The agreement also integrates Kodiak’s global pharmaceutical supply chain including antibody, small molecule, biopolymer and bioconjugate manufacturing
Kodiak Sciences, a clinical-stage biopharmaceutical company specialising in novel ophthalmic therapies, and Lonza have announced that the companies have signed a long-term contract for manufacturing KSI-301, an Antibody Biopolymer Conjugate (ABC) that is a potential first-line treatment for retinal vascular diseases.
Kodiak’s ABC Platform is its core, proprietary technology for next-generation, long-durability ophthalmic therapies. KSI-301 is an antibody biopolymer conjugate comprising an antibody inhibiting Vascular Endothelial Growth Factor (VEGF), a potent cytokine known to contribute to the pathology of retinal vascular diseases, conjugated with a phosphorylcholine biopolymer. Emerging clinical data suggest the potential for extended dosing schedules of up to six months. With KSI-301 currently in a pivotal clinical trial for wet age-related macular degeneration and with additional pivotal clinical studies scheduled to begin this year in diabetic macular edema, retina vein occlusion and non-proliferative diabetic retinopathy, Lonza will support Kodiak in scaling up and securing their supply chain as the company moves through BLA readiness to commercial launch to meet growing market demands.
Building on a long-term partnership for the clinical supply of antibody and biopolymer, the new agreement will provide Kodiak with a custom-built bioconjugation facility as part of Lonza’s Ibex Dedicate business model. This agile, technology-agnostic biomanufacturing concept fits into prebuilt shells at Lonza’s new biopark in Visp (CH). In addition to reducing build-time, Ibex Dedicate taps into existing infrastructure and provides the flexibility needed for manufacturing a broad range of innovative medicines, from drug substance to drug product.
With construction targeted for completion in 2021, the Lonza-Kodiak Ibex facility is designed to provide Kodiak with the facility needed for commercial-scale manufacturing of KSI-301. Lonza will also utilise its global network of facilities, including Nansha (CN) and Visp (CH) to produce the biopolymer, and Portsmouth (US) to produce the antibody. The timing of this expanded partnership is designed to support Kodiak’s BLA submission timeline in 2022, and the scale is designed to support KSI-301’s potential to achieve significant market share as a new first-line agent designed to improve outcomes for patients with common and serious retinal vascular diseases.
Lonza’s leadership in bioconjugation, together with experience in managing the complex supply chains under one quality system, will help Kodiak meet the precision standards required for ophthalmic intravitreal injected therapies and retinal vascular diseases in particular. The new dedicated bioconjugation facility will allow for rapid product launch and provide flexible commercial manufacturing capacity that can scale to meet market needs. Kodiak Sciences, a clinical-stage biopharmaceutical company specialising in novel ophthalmic therapies, and Lonza announced that the companies have signed a long-term contract for manufacturing KSI-301, an Antibody Biopolymer Conjugate (ABC) that is a potential first-line treatment for retinal vascular diseases.