Slide 1: Developing personalized bio-therapeutics
Exhibit 99.2 Developing personalized bio-therapeutics Investor Presentation October 2012 ASX:PRR; NASDAQ:PBMD; ISIN:US74154B2034
Slide 2: Important Notice
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 and NASDAQ:PBMD). These slides have been prepared as a presentation aid only and the information they contain may require further explanation and/or clarification. Ac
Slide 3: Forward Looking Statements
Forward Looking Statements The statements in this presentation regarding the future and commercial prospects of Prima including statements regarding the efficacyof CVac™,the timetable and successof clinical trials and the potential market for CVac™are forward looking and actual results could be mate
Slide 4: Prima Biomed: Snapshot
Prima Biomed: Snapshot Key metrics ASX Code: PRR (Australian Stock Exchange) Shares on issue*: 1,066.1 million Share Price*: A$0.145 Market Capitalization*: ~A$155m Cash Position: A$38.0m (as at 30 June 2012) Avg Daily Trading Volume*: ~A$0.8m Board of Directors Ms. Lucy Turnbull AO Chairman Mr. Alb
Slide 5: Prima BioMed: Mission
1 Prima BioMed: Mission • Mission: Develop novel and high-value personalized bio-therapeutic products with a focus in immune cell therapy for oncology. • Lead product: CVac™ is made of autologous dendritic cells pulsed with mannan- mucin-1 fusion protein. In advanced clinical development for ovarian
Slide 6: Prima BioMed: Leadership
Prima BioMed: Leadership Mathew Lehman CEO Extensive global management Dr. Sharron Gargosky experience & execution of 100s Marc Voigt Chief Technical Officer of clinical trials in US & EU Chief Business Officer Biochemist with 17 + years 14+ years in corporate and development experience and biotech
Slide 7: General Cancer Market
General Cancer Market • Estimated 24.6 million people in the world living with cancer • World Health Organization (WHO) has predicted: global cancer incidence will increase by 50% between 2000 and 2020 • Cancer becomes increasingly common in both developed and developing countries due to the increas
Slide 8: Ovarian cancer – an unmet medical need
Ovarian cancer – an unmet medical need • Annual incidence of epithelial ovarian cancer in Australia & “major markets” (USA, Japan, UK, Germany, France, Italy, Spain) ~ 61,283 p.a. (2010) • 70-75% diagnosed in late stage ~ 44,400 p.a. • 70-80% of those achieve remission ~ 33,300 p.a. • Since ovarian
Slide 9: Immunotherapy for cancer
Immunotherapy for cancer • Induce and/or enhance a body’s immune response to target and kill cells that express certain antigens • Immunotherapy has the potential to be highly potent and specific against tumor cells with an excellent safety and toxicity profile • Research into cancer immunotherapy h
Slide 10: Prima’s Technology & Platform
Prima’s Technology & Platform Cryopreserved cell formulation minimizes cell collections (leukapheresis procedures) from patients and reduces cost Intradermal injections maximizes delivery of maturing dendritic cells to drain to lymph nodes and migrate to tumor cells Automated logistics labeling with
Slide 11: Prima’s Technology & Platform
Prima’s Technology & Platform Cell collection expertise 40+ qualified and trained cell collection centers worldwide to provide material for high-quality products Global breadth experience in tech transfers, comparability protocols, and regulatory licensing of manufacturing facilities in Australia,US
Slide 12: CVac™ Targeting Ovarian Cancer
CVac™ Targeting Ovarian Cancer 8
Slide 13: CVac - Prima’s Lead Product
CVac - Prima’s Lead Product • Autologous dendritic cells (DC) pulsed with recombinant human fusion protein (mucin-1–glutathione-S-transferase) coupled to oxidized polymannose (mannan) • In development to treat epithelial ovarian cancer patients in complete remission after first-line surgery and chem
Slide 14: Antigen Target: Mucin-1
Antigen Target: Mucin-1 Normal MUC1 Tumor MUC1 • more complex • simpler and fewer O-linked sugar sugar chains chains • underglycosylated • glycosylated • “naked“ structure • tandem repeat carbohydrate and sequence peptide epitopes (VNTR-variable are exposed number tandem repeat)
