Kodiak Sciences Inc · NASDAQ:KOD
Kodiak Sciences — American Academy of Ophthalmology – Retina Subspecialty Day 2023
24 slides from Kodiak Sciences's conference presentation, Nov 3, 2023
Slide 1: Tarcocimab Tedromer for Diabetic Retinopathy: GLOW Phase 3 Primary Endpoint Outcomes
Tarcocimab Tedromer for Diabetic Retinopathy: Primary Endpoint Efficacy and Safety Outcomes of the GLOW Phase 3 Pivotal Study Charles C. Wykoff, M.D., Ph.D. Deputy Chair of Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital Director of Research, Retina Consultants of Texas; Retina Cons
Slide 2: Disclosures
Disclosures This presentation will discuss IRB/IEC approved research of an investigational medicine. Charles Wykoff has the following financial interests or relationships to disclose: 4DMT (C, R), Abbvie (C), Adverum (C,R), Aerie (C), AffaMed (R), AGTC (C), Alcon (C), Alexion (R), Alimera (R), Allge
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 KSI-301 (tarcocimab tedromer) is an anti-VEGF ABC that blocks all VEGF-A isoforms 3
Slide 4: GLOW – Study design – 4 total doses in Year 1
GLOW – Study design – 4 total doses in Year 1 Unprecedented progressive extension of intervals to 6-month dosing Randomized, double-masked, multi-center Phase 3 superiority study of tarcocimab tedromer 5 mg in moderately severe to severe non-proliferative diabetic retinopathy Tarcocimab 5 mg Sham Ex
Slide 5: GLOW: Key eligibility criteria
GLOW: Key eligibility criteria Key Inclusion Criteria ▪ Anti-VEGF treatment-naïve moderately severe to severe NPDR (DRSS levels 47 and 53) determined by the central reading center in whom PRP can safely deferred for at least 6 months ▪ BCVA ≥ 69 letters (≥20/40 Snellen equivalent) ▪ HbA1c of ≤12% Ke
Slide 6: First Time Results
First Time Results 6
Slide 7: Baseline patient demographics and general characteristics
Baseline patient demographics and general characteristics Tarcocimab Sham n = 128 n = 125 Age, years, mean (SD) 56.4 (11.39) 57.0 (9.63) Female, n (%) 51 (39.8) 56 (44.8) Race, n (%) White 108 (84.4) 96 (76.8) Black or African American 13 (10.2) 23 (18.4) Asian 3 (2.3) 3 (2.4) Other 4 (3.1) 3 (2.4)
Slide 8: Baseline ocular characteristics and patient disposition
Baseline ocular characteristics were well-matched between groups and typical of treatment-naïve NPDR patients. Most patients (≥92%) completed the study Baseline ocular characteristics and patient disposition Tarcocimab Sham n = 128 n = 125 BCVA, ETDRS Letters, mean (SD) 81.8 (5.79) 81.2 (5.76) Centr
Slide 9: Baseline ocular characteristics and patient disposition
Baseline ocular characteristics were well-matched between groups and typical of treatment-naïve NPDR patients. Most patients (≥92%) completed the study Baseline ocular characteristics and patient disposition Tarcocimab Sham n = 128 n = 125 BCVA, ETDRS Letters, mean (SD) 81.8 (5.79) 81.2 (5.76) Centr
Slide 10: Patients treated with tarcocimab received only 4 injections in Year 1
Patients treated with tarcocimab received only 4 injections in Year 1 Mean number of active treatments in the Study Eye 5 4 3.8 3 2 1 4 Planned 0 Injections 0 Sham Tarcocimab Sham (n=125); Tarcocimab (n=128) 10
Slide 11: Primary Endpoint Met – superiority in ≥2-step improvement in DRSS
Primary Endpoint Met – tarcocimab established superiority in ≥2-step improvement in DRSS Proportion of patients with ≥2-Step improvement in DRSS from Baseline to Week 48 50% 41.1% 40% 30% 29x increased response rate ratio 20% 10% 1.4% p<0.0001 0% Sham Tarcocimab Sham (n=125); Tarcocimab (n=128); Wee
Slide 12: Key Secondary Endpoint Met – superiority in ≥3-Step improvement in DRSS
Key Secondary Endpoint Met – tarcocimab also demonstrated superiority in ≥3-Step improvement in DRSS Proportion of patients with ≥3-Step improvement in 15% DRSS from Baseline to Week 48 10% 5.6% 5% 0.0% p<0.0058 0% Sham Tarcocimab Sham (n=125); Tarcocimab (n=128); Week 48 (LOCF) represents the last
Slide 13: Tarcocimab improved DRSS irrespective of baseline diabetic retinopathy level
Tarcocimab improved the DRSS score irrespective of the baseline diabetic retinopathy level, showing excellent control in more severe disease Proportion of patients with ≥2-Step improvement in 70% DRSS from Baseline to Week 48, by baseline DRSS Sham Tarcocimab 60% 51.8% 50% 40% 30% 22.2% 20% 10% 2.2%
