Post on 13-Apr-2017
TMi de-risks & accelerates drug development for dry AMD
Shelley Boyd, MD, FRCSCClinician-Scientist, Ophthalmologist, specializing in diseases of the Retinaformerly Global Head, Ocular Angiogenesis Research Program, Novartis, SwitzerlandFounder & Chief Scientific Officer, TMi
Age Related Macular Degeneration
Dry AMD85%
Geographic atrophy (GA)= loss of the photoreceptors & retinal pigment epithelium (RPE)
the leading cause of blindness in developed world
Multi-billion $ market
No approved therapies
The Challenge
1) complex disease of innate immunity
2) no animal models develop dry AMD
3) clinical trial design is complex
4) sustained release will be required
Mariam Karmal, AAO EyeNet, 2011
Fundus Autoflourescence(FAF)
Quantification of GA is central to clinical trial design
Size of GA is an entrance criterion
Rate of expansion of GA is a clinical trial endpoint
Quantification of GA is central to clinical trial design
Fundus Autoflourescence(FAF)
A. animal model uniquely mimics disease
quantifiable regions of tissue loss analogous to GA
rodenthuman
Macrophages RPE
… with excess M1 activity
M1 macrophage mRNA
mR
NA
fo
ld c
han
ge
Time (days/weeks/months)BL
Macrophages RPE
… with shift in M1/M2 polarization
M1 macrophage mRNA
mR
NA
fo
ld c
han
ge
Time (days/weeks/months)BL
2. Lead compound TMi-018
1st in class transcriptional regulator
proximal
Basal conditions
mRNA
distal proximal
Inflammatory conditions
mRNA
B. Lead compound TMi-018
1st in class transcriptional regulator reduces M1-related gene expression
X
proximal
Basal conditions
mRNA
distal proximal
Inflammatory conditions
mRNA
TMi-018 – known to be clinically safe
• demonstrated to be safe in Phase II clinical trial• for non-ophthalmic autoimmune disease
• 400+ patients
• known MoA & confirmed druggable target
• demonstrated scalability for GMP production
• successfully prosecuted US Patent Office
• on accelerated Patent Prosecution Highway internationally
Cooley LLP, Morgan Lewis LLP
TMi-018 - patent protected
TMi de-risks drug development
B. Lead compound – TMi-018• 1st in-class regulator of M1 macrophages
• is dose-dependently efficacious reducing onset & expansion of GA
• is systemically safe
• is scalable
• is patent-protected
A. Animal model uniquely mimics disease• aligns with acceptable clinical trial endpoints
• and supports role of macrophages
• Transition to early phase clinical trial
• ocular toxicity
• IND approval from US FDA
TMi is poised to accelerate:
TMi has raised seed funds
• closed seed round of investment, effective October 31st, 2015
• in discussions for next rounds
President & CSO: Shelley Boyd, formerly Head Ocular Angiogenesis Research Program, Novartis
Chief Business Officer: Wayne Schnarr, formerly VP Oncolytics Biotech, Equicom
Strategic Advisory Committee:
Mike Grey, Pappas Ventures; formerly CEO Lumena, SGX, VP Corporate Development, Glaxo
Scientific & Medical Advisory Committee:
David Boyer, KOL, Retina Associates
Julia Levy, formerly CEO &CSO, QLT
Barrett Katz, Director, Clinical Trials, Albert Einstein, NY; formerly CMO Fovea, CEO Danube
TMi’s team