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Graybug
GrayBug is developing an injectable, long-acting ocular drug delivery technology called GB-102 for treating wet age-related macular degeneration. GB-102 is a dual anti-VEGF/anti-PDGF therapeutic that enables injections every 4-6 months, compared to monthly injections currently required. GrayBug has worldwide rights to the technology from Johns Hopkins University and aims to file an IND for GB-102 in wet AMD in 2016. The company is also exploring applications of its technology for glaucoma and other ocular diseases, with the goal of developing long-acting drugs that improve compliance over daily eye drops.
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Graybug
- 1. GrayBug OIS Presentation JeffreyL. Cleland,PhD InterimCEO N o v e m b e r 1 2 , 2 0 1 5
- 2. 60CONFIDENTIAL AND PROPRIETARY| CompanyHighlights Ocular Therapeutics Represents a $10B+ Global and Growing Market GB-102, a Dual Anti-VEGF/Anti-PDGF Therapeutic, Enables Once Every 4 to 6 Month Intravitreal Injections (2-3 vs ≥ 20 injections per year) • On track for IND in 2016 for wet AMD indication GrayBug Technology Solves Key Challenges for Sustained Ocular Delivery • Injection with small gauge needle – no surgical procedure • Minimal side-effects, no interference with visual axis • Tunable approach – release rate and duration Exclusive Rights for Technology • Worldwide rights from Wilmer Eye Institute, Johns Hopkins University • Patent Protection to at least 2030 (additional filings ongoing) Technology Enables Broad Portfolio of Ocular Products • Age-related macular degeneration (wet & dry), glaucoma, neuroprotection, etc • NCEs for glaucoma and neuroprotection as a novel technologies • Potential for Product Specific Partnerships; Aerie Pharmaceuticals Deal Experienced and Knowledgeable Team • Ophthalmology & Drug Delivery Experts
- 3. 61CONFIDENTIALAND PROPRIETARY | AnExperienced LeadershipTeam Jeffrey Cleland,PhD Interim CEO BoardMember 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 Christy Shaffer,PhD BoardMember Partner, Hatteras Ventures; Former CEO, Inspire Gerald Cagle,PhD BoardMember Former CSO, Senior VP R&D, Alcon Justin Hanes, PhD Founder, Chair SAB BoardMember Lewis J. Ort Professor of Ophthalmology & Director of the Center for Nanomedicine, Wilmer Eye Institute, Johns Hopkins School of Medicine Peter Campochiaro,MD Founder, SAB Member Eccles Professor of Ophthalmology and Neuroscience, Wilmer Eye Institute, Johns Hopkins School of Medicine Peter McDonnell,MD Founder, SAB Member William Holland Wilmer Professor and Chair of Ophthalmology, Director of the Wilmer Eye Institute, Johns Hopkins School of Medicine OPHTHALMOLOGY & INTRAOCULAR THERAPY LONG ACTING PRODUCTS VRS-317 ACADEMIC OPHTHALMOLOGY
- 4. 62CONFIDENTIAL AND PROPRIETARY| GrayBug TechnologyAdvantages • Tunable release profile (up to 6+ months) • Injection with small gauge needle (27-29 G) • Minimizes inflammation • Forms implant outside visual axis • Ability to deliver compounds with different properties from small molecules to biologics • Scalable aseptic manufacturing process (no terminal sterilization required) In vivo data to date (rabbits): >3 month sustained delivery, no inflammation or toxicity
- 5. 63CONFIDENTIALAND PROPRIETARY | InjectableHigh Capacity Reservoirand Localization of Microparticles INTRAVITREAL INJECTION WITH SMALL GAUGE NEEDLE ENCAPSULATED DRUG Biodegradability Biocompatibility Bioabsorbability Polymer Modified to Reduce Inflammation FUNDUS PHOTOS, DAY 7 Microparticle Localization Designed to Aggregate and Remain Outside Visual Axis
- 6. 64CONFIDENTIALAND PROPRIETARY | MeanAreaofCNV(mm2) Control (PBS) GB-102 (10ug) 0 0.012 0.008 0.004 0.016 P<0.05 GB-102:Long-Term Suppressionof Neovascularization Laser-Induced Model of CNV; P.Campochiaro MD, J.Hanes PhD - Wilmer Eye Institute SUSTAINED EFFICACY: 5 WEEKS (Laser at 4 weeks) SUSTAINED EFFICACY: 9 WEEKS (Laser at 8 weeks) P<0.05 MeanAreaofCNV(mm2) GB-102 Control (10 ug) (PBS) 0 0.01 0.02 0.03 Control GB102 Lucentis® lasts only 2 weeks in mouse model Control GB102
- 7. 65CONFIDENTIAL AND PROPRIETARY| Challenges with Current GlaucomaDrugs • 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) • Lack of compliance leads to neurological complications and loss of vision – No compounds are approved for neuroprotection & trials may be challenging to prove effects • Sustained release versions of prostaglandins (PG; e.g. lantanoprost, travoprost) are in development • Sustained release of carbonic anhydrase inhibitors (CAIs) complicated by solubility in aqueous solutions • Need drugs with IOP lowering and neuroprotection Library of compounds being synthesized to address these challenges
- 8. 66CONFIDENTIALAND PROPRIETARY | GrayBugPipeline :GB-102 LeadProduct FORMULATION IN VIVO NON-GLP GLP PROJECTED INDICATION DEVELOPMENT EFFICACY PK/PD TOXICOLOGY STUDIES IND PHASE1 PHASE2 GrayBug’s Focus on GB-102 Enables Potential for: - First and Best in Class, Single Dose Dual Inhibitor with 4-6 Month Dose Interval - Rapid Validation of GrayBug Technology in Humans - Expansion of Patent Portfolio - Ability to Leverage GB-102 Experience to Partner Programs WetAMD GB-102 2016 2016 2018 Glaucoma IOP Lowering Neuroprotection 2017 Corneal Graft Rejection WetAMD AR13154 + others
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