27 Jul 2020
Lonza's Ibex Dedicate to Support the Commercial Manufacture of Kodiak's KSI-301 - an Antibody Biopolymer Conjugate for Retinal Diseases

Purpose-built bioconjugation facility in Lonza's Ibex™ Dedicate Biopark to support the potential commercial launch of Kodiak's leading ophthalmic therapeutic candidate KSI-301 with a capacity to supply millions of doses per year

Provides accelerated build-time and flex up and flex down capabilities with facility construction targeted for completion from end 2021

The agreement also integrates Kodiak's global pharmaceutical supply chain including antibody, small molecule, biopolymer and bioconjugate manufacturing

Quote from Jean Christophe Hyvert, Chief Commercial Officer, Lonza:

We are committed to supporting Kodiak as they bring their highly innovative, sight-saving treatment option to patients with vision-threatening retinal diseases. Since 2014, we have been partnering with Kodiak to support the supply of KSI-301 drug substance for use in clinical trials. Together, we are now preparing for scale-up, BLA readiness and future commercial supply. These activities include the build of a new bioconjugation facility in an Ibex® Dedicate partnership with Kodiak with the capability to supply millions of doses of KSI-301 and to flex up / flex down capacities quickly in response to the market demand.”

Quote from Victor Perlroth, MD, Chairman and Chief Executive Officer, Kodiak Sciences:

“Manufacturing is a critical element of Kodiak's 2022 Vision, as we scale our efforts and realize the potential of KSI-301 to be an extended durability medicine for treating retinal diseases. We are planning to file a Biologics Licensing Application (BLA) for KSI-301 in 2022, with the goal of commercial launch in wet age-related macular degeneration, diabetic macular edema and retinal vein occlusion in 2023. To meet our objectives for BLA readiness and large-scale commercial supply, we are thrilled to build on an already successful partnership with Lonza. The IBEX Dedicate allows us to build significant dedicated manufacturing capacity while also leveraging Lonza's high-quality network and expertise that have enabled our manufacturing success thus far.”

Basel, Switzerland, and Palo Alto, US, 27 July 2020 – Kodiak Sciences, a clinical-stage biopharmaceutical company specializing in novel ophthalmic therapies, and Lonza announced today 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 PlatformTM 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 utilize 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.