Slide 1: Supplemental information: CAN-003 Phase 2 PRIMA trial of CVac in ovarian cancer
Exhibit 99.1 CAN-003 Phase Supplemental ASX:PRR; CVac PRIMA 2 trial BIOMED Analysis NASDAQ:PBMD; ofinformation CVac for the to treatment management ISIN:US74154B2034 of ovarian presentation canceronpatients October in 2, first 2013 or second remission
Slide 2: Important Notice
Important presentation announcements The or expectations from plans, forecast PRIMA reliability purpose views assumptions expectations BIOMED byNotice expressed Prima aid of andthe made only beliefs BioMed. orinformation. presentation and expectations in and bybeliefs this about Prima theNothing pre
Slide 3: CAN-003 Study Design
CAN-003 Treatment Control 63 Patients first 56 43 enrolled Design 2CVac Progression Primary Endpoints Secondary Safety Analysis 3ITT year PRIMA patients inefficacy 71st group dosing non observation population: --w/in remission observation Safety BIOMED Study randomized -randomized enrolled determine
Slide 4: CAN-003 Safety and Immune Monitoring Data Summary
CAN-003 Safety Immune CVac No Free Progression 8Divergent Survival Overall 4observation deceased PRIMA antibody statistically wasMonitoring induced BIOMED Data well trends out ongoing response aof tolerated significant Analysis mucin observed 58 evaluable generated 1 and specific Summary differences
Slide 5: CAN-003 Statistical Considerations
CAN-003 This The 5trials. PRIMA Intent-to-Treat trial was sampleBIOMED Statistical size notconsidered powered (ITT) Considerations population toadequate detect aincludes statistically on clinical all subjects grounds significant randomized to evaluate difference rates tointreatment PFS of tumorwith
Slide 6: Serious Adverse Events
Serious (as -Total 6SAEs “Unlikely Death PRIMA of of Sept byAdverse was 10 causality country category outcome BIOMED 9SAEs related” unrelated 2013) Events (7 in(9 (8 (9Australia three event hospitalizations recovered, Not to(SAE) study Related, years was/ small agent 31USA) ongoing, 1 Unlikely bowel
Slide 7: Adverse Events
Events symptoms events Majority All Severe 1except 7CVac event PRIMA Adverse severe was of for events deemed ofof fatigue, BIOMED well headache 1events atevents event Event injection were tolerated asresolved lethargy, definitely of were (AE) mostly which widespread site mild Data and (localized exc
Slide 8: Immune Monitoring Data: Anti-Mucin 1 Antibody Response
Immune No 6.00E+05 V1= V6 V13- V17 5.00E+05 Anti 4.00E+05 positive 013.00E+05 0.00E+00 1.00E+05 2.00E+05 8SOC Patient 70 60 50 40 30 20 0PRIMA –antibody -mucin baselines 310 EOS doses data control doses Monitoring BIOMED 1points response [lightare intensity] - generated anti Mucinby 1 treatment with
Slide 9: Immune Monitoring Summary: T Cell Response
T PRIMA (Table CD4 CD8 CR2 *CR1 9CVac P< cell+ ** * 0.1 TNFa IL-2 IL-4 IFNg IL-17 induced Immune of ** * CR2 ** *CVac ** ** BIOMED *P* <0.05 *aMonitoring patients’ *mucin 1 best specific Summary immune T cellresponses) response
Slide 10: Progression-Free Survival (ITT) Kaplan-Meier
Kaplan-Meier Data OSC: 1.00 CVAC: Hazard P=0.9 0.75 061Progression 0.00 0.25 0.50 1/10 1/11 5/16 9/27 OSC Months 30 24 18 (#events/#at 1/5 2/11 2/13 7/20 8/29 CVAC 10 2 PRIMA 0/0 ofmedian byratio median alllog-rank 56 BIOMED Probability risk) 1.04 PFS patients Estimates PFS(95% test 10.18 10.87 comb
Slide 11: Progression-Free Survival by Remission Stratum
Kaplan-Meier While remission First P=0.16 2/7 2/9 5/14 5/19 1/9 0/9 3/12 3/17 Second OSC: 1.00 CVAC: Progression Hazard P=0.2 0610.75 0.00 0.25 0.50 (#events/#at 0/3 0/4 2/6 3/10 CVAC 0/0 0/1 1/2 2/4 6/10 OSC Months 30 24 18 11 2 PRIMA median by not by ratio median remission log-rank statistically l
Slide 12: Overall Survival
Overall OS As –(4 1285CVac 248 PRIMA of patients have are data have September unknown Survival is /been 4been immature; BIOMED SOC) had confirmed confirmed withdrawn 9, 2013: observation asasconsent deceased alivewill (28 =>continue CVac 58 patients / 20 SOC)
Slide 13: CAN-003 Conclusions
CAN-003 Multinational CVac Similar It 13 will PRIMA was betoimportant Conclusions very many BIOMED manufacture well recent to tolerated 13 observe trialsand of &signals distribution immunotherapy induces in cellular Overall of CVac, for immune Survival solid an autologous-DC cancer, activity to asse
Slide 14: Development Implications of CAN-003
Development CAN-003 –Recruitment Prima Significant 14 Agreement Review PRIMA to review endpoints patient trial BIOMED reduction of to implications extended new revised designs numbers patients (immunological in trial expenses and to monitor design on patient CANVAS going with patients numbers andfor