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Sustained Release Ocular Therapeutics
OIS – ASRS
1
25th July 2019
Re-Vana Therapeutics - Queens University Belfast UK Spin Out
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Queen’s University
Belfast U.K. Spin Out
Novel Technologies
Two Photo crosslinked technologies
➢ Implant and In situ implant forming gel
➢ Sustained Release : Large and Small
molecule drug delivery - 4 months or greater
➢ > 50% biologic drug loading
Experienced Team
➢ Extensive global, commercial and drug
delivery development expertise
Tolerability and PK Data
Six-month in vivo study complete
➢ Sustained drug delivery projected
delivery to 4 months or more with an anti-
VEGF drug
➢ Outstanding tolerability out to six months
in a challenging animal model
Capital Raised
➢ $1.6M Seed
➢ $2.0M Pre-Series A (Term sheet executed)
➢ $600K Innovate UK Grant
➢ One collaboration to date - additional strategic discussions in progress
C
Innovative Delivery Platforms and Therapeutic Opportunities
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EyeLiefTM OcuLiefTM
Pre-formed photocrosslinked implant In situ implant forming gel
Injected with a conventional applicator Novel applicator with a built-in UV source
Tailored crosslinking ➔ tailored release profiles
Suitable for both small and large drug molecules
Injecting solid implant In situ UV crosslinking of injected gel
EyeLief™ – Advancing Large and Small Drug Delivery
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In vitro release of
Triamcinolone Acetonide
(6-9 months)
➢ High loading (>50% w/w) of both Large and Small molecules has been achieved
➢ Fabrication procedure avoids extreme pH conditions, elevated temperatures or use of organic
solvents – reduces stability risks for biologics (activity of released biologic is >80%)
➢ Tailored release profiles, biodegradable/biocompatible
In vitro release of Bevacizumab
(Approx. 3 months)
0
20
40
60
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0 4
10
21
35
49
70
112
168
224
Cu
mu
lati
ve r
ele
ase (
%)
Time (days)
EyeLief implant
inside 30G needle
OcuLief™ – Advancing Large and Small Drug Delivery
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In vitro release of
Triamcinolone Acetonide
In vitro release of Bevacizumab
(Approx. 6 months)
0
20
40
60
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0 50 100 150% C
um
ula
tive r
ele
ase o
f B
evaciz
um
ab
Time (Days)
0
20
40
60
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100
0 20 40 60 80
% C
um
ula
tive r
ele
ase
of
TA
Time (Days)
Gel-based depot delivery system
➢ Gel-based in situ depot forming photo-crosslinked delivery system
➢ High drug loading of biologics >30% w/w
➢ Low injectable volumes (20 - 50 µL) with higher release rates (e.g., 10-25 µg/day)
➢ Tailored release profiles & biodegradable/biocompatible
6 Month Safety/Tolerability-PK Studies Bevacizumab w. EyeLief™
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Ocular Examinations
Day 7 Day 28Day 0 (Retinal baseline) Month 3 Month 6
Implant structure maintained throughout the release period
1. Avery RL, Castellarin AA, Steinle NC, Dhoot DS, Pieramici DJ, See R, et al. Systemic pharmacokinetics and pharmacodynamics of intravitreal aflibercept, bevacizumab, and ranibizumab. Retina 2017;37:1847–58.
doi:10.1097/IAE.0000000000001493.
2. Yu L, Liang XH, Ferrara N. Comparing protein VEGF inhibitors: In vitro biological studies. Biochem Biophys Res Commun 2011;408:276–81. doi:10.1016/j.bbrc.2011.04.014.
➢ Excellent Tolerability: No evidence of irritation or significant inflammatory response
➢ No increases in IOP values between Days 0, 7, 28 and month 3
➢ Maintained therapeutic concentrations, predicted sustained release for 4 months
➢ At 3 months, Bevacizumab concentrations in rabbits vitreous humor were approx.
7 times higher of the IC50 of BEZ, which is 0.67 nM (i.e., 0.1 µg/mL)1,2
Re-Vana Strategy
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Internal Product Development
EyeLief Implant:
Sustained delivery of established
anti-VEGF biologic 4+ months
External Collaborations
EyeLief and OcuLief Platforms:
Sustained delivery for novel biologic
and small molecule drugs
Re-Vana Therapeutic Strategic Partnerships
Planned Product Portfolio
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RT1: EyeLief –Sustained delivery of
anti-VEGF
PRODUCT
RT2: EyeLief –Sustained release small
molecule anterior segment drug
RT3: OcuLief –Sustained delivery of
novel compound
➢6 Month Tolerability/PK study completed
➢Proof of Concept study in progress
➢Discussions in progress with API suppliers
➢Pre-clinical
ST
AT
US
➢4-6 Month Proof of Concept 2019
➢In vitro
➢Strategic collaboration Proof of Concept agreement in negotiation
➢Ongoing
Financing
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Pre-Series A $2M
• Term sheet executed – ExSight Ventures
• Existing investor commitments - $700k
• Planned closing Q3 2019
Use of Proceeds
• Finalize lead API candidate for
internal development
• Initiate pre-IND activities
• Expand operations
• Strengthen and expand IP
portfolio - existing and
new filings
• Execute 1 long-term partnership
with world class pharma
company
Extensive Experience in Ocular Drug Development & Delivery
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Michael O’RourkeCEO
Mr Jim Sharkey Retina Physician Director
Prof Clive WilsonCSO &
Scientific Advisor Europe
Dr Brian LevyScientific Advisor
USA
Prof. Barry KuppermannScientific Advisor
USA
David Guyer MD Scientific Advisor
USA
Re-Vana Offers a Major Investment Opportunity
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➢ Sustained release platforms for both large and small molecules
➢ $19.2B anterior and posterior segment market opportunity (2022)
➢ > 50% biologic drug loading
➢ Projected 4 months + delivery
➢ Large and small molecule capability
➢ Proven EyeLief™ Tolerability
➢ Customized delivery
➢ Highly-differentiated photo-crosslinked technologies
➢ Robust IP estate
➢ Strategic partnership milestones achieved
➢ Extensive global, commercial and development expertise
EXPERIENCED
TEAM
LARGE ESTABLISHED
OPHTHALMIC MARKETS
MAKING GREAT
DRUGS BETTER NOVEL TECHNOLOGY
MAJOR COMPETITIVE
ADVANTAGES
