Kodiak Sciences Inc · NASDAQ:KOD
Kodiak Sciences — Angiogenesis, Exudation, and Degeneration 2021
38 slides from Kodiak Sciences's conference presentation, Feb 13, 2021
Slide 1: Extended Durability in Exudative Retinal Diseases Using KSI-301
Extended Durability in Exudative Retinal Diseases Using the Novel Intravitreal Anti-VEGF Antibody Biopolymer Conjugate KSI-301 Phase 1b Study in Patients with wAMD, DME and RVO Year 1 Results Diana V. Do, MD Professor of Ophthalmology Vice Chair of Clinical Affairs Byers Eye Institute Stanford Unive
Slide 2: Disclosures
Disclosures ▪ Financial: Aerie (C, R), Allergan (C), Asclepix (C, R), Boehringer Ingelheim (C, R), Genentech (C), Kodiak (C, S) Novartis (C, R), Regeneron (C, R) , Santen (C, R) ▪ Study Disclosures: This study of an investigational product includes research conducted on human subjects. Institutional
Slide 3: KSI-301 Phase 1b Study – Year 1 Results: Key Questions
KSI-301 Phase 1b Study – Year 1 Results Key Questions Do the data support the potential for KSI-301 to meaningfully advance the treatment paradigm for major retinal vascular diseases? Can KSI-301 provide the expected efficacy gains in line with current anti-VEGF agents? Can KSI-301 achieve clinical
Slide 4: Current anti-VEGF agents depend on high-frequency treatment
Current anti-VEGF agents depend on high-frequency treatment to be most efficacious Mean number of injections required in Year 1 9.2 9.7 9.4 8.0 8.1 8.1 3.2 3.7 3.4 7.1 Maintenance doses 4.1 4.1 5.0 3.1 6.0 6.0 6.0 Monthly 4.0 4.0 4.0 3.0 loading doses Aflibercept Aflibercept Bevacizumab Ranibizumab
Slide 5: KSI-301 shows impressive and consistent durability across retinal vascular diseases
KSI-301 shows impressive and consistent durability across retinal vascular diseases in Year 1 2 in every 3 patients are on a ≥ 6-month treatment-free interval at Year 1 after only 3 loading doses Interval at wAMD DME RVO Year 1 n=50 n=32 n=32 ≥6 months 66% 69% 66% Phase 1b interim data. 2.5 & 5 mg d
Slide 6: Clinical Data
KSI-301 Clinical Data 130 patients dosed in Phase 1a/1b Program 168+ patient years of clinical experience 6
Slide 7: Phase 1b Study Design
KSI-301 Phase 1b Study Design Randomized, open label study to evaluate multidose safety, efficacy & durability wAMD (n=51) DME (n=35) RVO (n=35) Randomized 1:3 KSI-301 2.5 mg (50 mL) KSI-301 5 mg (100 mL) Loading Phase Durability Assessment Phase Extension Study Weeks 0 4 8 12 to 72 (months 3 to 18)
Slide 8: Phase 1b Retreatment Criteria
KSI-301 Phase 1b Retreatment Criteria ▪ wAMD – Increase in CST ≥75 µm with a decrease in BCVA of ≥ 5 letters compared to Week 12, OR – Decrease in BCVA of > 5 letters compared to Day 1, due to worsening wAMD activity, OR – Decrease in BCVA of ≥ 10 letters compared to the best prior BCVA, due to wors
Slide 9: Baseline Characteristics
Baseline Characteristics wAMD Cohort DME Cohort RVO Cohort Variable (n=51) (n=35) (n=35) Age, mean (SD), years 77.9 (10.5) 59.7 (11.7) 63.6 (12.6) Gender, n (%), female 32 (62.7) 14 (40.0) 13 (37.1) Race, n (%), White 48 (94.1) 28 (80.0) 31 (88.6) BCVA, mean (SD), ETDRS letters 63.3 (13.3) 66.8 (10.
