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IMMUTEP LIMITED Investor Presentation 2011

Jul 11, 2011

65122_rns_2011-07-11_f7bd80cc-2258-4df0-97ff-04756d51d934.pdf

Investor Presentation

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Developing the world’s first Ovarian Cancer Therapeutic Vaccine

Investor Presentation , July 2011

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Important Notice

The purpose of the presentation is to provide an update of the business of Prima Biomed Ltd ACN 009 237 889 (ASX:PRR) (Prima). These slides have been prepared as a presentation aid only and the information the y contain ma y re q uire further ex p lanation and/or clarification. Accordin g l y , these slides and the information they contain should be read in conjunction with past and future announcements made by Prima and should not be relied upon as an independent source of information. Please contact Prima and/or refer to the Company's website for further information.

The views expressed in this presentation contain information derived from publicly ava il a bl e sources th a t h ave no t b een n i d epen d en tl y ver ifi e d . N o represen a t ti on or warran y t is made as to the accuracy, completeness or reliability of the information. Any forward looking statements in this presentation 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 assumptions or expectations expressed or implied in this presentation include known and unknown risks. Because actual results could differ materially to assumptions made and Prima Biomed’s current intentions, plans, expectations and beliefs about the future, you are urged to view all forward looking statements contained in this presentation with caution. This presentation should not be relied on as a recommendation or forecast by Prima Biomed Limited. Nothing in this presentation should be construed as either an offer to sell or a solicitation of an offer to buy or sell shares in any jurisdiction.

2

About Prima Biomed

Prima BioMed (ASX:PRR) is a biotechnology company focused on developing new oncology therapies.

Ovarian cancer has one of the lowest survival rates of all gynaecological cancers. CVa c ™ is likely to addresses the huge unmet medical need for t rea men o ovar an cancer. t t f i

. The Company’s strategy is to commercialize CVac

The addressable market for CVaccould exceed $1 billion.

Other p roducts in the develo p ment p i p eline at an earlier sta g e of develo p ment include

  • Oral HPV vaccine created using dense gas technology

  • Humanized monoclonal antibod tar etin Cri to-1 y g g p

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Executive Leadership

  • Mr Martin Rogers, CEO

  • Extensive business management experience and scientific background

  • Mr Ian Bangs, CFO

  • CFO and company secretary for several publicly traded ASX companies

  • Dr Neil Frazer, CMO

  • Former Glaxo, 25 years drug development experience including 10 FDA approvals

  • Amy Brewer, US Project Manager

  • Has several years of pharmaceutical project management at SPRI (contract research organisation)

  • Dr Sharron Gargosky, SVP CVac™ Program

  • 3 previous successful Orphan Drug approvals with FDA

  • Mr Matthew Lehman, COO

  • Has experience in execution of over 100 clinical trials

4

CVac™- Lead Program

  • CVac™ is an autologous, dendritic-cell (DC) based therapy or cancer vaccine similar to Dendreons Provenge

  • CVac™ is currently in the clinic with a third clinical study ongoing

  • Results from phase I and phase IIa trials were very promising

  • Ongoing phase IIb and upcoming phase III trial is likely to provide further proof of concept for global registration

• If CVac™ progresses to full commercialisation, CVac™ - cou ld cap ure a s gn t i ifi can t s h are o f th e mu lti billi on o d ll ar ovarian cancer treatment vaccine market , and revalue the sector

5

How CVac™Works

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How CVac™Works

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Demand for CVac™

  • The global market size for ovarian cancer therapy was estimated to be US$3.6bn in 2010*

  • Each year 73,000 women are diagnosed with ovarian cancer in the US, Europe, Australia and Japan and 318,000 women globally*

  • Since ovarian cancer is generally diagnosed at a late stage, only 20-30% of patients with late stage disease survive for 5 ears y*

  • A maintenance style treatment like CVac™ would be the first of its type in the market and Prima Biomed believe the com an has otential to achieve 10% market enetration p y p p

  • within the first year

  • 10% market penetration could generate $500m+ in sales in the develo ed world p

[* Thomson Business Intelligence, Ovarian Cancer Therapeutics Industry Analysis 2007 ]

Demand for CVac™

  • Median progression free survival after optimal surgery and chemotherapy is only 22 months

  • Non-toxic nature of CVac™ will make it attractive for the oncologist to prescribe, a no-brainer for doctor and patient

  • Analysts reviewing the market based on Dendreon Corp. forecasts predict the market size could be greater than US$1.5Bn per indication*

  • Subject to the outcome of additional clinical trials CVac™ may have an indication in several additional mucin-1 positive cancers

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  • Morgan Joseph and Roth Capital

