Kodiak Sciences Inc · NASDAQ:KOD
Kodiak Sciences — Clinical Trials at the Summit 2023
16 slides from Kodiak Sciences's conference presentation, Jun 10, 2023
Slide 1: KSI-501: A Novel Bispecific Antibody Biopolymer Conjugate Targeting IL-6 and VEGF
KSI-501: A Novel Bispecific Antibody Biopolymer Conjugate Targeting IL-6 and VEGF Mark Barakat, M.D. Retinal Consultants of Arizona Clinical Trials at the Summit 2023 10 June 2023
Slide 2: Disclosures
Disclosures • Presenter’s Financial Disclosures: ‒ Kodiak (C, R) • This presentation will discuss IRB/IEC approved research of an investigational medicine. AbbVie IncC Bausch and LombC Kodiak SciencesCR Palatin TechnologiesC Adverum BiotechCR BiogenC NovartisBCR RegeneronB AlconC Clearside Biomedica
Slide 3: Key Points and Conclusions
Key Points Unmet need Anti-VEGF therapy has transformed the retinal exudative disease landscape, but response to treatment is heterogenous, and treatment burden remains a substantial challenge Conclusions The pathophysiology of retinal vascular and hyperpermeability disorders is multifactorial Multi
Slide 4: Substantial patient-to-patient variability is the norm for patients treated with anti-VEGF monotherapy
Substantial patient-to-patient variability is the norm for patients treated with anti-VEGF monotherapy BCVA change from baseline during year 1 for OCT CST change from baseline during year 1 individual patients treated with Q8W for individual patients treated with Q8W aflibercept aflibercept OCT CST
Slide 5: The pathophysiology of retinal vascular and hyperpermeability disorders involves multiple cytokines
The pathophysiology of retinal vascular and hyperpermeability disorders involves multiple cytokines • IL-6 is a pro-inflammatory cytokine and IL-6 Pathway immune growth factor implicated in the pathophysiology of multiple retinal diseases IL-6 Rα gp130 and is associated with poor anti-VEGF treatment
Slide 6: KSI-501 is a first-in-class bispecific that inhibits IL-6 and VEGF
KSI-501 is a first-in-class bispecific that inhibits two powerful pathophysiologic mechanisms in retinal disease – IL-6 and VEGF VEGF Pathway IL-6 Pathway VEGFR IL-6 Rα gp130 Endothelial Endothelial Endothelial Endothelial Vascular Survival Proliferation Migration Activation Hypertrophy Vascular End
Slide 7: ABC platform gives KSI-501 increased molecular size and extended ocular half-life
By leveraging the Antibody Biopolymer Conjugate (ABC) platform KSI-501 has an increased molecular size, and in turn an extended ocular half-life + = BISPECIFIC BIOPOLYMER CONJUGATE lgG1 anti-IL-6 Antibody Branched, Optically Clear, + VEGF Trap High Molecular Weight Fusion Protein Phosphorylcholine P
Slide 8: KSI-501 inhibits angiogenesis and normalizes the inner and outer blood retinal barriers
KSI-501 inhibits angiogenesis and normalizes the 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
Slide 9: Dual inhibition of VEGF and IL-6 confers superior normalization compared to monotherapy
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 10: Dual inhibition provides opportunity for KSI-501 across a range of retina disease indications
Dual inhibition of IL-6 and VEGF provides ample opportunity for clinical use of KSI-501 across a range of retina disease indications • Preclinical and clinical data support the role of IL-6 as a key inflammatory modulator in retinal vascular diseases and seems to be related to the potential response
Slide 11: KSI-501 evaluated in Phase 1 multiple ascending dose study in diabetic macular edema
KSI-501 is now being evaluated in a phase 1 multiple ascending dose study in patients with diabetic macular edema – plan to study additional disease indications later this year Primary Endpoint: Ocular and systemic safety at Week 24 KSI-501 dose Key Inclusion Criteria • Multiple ascending dose desig
Slide 12: KSI-501 Phase 1 Study
KSI-501 Phase 1 Study Early clinical cases from ongoing dose escalation
Slide 13: Study KS501P101 - Clinical Case – lowest dose tested (25 µL)
Study KS501P101 - Clinical Case – lowest dose tested (25 µL) Day 1 70 Letters 641 microns Week 1 +9 Letters -79 microns Week 4 +12 Letters -269 microns
Slide 14: Study KS501P101 - Clinical Case mid-level dose (50 µL)
Study KS501P101 - Clinical Case mid-level dose (50 µL) Day 1 35 Letters 609 microns Week 1 +5 Letters -277 microns
Slide 15: 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, Many Targets Antibody conjugated to Dual inhi
Slide 16: Key Points and Conclusions
Key Points Unmet need Anti-VEGF therapy has transformed the retinal vascular disease landscape, but response to treatment is heterogenous, and treatment burden remains a substantial challenge Conclusions The pathophysiology of retinal vascular and hyperpermeability disorders is multifactorial Multif