which comprised seven patients who met the Phase IIb Trial’s eligibility criteria, completed their first injection of the CVac[TM] vaccine and were then monitored for a period of (at least) 28 days to assess any treatment-related adverse effects.

The Company has been delighted with the progress of its Phase IIb Trial for CVac[TM] to date.

We recently reported a major milestone in the trial; that the initial patient group had successfully completed its first treatment with the CVac[TM] immunotherapy vaccine and that, importantly, no safety data concerns had been expressed by the Data Safety Monitoring Board.

Prima was delighted to report to the market that this patient group did not suffer any therapy related adverse effects. As a result, the Data Safety Monitoring Board advised that the Phase IIb Trial was safe to proceed.

The represents a significant achievement for the Company, and the progression of its clinical trials. It not only marks the treatment of the first group of trial patients, but it also paves the way for the enrollment of the balance of patients into the Phase IIb Trial.

Its positive verdict was based on a detailed review of patients’ safety laboratory measures of blood, serum and urine chemistry, vital signs, and any reported study agent effect.

Further information on the Phase IIb Trial will be released on the ASX as it becomes available.

Patient enrollment into the randomised component of the trial will now proceed. This will include a further 54 pati-

‘It not only marks the treatment of the first group of trial patients, but it also paves the way for the enrollment of the balance of patients into the Phase iib trial’.

Planned upcoming activity

The Company is entering an extremely active phase in its development plans for CVac™, and also its other clinical programs. Following is an overview of some of the key pieces of upcoming Company activity to anticipate.

event indicative timeline*
Potency Assay qualifed for Phase IIb Clinical Trial Q1, 2011
Fast Track Status for Phase IIb Clinical Trial expected to be granted by FDA Q2, 2011
Phase IIb Clinical Trial completing enrollment Q3, 2011
Phase III Clinical Trial commences enrollment Q3, 2011
Initial data for Oral HPV vaccine received Q3, 2011
  • The timelines listed above are indicative only, and are designed to provide a guide on timing of key upcoming events. The actual times of delivery of these events is subject to change and may vary depending on a number of internal and external factors

The above represents some of the major upcoming events scheduled for 2011. For details of all material information releases from Prima, please refer to the Company’s ASX announcements during the course of the year.

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strengthening the Prima team – new CFo appointed

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Prima prides itself on the calibre of people it attracts to the Company. It has assembled a world-class clinical team and management team, and is delighted to welcome the latest addition to the team, the Company’s new CFO Ian Bangs.

Ian has more than 25 years experience in senior finance positions with companies across a range of diversified industries. With the continued strong growth in Prima’s business, he will play a key role in the Company’s corporate management team. He has previously been Chief Financial Officer and Company Secretary for a number of ASX-listed companies, including LandMark White Limited and IFC Capital Limited.

He also spent 10 years as the CFO of the Regent Hotel in Sydney. Ian has expertise in the day to day financial and administrative operations of businesses, together with their statutory reporting and compliance obligations. He has a Bachelor of Commerce degree and is a Fellow CPA.

Prima Biomed – Fast Facts

Listings Australian Securities Exchange

ASX Code: PRR

Issued Capital - Ordinary shares 774.6M

(Listed) Options 102.1M (exercise price $0.02 on or before 31 Dec 2011)

Market Capitalisation(fully diluted) A$201.4M (@ 14/02/11)

Cash Position A$14.4M (@ 31/12/10)

Non-executive Chairman

Ms Lucy Turnbull

Mr Albert Wong

Non-executive Deputy Chairman

For further information please contact:

Mr Martin Rogers

Managing Director and Chief Executive Officer

mr martin rogers Chief Executive Officer

Dr Neil Frazer

Executive Director and Chief Medical Officer

Prima BioMed

Dr Richard Hammel Non-executive Director

Ph: +61 (0) 3 9824 5254 mob: +61 (0) 4282 268 357 e: [email protected] W: www.primabiomed.com.au

Forward looking statement

Any forward looking statements in this newsletter have been prepared on

the basis of a number of assumptions which may prove incorrect and the current intentions, plans, expectations and beliefs about future events are subject to risks, uncertainties and other factors, many of which are outside Prima Biomed Ltd’s control. Important factors that could cause actual results to differ materially from any assumptions or expectations expressed or implied in this newsletter include known and unknown risks. As actual results may differ materially to any assumptions made in this newsletter, you are urged to view any forward looking statements contained in this newsletter with caution.This newsletter should not be relied on as a recommendation or forecast by Prima Biomed Limited, and should not be construed as either an offer to sell or a solicitation of an offer to buy or sell shares in any jurisdiction.

senior management

Chief Operating Officer

Matthew Lehman

Dr Sharron Gargosky Senior Vice President, CVac™ Program

Vanessa Waddell

Business Development and Intellectual Property Manager

Larisa Chisholm Intellectual Property Manager