Kodiak Sciences Inc. announced that nine scientific presentations on its clinical and research pipeline programs will be made at the Association for Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting, being held from May 5 ? 9 in Seattle, Washington. Presentations on tarcocimab tedromer (KSI-301): Title: Tarcocimab tedromer (KSI-301) 5mg: outcomes of the Phase 3 GLOW1 Study in patients with non-proliferative diabetic retinopathy.

Session Title: Diabetic retinopathy I. Session Date and Time: May 6, 2024; 8:30 ? 10:15 AM PT. Presentation Type: Poster Session.

Poster Number: 221 ? B0116. Title: Metabolic control in patients with non-proliferative diabetic retinopathy (NPDR) treated with anti-VEGF active injections or sham injections.

Prespecified results from the Phase 3 GLOW Study in patients treated with tarcocimab tedromer. Session Title: Diabetic retinopathy II. Session Date and Time: May 7, 2024; 8:30 ?

10:15 AM PT. Presentation Type: Poster Session. Poster Number: 323 ?

B0508. The prespecified analysis of the GLOW1 study demonstrated that both the tarcocimab treatment arm and sham arm had negligible change in systemic metabolic control as measured by HbA1c levels, and both arms showed similar distribution of change in HbA1c from baseline to primary endpoint at Week 48. These results suggest that subjects in the tarcocimab arm achieved superiority in =2-step improvement in DRSS over sham injections irrespective of baseline and systemic metabolic control, as evidenced by HbA1c levels, and any potential presumed knowledge by the patient about treatment assignment due to the use of sham as a comparator did not systematically influence their glycemic control.

Title: An embryo-fetal development study of tarcocimab after intravenous injection in rabbits. Session Title: Retina/RPE: New drugs, mechanisms of action, and toxicity. Session Date and Time: May 8, 2024; 2:15 ?

4:00 PM PT. Presentation Type: Poster Session. Poster Number: 5100 ?

A0357. Presentations on KSI-501: Title: Ocular and systemic toxicity study of KSI-501 demonstrates tolerability after intravitreal and intravenous administration in cynomolgus monkeys. Session Title: Retina/RPE: New drugs, mechanisms of action, and toxicity.

Session Date and Time: May 8, 2024; 2:15 ? 4:00 PM PT. Presentation Type: Poster Session.

Poster Number: 5094 ? A0351. The non-clinical study demonstrated that repeated monthly bilateral intravitreal administration of up to 5.25 mg/eye/dose (maximum feasible dose) or intravenous dosing of up to 5 mg/kg/dose (maximum tested dose) of KSI-501 in cynomolgus monkeys was safe and well tolerated.

Due to the mild severity of findings and the lack of impact on the health and well-being of animals administered 5 mg/kg IV or 5.25 mg/eye IVT, these doses were considered the No Observed Adverse Effect Levels (NOAELs) for systemic and ocular administration, respectively. These results provide a clear margin of safety for repeat dosing and information for adequate safety monitoring to support further clinical investigations with KSI-501 (bioconjugate) and KSI-101 (bispecific protein) which are ongoing. These results are also consistent with non-clinical data generated with tarcocimab, another ABC Platform derived therapeutic candidate, and suggest the continued safety profile of the ABC Platform. Title: 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. Session Title: Diabetic macular edema. Session Date and Time: May 9, 2024; 11:45 AM ?

1:30 PM PT. Presentation Type: Poster Session. Poster Number: 530 ?

B0162. This first-in-human study was Part 1 of a Phase 1 multiple ascending dose study of KSI-501 in both treatment naïve and treatment experienced patients with DME. Part 1 demonstrated that repeated monthly dosing of KSI-501 was safe and well tolerated and achieved meaningful and sustained improvement in BCVA and OCT CST.

These results support further clinical development of both (1) KSI-501, a bispecific antibody biopolymer conjugate, for high prevalence retinal diseases to address the leading unmet needs of durability and targeting multiple disease biologies; and (2) KSI-101, a bispecific protein with high potency and high formulation strength for inflammatory diseases of the eye. Presentations on Research Pipeline: Title: Identification and characterization of novel NLRP3 inflammasome Inhibitors for the potential treatment of retinal disease. Session Title: Treatment strategies for inherited retinal disease.

Presentation Date and Time: May 6, 2024; 3:00 ? 4:45 PM PT. Presentation Type: Poster Session.

Poster Number: 2208 ? A0062. Title: Development of anti-inflammatory bispecific trap-antibodies.

Session Title: Diabetic retinopathy, anti-inflammatory agents, antibiotics and antivirals. Session Date and Time: May 8, 2024; 10:30 AM - 12:15 PM PT. Presentation Type: Poster Session.

Poster Number: 4599 ? A0328. The company present a portfolio of novel bispecific anti-inflammatory biologics targeting proinflammatory cytokines.

This work highlights the expansion of its modular trap-antibody platform and presents a group of promising therapeutic candidates with the potential to mitigate the complex effects of ocular inflammation in a controlled, multi-specific manner. Title: Internalization of antibody biopolymer conjugate via receptor-mediated mechanism. Session Title: AMD New drugs, delivery systems and mechanisms of action II.

Session Date/Times: May 9, 2024; 8:00 - 9:45 AM PT. Presentation Type: Poster Session. Poster Number: 6120 ?

B1019. Title: Development of enhanced complement regulators for the treatment of geographic atrophy. Session Title: AMD New drugs, delivery systems and mechanisms of action II.

Session Date/Times: May 9, 2024; 8:00 ? 9:45 AM PT. Presentation Type: Poster Session.

Posterboard Number: 6119 ? B1018. Geographic atrophy (GA), the advanced form of dry age-related macular degeneration, affects approximately one million patients in the U.S. and is characterized by atrophic lesions in the retina that progressively expand to the central macular and fovea, leading to irreversible vision loss.

Currently there are two approved therapies for GA, both are anti-complement therapies that offer modest therapeutic benefit and require monthly or every other month intravitreal injections. Here the company present a promising therapeutic strategy to treat GA and potentially wet AMD by combining complement regulators with an anti-VEGF Fab to achieve potent, concurrent inhibition of complement pathway activation and VEGF pathway signaling.