Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 904 |
| INN | Tarcocimab tedromer |
| Status | Clinical |
| Drug code(s) | KSI-301, OG1953 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Immunoconjugate |
| Format, general category | Full length Ab conjugate |
| Format details | ABC |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | Biopolymer |
| Discovery method/technology | None |
| Target(s) | VEGF |
| Indications of clinical studies | Diabetic Retinopathy, Diabetic Macular Edema, Wet Macular Degeneration |
| Primary therapeutic area | Ophthalmic disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 26, 2018 |
| Start of Phase 2 | September 30, 2019 |
| Start of Phase 3 | October 01, 2020 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Kodiak Sciences Inc |
| Licensee/Partner | None |
| Comments about company or candidate | NCT06556368 Phase 3 in wet AMD started in August 2024. NCT06270836 Phase 3 in Non-proliferative Diabetic Retinopathy due to start in March 2024 Nov 2023: Kodiak Sciences Inc. announced that its Phase 3 GLOW superiority study evaluating tarcocimab tedromer 5 mg in moderately severe to severe NPDR met its one-year primary endpoint. Based on discussions with FDA, The company believes they have a clear regulatory pathway requiring one additional positive study to support a single BLA submission for macular edema following retinal vein occlusion (RVO), wet age-related macular degeneration (wAMD) and non-proliferative diabetic retinopathy (NPDR). July 2023: GLEAM and GLIMMER studies did not meet their primary efficacy endpoints of showing non-inferior visual acuity gains for tarcocimab dosed every 8 to 24 weeks after 3 monthly loading doses compared to aflibercept given every 8 weeks after 5 monthly loading doses; the DAYLIGHT study met the primary endpoint of non-inferior visual acuity gains for tarcocimab dosed monthly compared to aflibercept dosed every 8 weeks following 3 monthly loading doses. Based on these data, and despite demonstrating great potential, Kodiak has made a business decision to discontinue further development of tarcocimab. First quarter 2023 financial results (May 15, 2023) "The BEACON study met its primary endpoint in 2022, and four Phase 3 clinical studies are expected to announce topline data in 3Q2023. If successful, Kodiak plans to file a single Biologics Licensing Applications ("BLA") for tarcocimab in the four major retinal vascular disease indications." https://ir.kodiak.com/news-releases/news-release-details/kodiak-sciences-announces-first-quarter-2023-financial-results. Phase 3 studies for Diabetic macular edema (NCT04603937, NCT04611152) are active non recruiting as of May 25, 2023; Macular edema due to retinal vein occlusion (NCT04592419) is completed as of February 9, 2023; Wet macular degeneration (NCT0964089) is completed as of May 30, 2023; Non-proliferative diabetic retinopathy (NCT05066230) is active non recruiting as of September 26, 2022. Mar 2023: Company is currently on track to release topline data from the four ongoing Phase 3 studies in the third quarter of 2023. Feb 2022: The Company's DAZZLE and DAYLIGHT pivotal studies in patients with treatment-naïve wet AMD, GLEAM and GLIMMER pivotal studies in patients with diabetic macular edema, and the BEACON pivotal study in patients with retinal vein occlusion are anticipated to form the basis of the Company's initial BLA to support potential approval and commercialization in multiple indications and with a full range of labeled and reimbursable dosing frequencies in each indication. An additional Phase 3 pivotal study, GLOW, in patients with non-proliferative diabetic retinopathy is also underway. NCT04611152 Phase 3 GLEAM study started Sep 30, 2020; NCT04603937 Phase 3 started in Sep 2020; NCT04592419 Phase 3 in Participants With Visual Impairment Due to Treatment-naïve Macular Edema Secondary to Retinal Vein Occlusion started in Sep 2020. Oct 2020: Kodiak Sciences Inc., a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases, announced that the first patients have been treated in the randomized, double-masked GLEAM, GLIMMER and BEACON studies, three pivotal Phase 3 studies of KSI-301, Kodiak's anti-VEGF antibody biopolymer conjugate, in treatment-naïve patients with diabetic macular edema (GLEAM and GLIMMER) and macular edema due to retinal vein occlusion (BEACON). Aug 2020 company presentation: Five pivotal KSI-301 studies in serious, vision-threatening diseases scheduled to run concurrently in 2020. NCT04049266 Phase 2/3 DAZZLE study in wet macular degeneration started in Sep 2019. Sept. 15, 2019: Kodiak Sciences Inc. announced emerging durability data in patients with wet age-related macular degeneration (AMD) treated in its Phase 1b clinical study of its investigational therapy KSI-301. The results were presented by David M. Brown, M.D., FACS, an investigator in the study, as a late-breaking oral presentation at The Retina Society Annual Meeting on September 15 in London, U.K. NCT03790852 Phase 1 started in Dec 2018. |
| Full address of company | Palo Alto, California, United States North America United States of America https://kodiak.com/ |
KSI-301 is a novel anti-VEGF antibody biopolymer conjugate. Site-specific conjugation (L443C). The ABC platform comprises a humanized IgG1 antibody with inert immune effector function and a biopolymer which is an optically clear, high molecular weight phosphorylcholine polymer covalently bound by single-site specific linkage. Its design optimized both size and molar dose to increase intraocular durability. The molecular weight of KSI-301 is 950 kDa and that of biopolymer is 800 kDa. https://cdn.who.int/media/docs/default-source/international-nonproprietary-names-(inn)/pl126.pdf?sfvrsn=a37e0953_7&download=true https://kodiak.com/our-pipeline/#modal-tarcocimab
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |