Posterior Segment Company Showcase - Graybug Vision at OIS@AAO 2016.
Presenter:
Jeffrey Cleland, PhD, President & CEO
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2. 2
Company Highlights
Ocular Therapeutics Represents a $10B+ Global and Growing Market
GB-102: Dual VEGFR/PDGFR tyrosine kinase inhibitor dosed twice per year
(potential for superiority to EyleaÂŽ and reduced injection frequency)
⢠On track for IND in 2017 for wet AMD indication (pre-IND meeting with FDA completed)
Graybug Visionâs Patented Technology Solves Key Challenges for
Sustained Ocular Delivery
⢠Injectable with minimal side effects & no visual disturbance
⢠Tunable approach â release rate and duration up to 1 year
⢠No inflammation, no toxicity, 6 month in vivo release
Technology Enables Broad Portfolio of Ocular Products
⢠Age-related macular degeneration (wet) lead program
⢠Glaucoma programs with 6 month subconjunctival dosing regimen
⢠Pipeline development to leverage delivery and prodrug platforms
Experienced and Knowledgeable Team
⢠Ophthalmology & Drug Delivery Experts
3. 3
An Experienced Management Team
Jeffrey Cleland, PhD
President & CEO
Board Member
Former CEO, Co-Founder, Versartis
>20 Years of Drug Development Experience
Team Leader Through Launch of Only FDA
Approved Long-Acting hGH Product; Early
development of Lucentis
Charles Semba, MD
Chief Medical Officer
Former CMO at Forsight VISION 5 and SARcode.
VP, Shire. Led clinical development of Lucentis at
Genentech. >15 Years of Drug Development
Expertise
Ward Peterson, PhD
SVP, Preclinical
Development
Former SVP, Inspire. Research scientist at
Regeneron. > 20 Years of Drug Development
Expertise
OPHTHALMOLOGY
& INTRAOCULAR
THERAPY
LONG ACTING
PRODUCTS
Somavaratan
4. 4
GB-102 (Sunitinib):
Dual VEGFR/PDGFR tyrosine kinase inhibitor (TKI)
Sunitinib is the active ingredient in GB-102 and SUTENTÂŽ
⢠Oral dosing of SUTENT leads to higher ocular levels than GB-102 without ocular
toxicity
⢠Oral dosing of SUTENT is effective in mouse CNV model and a patient treated for
RCC with anti-VEGF refractory wet AMD (visual acuity improved)
⢠Oral doses of SUTENT required for ocular disease leads to systemic adverse events
GB-102 provides sustained intravitreal delivery minimizing systemic exposure
⢠A twice per year (or longer) dose interval may increase compliance and sustained
levels may increase durability of response
⢠Targeting VEGF & PDGF at the receptor level may increase response rates
⢠Opportunity for superiority compared to EyleaŽ (see FovistaŽ results) from a
single agent
GB-102 (Sunitinib) may become âBest in Classâ Therapy to treat wet AMD
5. 5
Injectable High Capacity Reservoir and
Localization of Microparticles
Biodegradability
Biocompatibility
Bioabsorbability
Polymer
Modified to
Reduce
Inflammation
ENCAPSULATED DRUG INTRAVITREAL INJECTION
WITH SMALL GAUGE
NEEDLE
Microparticle
Localization
Designed to Aggregate
and Remain Outside
Visual Axis
FUNDUS PHOTOS, DAY 7
6. 6
Long Term Efficacy of Single Dose of GB-102:
Potential for Superiority over Aflibercept
GB-102 Dose Groups
0.5 mg GB-102 (0.05 mg Sunitinib)
1 mg GB-102 (0.1 mg Sunitinib)
3 mg GB-102 (0.3 mg Sunitinib)
3 months
3 wk
3 wk
Aflibercept (EyleaÂŽ)
0.7 mg same day as laser
Fluorescein
Angiograms
(CNV area)
LaserDosing
GB-102 Dose 0.5 mg 1.0 mg 3 mg
Sunitinib Dose 0.05 mg 0.10 mg 0.30 mg Aflibercept Placebo
p < 0.01
Rabbit CNV
Model
Poster Presentation, PO268, Sunday, Oct 16, 12:30 pm
⢠All three dose levels more effective
than aflibercept
⢠Benefit of targeting receptors
⢠Once receptors blocked, increased
dose does not increase response
⢠Additional dose/duration studies
ongoing
en
7. 7
Single Dose of GB-102 Every 6 months
IVT Injection in Pigmented Rabbits
10 mg GB-102 (1 mg sunitinib)
50 ÂľL
Data Supports Twice Per Year or Less Frequent Dosing
With Comparable Safety to Current Products
(Selected tissues)
PK/PD Modeling:
Levels Achieved at 6 mo Match Effective Doses
Effective for
Inhibition of CNV
10 mg GB-102 (1 mg sunitinib)
8. 8
Challenges with Current Glaucoma Drugs
⢠Current approved glaucoma products require daily or BID topical dosing
⢠Patients are non-compliant with therapy (72% in controlled setting; 50%
or less in clinical practice; Quigley et al)
⢠Neuroprotective agent desirable but clinical trials are long and expensive
(none approved to date) â dual acting agent (IOP+) allows development
⢠Programs under evaluation (all NCEs) â all 6 month subconjunctival
depot formulations
â All parent drugs are approved drugs
â Single agent IOP lowering prodrug
â Dual agent (two MOAs) IOP lowering (single prodrug)
â IOP lowering and neuroprotection (single prodrug)
9. 9
Preclinical POC on Glaucoma Programs 2H 2017
Key Milestones for Value Creation
Initiate Phase 1/2 Trial with GB-102
(patients on anti-VEGF with nAMD)
1H 2017
GB-102 Phase 1/2
Prelim Safety & Efficacy 1H 2018 nAMD
Glaucoma
Program
Glaucoma Product Phase 1/2
Prelim Safety & Efficacy 1H 2019
Glaucoma Product IND &
Initiate Phase 1/2 Trial 1H 2018
GB-102 Phase 1/2 (US)
Top Line Safety & Efficacy 2H 2019
10. 10
Company Highlights
Ocular Therapeutics Represents a $10B+ Global and Growing Market
GB-102: Dual VEGFR/PDGFR tyrosine kinase inhibitor dosed twice per year
(potential for superiority to EyleaÂŽ and reduced injection frequency)
⢠On track for IND in 2017 for wet AMD indication (pre-IND meeting with FDA completed)
Graybug Visionâs Patented Technology Solves Key Challenges for
Sustained Ocular Delivery
⢠Injectable with minimal side effects & no visual disturbance
⢠Tunable approach â release rate and duration up to 1 year
⢠No inflammation, no toxicity, 6 month in vivo release
Technology Enables Broad Portfolio of Ocular Products
⢠Age-related macular degeneration (wet) lead program
⢠Glaucoma programs with 6 month subconjunctival dosing regimen
⢠Pipeline development to leverage delivery and prodrug platforms
Experienced and Knowledgeable Team
⢠Ophthalmology & Drug Delivery Experts