PROGRAM HIGHLIGHTS Administrative Team PROGRAM HIGHLIGHTS Administrative Team.
Stressgen Highlights
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Transcript of Stressgen Highlights
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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
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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
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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
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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
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The Immune System
ImmuneSystem
• 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
Cellular Immunity Humoral Immunity
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CoValTM Fusion ProductsThe Stressgen Solution
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HspE7 Development Pathways
HspE7
Use in RRP primary registration trial
Use in phase I/II proof-of concept study in GW or LEEP
Failures
1st Generation HspE7 2nd Generation HspE7(reformulated with adjuvant)
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Interim day 28 TC-1 Tumor Regression Data for Dose Response Studies Utilizing an Admix of
HspE7 and Adjuvant DNA
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.
Average cGMP (historical)
0 100 200 300 400 500 600 700 8000
10
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100 3ug adjuvant10ug adjuvant30ug adjuvantcGMP
HspE7 Dose
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Inci
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• 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)
RRP Phase II Clinical Trial Results
Mean of First Post-treatment Interval Between
Surgeries Increased Significantly
55
106
0
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120
Baseline Post-treatment
Day
s
(p<0.02)
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RRP Phase II Study Data vs.National Registry
No
. su
rger
ies /
year
Redrawn from Fig. 3 in Reeves, W.C., et al, Arch Otolaryngology Head Neck/Vol 129, Sep. 2003
Age (years)
National Registry DataNational Registry Data
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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
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Randomized
Debulking surgery
HspE7 injection
Placebo injection
Intersurgical interval
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