Kodiak Sciences Inc · NASDAQ:KOD
Kodiak Sciences — Clinical Trials at the Summit 2024
17 slides from Kodiak Sciences's conference presentation, Jun 8, 2024
Slide 1: Bispecific Anti-VEGF / Anti-IL-6 Programs: KSI-501 and KSI-101
Clinical Trials at the Summit 2024 Salt Lake City – June 8, 2024 Bispecific Anti-VEGF / Anti-IL-6 Programs: KSI-501 in Retinal Vascular Diseases and KSI-101 in Macular Edema Secondary to Inflammation Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS Byers Eye Institute Stanford University School of Medi
Slide 2: Disclosures
Disclosures • Stanford University, the employer of Dr. Nguyen, has received research funding from Boehringer-Ingelheim, Genentech, Priovant, and Regeneron, among others • Dr. Nguyen serves on the scientific advisory boards for Acelyrin, Alumis, Boehringer-Ingelheim, Genentech, Regeneron, and Rezolut
Slide 3: Substantial patient-to-patient variability with anti-VEGF monotherapy
Substantial patient-to-patient variability is observed for patients treated with anti-VEGF monotherapy BCVA change from baseline during year 1 for OCT CST change from baseline during year 1 for individual patients treated with Q8W aflibercept individual patients treated with Q8W aflibercept OCT CST
Slide 4: Increased IL-6 levels are associated with poor functional outcomes in wAMD and DME
Increased levels of IL-6 are associated with poor functional outcomes in wAMD and DME patients treated with anti-VEGF monotherapy Eye, 2024
Slide 5: Increased IL-6 levels associated with poor outcomes with anti-VEGF monotherapy
Increased levels of IL-6 are associated with poor functional outcomes in wAMD and DME patients treated with anti-VEGF monotherapy BCVA change from month 2 over time in wAMD BCVA change from baseline over time in DME patients with high and low aqueous IL-6 levels patients stratified by baseline aqueo
Slide 6: Macular edema is the leading cause of vision loss among patients with uveitis
Macular edema is the leading cause of vision loss among patients with uveitis and IL-6 mediated pro-inflammatory signaling is a key disease driver Macular edema is the leading cause of vision Uveitis is the 4th leading cause of loss among uveitis patients vision loss in the developed world 1/3 of uv
Slide 7: Dual inhibition of VEGF and IL-6 confers superior normalization of complex biologies
Dual inhibition of VEGF and IL-6 confers superior normalization of complex biologies 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
Slide 8: KSI-101 and KSI-501 are based on a first-in-class bispecific protein
KSI-101 and KSI-501 are based on a first-in-class bispecific protein features a unique design that enables highly efficient binding to both IL-6 and VEGF “TWO HANDS ON THE BALL” VEGF Trap BEST-IN-CLASS VEGF INHIBITION BINDING CAPACITY OF The VEGF Trap mimics the native UP TO 3 MOLECULES receptor and
Slide 9: Electron microscopy images of KSI-501ABC show activation of the anti-VEGF trap
Negative-stain electron microscopy images of KSI-501ABC illustrate real time activation of the anti-VEGF trap in the presence of VEGF KSI-501 KSI-501 + VEGF VEGF anti-IL6 VEGF Trap Fab anti-IL6 Fab Fc Fc Biopolymer Biopolymer In the absence of VEGF, VEGF Upon VEGF binding, VEGF trap trap arms are no
Slide 10: KSI-501 and KSI-101 comparable binding affinity and potency to aflibercept and vamikibart
KSI-501 and KSI-101 demonstrate comparable VEGF binding affinity and potency to aflibercept and comparable IL-6 potency as vamikibart Key disease drivers in Aflibercept Vamikibart (anti-IL-6 mAb) KSI-501/KSI-101^ retinal diseases Inflammation Angiogenesis Barrier function Vascular leakage Preclinica
Slide 11: KSI-501 and KSI-101 developed in parallel addressing two different unmet needs
Both KSI bispecific programs, KSI-501 and KSI-101, will be developed in parallel, addressing two different unmet needs KSI-501 KSI-101 Bispecific Anti-IL-6 VEGF Trap Bispecific Anti-IL-6 VEGF Trap Protein Antibody Biopolymer Conjugate (ABC) ABC biologic for Unconjugated biologic for retinal vascular
Slide 12: KSI-501 and KSI-101 target indications
Both KSI bispecific programs, KSI-501 and KSI-101, will be developed in parallel, addressing two different unmet needs KSI-501 KSI-101 Bispecific Anti-IL-6 VEGF Trap Bispecific Anti-IL-6 VEGF Trap Protein Antibody Biopolymer Conjugate (ABC) ABC biologic for Unconjugated biologic for retinal vascular
Slide 13: KSI-501 Phase 1 Study Results
KSI-501 Phase 1 Study Results 13
Slide 14: Dosing with KSI-501 in DME patients resulted in robust visual and anatomical gains
Dosing with KSI-501 in DME patients resulted in robust visual and anatomical gains that were sustained over 16 weeks after the last dose Treatment Naïve Patients Previously Treated Patients Mean Change in BCVA (n=7) Mean Change in BCVA (n=9) 15 10 10 5 5 0 0 0 4 8 12 16 20 24 0 4 8 12 16 20 24 Mean
Slide 15: KSI-501 resulted in a meaningful increase of BCVA for the majority of patients
Treatment with KSI-501 resulted in a meaningful increase of BCVA for the majority of patients during the study 100% Proportion of patients with 2- and 3-line BCVA improvement at any time during the study, in at least 2 separate visits 75% 71.4% 66.7% Treatment naïve (n=7) Previously treated (n=9) 50
Slide 16: KSI-501 was safe and well tolerated
KSI-501 was safe and well tolerated KSI-501 Adverse Events (AEs) in the Study Eye N=16 Summary, n (%) Subjects with ≥1 AEs 7 (43.8) Treatment-related AEs 1 (6.3) Serious AEs 0 Treatment-related serious AEs 0 Severe AEs 0 AEs leading to study discontinuation 0 AEs in the Study Eye, n (%) Intraocular
Slide 17: Summary
Summary The pathophysiology of retinal vascular / hyperpermeability disorders and inflammatory conditions is multifactorial and multiple cytokines beyond VEGF are thought to be involved Retinal diseases multifactorial • IL-6 and VEGF are key mediators of inflammation, hyperpermeability/angiogenesis