The facility will play a role in the scaled manufacturing of Kodiak’s lead therapeutic candidate KSI-301
Kodiak Sciences, a biopharmaceutical company focused on therapeutics for retinal diseases, has announced the opening of a custom-built bioconjugation facility within Lonza’s manufacturing complex in Visp, Switzerland.
The facility will play a role in the scaled manufacturing of Kodiak’s lead therapeutic candidate KSI-301. Once fully operational (and pending the therapy’s approval for commercial use), the facility is expected to be able to supply over 10 million dose equivalents annually. The relationship between the companies has led to a multi-year commercial collaboration, creating 12 full-time positions at Kodiak in Visp and 70 positions at Lonza.
KSI-301 is the lead product candidate based on Kodiak’s antibody biopolymer conjugate (ABC) platform, consisting of a custom-built antibody inhibiting vascular endothelial growth factor (VEGF), a cytokine understood to contribute to the pathology of retinal vascular diseases, conjugated with a phosphorylcholine biopolymer.
KSI-301 is currently being studied in parallel Phase III trials for several conditions. If successful, Kodiak intends to include data from these trials in a biologics license application (BLA) with the FDA and potentially other global regulatory agencies. Lonza will support the company in scaling up and securing supply chain as it progresses towards BLA readiness and potential commercial launch.
Victor Perlroth, MD, CEO, Kodiak Sciences, said: “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, CEO, 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.”