Kodiak Sciences to Present Pipeline Advances and KSI-101 Clinical Data, Including Results from a MESI Cohort in a Tertiary Care Uveitis Practice, at Upcoming Scientific Conferences
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Clinical results of KSI-101 in macular edema secondary to inflammation (MESI) from a tertiary care uveitis practice demonstrate outcomes consistent with results from the
U.S. Phase 1b APEX study, supporting continued global development and expansion of the Phase 3 PEAK and PINNACLE program intoAsia . - Ongoing advancement of bispecific therapies in geographic atrophy and ocular inflammatory disease; preclinical data continue to support a multi-target approach to address limitations of current single-target therapies.
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The ABCD Platform
TM
, an evolution of Kodiak's
ABC platform to include conjugation of small molecules and other drugs, continues to advance as a versatile system for targeted, multi-modal drug development in retina and glaucoma optic neuropathy.
"Results from a tertiary care uveitis practice were highly consistent with those observed in the
"Our presentations at the
Presentations at
- Format: Oral presentation
- Presentation Title: Bispecific Trap-antibody Inhibiting Interleukin-6 and Vascular Endothelial Growth Factor (KSI-101): Week 24 Results from the Phase 1b APEX Study in Patients with Macular Edema Secondary to Inflammation (MESI)
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Speaker: Dr.
Edmund Tsui , M.D., Associate Professor-in-Residence of Ophthalmology,Stein Eye Institute ,David Geffen School of Medicine ,University of California, Los Angeles (UCLA),USA -
Time:
7:45pm MT
Presentations at
These presentations will be made available under Kodiak's "Scientific Presentations" page on kodiak.com.
Phase 1b APEX Data of KSI-101 in
KSI-101 is a first-in-class, locally administered, high-strength bispecific protein in clinical development for the treatment of
KSI-101 was further evaluated in an Asian clinical cohort. Results from this cohort were consistent with those observed in the
1.Title: Bispecific Trap-Antibody Inhibiting Interleukin-6 and Vascular Endothelial Growth Factor (KSI-101): Clinical PK/PD Cohort in Asian Patients with Macular Edema Secondary to Inflammation (MESI)
Poster Session: Clinical features and treatment outcomes in uveitis
Date and Time:
Poster Number: 1568-0229
Speaker: Dr.
We will present first-time results from a clinical cohort of Asian patients with
2.Title: Bispecific Trap-Antibody Inhibiting Interleukin-6 and Vascular Endothelial Growth Factor (KSI-101): Phase 1b APEX Study in Patients with Macular Edema Secondary to Inflammation (MESI)
Poster Session: Translational uveitis research and quality-of-life in uveitis
Date and Time:
Poster Number: 4282-0552
Speaker: Dr.
In the Phase 1b APEX study over 24 weeks in patients with
Ocular Inflammatory Disease
Ocular inflammatory disease is the fourth leading cause of vision loss among working-age adults in the developed world. Approximately one-third of patients with ocular inflammation develop macular edema, the leading cause of vision loss in this population. Steroids remain the mainstay treatment but can cause significant and permanent ocular adverse effects, especially with long-term use or high doses. There are no approved, locally administered biologics. Beyond KSI-101, currently in Phase 3 clinical development, Kodiak is advancing KSI-102 and KSI-103, two novel biologic therapies designed to address the complex cytokine interactions driving chronic inflammatory ocular diseases.
3. Title: Novel Intravitreal Bispecific Anti-Inflammatory Biologics Designed for Retinal Inflammatory Diseases Preserve Endothelial Barrier and Prevent Leukocyte Adhesion in Cell-Based Assays
Poster Session: AMD pathology I
Date and Time:
Poster Number: 76-0106
Elevated levels of pro-inflammatory cytokines such as tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6) play distinct yet complementary roles in driving inflammation and vascular permeability in retinal inflammatory diseases. Therapies targeting these cytokines individually may not fully address both disease drivers. We present cell-based data demonstrating the biological activity of KSI-102, a novel bispecific antibody that potently inhibits both TNF-α and IL-6 simultaneously. These findings support further development of intravitreal bispecific therapies, including KSI-102 and the broader anti-inflammatory bispecific franchise such as KSI-103 (an IL-1 trap and anti-IL-6 antibody fusion), with the potential to enhance therapeutic outcomes in inflammatory ocular diseases.
