Grand Opening of Kodiak Sciences' Purpose-built Bioconjugation Facility to Support Potential Commercial Manufacture of KSI-301, an Antibody Biopolymer Conjugate for Retinal Diseases
BASEL, Switzerland and PALO ALTO, Calif., May 19, 2022 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases, and Lonza announced today the opening of a new, custom-built, bioconjugation facility within Lonza's Ibex® Dedicate manufacturing complex in Visp (CH).
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 Kodiak Sciences in Visp and 70 positions at Lonza.
Kodiak Sciences leverages its core technology, the Antibody Biopolymer Conjugate (ABC) PlatformTM, to develop next-generation, long-durability ophthalmic therapies. KSI-301 is the lead product candidate based on the ABC Platform, consisting of a custom-built 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. Existing clinical data has demonstrated the potential for extended dosing of up to six months in certain patients treated with KSI-301. KSI-301 is currently being studied in parallel Phase 3 trials for wet age-related macular degeneration ("wet AMD"), diabetic macular edema ("DME"), retina vein occlusion ("RVO"), and non-proliferative diabetic retinopathy ("NPDR"). If successful, Kodiak Sciences intends to include data from these trials in a Biologics License Application (BLA) with the U.S. FDA and potentially other global regulatory agencies. Lonza will support Kodiak in scaling up and securing supply chain as Kodiak progresses towards BLA readiness and potential commercial launch to meet growing market demand.
Victor Perlroth, MD, Chief Executive Officer, Kodiak Sciences Inc., commented: "The grand opening of Ursus, our dedicated bioconjugate facility, is an important milestone in our journey to develop medicines for patients in need worldwide. We are thankful to have our trusted partner Lonza, a global leader with the needed expertise, systems and production capacity, navigate the challenges of manufacturing and supplying KSI-301, our lead product candidate. We are also very appreciative of the long-standing support from the local community of Visp and the canton of Valais."
Pierre-Alain Ruffieux, Chief Executive Officer, Lonza, added: "It is a privilege to work alongside Kodiak to develop this world-class suite for ophthalmic technologies through our innovative Ibex® Dedicate offering. Our relationship with Kodiak has evolved over the last seven years, from the development of the antibody, to incorporating conjugation and now opening this dedicated suite. This journey reflects how our two businesses are able to work as one team towards a single purpose."
Christophe Darbellay, Conseiller d'Etat, Chef du Département de l'Economie et de la Formation du Canton du Valais, added: "The grand opening of Kodiak Sciences' manufacturing facility confirms and reinforces the position of Valais in life sciences. I would like to thank Kodiak Sciences for having chosen and trusted our canton and its capacities."
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 (U.S.) to produce Kodiak's monoclonal antibody.
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 CHF 5.4 billion with a CORE EBITDA of CHF 1.7 billion in Full-Year 2021. Find out more at www.lonza.com.
About Kodiak Sciences
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.
Kodiak Sciences Inc. is headquartered in Palo Alto, California, USA, and is listed on the NASDAQ Stock Exchange. Kodiak has additional facilities in Zug, Switzerland and Valais, Switzerland.
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 Basel, Switzerland, and is listed on the SIX Swiss Exchange. It has a secondary listing on the Singapore Exchange Securities Trading Limited ("SGX-ST"). Lonza Group Ltd is not subject to the SGX-ST's continuing listing requirements but remains subject to Rules 217 and 751 of the SGX-ST Listing Manual.
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 Kodiak Sciences
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 Securities and Exchange Commission. 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. Kodiak®, Kodiak Sciences®, ABC™, ABC Platform™ and the Kodiak logo are registered trademarks or trademarks of Kodiak Sciences Inc. in various global jurisdictions.
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Company Codes: NASDAQ-NMS:KOD