Genocea Biosciences Inc · OTC:GNCAQ
Genocea Biosciences — Corporate Update (October 2015)
16 slides from Genocea Biosciences's corporate update, Oct 7, 2015
Slide 1: Positive 6 Month Durability Results GEN-003 Immunotherapy for Genital Herpes
Positive 6 Month Durability Results GEN-003 Immunotherapy for Genital Herpes Phase 2 Dose Optimization Study 7 October 2015 Exhibit 99.2
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation contains “forward-looking” statements that are within the meaning of federal securities laws and are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include information concerni
Slide 3: Highlights
Highlights 3 • Improved impact on viral activity • Durable clinical efficacy demonstrated across potential Phase 3 endpoints • Potential for GEN-003 to serve as cornerstone treatment for genital herpes reinforced • Clear path to FDA end of Phase 2 meeting in Q4 2016 • Data will be presented at IDWee
Slide 4: Agenda for Today's Call
Agenda for Today’s Call • Disease pathology of genital herpes • Current treatment paradigms • Ongoing Phase 2 dose optimization trial – Study goals – Positive 6-month durability data • GEN-003 value proposition • Upcoming GEN-003 milestones • Conclusions • Q&A 4
Slide 5: Viral Shedding Underpins Pathology of Genital Herpes
Viral Shedding Underpins Pathology of Genital Herpes • A serious chronic infection caused by herpes simplex viruses (HSV) • Periodic disease reactivation causes viral shedding at rates specific to individual patients • Shedding necessary for genital lesions, disease transmission 5 Virus moves from n
Slide 6: Current Genital Herpes Treatment Paradigms
Current Genital Herpes Treatment Paradigms • Approximately two thirds (~4.5m) of treated U.S. patients use oral antivirals episodically – No impact on asymptomatic viral shedding/transmission risk – No impact on frequency of lesion outbreaks – Modest impact on duration of lesion outbreaks • Remainin
Slide 7: Phase 2 Dose Optimization Trial Goals and Objectives
Phase 2 Dose Optimization Trial Goals and Objectives • Goal: Select dose for late stage clinical trials • Primary endpoint: Reduction in viral shedding vs. baseline* • Secondary objectives: – Impact on clinical disease • Lesion rates* • Proportion recurrence free at 6* and 12 months • Time to next r
Slide 8: Sustained Reduction in Viral Shedding Rate at 6 Months
-100% -50% 0% Baseline Post dose 3 6 Months Chang e v s. b a se lin e 30/25 µg 30/50 µg 30/75 µg 60/25 µg 60/50 µg 60/75 µg Sustained Reduction in Viral Shedding Rate at 6 Months 8 • Sustained viral shedding reductions across several doses • Stronger response at 6 months than in Ph 1/2 – 58% vs. 40%
Slide 9: Genital Lesion Rate Reduction Sustained at 6 Months
-100% -50% 0% Baseline Post dose 3 6 Months Chang e v s. b a se lin e 30/25 µg 30/50 µg 30/75 µg 60/25 µg 60/50 µg 60/75 µg Genital Lesion Rate Reduction Sustained at 6 Months 9 • Sustained reductions at 6 months • Lesion rates results broadly parallel viral shedding rate reductions Genital Lesion R
Slide 10: Consistent Efficacy on % Lesion Free at 6 Months Post Dosing
0% 20% 40% 60% 80% % Lesion Free at Six Months 30/25 µg 30/50 µg 30/75 µg 60/25 µg 60/50 µg 60/75 µg Consistent Efficacy on % Lesion Free at 6 Months Post Dosing 10 • Multiple doses similar to suppressive oral anti-viral therapy and superior to placebo from previous trials • Small sample size – ~45
Slide 11: Time to First Recurrence Results Consistent Across Dose Groups
Time to First Recurrence Results Consistent Across Dose Groups • Same data as % lesion free, analyzed slightly differently • Consistent time to first recurrence across groups – Range of 152 to >180 days • Efficacy similar to expected performance of orals, superior to placebo 11 Dose Group (protein d
Slide 12: 6 Months Durability Confirms GEN-003 Value Proposition
6 Months Durability Confirms GEN-003 Value Proposition • Convenient, durable efficacy may improve upon dominant treatment paradigm (episodic anti-viral therapy) – Reduce outbreaks – Reduce shedding to reduce transmission risk • Potential benefits vs. chronic suppressive therapy – Durable efficacy vi
Slide 13: Two Further Significant GEN-003 Catalysts in Coming Quarters
Two Further Significant GEN-003 Catalysts in Coming Quarters; FDA End of Phase 2 Meeting on Track for Q4 2016 13 TODAY Ph 2 – 6 Month Data Q2 2016 Ph 2b – Bridging Q1 2016 Ph 2 – 12 Month Data • Confirmed 6 month durability of effect • Encouraging and consistent first read on 2o clinical endpoints •
Slide 14: Conclusions
Conclusions 14 • Improved impact on viral activity • Durable clinical efficacy demonstrated across potential Phase 3 endpoints • Potential for GEN-003 to serve as cornerstone treatment for genital herpes reinforced • Clear path to FDA end of Phase 2 meeting in Q4 2016 • Data will be presented at IDW
Slide 15: Questions & Answers
Questions & Answers 15
Slide 16: Investor and media contacts
Jonathan Poole Chief Financial Officer Phone: +1 617-876-8191 jonathan.poole@genocea.com Megan Lustig Spectrum Science Communications Phone: +1 202-955-6222 mlustig@spectrumscience.com Investor inquiries: Media inquiries:
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