Geographic Atrophy
Geographic atrophy (GA), the advanced form of dry age-related macular degeneration, affects approximately one million patients in the
4.Title: IL-6/Complement and VEGF/Complement Dual Inhibitors for Geographic Atrophy
Poster Session: AMD: New drugs, delivery systems, and mechanisms of action II (section: Physiology/Pharmacology)
Date and Time:
Poster Number: 447-0184
We engineered bispecific molecules by fusing complement inhibitors targeting C3b/C4b with anti-VEGF or anti-IL-6, creating multimodal candidates that demonstrate potent, broad complement inhibition while simultaneously blocking VEGF or IL-6 signaling. These results support a multi-target approach to addressing the underlying drivers of GA pathology and highlight the potential to improve outcomes beyond single-target therapies.
Enhancing Therapeutic Efficacy with the ABCD Platform
Antibody Drug Conjugates (ADCs) and Antibody Oligonucleotide Conjugates (AOCs) are promising platforms for targeted drug delivery but have a limited drug antibody ratio (DAR), which poses significant challenges in optimizing therapeutic efficacy. Kodiak's Antibody Biopolymer Conjugate Drug (ABCD) platform addresses this limitation by utilizing a customizable biopolymer to enable the design and development of multifunctional, high DAR therapeutics with the potential of a quarterly dosed intravitreal therapy for ophthalmic and systemic applications.
5.Title: Mechanistic Support for Ocular Intracellular Drug Delivery: Receptor-Mediated Uptake and Trafficking of Antibody-Biopolymer Conjugates (ABC) in Primary Endothelial Cells
Poster Session: AMD: New drugs, delivery systems, and mechanisms of action II (Section Physiology/Pharmacology)
Date and Time:
Poster Number: 451-0188
We evaluated the intracellular behavior of antibody biopolymer conjugates (ABC) in primary endothelial cells using an anti-VEGFR2 model system. ABCs internalized efficiently as intact conjugates and trafficked through endosomal pathways with sustained intracellular persistence. These findings expand the mechanistic evidence supporting the ABCD platform as a versatile system for high DAR, targeted intracellular delivery, highlighting its potential to enable delivery of a broad range of therapeutic payloads for retinal diseases.
6.Title: Biopolymer Platform for Controlled Loading, Release, and Extended Durability of Intraocular Therapeutics with Multiple Mechanisms of Action
Poster Session: AMD: New drugs, delivery systems, and mechanisms of action II (Section Physiology/Pharmacology)
Date and Time:
Poster Number: 444-0181
Here we present a glaucoma "duet" leveraging the ABCDTM platform and incorporating two small molecules –an inhibitor for the NLRP3 inflammasome for neuroprotection and an intraocular pressure (IOP)-lowering agent– at high DAR. Both drugs were loaded in equal proportion (DAR 125 each), confirming independent, sequential conjugation on the same polymer. Payload release characterization demonstrates successful drug unloading from ABCD molecules using pH-labile linkers. These data continue to support the dual-action approach to address the multifactorial nature of glaucoma optic neuropathy and highlight the versatility of the ABCD platform across ophthalmic indications.
About
Kodiak Sciences (Nasdaq: KOD) is a precommercial retina-focused biotechnology company committed to researching, developing and commercializing transformative therapeutics. We are focused on bringing new science to the design and manufacture of next-generation retinal medicines to prevent and treat the leading causes of blindness globally. We are developing a portfolio of three late-stage clinical programs. Zenkuda™ (tarcocimab tedromer) has a BLA-ready profile in diabetic retinopathy, retinal vein occlusion and wet AMD, and, together with KSI-501, is being explored in the BLA-facing Phase 3 DAYBREAK wet AMD study, with topline data expected in 3Q 2026. Zenkuda and KSI-501 target the $15 billion anti-VEGF market across retinal vascular diseases. KSI-101 is a bispecific protein being explored in two BLA-facing Phase 3 studies in Macular Edema Secondary to Inflammation (MESI), with topline data readouts expected to begin in 4Q 2026.
Forward-Looking Statements:
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include, but are not limited to, statements regarding: the sufficiency of clinical results from the Asian cohort to support continued global development and expansion of the Phase 3 PEAK and PINNACLE program into
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