Kodiak Sciences Inc · NASDAQ:KOD
Kodiak Sciences — 2022 American Academy of Ophthalmology Annual Meeting
23 slides from Kodiak Sciences's conference presentation, Sep 30, 2022
Slide 1: KSI-301 for Retinal Vein Occlusion: BEACON Primary 24-Week Outcomes
KSI-301 Anti-VEGF Antibody Biopolymer Conjugate for Retinal Vein Occlusion: Primary 24-Week Efficacy and Safety Outcomes of the BEACON Phase 3 Pivotal Study Michael Singer, M.D. Clinical Professor of Ophthalmology, University of Texas Health Science Center Director of Clinical Research, Medical Cent
Slide 2: Disclosures
Disclosures • Presenter’s Financial Disclosures: ‒ Consultant: Aerie, Allegro, Alimera, Allergan, Eyepoint, Genentech, Kodiak Sciences, Novartis, Regeneron, Santen ‒ Contracted Research: Aerie, Alimera, Allegro, Allergan, DRCR.net, Genentech, Icon, Ionis, Kalvista, Kodiak Sciences, Novartis, Opthea,
Slide 3: RVO real-world anti-VEGF outcomes fall short of clinical trial outcomes
RVO real-world anti-VEGF treatment outcomes fall short of clinical trial outcomes – more durable treatments are needed BRVO CRVO 3,000 2,500 2,637 2,043 2,500 2,000 2,049 2,000 1,567 Monthly dosing is difficult to achieve in 1,699 # Eyes # Eyes 1,500 1,311 1,500 clinical practice, where 72% of patie
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: Phase 3 non-inferiority study design
BEACON: Phase 3 non-inferiority study of tarcocimab tedromer every 2 months after only two loading doses vs aflibercept every 1 month in treatment-naïve RVO patients Matched Maintenance phase PE phase Week 0 4 8 12 16 20 24 Months 6-12: Individualized dosing Tarcocimab tedromer 5 mg Q8W in both arms
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
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: Tarcocimab Q8W comparable to aflibercept Q4W in BRVO patients
Tarcocimab Q8W improved BCVA and OCT CST comparably to aflibercept Q4W from baseline to Week 24 in BRVO patients – non-inferiority to aflibercept demonstrated BCVA Change Over Time from Baseline: ETDRS Letters Adjusted Mean BCVA Change 15.6 14.2 Non-inferiority P-value = 0.0004 OCT CST Change Over T
Slide 11: Tarcocimab Q8W comparable to aflibercept Q4W in all RVO patients
Tarcocimab Q8W improved BCVA and OCT CST comparably to aflibercept Q4W from baseline to Week 24 in all RVO patients – non-inferiority to aflibercept demonstrated BCVA Change Over Time from Baseline: ETDRS Letters Adjusted Mean BCVA Change 15.5 13.0 Non-inferiority P-value = 0.0243 OCT CST Change Ove
Slide 12: Comparable visual and anatomical outcomes in BRVO patients
Tarcocimab achieved comparable visual and anatomical outcomes in BRVO patients, in both the matched phase and the maintenance phase Matched Phase Maintenance Phase Strong immediate improvements Similar visual and anatomical gains are achieved by are seen as early as Week 1 tarcocimab from Week 8 to
Slide 13: Comparable visual and anatomical outcomes in all RVO patients
Similarly, tarcocimab achieved comparable visual and anatomical outcomes in all RVO patients, in both the matched phase and the maintenance phase Matched Phase Maintenance Phase Strong immediate improvements Similar visual and anatomical gains are achieved by are seen as early as Week 1 tarcocimab f
Slide 14: Secondary endpoints: gained or maintained vision at Week 24
Secondary endpoints: Comparable proportions of tarcocimab Q8W and aflibercept Q4W patients gained or maintained vision at Week 24 BRVO All patients (BRVO + CRVO) 100% 100% 100% 99% 100% 100% (weighted percentages, %) (weighted percentages, %) 80% 80% Proportion of Patients Proportion of Patients 60%
Slide 15: Secondary endpoints: good vision and avoided poor vision
Secondary endpoints: Comparable proportions of tarcocimab Q8W and aflibercept Q4W achieved good vision (≥20/40) and avoided poor vision (≤20/200) at Week 24 BRVO All patients (BRVO + CRVO) 100% 100% 81% (weighted percentages, %) 80% (weighted percentages, %) 80% 80% 75% 77% Proportion of Patients Pr
Slide 16: 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 17: First anti-VEGF 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 18: Safety: tarcocimab Q8W well-tolerated with low adverse event rates
Safety: tarcocimab Q8W was well-tolerated, with low rates of adverse events Tarcocimab Q8W Aflibercept Q4W Adverse Events (AEs) up to Week 24 (n=284) (n=284) Ocular - Study Eye Subjects with any ocular AE 86 (30.3%) 71 (25.0%) Subjects with any ocular serious AE (SAE) 4 (1.4%) 0 Subjects with any In
Slide 19: Low rates of intraocular inflammation, no endophthalmitis
Rates of intraocular inflammation were low and comparable between treatment groups, and there were no cases of endophthalmitis 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%
Slide 20: Common ocular adverse events and serious adverse events were low
Rates of common ocular adverse events (≥1.5% in either study arm) and ocular serious adverse events were low Tarcocimab Q8W Aflibercept Q4W Common Ocular Adverse Events (AEs) up to Week 24 (n=284) (n=284) Subjects with any AE in the Study Eye 86 (30.3%) 71 (25.0%) Conjunctival haemorrhage 25 (8.8%)
Slide 21: Relevance: reducing treatment burden while maintaining vision outcomes
Relevance: reducing the treatment burden from 6 to 4 doses/injections/visits 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 22: Conclusions
Conclusions BEACON 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 Similar efficacy, •
Slide 23: Thank you to all BEACON investigators and site staff!
Thank you to all BEACON investigators and site staff! Czech Republic: Oftex S.R.O., Vseobecna Fakultni Nemocnice V Praze; France: Centre Paradis Monticelli, Centre Hospitalier Universitaire de Bordeaux - Hôpital Pellegrin, Centre Hospitalier Intercommunal de Créteil, Fondation Rothschild, CHRU Dijon
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