Kodiak Sciences, a clinical-stage biopharmaceutical company specializing in ophthalmic therapies, and Lonza 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.
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. Clinical data suggest the potential for extended dosing schedules of up to six months. KSI-301 is currently in a clinical trial for wet age-related macular degeneration and additional studies are 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.
The new agreement will provide Kodiak with a custom-built bioconjugation facility as part of Lonza’s Ibex Dedicate business model. This technology-agnostic biomanufacturing concept fits into prebuilt shells at Lonza’s new biopark in Visp (CH). Ibex Dedicate leverages existing infrastructure and provides the flexibility needed for manufacturing a broad range of 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 utilize its global network of facilities, including Nansha (CN) and Visp (CH) to produce the biopolymer, and Portsmouth (US) to produce the antibody. The expanded partnership aims to support Kodiak’s BLA submission timeline in 2022.