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, Switzerland to 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, 2022 following mechanical completion of the facility in March 2022
Basel, Switzerland and Palo Alto (CA), USA, 18 May 2022 – 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.
The official opening of the bioconjugation facility was conducted by Christophe Darbellay, Conseiller d’Etat, Chef du Département de l’Economie et de la Formation du Canton du Valais, Albert M. Baehny, Chairman of the Board of Directors of Lonza, Victor Perlroth, MD, Chief Executive Officer of Kodiak Sciences and Pierre-Alain Ruffieux, Chief Executive Officer of Lonza.