Kodiak Sciences Inc · NASDAQ:KOD
Kodiak Sciences — Angiogenesis, Exudation, and Degeneration 2023
21 slides from Kodiak Sciences's conference presentation, Feb 11, 2023
Slide 1: Update on KSI-301 (tarcocimab tedromer) and Antibody Biopolymer Conjugate Development Programs
Update on KSI-301 (tarcocimab tedromer) and Antibody Biopolymer Conjugate Development Programs Diana Do, M.D. Professor of Ophthalmology Vice Chair of Clinical Affairs Byers Eye Institute Stanford University School of Medicine Angiogenesis, Exudation, and Degeneration 2023 11 February 2023
Slide 2: Disclosures
Disclosures • Presenter’s Financial Disclosures: ‒ Apellis (C), Biogen (C), Boehringer Ingelheim (C, R), Genentech (C), Iveric (C), Kodiak (C, S), Kriya (C, R), Regeneron (C, R) , Santen (C, R) • This presentation will discuss IRB/IEC approved research of an investigational medicine. (C): Consultant
Slide 3: Key Points
Key Points BEACON study met Mean change in BCVA with tarcocimab Q8W was non-inferior to aflibercept Q4W in RVO primary endpoint Conclusions Tarcocimab is the first anti-VEGF therapy to show comparable visual acuity outcomes to monthly aflibercept while doubling the treatment interval for all RVO pat
Slide 4: KSI-301 (tarcocimab tedromer): Antibody Biopolymer Conjugates (ABCs)
KSI-301 (tarcocimab tedromer): Antibody Biopolymer Conjugates (ABCs) A novel class of biologics engineered for increased durability and efficacy + = ANTIBODY BIOPOLYMER CONJUGATE lgG1 Anti-VEGF Antibody Branched, Optically Clear, Immunologically inert High Molecular Weight Phosphorylcholine Polymer
Slide 5: BEACON: non-inferiority study of tarcocimab tedromer vs aflibercept in RVO
BEACON: non-inferiority study of tarcocimab tedromer every 2 months after only two loading doses vs aflibercept every month in treatment-naïve RVO patients Matched phase Maintenance phase PE Week 0 4 8 12 16 20 24 Tarcocimab tedromer 5 mg Q8W (N~275) Aflibercept 2 mg Q4W (N~275) Tarcocimab injection
Slide 6: Patient Eligibility Criteria
Patient Eligibility Criteria Key Ophthalmic Inclusion Criteria ▪ Treatment-naïve macular edema secondary to RVO (BRVO or CRVO) of ≤ 6 months duration ▪ BCVA of 80 to 25 ETDRS letters (≈20/25 to 20/320 Snellen) ▪ CST of ≥320 microns on SD-OCT Key Ophthalmic Exclusion Criteria ▪ Macular edema in the S
Slide 7: Patient Disposition – discontinuations were low and balanced between groups
Patient Disposition – discontinuations were low and balanced between groups; over 95% of patients remained on treatment at Week 24 755 patients screened at 138 sites in US, EU and Israel 568 patients randomized Arm A: Arm B: Tarcocimab Q8W Aflibercept Q4W n = 284 n = 284 284 patients treated 284 pat
Slide 8: Baseline Ocular Characteristics
Baseline Ocular Characteristics – tarcocimab treated patients started at a slightly higher baseline BCVA Tarcocimab Q8W Aflibercept Q4W Parameter (n=284) (n=284) RVO Type, n (%) BRVO 220 (77.5%) 218 (76.8%) CRVO 64 (22.5%) 66 (23.2%) BRVO All Patients BRVO All Patients n=220 n=284 n=218 n=284 BCVA,
Slide 9: Results
Results Primary Endpoint Met Tarcocimab Q8W was non-inferior to aflibercept Q4W in both BRVO and All RVO patients
Slide 10: Comparable vision and anatomical outcomes in BRVO patients
Tarcocimab achieved comparable vision and anatomical outcomes in BRVO patients, demonstrating non-inferiority to aflibercept Q4W Matched Phase Maintenance Phase Strong immediate improvements are Similar visual and anatomical gains are achieved by tarcocimab from seen as early as Week 1 Week 8 to Wee
Slide 11: Non-inferiority to aflibercept Q4W in all RVO patients
Similarly, tarcocimab demonstrated non-inferiority to aflibercept Q4W in all RVO patients, achieving comparable vision and anatomical outcomes Matched Phase Maintenance Phase Strong immediate improvements are Similar visual and anatomical gains are achieved by tarcocimab from seen as early as Week 1
