Download No Slide Title - Recurrent Respiratory Papillomatosis Foundation

Stressgen Highlights
• Late-stage lead product candidate, HspE7, addressing large,
unmet clinical need of HPV-related diseases including:
–
–
–
–
Recurrent Respiratory Papillomatosis (RRP)
High-grade cervical dysplasia and LEEP Failures,
Patients co-infected with HIV and HPV
Genital Warts
• Near-term product launch opportunity with 1st generation HspE7
in initial indication, RRP (orphan/fast track)
– Q1:06 - Initiate primary RRP registration trial
• Clinical proof-of-concept in multiple phase II studies, including
studies in patients with RRP, high-grade dysplasias, and GW
2
Stressgen Highlights
• Reproducible, large scale cGMP manufacturing process in hand
• Parallel 2nd generation HspE7 development pathway with drug
that may provide greater efficacy in difficult-to-treat HPV patients
• Platform technology with capacity to generate additional product
candidates targeting Hepatitis B, HSV, and Influenza
3
Management Team
Gregory M. McKee, President, Chief
Executive Officer
Genzyme, Valentis, GeneSoft
Marvin I. Siegel, Ph.D., EVP, Research
& Development
Telik, Schering-Plough, Burroughs
Wellcome
John Neefe, M.D., SVP, Clinical
Development
Sanofi, Sterling-Winthrop, Centocor
Howard T. Holden, Ph.D., VP,
Regulatory Affairs and Compliance
Ligand, Parke-Davis, Centocor
Kendra Berger, Executive Director
Finance & Controller
Discovery Partners Int’l., FPA Medical
Management, Price Waterhouse
Michael Brown
Acting General Counsel
Paramount Law, DLP (Formerly Gray
Cary)
Derek Kelaita, Director – Business
Development
Corvas, Dendreon
4
Recent and Anticipated Milestones
 Q2:05 - Announced new President and Chief Executive Officer
 Q2:05 - Announced and closed sale of bioreagent business to
Ampersand Ventures for C$8.0
 Q2:05 - Announced corporate restructuring with 50% staff
reduction, planned closure of Collegeville, PA office and annual
saving of approximately C$5.0M/year
 Q2:05 - Announced successful completion of process
development and cGMP production of HspE7 bulk drug
• Q3:05 - Complete fill/finish of cGMP bulk HspE7
• Q4:05 Announce outcome from European Patent Office on IP
challenge
• Q1:06 – Initiate RRP primary registration trial
• 1H:06 - Initiate Phase I/II proof-of concept trial GW or LEEP
failures
• Begin additional NCI studies
5
The Immune System
Immune
System
Cellular Immunity
Humoral Immunity
• Killer T cells
• Destroy cells already
infected or diseased
• Therapeutic vaccines
– In development e.g. cancer,
chronic viral infections
• Antibodies
• Destroy viruses outside of cells
• Preventive vaccines
– Marketed e.g. polio,
influenza, HBV
6
CoValTM Fusion Products
The Stressgen Solution
HspE7 Development Pathways
HspE7
1st
2nd Generation HspE7
(reformulated with adjuvant)
Generation HspE7
Use in RRP primary
registration trial
Use in phase I/II proof-of
concept study in GW or LEEP
Failures
8
Interim day 28 TC-1 Tumor Regression Data for
Dose Response Studies Utilizing an Admix of HspE7
and Adjuvant DNA
100
3ug adjuvant
10ug adjuvant
30ug adjuvant
cGMP
Average cGMP (historical)
90
Percent Tumor Incidence
80
70
60
50
40
30
20
10
0
0
100
200
300
400
500
HspE7 Dose
600
700
800
9
Even at the lowest doses
of HspE7 and adjuvant
tried (25ug HspE7 and
3ug adjuvant) tumor
incidence was only 10%.
This is better than an
800ug dose of cGMP
Process B material.
RRP Phase II Clinical Trial Results
• In overall population, first post-treatment
interval increased 95% (p<0.02)
• Median of all surgeries reported following
treatment suggests 87 fewer surgeries
• Statistically significant decrease in Adjusted
Derkay-Coltera Score at end of study (p<0.04)
Mean of First Post-treatment Interval Between
Surgeries Increased Significantly
120
106
(p<0.02)
100
Days
80
55
60
40
20
0
Baseline
Post-treatment
10
RRP Phase II Study Data vs.
National Registry
8
7
6
5
4
3
2
National Registry Data
1
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
Age (years)
Redrawn from Fig. 3 in Reeves, W.C., et al, Arch Otolaryngology Head
Neck/Vol 129, Sep. 2003
11
15
16
17
18
Next Steps for RRP
 Manufacture commercial grade API (active pharmaceutical
ingredient) material (Avecia, Ltd.)
• Complete fill-finish of final drug product
• Initiate primary registration trial
– Expected design
• Placebo controlled, double - blinded
• 160 Patients, 55 sites in US/Canada
• Similar endpoint as Phase II study (post-treatment surgical
interval)
• Start Date: Q1:06
– Anticipated trial timelines:
•
•
•
•
•
Patient recruitment: six months
Patient follow-up: 1 year
File BLA: six months
Launch HspE7 for RRP six months after filing BLA
Total timeframe: 2 ½ years from start of phase III
12
Randomized
Debulking surgery
HspE7 injection
Placebo injection
Intersurgical interval
13