Kodiak Sciences Inc · NASDAQ:KOD
Kodiak Sciences — 56th Annual Scientific Meeting of the Retina Society (October 2023)
19 slides from Kodiak Sciences's conference presentation, Oct 13, 2023
Slide 1: Tarcocimab tedromer (KSI-301) 5 mg for wAMD: One-year DAYLIGHT Phase 3 outcomes
Tarcocimab tedromer (KSI-301) 5 mg for the treatment of wAMD: One-year primary efficacy and safety outcomes of the Phase 3 DAYLIGHT Study Brandon Busbee, M.D. Partner Tennessee Retina and Retina Consultants of America on behalf of the DAYLIGHT Investigators 56th Annual Scientific Meeting of the Reti
Slide 2: Disclosures
Disclosures This presentation will discuss IRB/IEC approved research of an investigational medicine. Brandon Busbee has the following financial interests or relationships to disclose: Apellis (Speaker), Genentech (Consultant) 2
Slide 3: KSI-301 (tarcocimab tedromer) and Antibody Biopolymer Conjugates (ABCs)
KSI-301 (tarcocimab tedromer) and Antibody Biopolymer Conjugates (ABCs) + = ANTIBODY BIOPOLYMER CONJUGATE lgG1 Anti-VEGF Antibody Branched, Optically Clear, High Molecular Weight Phosphorylcholine Polymer Tarcocimab is an anti-VEGF ABC that blocks all VEGF-A isoforms 3
Slide 4: DAYLIGHT: Schematic Study Design
DAYLIGHT: Schematic Study Design Prospective, randomized, double-masked, multi-center, Phase 3, non-inferiority study of tarcocimab tedromer 5 mg vs aflibercept 2 mg in treatment-naïve wAMD Aflibercept dosed Tarcocimab monthly dosing every 2 months after 3 monthly loading doses Primary endpoint Mean
Slide 5: Randomized Phase 3 non-inferiority study of monthly tarcocimab vs aflibercept in wAMD
A randomized, double-masked, multi-center Phase 3 non-inferiority study of intensive dosing (monthly) of tarcocimab tedromer 5 mg vs aflibercept 2 mg in treatment-naïve wAMD Week 0 4 8 12 16 20 24 28 32 36 40 44 48 52 Tarcocimab 5 mg Monthly Aflibercept 2 mg Q8W Tarcocimab injection Aflibercept inje
Slide 6: Patient Disposition
Patient Disposition 815 patients screened at 93 sites in US and EU 557 patients randomized Arm A: Arm B: Tarcocimab Q4W Aflibercept Q8W n = 276 n = 281 276 patients treated 281 patients treated 253 (91.7%) patients 23 (8.3%) discontinued treatment 268 (95.4%) patients 13 (4.6%) discontinued treatmen
Slide 7: Baseline ocular characteristics were well-matched between groups
Baseline ocular characteristics were well-matched between groups and typical of treatment-naïve wAMD patients Tarcocimab Q4W Aflibercept Q8W n=276 n=281 BCVA, ETDRS Letters, mean (SD) 63.7 (13.06) 64.0 (13.09) ≥20/40 Snellen equivalent, n (%) 122 (44.2%) 129 (45.9%) ≤20/200 Snellen equivalent, n (%)
Slide 8: Primary endpoint: tarcocimab demonstrated non-inferior mean change in BCVA to aflibercept
Primary endpoint: tarcocimab demonstrated non-inferior mean change in BCVA from baseline at average of weeks 40-48 to aflibercept Mean Change in BCVA from Baseline 15 Aflibercept (n=281) Tarcocimab (n=276) ETDRS Letters 10 Avg of Weeks 40-48 (SD) 5.5 (10.7) 5 3.9 (10.7) 0 0 4 8 12 16 20 24 28 32 36
Slide 9: Continued dosing resulted in comparable drying over time
Continued dosing resulted in comparable drying over time Mean Change in OCT CST Over Time 0 -50 Week 48 (SD) -100 -109 (121) -117 (114) µm -150 -200 Aflibercept Q8W (n=281) Tarcocimab Q4W (n=276) -250 0 4 8 12 16 20 24 28 32 36 40 44 48 Week Observed values. OCT: optical coherence tomography; CST: c
