Immutep Ltd · ASX:IMM
Immutep — Prima BioMed — Commercial Translation of Regenerative Medicine 2013
31 slides from Immutep's conference presentation, Nov 26, 2013
Slide 1: Immunocellular Cell Therapy Approach to Clinical Success: Case Study of CVac
Immunocellular Cell Therapy Approach to Clinical Success Case Study of CVac™ Commercial Translation of Regenerative Medicine 25 & 26 November 2013 London, United Kingdom Matthew Lehman Chief Executive Officer Prima BioMed Ltd ASX:PRR; NASDAQ:PBMD; ISIN:US74154B2034 PRIMA BIOMED
Slide 2: Notice: Forward Looking Statements
Notice: Forward Looking Statements The purpose of the presentation is to provide on update of the business of Primo BioMed Ltd ACN 009 237 889 (ASX:PRR; NASDAQ:PBMD; Deutsche Börse: YP1B.F). These slides hove been prepared os a presentation aid only and the information they contain may require furth
Slide 3: Cancer vaccines have great potential
Cancer vaccines have great potential For Drew Pardoll, Director of the Cancer Immunology Program in Johns Hopkins University’s Sidney Kimmel Comprehensive Cancer Center:—Nature Reviews Drug Discovery, Vol 12, July 2013 PRIMA BIOMED 3
Slide 4: The market for cancer immunotherapies is enormous
The market for cancer immunotherapies is enormous22 May 2013 | 52 pages Drugs (Citi) Europe | United Kingdom ? Industry Overview Andrew S Baum +44-20-79864498 andrew.baum@citi com Mark Dainty, ACA mark.dainty@citi.com PRIMA BIOMED 4
Slide 5: Multiple immunotherapy approaches & possible combinations
Multiple immunotherapy approaches & possible combinations Andrew Baum Citi Research May 2013 PRIMA BIOMED 5
Slide 6: Moving through development. Where to invest? When?
Moving through development. Where to invest ? When? Does one affect the other? Can we find balance? ‘PRIMABIOMED 6
Slide 7: CVac: Case Study of Personalized Immunocellular Product
CVAC—CASE STUDY OF PERSONALIZED IMMUNOCELLULAR PRODUCT PRIMA BIOMED
Slide 8: CVac Overview
CVac Overview Manufacturing of CVac MNCs (white blood cells) taken from the patient by apheresis and sent to lab MNCs separated and matured to dendritic cells (DCs) with growth factors DCs are pulsed with the antigen Mannanosylated Fusion Protein containing mucin 1 (M-FP) Mucin 1 antigen is internal
Slide 9: Antigen Target: Mucin 1
Antigen Target: Mucin 1 Tumor MUC1 Aberrant version of Mucin 1 on cancer cells Much less glycosylation Highly over expressed on cancer cells Mucin 1 Over-expression Ovarian cancer-83% Pancreatic cancer-81% Mucin 1 Screening • Prima has developed IHC screening assay of tumor tissue for CVac eligibili
Slide 10: MUC1 high priority cancer antigen
MUC1—high priority cancer antigen Cheever, et al. The Prioritization of Cancer Antigens: A National Cancer Institute Pilot Project for the Acceleration of Translational Research. Clin Cancer Res 2009; 15:5323-5337 PRIMA BIOMED 10
Slide 11: CVac clinical trials
CVac clinical trials CAN-001 ‘ Saf6ty , 10 Incurable adenocarcinoma (single arm) S Feasibility S Immune response CAN-002 Ovarian cancer with no other treatment S Safety Phase 2 options (single arm) S Response by CA-125 •S Safety pan nm Ovarian cancer in 1st or 2nd remission S Immune response 63 (ran
Slide 12: CVac Ovarian Cancer Commercial Opportunity
CVAC™ OVARIAN CANCER COMMERCIAL OPPORTUNITY PRIMA BIOMED
Slide 13: Compelling signal from CAN-003
Compelling signal from CAN-003 Improving progression-free survival (PFS) OSC 6/10 2/4 1/2 1/1 0/0 CVAC 3/10 2/6 0/4 1/3 0/0 PRIMA BIOMED 13
Slide 14: Ovarian cancer second remission
Ovarian cancer- second remission “80%-85% of patients tend to undergo second line therapy or maintenance therapy. Therefore, a large group of patients seeking for second line is a significant sales driver for second line treatment drugs in the ovarian cancer market/7 Global Data’s 2011 report “Pacli
Slide 15: Addressable market: 2nd remission ovarian
Addressable market: 2nd remission ovarian Annual incidence of 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 platinum sensitive “33,300 p.a. 70-80% continue through second l
Slide 16: CVac's place in ovarian cancer treatment
CVac’s place in ovarian cancer treatment ^. „ 1st line platinum + „. 1st disease I Diagnosis Surgery ^ . 1st remission #r^. I taxane chemo progression (PD) I Surgery+/- 2nd remission „. ~ „ . , H ,nHl. ‘ ^, -r *n *.- *n ci 2nd PD Overall survival 2nd line chemo CVac Target Patient Profile H PRIMA BI