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CVac™- Lead Program

  • CVac™ could revolutionize treatment for tumors that over-

  • express mucin 1

  • Ovarian cancer, the first target, has the highest mortality of all gynecological cancers

  • Drugs used for treatment of ovarian cancer have not changed in over a decade

  • CVac has the potential to alter the treatment paradigm by prolonging periods of ovarian cancer remission with very low toxicity potential

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Clinical Evidence Demonstrates Disease Modification

  • Phase Ib - CVac™(5[th] Phase I study, first with DC)

– 14 patients with terminal cancer (3-6months life expectancy), broad range of adenocarcinomas including renal, breast, ovarian, fallopian tube, colon, lung and oesophageal

– Objectives:

  • Primary:

• Secondary:

assess toxicity

assess anti-tumor efficacy , immune response and procedure feasibility

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Clinical Evidence Demonstrates Disease Modification

– Results:

  • First time that every patient had a immune response

  • All patients produced desired cellular immune response

  • No treatment related toxicity

  • Patient’s cells were successfully cryopreserved

  • Of nine evaluable patients , four had stable disease during the assessment period of one year

  • Two patients received ongoing therapy for >40mths

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Why target Ovarian cancer?

Cvac[TM] targets ovarian cancer, a disease with a very low five year survival and late stage detection

Example: Stage III ovarian cancer patient

  • Incurable recurrent disease, diagnosed by elevated CA125 marker

  • CVac[TM] treatment demonstrates stabilization of CA125, initially for 4mths, then for a further 18mths post further injections of CVac[TM]

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St a bl e sease di 4 m th s 18 m th s
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Phase IIa Trial Demonstrates Disease Stabilization

CVac™ results – 21% of patients responded to therapy

Protocol: Enrolled 28 patients (21 evaluable) with incurable ovarian cancer (life expectancy at least 6 months), and rising CA125 levels defined as at least 25% over baseline within one mon th con fi rm ng rap i idl y progress ng sease. a i di P ti en s a t h d received multiple courses of chemotherapy/ radiotherapy • Patients received 3 injections of CVac[TM] over a ten week period, f o ll owe d b 4 i n ec ti ons a t 10 wee k i n erva s t l y jObjectives:

  • Primary:

CA125 response or stabilization in at least 15% patients

  • Secondary:

Disease progression-free survival, immune response and safety

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Phase IIa Trial Demonstrates Disease Modification

CVac™ results – 21% of patients responded to therapy (CA-125 reduction or prolonged stabilization) and 47% of patients had disease stabilization (CA-125 remained stable)

  • results

  • N o vac C th erapy-re a e l t d t ox c i it y

  • Ovarian tumors respond to therapy with CA125 reduction or stabilization

  • Progression Free Survival averaged 127 days (95% confidence limits 96 to 219 days).

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Comparison with Marketed Oncology
d
Ph
II
lt
rugs
ase resu s
Phase IIa disease intervention trials, response rates
Drug
Activity
Disease
modification
Stable disease
Avastin (Roche,
$7bn sales)
VEGF Mab
Colon Cancer
16%
Aromasin
Anti-estrogen
36%
(Pfizer >$1bn
sales)
Breast Cancer
Tarceva
EGFR inhibitor
10-20%
(Astellas
>$1.5bn)
NSCLC
Provenge
PAP-GMCSF
19%
autologous cell
CVac
Mucin-1
autologous cell
21%
47%

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Clinical Trial Program

  • Phase I and IIa trials indicate CVac™ could be a strong candidate for treatment of ovarian cancer patients in remission and for other MUC-1 over-expressing tumors.

Phase IIb trial (60 patients) for ovarian cancer patients after successful 1[st] or 2[n] d line therapy is recruiting patients in USA and Australia in order to:

  • Assure comparability of multiple manufacturing centers

  • – Confirm safety and tolerability established in earlier trials

  • Compare CVac™ to standard of care in terms of progression-free survival (PFS)

  • Confirm host immunologic response to CVac™ therapy

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CVac™- Phase III Study design

  • Phase III trial for ovarian cancer patients in remission planned to commence by 3[r] d Quarter 2011 (Europe, USA, Australia):

  • 800 patients randomized, double-blinded , welldesigned efficacy trial

  • Definitively establish survival benefit – progression free survival (PFS) and overall survival (OS)

  • Assess quality of life and pharmacoeconomic parameters

  • Will support marketing authorizations globally

    • Interim data analysis set for Q4 2012-Q1 2013

    • Final data set for Q4 2013 – Q1 2014

    • Event driven study giving the interim analysis to allow flexibility to adjust for registration end point

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Value Drivers – Key Prima Biomed Attributes

  • If proven clinically successful CVac could address a major global unmet medical need

