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.
At Lonza, we combine technological innovation with world class manufacturing and process excellence. Together, these enable our customers to deliver their discoveries in the healthcare, preservation, and protection sectors.
We are a preferred global partner to the pharmaceutical, biotech and specialty ingredients markets. We work to prevent illness and promote a healthier world by enabling our customers to deliver innovative medicines that help treat or even cure a wide range of diseases. We also offer a broad range of microbial control solutions, which help to create and maintain a healthy environment.
Founded in 1897 in the Swiss Alps, Lonza today operates in 120 sites and offices in more than 35 countries. With approximately 15,500 full-time employees, we are built from high-performing teams and of individual employees who make a meaningful difference to our own business, as well as the communities in which we operate. The company generated sales of CHF 5.9 billion in 2019 with a CORE EBITDA of CHF 1.6 billion. Find out more at www.lonza.comand follow us on Twitter @LonzaGroup or Facebook @LonzaGroupAG.
About Kodiak Sciences
Kodiak Sciences is a clinical stage biopharmaceutical company developing novel therapeutics to treat chronic, high-prevalence retinal diseases. Founded in 2009, we are focused on bringing new science to the design and manufacture of next generation retinal medicines to prevent and treat the leading causes of blindness globally.
Our ABC Platform™ uses molecular engineering to merge the fields of antibody-based and chemistry-based therapies and is at the core of Kodiak’s discovery engine. Kodiak’s lead product candidate, KSI-301, is a novel anti-VEGF antibody biopolymer conjugate being developed for the treatment of retinal vascular diseases, including age-related macular degeneration, a leading cause of blindness in elderly patients, and diabetic eye diseases, a leading cause of blindness in working-age patients.
Kodiak has leveraged its ABC Platform to build a pipeline of product candidates in various stages of development including KSI-501, our bispecific anti-IL-6/VEGF biopolymer conjugate for the treatment of neovascular retinal diseases with an inflammatory component, and we are expanding our early research pipeline to include ABC Platform based triplet inhibitors for multifactorial retinal diseases such as dry AMD and glaucoma. Kodiak is based in Palo Alto, CA.