tabirafusp tedromer (KSI-501) / Kodiak Sciences - LARVOL DELTA

A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants With DME - ALTO (clinicaltrials.gov) - P3 | N=910 | Recruiting | Sponsor: Kodiak Sciences Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetic Macular Edema • Ophthalmology

Kodiak continues execution of the Phase 3 DAYBREAK study evaluating both Zenkuda and KSI-501 in patients with treatment-naïve wet age-related macular degermation (wet AMD) (PRNewswire) - "Topline data for the one-year primary endpoint (Zenkuda and KSI-501) are expected in September 2026."

P3 data: top line • Wet Age-related Macular Degeneration

Kodiak Sciences Announces First Patients Enrolled in Global Phase 3 ALTO trial of KSI-501 in Patients with Diabetic Macular Edema (PRNewswire) - "The ALTO Study (KSMP002-S1) is a global, multicenter, randomized, double-masked, active comparator-controlled Phase 3 study evaluating the efficacy and safety of intravitreal KSI-501 5 mg compared with intravitreal aflibercept 2 mg in patients with visual impairment secondary to center-involved DME. Approximately 910 patients, treatment-naïve or previously treated, will be randomized 5:3:5 to one of three arms..."

Trial status • Diabetic Macular Edema

A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants With DME - ALTO (clinicaltrials.gov) - P3 | N=910 | Not yet recruiting | Sponsor: Kodiak Sciences Inc

New P3 trial • Diabetic Macular Edema • Ophthalmology

Phase 3 DAYBREAK Study - Topline Data Expected September 2026 (PRNewswire) - "Enrollment in the DAYBREAK Phase 3 study of both Zenkuda and KSI-501 in patients with treatment-naive neovascular age-related macular degeneration (wet AMD) was completed with approximately 690 subjects enrolled. Topline data from the one-year primary endpoint for DAYBREAK are expected in September 2026, evaluating both Zenkuda and KSI-501."

Enrollment closed • P3 data: top line • Wet Age-related Macular Degeneration

Based on the strong safety, efficacy and durability data demonstrated in the GLOW2 study, Zenkuda now has a multi-indication Biologics License Application (BLA)-ready profile, and Kodiak intends to accelerate the BLA submission timeline. (PRNewswire) - "'Leaning into FDA's new single-pivotal-trial default option for approval, we are also anticipating a potential BLA submission for KSI-501 in wet AMD after the DAYBREAK study primary endpoint readout (expected 3Q2026, if successful) and for KSI-101 in Macular Edema Secondary to Inflammation (MESI) after the PEAK study pivotal analysis 1 readout (expected 4Q2026, if successful).'...'four different Phase 3 studies with three readouts expected in 2026...'"

Clinical data • FDA filing • Diabetic Retinopathy • Macular Edema • Ocular Inflammation • Wet Age-related Macular Degeneration

Tarcocimab – Phase 3 topline data expected in 1Q 2026 (6 months) and 3Q 2026 (12 months) (PRNewswire) - "Phase 3 GLOW2 diabetic retinopathy study...Phase 3 DAYBREAK wet AMD study....Completed the manufacturing and release of BLA-facing commercial-scale batches in Kodiak's URSUS facility."

P3 data: top line • Diabetic Retinopathy • Wet Age-related Macular Degeneration

Emerging solutions for neovascular age-related macular degeneration. (PubMed, Curr Opin Ophthalmol) - "Therapeutic innovation in nAMD is transitioning from incremental refinements in intravitreal anti-VEGF delivery to strategies aimed at extending durability or targeting alternative contributory pathways. Long-term safety, efficacy, and durability will determine which of these candidates redefine standard care."

Journal • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • FGF2

A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK (clinicaltrials.gov) - P3 | N=675 | Active, not recruiting | Sponsor: Kodiak Sciences Inc | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2027 ➔ Aug 2027 | Trial primary completion date: Apr 2026 ➔ Aug 2026

Enrollment closed • Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Beyond the injection: delivery systems reshaping retinal disease management. (PubMed, Expert Opin Pharmacother) - "Specific innovations discussed include the ranibizumab port delivery system, EYP-1901 (Duravyu, vorolanib implant), KSI-301 (tarcocimab tedromer), KSI-501, OTX-TKI (Axpaxli, axitinib implant), 4D-150, revakinagene taroretcel-lwey (Encelto, NT-501, encapsulated cell therapy), Xipere (triamcinolone acetonide injectable suspension), AU-011 (belzupacap sarotalocan targeted delivery), ABBV-RGX-314, elamipretide, and OCS-01 (high concentration dexamethasone)...Challenges include overcoming the blood-retinal barrier, surgical complications with implantable devices, and ensuring patient adherence. Advances in smart delivery systems, drug formulations, and predictive models, alongside interdisciplinary collaboration, will be crucial in achieving personalized, effective, and sustainable retinal therapies."