  • Depth and experience in management for drug approval

  • Global ovarian cancer treatment market estimated to be worth US$3.6b in 2010, and Cvac™ could revalue the market

  • 10% of all ovarian cancer patients per annum (7000+) would give Prima BioMed Ltd potential revenues greater than $500m annually

  • FDA accepted the Investigational New drug (IND) application in 2009

  • Phase IIb study (61 patients) recruited first patients Q3 2010

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Value Drivers – Key Program Attributes

  • Phase IIb trial leadership from prestigious Fred Hutchinson Cancer Centre in Seattle and Stanford Medical Centre in the USA http://www.investorcalendar.com/IC/CEPage.asp?ID=163542

  • Progressing clinical studies of world’s first ovarian cancer vaccine, CVac

  • Pursuing global fast-track commercialisation

  • Phase III study to be conducted in Europe, US and Australia and New Zealand commencing recruitment by Q3 2011

  • Full patient recruitment for the phase III study expected by Q4 2012

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Value Drivers – Key Program Attributes

  • Highly experienced scientific advisory team including Prof. Ian Frazer, co-inventor of Merck/CSL’s cervical cancer vaccine, Gardasil™

  • Experienced pharmaceutical sector expert Dr Neil Frazer appointed Chief Medical Officer to oversee CVac™ clinical trials

  • Prima BioMed Ltd has a pipeline of earlier stage oncology products which are under investigation

  • Company in solid financial position

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Clinical Leader Opinions

Further commentary is available from key opinion leaders

• Dr. Jonathan Berek, MD

  • Stanford Medical Centre, Head of Women's Cancer Centre htt p: // www. nves orca en i t l d ar.com /IC/CEP age.asp ?ID = 163542

  • Prof. Ian Frazer, MD

  • University of Queensland, Diamantia Centre for Immunology

  • Dr . Heidi Gray , MD

  • Fred Hutchinson Cancer Centre, University of Washington

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Clinical Leader Opinions

  • “These results indicate the potential of dendritic cell therapy and the CVac approach to harness the immune system to intervene in tumour growth, even in patients with advanced disease. In addition, the targeting of Mucin-1 is again validated for cancer thera ies.” p

Prof Bruce Loveland, Burnet Cancer Research Centre

  • Despite the advanced stage of disease this new product

  • candidate CVac™ clearly showed benefit in a statistically significant number of these patients.”

Principal Investigator , Prof Paul Mitchell , Director Cancer Services, Austin Hospital

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Anti-Cripto-1 Mab (early deve opmenl t)

  • Prima has raised various murine and human monoclonal antibodies ( Mabs ) reco g nizin g the EGF-CFC famil y member named Cripto-1.

  • Human Cripto -1 is a M r 36,000 molecule. Cripto-1 is also an oncogenic growth factor that is involved in cancer cell proliferation and metastasis

  • The Mabs inhibit tumor growth in vitro of most cancers of the breast, colon, lung, stomach and pancreas but only exhibit a weak reaction with normal tissues . were The effects of the cripto-1 Mab

  • greater in the presence of cytotoxic drugs such as 5-fluorouracil, epirubicin, and cisplatin.

Plan of Action:

  1. Update with Anti-Cripto-1 Mab – 3Q 2011

  2. Preclinical studies to support an IND and human trials – 2013

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Oral HPV Vaccine

  • Prima has partnered with Prof. Ian Frazer and Prof. Neil Foster to use dense gas technology to attempt to formulate of an oral HPV vaccine

  • The technology reformulates large, irregular particles into smaller, consistent sizes, allowing for higher bioavailability at lower doses of a dru and enca sulation for oral dosin g p g

  • • Studies with Eudragit ® coated lyzosyme completed and feasibility studies with ovalbumin are ongoing. Animal studies to evaluate immunogenicity will occur in Q3 2011

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Usin g dense g as technolo gy ( l y soz y me framework ) reduced the particle size seventy-fold and produced a much more regular shape.

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Newsflow

  • Phase IIb randomized p hase Feb 2011 ( complete )

  • • Regulatory agreement on phase III completed Scientific Advice with European Union ( complete )

  • - Potency assay expected to be qualified Q2 Q3 2011( complete )

  • European license for Manufacturing Q2-Q3 2011

  • • Phase III study recruitment commencement Q3 2011

  • • FDA meeting for registration study review Q3 2011

  • - Update Cripto 1 progress Q3 Q4 2011

  • • Oral HPV vaccine progress update Q3-Q4 2011

  • Dubai sales in pilot commercialisation program

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Conclusions

  • There is a major unmet medical need for new therapies for ovarian cancer

  • CVac™ has the potential to transform the treatment of ovarian cancer in remission

• Cvac™ may also have potential to treat other mucin-1 over-expressing tumours. Examples include breast colorectal , , lung , gastric and pancreatic cancers.