Slide 15: CVac Overview
CVac Overview Manufacturing of CVac MNCs (white blood cells) DCs are pulsed with the Mucin-1-antigen is The DCs washed, MNCs separated and taken from the patient by antigen Mannan-Mucin-1 internalized by the DCs formulated, and matured to decdritic cells apheresis and sent to lab Fusion Protein (MFP
Slide 16: Clinical development
Clinical development Phase Name Indication Patients I CAN-001 Terminal cancer adenocarcinoma 10 (breast, ovarian, fallopian tube, colon, lung, oesophageal) II CAN-002 Ovariancancerpatientswith no further 28 treatment options II CAN-003 Ovariancancerpatientsin remission 63 after 1st or 2nd line thera
Slide 17: CAN-003 Study Overview
CAN-003 Study Overview • Protocol: – 63 epithelial ovarian cancer patients nd enrolled in complete remission after successful 1st or 2 line chemotherapy – 7 non randomized CVac; 29 randomized to CVac; 27 to observation standard of care • Objectives: – Primary: progression free survival (PFS) as defi
Slide 18: CAN-003 Interim Safety Data
CAN-003 Interim Safety Data CVac is very well tolerated • Only1 SAEpossibly relatedto CVactreatment • Total of 5 serious adverse events (SAE) in the CVac arm (2 disease progression, abdominal pain, small bowel obstruction and febrile neutropenia) compared to 2 SAE in control arm (abdominal pain; hem
Slide 19: CAN-003 Interim Efficacy Data
CAN-003 Interim Efficacy Data Promising trend in PFS data First Median PFS remisson (as of Aug 2012) NRCVac: 421 D CVac: 365 D Control: 321 D Second remisson
Slide 20: CAN-003 Immune Monitoring Data
CAN-003 Immune Monitoring Data Inital 3 patients analyzed by intracellular cytokine staining (ICS) – demonstratesignificantincreasein mucin1 specificcytotoxicTcell activity after first 3 doses of Cvac
Slide 21: Understanding Immunotherapy
Understanding Immunotherapy Summary data from ipilimumab phase III trial of patients with previously treated, unresectable stage III or IV melanoma S. O’Day et. al. J Clin Oncol 28:18s, 2010 (suppl; abstr 4) Comparison Ipilimumab Ipilimumab Ipilimumab Ipilimumab vs. + gp100 + GP100 Ipilimumab gp100
Slide 22: Understanding Immunotherapy (2)
Understanding Immunotherapy (2) PROVENGE provided a survival benefit for every year studied in the IMPACT phase III trial http://www.provenge.com/hcp/survival-rate.aspx
Slide 23: Phase II/III – CANVAS
Phase II/III – CANVAS CANVAS (CANcer VA ccine S tudy) is multinational, multi-center, randomized, double-blinded, placebo-controlled for a robust analysis, started in Feb 2012 Stage III/IV patients eligible after optimal debulking surgery 800 patients randomized 1:1 CVac : placebo Patients must be i
Slide 24: CANVAS goals
CANVAS goals Validate and plan for a commercial-ready manufacturing process in 3 global regions Validate a companion Mucin-1 diagnostic test Confirm acute and longer-term safety and tolerability of CVac™ in a larger patient population Establish CVac efficacy by PFS and/ or OS Investigate CVac impact
Slide 25: Significant progress: key milestones
Significant progress: key milestones Phase I CAN-001 Trial completed Phase II CAN-002 Trial completed NASDAQ Listing Development of manufacturing, logistics and quality control procedures (three manufacturing centers) Phase II/III Trial design regulatory approval in Australia and U.S and different E
Slide 26: Outlook
Outlook • Key milestones (all subject to exact timing of patient outcomes) – ICS (immune) data for next cohort of 7 patients (4Q 2012) – Initiation of exploratory trial in new cancer indication(s) – pending ICS data (~2Q 2013) – Final CAN-003 ICS data (3Q 2013) – Final CAN-003 efficacy data (4Q 2013
Slide 27: Conclusion
Conclusion • Ovarian cancer presents a significant unmet medical need • CVac would be the first of its type in the market, with potential to achieve rapid market penetration • Positive data from CAN-003 demonstrate a favorable safety profile and provide indication of CVac’s efficacy • Phase II/III T