Slide 10: Phase 1b wAMD Year 1 Data
KSI-301 Phase 1b wAMD Year 1 Data 10
Slide 11: Efficacy of KSI-301 in Wet AMD
Efficacy of KSI-301 in Wet AMD Change from baseline to Week 52 in mean BCVA & OCT 75 ETDRS letters 70 BCVA +5.7 65 20/40 60 0 4 8 12 16 20 24 Weeks 28 32 36 40 44 48 52 500 OCT CST 450 microns 400 -105 350 N=50 300 3.0 2.0 Loading doses Individualized doses mean injections Interim data; 2.5 & 5 mg d
Slide 12: Durability of KSI-301 in Wet AMD
Durability of KSI-301 in Wet AMD 80% of patients received 2 or fewer retreatments in Year 1 100 54% of patients required only Percentage of patients (%) Mean injections 5.0 in Year 1 80 1 retreatment Individualized 60 54.0 2.0 doses 40 Monthly loading 3.0 doses 26.0 20 KSI-301 8.0 4.0 6.0 2.0 0 1 2
Slide 13: Durability of KSI-301 in Wet AMD: retreatment intervals
Durability of KSI-301 in Wet AMD Distribution of retreatment intervals at Year 1 100 66% of patients were on a 80 6-month treatment-free Percentage of patients (%) interval at Year 1 66.0 60 40 20 14.0 6.0 8.0 2.0 4.0 0 1 2 3 4 5 6 month months months months months months Treatment interval at Year
Slide 14: KSI-301 in wAMD: majority of patients can achieve 6-month durability
KSI-301 in wAMD: the majority of patients can achieve 6-month durability Loading Year 1 Year 2 Overall Time on Study (weeks) 0 8 16 24 32 40 48 56 64 72 80 88 96 104 Interval at Year 1* n=50 1 KSI-301 3 2.5 mg 5 1 month 2% 7 (n=12) 9 11 2 months 14% 1 3 5 3 months or longer 84% 7 9 11 4 months or lo
Slide 15: Phase 1b DME Year 1 Data
KSI-301 Phase 1b DME Year 1 Data 15
Slide 16: Efficacy of KSI-301 in DME
Efficacy of KSI-301 in DME Change from baseline to Week 52 in mean BCVA & OCT 80 ETDRS letters 75 BCVA 70 +7.6 65 ⁓20/32 60 0 4 8 12 16 20 24 Weeks 28 32 36 40 44 48 52 500 450 OCT CST microns 400 350 -136 300 N=32 250 3.0 1.0 Loading doses Individualized doses mean injections Interim data; 2.5 & 5
Slide 17: Durability of KSI-301 in DME
Durability of KSI-301 in DME 90% of patients received 2 or fewer retreatments in Year 1 100 50% of patients did not require Percentage of patients (%) Mean injections 4.0 in Year 1 80 any retreatment Individualized 60 1.0 doses 50.0 40 Monthly loading 3.0 doses 21.9 18.8 20 KSI-301 6.3 3.1 0.0 0.0 0
Slide 18: Durability of KSI-301 in DME: retreatment intervals
Durability of KSI-301 in DME Distribution of retreatment intervals at Year 1 100 69% of patients were on a 6-month or longer Percentage of patients (%) 80 68.8 treatment-free interval 60 at Year 1 40 20 9.4 9.4 3.1 6.3 3.1 0 1 2 3 4 5 6 months month months months months months or longer Treatment in
Slide 19: KSI-301 in DME: 3 loading doses can provide sustained disease control
KSI-301 in DME: 3 loading doses can provide sustained disease control of 3 to 6+ months Loading Year 1 Year 2 Overall Time on Study (weeks) 0 8 16 24 32 40 48 56 64 72 80 88 96 104 Interval at Year 1* n=32 1 KSI-301 3 1 month 3% 2.5 mg 5 7 (n=9) 9 2 months 3% 1 3 3 months or longer 94% 5 KSI-301 7 4
Slide 20: 6-month disease control after 3 loading doses in proliferative diabetic retinopathy
6-month disease control after only 3 loading doses is also seen in proliferative diabetic retinopathy DAY 1 WEEK 12 WEEK 72 Proliferative DR (DRSS 71) Non-Proliferative DR (DRSS 53) Non-Proliferative DR (DRSS 53) KSI-301 Two 5 mg additional 3 loading doses doses PDR Regression from PDR to NPDR Fast
Slide 21: Phase 1b RVO Year 1 Data
KSI-301 Phase 1b RVO Year 1 Data 21
Slide 22: Efficacy of KSI-301 in RVO
Efficacy of KSI-301 in RVO Change from baseline to Week 52 in mean BCVA & OCT 80 ETDRS letters 75 70 +22.2 BCVA 65 ⁓20/32 60 55 50 0 4 8 12 16 20 24 Weeks28 32 36 40 44 48 52 750 650 OCT CST microns 550 450 BRVO n= 19 CRVO n= 15 -357 350 250 N=34 3.0 1.7 Loading doses Individualized doses mean injec
Slide 23: Durability of KSI-301 in RVO
Durability of KSI-301 in RVO 72% of patients received 2 or fewer retreatments in Year 1 100 Percentage of patients (%) Mean injections 4.7 in Year 1 80 Only 28% of patients Individualized 60 1.7 doses required more than 5 total injections in Year 1* 40 31.3 Monthly loading 3.0 doses 25.0 20 15.6 12.
