Stressgen Highlights

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description

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 - PowerPoint PPT Presentation

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

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100 3ug adjuvant10ug adjuvant30ug adjuvantcGMP

HspE7 Dose

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cen

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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

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20

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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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