Grand Opening of Kodiak Sciences' Purpose-built Bioconjugation Facility to Support Potential Commercial Manufacture of KSI-301, an Antibody Biopolymer Conjugate for Retinal Diseases
- Purpose-built bioconjugation facility in Lonza's Ibex® Dedicate Biopark in Visp,
Switzerlandto support the potential commercial launch of Kodiak's lead product candidate KSI-301 for high-prevalence retinal diseases
- The opening ceremony took place on
May 17, 2022following mechanical completion of the facility in March 2022
The facility will play a key role in the scaled manufacturing of Kodiak's lead therapeutic candidate KSI-301 to support a potential global commercial launch. Once fully operational and if KSI-301 is approved for commercial use, the facility is expected to have the capacity to supply over 10 million dose equivalents of KSI-301 annually. The strong relationship between Kodiak and Lonza has led to a multi-year commercial collaboration that has created 12 full-time positions at
Lonza's leadership in bioconjugation, together with its experience in managing the complex supply chains under one quality system, will help Kodiak meet the precision standards required for ophthalmic intravitreal injected therapies. The new dedicated bioconjugation facility will allow for rapid product launch and provide flexible commercial manufacturing capacity that can scale to meet market needs. Lonza will also utilize its global network of facilities, including Nansha (CN) and Visp (CH) to produce Kodiak's biopolymer, and Portsmouth (
Lonza is a preferred global partner to the pharmaceutical, biotech and nutrition markets. We work to enable a healthier world by supporting our customers to deliver new and innovative medicines that help treat a wide range of diseases. We achieve this by combining technological insight with world-class manufacturing, scientific expertise and process excellence. Our unparalleled breadth of offerings enables our customers to commercialize their discoveries and innovations in the healthcare industry.
Founded in 1897 in the Swiss Alps, today, Lonza operates across five continents. With approximately 16,000 full-time employees, we comprise high-performing teams and individual talent that make a meaningful difference to our own business, as well as to the communities in which we operate. The company generated sales of
Kodiak (Nasdaq: KOD) is a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases. Founded in 2009, Kodiak is 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. Kodiak's 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 wet age-related macular degeneration, the leading cause of blindness in elderly patients in the developed world, and diabetic eye diseases, the leading cause of blindness in working-age patients in the developed world. Kodiak has leveraged its ABC Platform to build a pipeline of product candidates in various stages of development. KSI-501 is a dual inhibitor antibody biopolymer conjugate targeting both VEGF (VEGF-trap) and IL-6 (anti-IL-6 antibody) for the treatment of retinal diseases. Kodiak is expanding its early research pipeline to include ABC Platform based triplet inhibitors for multifactorial retinal diseases such as dry AMD and glaucoma. For more information, please visit www.kodiak.com.
KSI-301 is an investigational anti-VEGF therapy built on Kodiak's Antibody Biopolymer Conjugate (ABC) Platform and is designed to maintain potent and effective drug levels in ocular tissues for longer than existing available 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. The KSI-301 clinical program is designed to assess KSI-301's durability, efficacy and safety in wet AMD, DME, RVO and non-proliferative DR (without DME) through clinical studies run in parallel. If successful, Kodiak's GLEAM and GLIMMER pivotal studies in patients with diabetic macular edema, the BEACON pivotal study in patients with retinal vein occlusion and the DAYLIGHT pivotal study in patients with wet AMD are anticipated to form the basis of Kodiak's initial BLA to support potential approval and commercialization in multiple indications. An additional Phase 3 pivotal study, GLOW, in patients with non-proliferative diabetic retinopathy is also underway. The global KSI-301 clinical program is being conducted at over150 study sites in more than 10 countries. Kodiak is developing KSI-301 and owns global rights to KSI-301.
Additional Information and Disclaimer
Lonza Group Ltd has its headquarters in
Certain matters discussed in this news release may constitute forward-looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward-looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ materially in the future from the forward-looking statements included in this news release due to various factors. Furthermore, except as otherwise required by law, Lonza Group Ltd disclaims any intention or obligation to update the statements contained in this news release.
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. Any forward-looking statements are not based on historical fact and 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. 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," "could," "expect," "plan," "believe," "intend," "pursue," and other similar expressions among others. Forward-looking statements include statements regarding the anticipated fully operational status of the Ursus facility, potential manufacture and supply of KSI-301, approval of KSI-301 for commercial use, the supply capacity of the facility once operational, the ability of Lonza to help Kodiak meet standards, the ability of the facility to allow for rapid launch and provide for sufficient manufacturing capacity, and the potential use of facilities in various locations to produce Kodiak's monoclonal antibody. For a discussion of risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in our most recent Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Kodiak's subsequent filings with the
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Lonza, Victoria Morgan, Head of External Communications, Lonza Group Ltd, +41 61 316 2283, firstname.lastname@example.org; Dirk Oehlers, Investor Relations, Lonza Group Ltd, +41 61 316 8540, email@example.com; Kodiak, John Borgeson, Senior Vice President and Chief Financial Officer, Kodiak Sciences Inc, +1-650-281-0850, firstname.lastname@example.org