KODIAK SCIENCES INC. 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.
About Lonza
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
About
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
About KSI-301
KSI-301 is an investigational therapy built on Kodiak's proprietary Antibody Biopolymer Conjugate (ABC) Platform and is designed to maintain potent and effective drug levels in ocular tissues for longer than existing agents. Kodiak's objective with KSI-301 is to develop a new first-line agent to improve outcomes for patients with retinal vascular diseases and to enable earlier treatment and prevention of vision loss for patients with diabetic eye disease.
Forward-Looking Statements for
This release contains 'forward-looking statements' within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding the ability to commence operations at the Lonza-Kodiak Ibex facility in 2021; the ability of the Lonza-Kodiak Ibex facility to provide sufficient manufacturing capacity for the potential commercial launch of KSI-301; Kodiak's potential BLA submission in wet AMD, DME, RVO and diabetic retinopathy in 2022; the potential licensure and commercial launch of KSI-301 in 2023; clinical and regulatory objectives and the timing thereof, expectations regarding the potential efficacy and commercial potential of Kodiak's product candidates and the results of our research and development efforts. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as 'may,' 'will,' 'should,' 'would,' 'expect,' 'plan,' 'believe,' 'intend,' 'pursue,' and other similar expressions among others. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These forward-looking statements speak only as of the date hereof and Kodiak undertakes no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.
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