Kodiak Sciences and Lonza announced 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, diabetic macular edema, retina vein occlusion and non-proliferative diabetic retinopathy. 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, 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.”