Slide 10: Similar proportion achieved BCVA of 20/40 or better and avoided 20/200 or worse
Similar proportion of patients achieved a BCVA of 20/40 or better and avoided dropping to 20/200 or worse with tarcocimab when compared to aflibercept 20/40 or Better 20/200 or worse 70% 70% 60% 60% 50% 50% 40% 40% 30% 30% 20% 20% 10% 10% 0% 0% Baseline Primary Endpoint Baseline Primary Endpoint 20/
Slide 11: Rates of common ocular adverse events were low
Rates of common ocular adverse events were low. Tarcocimab dosed monthly for 12 injections was safe and well tolerated. There was no observed imbalance in cataracts. Tarcocimab Q4W Aflibercept Q8W Common Ocular Adverse Events (AEs)a n=276 n=281 Subjects with any AE in the Study Eye 107 (38.8%) 83 (2
Slide 12: GLEAM & GLIMMER showed increased cataracts in DME; not observed monthly in DAYLIGHT
The GLEAM & GLIMMER studies with tarcocimab in DME showed an increased incidence of cataracts with tarcocimab. This was not observed with monthly dosing in DAYLIGHT. GLEAM + GLIMMER DAYLIGHT DAZZLE BEACON (DME) (wAMD) (wAMD) (RVO) Duration of Follow-Up 64 Weeks 48 Weeks 52 Weeks 48 Weeks Tarcocimab
Slide 13: There were fewer cataracts but were they significant?
There were fewer cataracts but were they significant? 13
Slide 14: Phakic patients achieved comparable BCVA gains on both arms
Phakic patients achieved comparable BCVA gains on both tarcocimab and aflibercept arms, demonstrating no relevant impact from cataracts. Mean Change in BCVA from Baseline: Phakic Patients Aflibercept Q8W (n=127) Tarcocimab Q4W (n=129) 10 ETDRS Letters Avg of Weeks 40-48 (SD) 5.2 (11.3) 5 4.8 (9.9) 0
Slide 15: Why is there no increase in cataract events in DAYLIGHT?
Why is there no increase in cataract events in DAYLIGHT? 15
Slide 16: Increased cataract incidence seems specific to diabetic patients with retinopathy
The increased cataract incidence seen with tarcocimab seems to be highly specific to diabetic patients with diabetic retinopathy Tarcocimab across 5 pivotal trials Aflibercept across 5 pivotal trials (wAMD, DME and RVO patients combined) (wAMD, DME and RVO patients combined) Medical history Medical
Slide 17: Rates of intraocular inflammation were low in both treatment groups
Rates of intraocular inflammation were low in both treatment groups Tarcocimab Q4W Aflibercept Q8W Intraocular Inflammation in Study Eye n=276 n=281 Subjects with at Least 1 Intraocular Inflammation AE* 9 (3.3%) 1 (0.4%) Tarcocimab Q4W Aflibercept Q8W Endophthalmitis in Study Eye n=276 n=281 Subject
Slide 18: Conclusions
Conclusions DAYLIGHT met the Tarcocimab dosed monthly demonstrated non-inferior visual acuity gains at Year 1 compared to aflibercept dosed per label, and continued dosing through Year 1 resulted in primary endpoint comparable drying effect. Conclusions These positive results from the DAYLIGHT study
Slide 19: Thank you to all DAYLIGHT investigators, site staff and patients
Thank you to all DAYLIGHT investigators, site staff and patients Czech Republic: Fakultni nemocnice Kralovske Vinohrady; Hungary: Bajcsy-Zsilinszky Korhaz es Rendelointezet, Budapest Retina Associates, Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Debreceni Egyetem Klinikai Kozpon
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