  • A pivotal study has been designed to seek global registration in key markets for CVac™

  • Prima BioMed has recruited top tier advisers with a track record of successful commercialization

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Conclusions

  • Solid financial position

  • Strong management team

  • Pipeline of early stage research with other cancer treatment technologies

  • Success will provide considerable investment return in the foreseeable future

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Corporate Snapshot

Issued Capital

ASX Code: PRR (Australian Stock Exchange) Shares: [981 . 6M] Listed Options: [84.7M] (Exercisable at $0.02 on or before 31 Dec 2011) Total Issued Securities:[1065.3M]

Price & Capitalisation

Share Price: $0.30 (11/7/11) 2011 high: $0.42 (11/4/11) Mkt. Ca p( diluted ) $323.9M Cash Position: $[57.0M] (current average cash burn $0.9/month FY11Q1-Q3)

Board of Directors

Ms Lucy Turnbull AO Chairman Mr Albert Wong Deputy Chair Mr Martin Rogers Chief Executive Officer Dr Neil Frazer Chief Medical Officer Dr Richard Hammel Non-Executive Director

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Glossary

  • Dendritic cell -White blood cells that instruct the immune cells on what foreign thing (antigen) they should attack. They eat what they identify to be foreign substances in the blood then process (degrade) antigen into small peptides, place the peptides that indicate the characteristics of an antigen on their surface, and present the antigen to T cells so as to produce the appropriate immune system response. The class of cells called antigen presenting cells also includes dendritic cells or dendritic macrophages

  • Cancer Vaccine /Autologous - A vaccine that has been developed to target a cancer molecule to either prevent cancer (prophylactic vaccine) or treat existing cancer (therapeutic vaccine). CVac is a cancer vaccine.

  • Immunotherapy – A treatment that seeks to make use of the immune system so as to manage a disease condition.

  • CA125 - A tumour marker that is indicative of ovarian cancer.

  • CD4+ cells - White blood cells that assist in the body’s immune response by helping B cells create antibodies. CD4+ cells receive the antigen of foreign cells from the MHC Class II molecules on Antigen Presenting Cells.

  • CD8+ cells – White blood cells that assist in the body’s immune response by killing foreign cells, which is why CD8+ cells are also ca ll e d C y o ox c - t t i T L ymp h ocy es or t Kill er -ce T ll s. CD8 + ce ll s rece ve i th e an ti gen o f f ore gn ce i ll s rom f th e MHC Cl ass mo ecu es on I l l Antigen Presenting Cells.

  • Cell therapy - The process of introducing new cells into a tissue in order to treat a disease. CVac is a cell therapy in that it introduces an MFP into the body to generate an anti-cancer immune response.

  • Cisplatin – A platinum-containing chemotherapy drug first approved by the FDA in 1978. In conjunction with Taxol, it is the current standard for ovarian cancer treatment.

  • Progression free survival – The period of time in which a patient in a clinical trial for a cancer therapy experiences no worsening of their cancer after being administered the treatment .

  • MUC-1 – A mucin that Cancer Vac’s Mannan Fusion Protein targets. MUC-1 is of interest to cancer researchers because a wide variety of tumour cells, including those from breast, colon, prostate, pancreatic and lung cancers, not only overproduce mucin, and in particular MUC-1, but seem to produce a variety that is poorly glycosylated.

  • Antigen - The ‘bad guy’ substance that stimulates the immune system to respond to the perceived threat.

  • T-cell receptors – Receptors on the surface of Helper T lymphocytes that recognise the combined MHC Class II and peptide epitope and then pass the word on to create the appropriate B lymphocytes.

  • T Lymphocytes – White blood cells that are responsible for killing cells infected by viruses , in the case ofCytotoxic T cells ’, and inducing B lymphocytes to produce antibodies, in the case of ‘Helper T lymphocytes’.

  • Phase III – A clinical trial in humans to test efficacy in a large sample. Phase III is used for product registration

  • IND – Short for Investigation New Drug, an FDA designation of a drug that has been approved for clinical trials in the US.

  • Statistical significance - The probability, measured by the ‘p-value’, that an observed outcome of an experiment or trial is due to chance alone. Generally p-values below 0.05 are taken as markers of statistical significance

  • Event Driven Study - Phase III study where the timing is determinant on the outcome of progression free survival

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Contact

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Martin Rogers Chief Executive Officer Prima BioMed Ltd

E: [email protected] P: +61 2 9276 1242 M: +61 428 268 357

www.primabiomed.com.au

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