Slide 1: CAN-003 Interim Analysis
CAN-003 INTERIM ANALYSIS PRIMA BIOMED TELECONFERENCE November 2012 Exhibit 99.2
Slide 2: Forward-looking statements
The statements in this presentation regarding the future and commercial prospects of Prima, including statements regarding the efficacy of Cvac™, the timetable and success of clinical trials, and the potential market for Cvac™ are forward looking and actual results could be materially different from
Slide 3: Ovarian Cancer
• Typically late stage when diagnosed • No diagnostic tests to detect early • Symptoms are often non-specific. • Overall 20–30% 5-year survival – Stage I (15% of total) – 91% at 5 years – Stage II (17%) – 72% – Stage III (61%) – 27% – Stage IV (7%) – 22% • Responds well at first to chemotherapy and
Slide 4: Antigen Target: Mucin
Antigen Target: Mucin 1 Normal Mucin 1 • More complex O-linked sugar chains • Glycosylated • Tandem repeat sequence (VNTR [variable number of tandem repeats]) Tumor Mucin 1 • Simpler and fewer sugar chains • Underglycosylated • “Naked“ structure; carbohydrate and peptide epitopes are exposed
Slide 5: Cvac Overview
1 Cvac Overview MNCs (white blood cells) are taken from the patient by apheresis and sent to the lab MNCs are separated and matured to dendritic cells (DCs) with growth factors DCs are pulsed with the antigen, mannan-mucin 1 fusion protein (M-FP) Mucin 1-antigen is internalized by the DCs The DCs ar
Slide 6: CAN-003 Background
CAN-003 Background • The intent of the CAN-003 trial is to determine the safety and efficacy of Cvac compared with observational standard of care (SOC) in epithelial ovarian cancer patients who are in remission after first or second-line therapy. Primary Objectives: – To determine the safety of admi
Slide 7: CAN-003 Interim Safety Data
Cvac is very well tolerated. • Only 1 serious adverse event (SAE) was considered possibly related to Cvac treatment • Total of 5 SAEs in the Cvac arm (2 of disease progression, 1 each of abdominal pain, small bowel obstruction, and febrile neutropenia) compared with 2 SAEs in the SOC arm (abdominal
Slide 8: CAN-003 Interim Efficacy Data
7 First remission Second remission Promising trend in PFS data Median PFS (as of Aug 2012) NR Cvac: 421 D Cvac: 365 D Control: 321 D CAN-003 Interim Efficacy Data
Slide 9: Immune Monitoring: What Is It?
Antigenic stimulus + brefeldin A Incubate 4–6 h • Fix cells • Permeabilize • Stain PBMCs or whole blood Gate on cells of interest Stanford , HIMC labs Immune Monitoring: What Is It?
Slide 10: Immune Monitoring Representative Results
Immune Monitoring Representative Results: Mucin 1 Stimulation Unstimulated Mucin 1 stimulated
Slide 11: Immune Monitoring
Immune Monitoring • Time points tested are prior to Cvac treatment and during the course of Cvac treatment – Visit 1 = screening – Visit 6 = 3 Cvac doses – Visit 9 = 7 Cvac doses – Visit 11 = gap in dosing – Visit 13 = completed Cvac dosing • Average presented of 5 Cvac patients • Average presented
Slide 12: Immune Monitoring
Immune Monitoring • Results show stimulation of CD8+ or CD4+ cell types: CD8+: cytotoxic T cell (killer) CD4+: helper T cells • Different cytokines were tested: Tumor necrosis factor alpha (TNFa) Interferon gamma (IFNg) Interleukin 17 (IL-17) • Each patient sample was tested unstimulated and after s
Slide 13: Killer T Cells in SOC / Cvac – IL17
CD8+ Killer T Cells in SOC / Cvac – IL17 Little to no expression was measured in the SOC patients through the trial In Cvac treated patient, a mucin 1 specific cytotoxic T cells response is observed as seen with the increased expression of IL-17
Slide 14: Cytotoxic (Killer) T Cells in SOC vs Cvac Patients – TNFa
CD8+ Cytotoxic (Killer) T Cells in SOC vs Cvac Patients – TNFa In SOC patients who are not treated with Cvac showed a low level of T cell activity in some time. This was a limited response to mucin 1. Cytotoxic T cells show increased responses when stimulated or challenged with mucin 1. However , th
Slide 15: Cytotoxic (Killer) T Cells in SOC vs Cvac Patients – IFNg
CD8+ Cytotoxic (Killer) T Cells in SOC vs Cvac Patients – IFN g In Cvac treated patients there was a mucin 1 specific increase in IFNg activated killer T cells. In SOC patients there was limited response throughout the course of treatment
Slide 16: Helper T Cells in SOC – IL17
CD4+ Helper T Cells in SOC – IL17 In SOC patients there was little to no response from CD4+ when assessing IL-17 responses In Cvac treated patients, CD4+helper cells and IL-17 levels had little to no expression prior to treatment Testing with mucin 1 showed high levels of IL-17 across all time point
Slide 17: Helper T cells in SOC vs Cvac – TNFa
CD4+ Helper T cells in SOC vs Cvac – TNFa In Cvac treated patients, CD4+ helper cells showed some up regulation when challenged with mucin 1 However, there variability. CD4+ helper cells showed some basal expression on TNFa in SOC patients
Slide 18: Helper T Cells in SOC vs Cvac Patients – IFNg
CD4+ Helper T Cells in SOC vs Cvac Patients – IFN g In Cvac treated patients, the CD4+ helper cells showed little stimulation with mucin 1 with substantial noise and variability. In SOC patients, there was little to no expression
Slide 19: Immune Monitoring Conclusions
Immune Monitoring Conclusions • Standard of Care (SOC) patients had limited or no response when challenged with mucin 1 • Patients receiving Cvac showed responsive T cells – both CD4+ (helper T cells) and CD8+ (killer T cells). • In this cohort of patients, CD8+ cytotoxic T cells showed more greater
Slide 20: Prima BioMed Ltd
PRIMA BIOMED LTD Cell Therapy - A new paradigm for the treatment of cancer Aasrman Cancer Weaver Company,