Slide 14: Risk reduction of 2- and 3-step worsening in DRSS
Treatment with tarcocimab resulted in a meaningful risk reduction of 2- and 3-step worsening in DRSS 30% Proportion of patients with ≥2- and ≥3- Step Worsening in DRSS from Baseline to Week 48 25% Sham 20% Tarcocimab 15% 10% 5% 3.9% 2.3% 0.7% 0.0% 0% ≥2-Step Worsening ≥3-Step Worsening DRSS: diabeti
Slide 15: Majority of patients showed at least 1-step improvement in DRSS
The majority of patients treated with tarcocimab demonstrated at least 1-step improvement in DRSS Distribution of DRSS-step changes at Week 48 80% 78.0% Sham 70% Tarcocimab 70% of tarcocimab-treated patients improved at least 1-step, 60% compared to 10% of sham 50% 40% 35.6% 29.1% 30% 27.3% 20% 9.1%
Slide 16: Visual acuity and retinal anatomy improved and stable on extended dosing
Visual acuity and retinal anatomy were improved and stable with tarcocimab on extended-dosing intervals 6 Mean Change in BCVA from Baseline Data censored after diagnosis of sight-threatening complications Tarcocimab ETDRS Letters 4 Sham 2 0 0 4 8 12 16 20 24 28 32 36 40 44 48 50 Mean Change in CST f
Slide 17: Key Secondary Endpoint Met – reduced risk of sight-threatening complications by ~90%
Key Secondary Endpoint Met – tarcocimab reduced the risk of developing pre-specified sight-threatening complications by ~90% 30% Proportion of patients developing sight-threatening complications from Baseline to Week 48 25% 21.0% Sham 20% Tarcocimab 15% 13.7% 89% risk reduction 10% 95% risk reductio
Slide 18: Open-label tarcocimab treatment for patients developing sight-threatening complications
Participants developing sight-threatening complications in both groups were treated with open-label tarcocimab, starting with two monthly loading doses and then Q12W dosing Sham Development of sight- Open-label rescue threatening complications treatment with Tarcocimab (PDR, ASNV, DME) tarcocimab Tr
Slide 19: Patients developing DME: VA and CST rapidly controlled with Q12W dosing
In patients developing DME, the initial VA decrease and CST increase were both rapidly controlled and then stabilized with Q12W dosing 90 BCVA over time ETDRS Letters 6.6 letter decrease 85 from prior visit 80 75 Tarcocimab n=26 70 Baseline Visit Prior to Dx Visit Dx Dx Dx Dx Visit + 4 Weeks + 16 We
Slide 20: Safety: safe and well-tolerated, low rates of common ocular adverse events
Safety: tarcocimab was safe and well-tolerated, with low rates of common ocular adverse events Tarcocimab Sham Common Ocular Adverse Events (AEs) up to Week 48 n = 128 n = 125 Subjects with any AE in the Study Eye, n (%) 42 (32.8) 43 (34.4) Total number of AEs, n (%)a Cataract 13 (10.2) 5 (4.0) Conj
Slide 21: Rates of intraocular inflammation were low in both treatment groups
Rates of intraocular inflammation were low in both treatment groups Tarcocimab Sham Intraocular Inflammation in Study Eye up to Week 48 n = 128 n = 125 Subjects with at Least 1 Intraocular Inflammation AE*, n (%) 2 (1.6) 0 Tarcocimab Sham Endophthalmitis in Study Eye up to Week 48 n = 128 n = 125 Su
Slide 22: Clinically meaningful reduction in treatment burden for diabetic retinopathy
Tarcocimab can provide a clinically meaningful reduction in treatment burden for the management of diabetic retinopathy Currently approved anti-VEGF therapies for Diabetic Retinopathy Weeks 0 4 8 12 16 20 24 28 32 36 40 44 48 Doses in Year 1 Ranibizumab 0.3 mg Every month 13 Aflibercept 2 mg Every 8
Slide 23: GLOW Study Conclusions
Glow Study Conclusions • Primary Endpoint met: superiority in ≥2-step improvement (29x over sham) Tarcocimab met • Key Secondary Endpoint met: superiority in ≥3-step improvement superiority in NPDR • Key Secondary Endpoint met: superiority in reduction of development of sight- Conclusions threatenin
Slide 24: Thank you to all GLOW investigators, site staff and patients
Thank you to all GLOW investigators, site staff and patients Czech Republic: Axon Clinical, Oftex; Latvia: Pauls Stradins Clinical University Hospital, Latvian American Eye Center; Poland: Dr. Nowosielska Okulistyka i Chirurgia Oka, Optimum Profesorskie Centrum Okulistyki, Oftalmika Sp; Slovakia: Fa
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