Full Press Release Details
Australian Cancer Treatment Company
Release (Code: ASX: PRR; NASDAQ: PBMD; ISIN: US74154B2034)
PRESENTATION AT ANNUAL MEETING OF INTERNATIONAL SOCIETY FOR CELLULAR THERAPY
SYDNEY, AUSTRALIA - Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD; ISIN: US74154B2034) ( Prima , the
Company ) announced that its Chief Technical Officer, Dr. Sharron Gargosky, will deliver a presentation entitled Orchestrating Autologous Dendritic Cell Therapy Clinical Trials Across 15 Countries at 1:45pm (Auckland local
time) on April 24, 2013 at the 19th annual meeting of the International Society for Cellular Therapy (ISCT) to be held in Auckland, New Zealand.
Dr. Gargosky will discuss orchestrating Prima s CANVAS clinical trial of CVac across multiple clinical sites in 15 countries across the world. She will also provide an update and
a review of Prima s accomplishments in the successful implementation of CANVAS manufacturing among the Company s three CVac manufacturing facilities in Australia, the USA, and Germany.
Prima BioMed is a globally
active biotechnology company. As a leader in personalized bio-therapeutic products for cancer, Prima is dedicated to leveraging its current technology and expertise to develop innovative treatment options for patients and to maximize value to
shareholders. Prima s lead product is CVac , an autologous dendritic cell product currently in clinical trials for ovarian cancer patients who are in remission.
For further information please contact:
Ms. Jessica Brown, Prima BioMed Ltd.
+1 (919) 710-9061; jessica.brown@primabiomed.com.au
Australia Investor/Media:
Mr. James Moses, Mandate Corporate
991 574; james@mandatecorporate.com.au
Europe Investor/Media:
Mr. Axel M hlhaus, edicto GmbH
+49 (0) 69 905505-52; amuehlhaus@edicto.de
BioMed Ltd, Level 7, 151 Macquarie Street, Sydney NSW 2000
Phone: +61 2 9276 1224 Fax: +61 2 9276 1284
Orchestrating Autologous Dendritic Cell Therapy Clinical Trials Across 15 Countries
Dr. Sharron Gargosky
Chief Technical Officer Prima BioMed
1. Introduction Prima BioMed
4. Clinical Development Plan
1. Design and Duration
2. Organogram of systems
4.Blood Collection Centers / Clinical Sites / Radiology evaluations
3. CANVAS update and accomplishments
Orchestrating Autologous Dendritic Cell Therapy Clinical Trials Across 15 Countries
Why are we discussing clinical trials in a commercialization track session? Clinical trial data dictate final approval and
label, thus market, reimbursement and success of uptake.
Clinical trial in a given patient population
dictates your indication and label
Clinical data integrity is predicated on vendors, monitors ,
management and oversight
eCTD package and collection of data in CDISC compliant and CFR complaint data
bases. Integration of data and addressing issues raised by each NCA is key.
Interface between CMO and
CRO is critical in cell therapies unique to this area
Final clinical endpoints efficacy dictate
your market size and reimbursement
Safety impacts risk-benefit analysis and reimbursement and label
KoL in trial will impact market education and uptake
Today I will discuss Prima s learning lessons in cell therapy trials with focus on CANVAS the 1000 patient trial in
Each year 73,000 women are
diagnosed with ovarian cancer in the US, Europe, Australia and Japan. 318,000 women are diagnosed globally with the disease.
Since ovarian cancer is generally diagnosed at a late stage, only 20-30% of patients with late stage disease survive beyond 5 years
~80% of patients relapse within a year of chemotherapy
Standard of care is surgery and chemotherapy
Mucin 1 is a cell surface glycosylated phosphoprotein
It is over expressed in a number of different adenocarcinomas
Nasopharyngeal 100% Lung (NSCLC) 99% Breast 91% Renal 84% Ovarian 83% SCC HN 82% Colorectal 81% Pancreatic 81% Prostate
The mucin 1 found in tumor cells is aberrantly glycosylated compared with normal cell
Reference:Am J Clin Pathol 2004;122:61-69
Mucin 1 immunotherapy
immune system to target and destroy tumors, leaving normal tissue undamaged
Mucin 1 selected as the
target for immunotherapy
Up to a 40-fold increase in the amount of mucin 1 present in cancer cells
compared with normal cells
Alteration in cellular distribution of mucin1 in cancer cells, with mucin 1
being found ubiquitously throughout the cell rather than at the secreting pole
Differences in the structure of
the mucin MUC1 expressed by normal and tumor cells. Normal MUC1 (left) has more complex O-linked sugar chains than tumor MUC1 (right), which has simpler (and fewer) sugar chains. The tandem repeat sequence of 20 amino acids in exposed in the
under-glycosylated tumor MUC1 but not in normal tissue MUC1
Manufacturing of CVac
MNCs (white blood cells) taken from the patient by apheresis and sent to lab
MNCs separated and matured to decdritic cells (DCs) with growth factors
DCs are pulsed with the antigen Mannan-Mucin 1 Fusion Protein (MFP)
Mucin 1-antigen is internalized by the DCs
DCs washed, formulated, and frozen as 1ml vials
Mechanism after injection
Mucin 1 is overexpressed on ovarian cancer cells
Cvac administered as 4 intradermal injections at each dose
CVac activates CD8+ T-cells specific to mucin 1
cells target mucin 1 overexpressed on cancer cells
T cells kill cancer cells
CVac Clinical Development
1 CAN-001 Terminal cancer adenocarcinoma 10
(breast ovarian,fallopian tube,colon, lung AU
2 CAN-002 Ovarian cancer patients
with no further 28 treatment oprtions AU
2 CAN-003 Ovarian cancer patients in remission 60 after 1st or 2nd
2 CAN-003x Ovarian cancer patients who have 9
progressed on CAN-003 AU/USA
2/3 CAN-004 Ovarian cancer patients in remission 800(est)
after 1st line surgery and chemotheraphy
1. Introduction Prima BioMed
4. Clinical Development Plan
1. Design and Duration
2. Organogram of systems
4. Blood Collection Centers / Clinical Sites / Radiology
3. CANVAS update and accomplishments
A Randomized, Double-Blinded, Placebo-Controlled Trial of CVac as Maintenance Treatment in Patients with Epithelial Ovarian Cancer (EOC) in Complete Remission Following First-Line
Stage III/IV epithelial ovarian cancer
Screening (~1000 pts) after optimal surgery