Slide 17: Comparative ovarian cancer deal
Comparative ovarian cancer deal Merck and Endocyte Enter Exclusive Worldwide Agreement to Develop and Commercialize Phase III Cancer Candidate Vintafolide (EC145) WHITEHOUSE STATION NJ. & WEST LAFAYETTE. IndHBUSINESS WRE)- Merck, known as MSD outsde the United Slates and Canada. (NYSE MRK) and Endoc
Slide 18: CVac Clinical Pathway in Ovarian Cancer
CVAC CLINICAL PATHWAY IN OVARIAN CANCER PRIMA BIOMED
Slide 19: CAN-001 Conclusions
CAN-001 Conclusions Confirmed feasibility of production methods Very mild toxicity profile Signs of antitumor activity: Disease stabilization in 2 patients (A02, A10) Extended disease stabilization in 2 patients (43+ months) after disease progression (A08, A09) • Favorable immune profile IFNy-secret
Slide 20: CAN-002 Conclusions
CAN-002 Conclusions CVac was well tolerated Prior cycles of chemo = 2 (median) / 2.5 (mean) 21/28 patients evaluable 19/21 evaluable were MUC1+ by IHC 21% confirmed “response” rate of MUC1+ pts: 2/21 “major” (>50% reduction in CA-125 at 4wk) 1/21 “minor” (>25% reduction in CA-125 at 4wk) 1/21 “stabi
Slide 21: CAN-003: ovarian cancer patients in remission
CAN-003—ovarian cancer patients in remission (• Patient previously cytoreduced (lst/2nd) Stage lll/IVEOC First or Second Remission • After standard V treatments 1st randomized & controlled trial with CVac 1st multicenter trial (18 investigators in US and Australia) 1st trial with multiple cell colle
Slide 22: T Cell Immune Monitoring Summary
T Cell Immune Monitoring Summary -> CVac induces a T cell response above background and baseline immune signals T cell response is mucin 1 specific Broad individual signal variation is not “observed” with aggregate data CD4IL-2 I CD4IL-4 I CD4 IFNg I CD4TNFa I CD4 IL-17 CR1*** CR2***** CR1 + CR2 CD8
Slide 23: CAN-003 Overall Survival
CAN-003 Overall Survival -^ OS data is immature; observation will continue As of September 9, 2013: — 8 have been confirmed as deceased (4 Cvac / 4 SOC) — 48 have been confirmed as alive (27 Cvac/ 20 SOC) PRIMA BIOMED 23
Slide 24: CAN-003 PFS by remission status
CAN-003 PFS by remission status First remission Second remission -> Strong efficacy signal in second remission population PRIMA BIOMED
Slide 25: Prima has compelling clinical data & a clear development path
Prima has compelling clinical data & a clear development path 50% increase in median PFSfor ovarian cancer patients in 2nd remission Extended time in remission for the best responders to Cvac * PFS measured from randomization (not from start of 2nd line chemo) Data from CVac CAN-003 protocol PFS: pr
Slide 26: CAN-004 phase 2 trial: establish proof of concept in ovarian cancer
CAN-004 phase 2 trial: establish robust proof of concept in ovarian cancer CR = complete remission (by CT & CA-125) OS = overall survival 26
Slide 27: Immunocellular Product Operational Platform
IMMUNOCELLULAR PRODUCT OPERATIONAL PLATFORM PRIMA BIOMED
Slide 28: Prima's Operational Platform
Prima’s Operational Platform Cell collection control Automated scheduling Automated labeling Custom shipping material Supply & Logistics Product Processing Experience in 3 GMP sites Proven comparability Harmonized documents Scalable in 3 global regions \ —Formulation & Stability Quality Control Fina
Slide 29: Automated logistics management
Automated logistics management PRIMA BIOMED 29
Slide 30: Manufacturing: Development Stage to Commercial
Manufacturing Development Stage -> Commercial Significant (i.e. 12+ countries) regulatory exposure and feedback Screened & trained network of cell collections centers globally Validated packaging, shipping, enrichment, washing, fill, finish QC bio-assays for specifications & potency Demonstrated abi
Slide 31: Planning for commercial success
Planning for commercial success Clinical = define a commercially relevant target patient profile & approvable endpoints Manufacturing = assure comparability throughout trials & work toward a scalable and cost effective production method Invest in both. keep a balance. don’t break the bank! PRIMA BIO
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