Slide 12: Similar distribution of vision outcomes at Week 24
Tarcocimab Q8W and aflibercept Q4W had similar distribution of vision outcomes both among BRVO and all RVO patients at Week 24 BRVO All patients (BRVO + CRVO) BCVA category n=220 n=218 n=284 n=284 ETDRS letters (~Snellen) 100% 100% 6% 8% 6% 7% ≥90 (≥20/16) % of patients achieving BCVA category % of
Slide 13: First anti-VEGF therapy with non-inferior vision outcomes with fewer doses
Tarcocimab is the first anti-VEGF therapy to demonstrate non-inferior vision outcomes with fewer doses than the average used in clinical practice Real World Evidence1 BEACON Mean number of anti-VEGF injections Mean number of injections in the first 6 months of RVO treatment through Week 24 6 6 5.8 5
Slide 14: Safety: tarcocimab Q8W was well-tolerated
Safety: tarcocimab Q8W was well-tolerated, with low rates of adverse events Tarcocimab Q8W Aflibercept Q4W Intraocular Inflammation in Study Eye up to Week 24 (n=284) (n=284) Subjects Reporting at Least 1 Intraocular Inflammation AE 4 (1.4%) 1 (0.4%) Uveitis 2 (0.7%) 0 Keratic precipitates 1 (0.4%)
Slide 15: Reducing treatment burden from 6 to 4 injections while maintaining vision
BEACON Phase 3 study in RVO: Reducing treatment burden from 6 to 4 injections while maintaining vision outcomes is highly meaningful for patients Real World Evidence1 20 BRVO 20 CRVO Mean VA Change (Letters) Real world evidence showed that Mean VA Change (Letters) 14.4 15 13.1 15 reducing doses from
Slide 16: Four additional Phase 3 studies of tarcocimab expected to read out in 2023
Four additional Phase 3 studies of tarcocimab are expected to read out in 2023: DME (two studies), wet AMD and NPDR 2020 2021 2022 2023 2024 BEACON 550 Patients 6-month 6-month RVO Phase 3 Q8W tarcocimab tedromer vs Primary H2H “PRN” Primary endpoint met Q4W aflibercept Endpoint GLEAM 450 Patients D
Slide 17: A pipeline of ABCs for retinal diseases
A pipeline of ABCs for retinal diseases: leveraging bispecifics and small molecules on the biopolymer conjugate platform to further address major causes of vision loss MONOSPECIFIC BISPECIFIC TRIPLET 1 Molecule, 1 Target 1 Molecule, 2 Targets 1 Molecule, 3 Targets Antibody conjugated to Dual inhibit
Slide 18: KSI-501: new category of retinal medicine inhibiting VEGF and IL-6
KSI-501 is a new category of retinal medicine: first-in-class bispecific ABC that inhibits two powerful pathophysiologic mechanisms in retinal disease – VEGF and IL-6 ▪ IL-6 is a pro-inflammatory cytokine implicated in the pathophysiology of multiple retinal diseases and is associated with poor anti
Slide 19: KSI-501 inhibits angiogenesis and normalizes blood retinal barriers
KSI-501 inhibits angiogenesis and also normalizes inner and outer blood retinal barriers Inner blood-retinal barrier: leakage from vascular endothelium disruption leads to macular edema and hemorrhage1 Outer blood-retinal barrier: RPE integrity prevents choroidal vascularization from invading the re
Slide 20: Dual inhibition of VEGF and IL-6 by KSI-501 confers superior normalization
Dual inhibition of VEGF and IL-6 by KSI-501 confers superior normalization compared to either anti-VEGF or anti-IL-6 monotherapy alone Exogenous VEGF and IL-6 Normal tight junction disruption and changes in cell morphology Monotherapy Inhibition Dual inhibition No Inhibitors Anti-VEGF Anti-IL-6 KSI-
Slide 21: Key Points Conclusions
Key Points BEACON study met Mean change in BCVA with tarcocimab Q8W was non-inferior to aflibercept Q4W in RVO primary endpoint Conclusions Tarcocimab is the first anti-VEGF therapy to show comparable visual acuity outcomes to monthly aflibercept while doubling the treatment interval for all RVO pat
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