Journal • Review • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders

A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants with Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK (clinicaltrials.gov) - P3 | N=675 | Recruiting | Sponsor: Kodiak Sciences Inc | Trial completion date: Jan 2026 ➔ Apr 2027 | Trial primary completion date: Jan 2026 ➔ Apr 2026

Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Kodiak Sciences Announces Recent Business Highlights and Third Quarter 2024 Financial Results (PRNewswire) - "'It is our objective to complete enrollment for the Phase 3 GLOW2 and DAYBREAK studies of tarcocimab and KSI-501 in the first half of 2025, so we and all Kodiak stakeholders can have a clear line of sight to our 48-week topline data readouts....The decrease in R&D expenses for the third quarter of 2024, as compared to the same period in 2023, was primarily driven by reduced manufacturing activities, decreased clinical activities for completed trials, partially offset by costs from active clinical trials for the tarcocimab development program as well as expanding clinical activities for KSI-501 and KSI-101."

Commercial • Enrollment status • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Edema • Ophthalmology • Wet Age-related Macular Degeneration

Kodiak Sciences Announces Recent Business Highlights and Second Quarter 2024 Financial Results (PRNewswire) - "Following submission of the study protocol to the FDA in the first quarter of 2024, we began to operationalize the study including site selection in the second quarter of this year. The DAYBREAK Phase 3 study is now actively enrolling patients....Research and development (R&D) expenses were $32.5 million for the second quarter of 2024, as compared to $67.0 million for the second quarter of 2023. The R&D expenses for the second quarter of 2024 included non-cash stock-based compensation of $8.9 million, as compared to $14.7 million for the second quarter of 2023. The decrease in R&D expenses for the second quarter of 2024, as compared to the same period in 2023, was primarily driven by reduced manufacturing and clinical activities for tarcocimab."

Commercial • Enrollment status • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Ophthalmology • Wet Age-related Macular Degeneration

A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK (clinicaltrials.gov) - P3 | N=675 | Recruiting | Sponsor: Kodiak Sciences Inc

New P3 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

KSI-501: a bispecific fusion protein antibody inhibiting both interleukin-6 and vascular endothelial growth factor. First-in human-trial results of multiple ascending doses in patients with diabetic macular edema (ARVO 2024) - "IL-6 is a pro-inflammatory cytokine that has been implicated in the pathophysiology of multiple exudative retinal diseases including DME and has also been implicated in other retinal diseases with an inflammatory component, such as age-related macular edema, retinal venous occlusive disease and uveitic macular edema.KSI-501 is a novel, first-in-class biologic that inhibits both VEGF and IL-6. KSI-501 is an antibody biopolymer conjugate (ABC), designed for optimal durability in addition to its dual mechanism of action.Results on the safety, tolerability and biological activity of KSI-501 in this first-in-human study will be presented for at the ARVO 2024 meeting."

Clinical • P1 data • Diabetic Macular Edema • Ophthalmology • Retinal Disorders • IL6

Ocular and Systemic Toxicity Study of KSI-501 Demonstrates Tolerability after Intravitreal and Intravenous Administration in Cynomolgus Monkeys (ARVO 2024) - "Repeated bilateral IVT administration up to 5.25 mg/eye/dose (maximum feasible dose) or IV dosing up to 5 mg/kg/dose of KSI-501 in cynomolgus monkeys was safe and well tolerated. These results provide a clear margin of safety for repeat dosing to support further clinical investigations."

Ocular Inflammation • Ophthalmology • IL6

Kodiak Sciences Announces Recent Business Highlights and Fourth Quarter and Full Year 2023 Financial Results (PRNewswire) - "New Phase 3 GLOW2 study of tarcocimab in diabetic retinopathy actively recruiting...We are discussing the study design of DAYBREAK with the FDA and plan to initiate the study as soon as regulatory alignment is completed, which we hope is mid-2024....Tarcocimab commercial scale manufacturing: Our custom-built commercial scale manufacturing facility, Ursus, was commissioned as a cGMP facility in January 2023....In October 2023, we made a final payment of $26.8 million to Lonza for final activation of Ursus. Separately, tarcocimab drug product based on our go-to-market formulation was released in March 2024 and is ready for use in GLOW2 and DAYBREAK Phase 3 studies."

Commercial • New P3 trial • Trial status • Age-related Macular Degeneration • Diabetic Retinopathy • Ophthalmology • Wet Age-related Macular Degeneration

Kodiak Sciences Announces Third Quarter 2023 Financial Results and Recent Business Highlights (PRNewswire) - "KSI-501 clinical program: Our Phase 1 study of KSI-501 ABC has completed its enrollment and dosing phases, and patient data are continuing to be collected. Clinical data are expected to be presented in the first quarter of 2024 at an upcoming scientific meeting....Research and development (R&D) expenses were $36.2 million for the third quarter of 2023, as compared to $61.7 million for the third quarter of 2022....The decrease in R&D expenses for the third quarter of 2023 was primarily driven by reduction in expense during the pause of tarcocimab development and equity award forfeitures related to the 2021 Long-Term Performance Incentive Plan."