Slide 24: Durability of KSI-301 in RVO: retreatment intervals
Durability of KSI-301 in RVO Distribution of retreatment intervals at Year 1 100 66% of patients were on a 6-month or longer Percentage of patients (%) 80 treatment-free interval 65.6 60 at Year 1 40 20 12.5 9.4 3.1 6.3 3.1 0 1 2 3 4 5 6 months month months months months months or longer Treatment i
Slide 25: KSI-301 in RVO: 3 loading doses can provide sustained disease control
KSI-301 in RVO: 3 loading doses can provide sustained disease control of 2 to 6+ months Loading Year 1 Year 2 Overall Time on Study (weeks) 0 8 16 24 32 40 48 56 64 72 80 88 96 104 Interval at Year 1* n=32 1 KSI-301 3 1 month 3% 2.5 mg 5 (n=9) 7 2 months 9% 9 1 3 3 months or longer 87% 5 KSI-301 7 4
Slide 26: How can KSI-301 achieve strong efficacy and remarkable durability?
How can KSI-301 achieve strong efficacy and remarkable durability? 26
Slide 27: Antibody Biopolymer Conjugates (ABC)
Antibody Biopolymer Conjugates (ABC) Biologics precision-engineered for increased durability and efficacy SAME WHERE IT MATTERS Single Site-Specific • Clinically proven targets + Stable (Covalent) = • Antibody-based biologic • Intravitreal: safest method of administration Linkage • Optically clear,
Slide 28: KSI-301: Next-Generation anti-VEGF
KSI-301: Next-Generation anti-VEGF ABC Platform and higher dose for longer treatment duration Ranibizumab Bevacizumab Aflibercept KSI-301 Recombinant fusion Antibody Biopolymer Molecule type Antibody fragment Antibody protein Conjugate (ABC) Molecular structure Molecular weight 48 kDa 149 kDa 115 kD
Slide 29: Integrated properties of ABC Platform are ideal for long-acting intravitreal therapeutic
Integrated properties of ABC Platform are ideal for a long-acting intravitreal therapeutic More than the sum of its parts Remarkable Excellent Retinal Deeper Inhibitory Fast Systemic Intraocular Half-life1 Bioavailability2 Potency3 Clearance4 Primary human retinal cell-based assay Plasma concentrati
Slide 30: Phase 1b Safety
KSI-301 Phase 1b Safety 30
Slide 31: Safety of KSI-301: Excellent safety profile
Safety of KSI-301: Excellent safety profile 130 710 168 + 121 96 Subjects dosed Total doses Patient-years Completed the Phase 1b subjects at Week 12 or later that Across the Phase 1a/1b program loading phase in have received all three loading doses plus Phase 1b at least one additional retreatment ▪
Slide 32: How do the Phase 1b data inform the design of KSI-301 pivotal studies?
How do the Phase 1b Study data inform the design of KSI-301 pivotal studies? 32
Slide 33: Phase 1b data in treatment-naïve patients inform pivotal study design
KSI-301 Phase 1b data in treatment-naïve patients inform the design of Kodiak pivotal studies • Treatment-naïve patients Maintained • 3 loading doses in wAMD and DME • Monthly visits • Only high dose (5 mg) advanced • Tighter disease activity criteria • Proactive dosing • Tighter dosing intervals Op
Slide 34: KSI-301 pivotal program: long-interval dosing
KSI-301 pivotal program: long-interval dosing to meaningfully change the treatment paradigm Diabetic Non-Proliferative Wet AMD Retinal Vein Occlusion Macular Edema Diabetic Retinopathy Comparator Comparator Comparator Comparator Aflibercept Aflibercept Aflibercept Sham once every 2 months once every
Slide 35: What is the potential impact of KSI-301 in clinical practice and patients' lives?
What is the potential impact of KSI-301 in clinical practice and patients’ lives? 35
Slide 36: KSI-301 has the potential to be the longest-acting intravitreal biologic
KSI-301 has the potential to be the longest-acting intravitreal biologic 2 in every 3 patients are on a ≥ 6-month treatment-free interval at Year 1 after only 3 loading doses Interval at wAMD DME RVO Year 1 n=50 n=32 n=32 ≥6 months 66% 69% 66% Phase 1b interim data. 2.5 & 5 mg doses pooled. Includes
Slide 37: Phase 1b Study – Year 1 Results: Key Questions answered
KSI-301 Phase 1b Study – Year 1 Results Key Questions The data support the potential for KSI-301 to meaningfully advance the treatment paradigm for major retinal vascular diseases Can KSI-301 provide the expected efficacy gains in line with current anti-VEGF agents? Yes Can KSI-301 achieve clinical
Slide 38: Acknowledgements
Acknowledgements Principal Investigators Kodiak Sciences ▪ Mark Barakat, MD ▪ Pablo Velazquez-Martin, MD ▪ Brian Berger, MD ▪ Amy Duguay, BS ▪ David Boyer, MD ▪ Pam Henderson, RN ▪ David Brown, MD ▪ Sinette Heys ▪ Pravin Dugel, MD ▪ Daniel Janer, MD ▪ David Eichenbaum, MD ▪ Hong Liang, PhD ▪ Arshad
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