Commercial • P1 data • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Ophthalmology • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Kodiak Sciences Announces Upcoming Presentations on its Product and Research Pipeline at ARVO 2023 Annual Meeting (PRNewswire) - "Kodiak Sciences Inc...announced today that multiple scientific presentations on its clinical and research pipeline programs will be made at the Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting, being held from April 23 – 27 in New Orleans, United States....'Our efforts encompass Phase 3 clinical studies with our lead tarcocimab tedromer, a Phase 1 clinical study with our new bispecific KSI-501, and earlier discovery efforts. We believe the data being presented will demonstrate the robust retina-focused research and development engine at Kodiak. We remain committed to our mission of bringing new science to the prevention and treatment of high prevalence retinal diseases.'"

Clinical data • Preclinical • Age-related Macular Degeneration • Diabetic Macular Edema • Ophthalmology

Biological Benefits of KSI-501: Novel Bispecific Anti-Inflammatory and Anti-Angiogenic Therapy for the Treatment of both Retinal Vascular and Inflammatory Diseases (ARVO 2023) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Ophthalmology • Retinal Disorders • IL6

KSI-501 is a novel anti-VEGF and anti-IL-6 bispecific biopolymer conjugate to simultaneously address neovascularization and inflammation in retinal diseases (ARVO 2023) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Age-related Macular Degeneration • Diabetic Retinopathy • Macular Degeneration • Ocular Inflammation • Ophthalmology • Retinal Disorders • VEGFB

Kodiak Sciences Announces Third Quarter 2022 Financial Results and Recent Business Highlights (PRNewswire) - "Update on Tarcocimab tedromer Clinical Program: We continued to advance our ongoing, fully-enrolled Phase 3 pivotal studies, with four Phase 3 studies on track to read out topline data in 2023: GLEAM / GLIMMER: Our paired Phase 3 long-interval (as infrequently as every 6 months) studies GLEAM and GLIMMER in diabetic macular edema ('DME') are expected to report topline data in mid-2023...DAYLIGHT: Our Phase 3 short-interval study DAYLIGHT in wet age-related macular degeneration (wet 'AMD') is expected to report topline results in mid-2023....GLOW: Our Phase 3 long-interval (every 6 months) treatment and vision loss prevention study GLOW of tarcocimab versus sham in non-proliferative diabetic retinopathy without DME ('NPDR') is expected to report topline results in the second half of 2023....We believe we are on track to file the IND for KSI-501 in the fourth quarter of 2022 and to begin the Phase 1 clinical study in early 2023."

IND • New P1 trial • P3 data: top line • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Ophthalmology • Wet Age-related Macular Degeneration

Kodiak Sciences Announces First Quarter 2021 Financial Results and Recent Business Highlights (PRNewswire) - "We plan to initiate recruitment of DAYLIGHT in the summer of 2021 and to include data from this study in our initial BLA...we are focused on further promoting patient enrollment in a competitive recruiting environment towards our goal of completing patient recruitment in 4Q2021 for all three studies. We also intend to begin recruitment of our GLOW study of KSI-301 in patients with non-proliferative Diabetic Retinopathy in the summer of 2021...the DAZZLE study, our Phase 2b/3 study of KSI-301 in patients with wet AMD, remains on track with the last patient's last visit for the primary efficacy endpoint anticipated in late 4Q2021...Research and development (R&D) expenses were $40.3 million for the first quarter of 2021, as compared to $20.2 million for the first quarter of 2020. The increase in R&D expenses was primarily driven by higher clinical trial costs for KSI-301, as well as higher payroll and stock-based compensation expense."

Commercial • Enrollment status • New P3 trial • P2/3 data • Age-related Macular Degeneration • Diabetic Retinopathy • Ophthalmology • Wet Age-related Macular Degeneration

Kodiak Sciences Announces Fourth Quarter and Full Year 2020 Financial Results and Recent Business Highlights (PRNewswire) - "Expected Upcoming Events/Milestones: Initiate pivotal Phase 3 randomized study of KSI-301 in non-proliferative diabetic retinopathy patients (the GLOW study). Complete patient enrollment in DME (GLEAM and GLIMMER) and RVO (BEACON) studies. DAZZLE wet AMD last patient last visit for primary endpoint. Submit IND for KSI-501, a novel bispecific antibody biopolymer conjugate."

Enrollment status • IND • Diabetic Macular Edema • Ophthalmology • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Development of Novel Bispecific Anti-Inflammatory and Anti-Angiogenic Therapy for the Treatment of both Retinal Vascular and Inflammatory Diseases (ARVO 2019) - "Conclusions We have engineered a novel and highly potent bispecific molecule targeting VEGF and IL-6 using a trap antibody fusion approach; it demonstrated high binding affinity, bioactivity and synergistic inhibition in vitro. KSI-501 is being developed as a promising and differentiated new therapeutic candidate to address retinal vascular and inflammatory diseases."