Lonza’s Visp, Switzerland, manufacturing site will be responsible for producing Kodiak’s lead product candidate, KSI-301, as it moves closer to potential commercialization. Should the drug candidate receive approval, the bioconjugation manufacturing facility could be scaled up to produce over 10 million doses annually.
The partnership saw Lonza custom build the facility within its own Ibex Dedicate manufacturing complex, with 70 positions at the company dedicated to running the location. Alongside Lonza staff, Kodiak will also have 12 of its own employees working full-time in the facility.
Kodiak has been working with Lonza on the manufacture of its drug candidates since 2016. The companies noted that the new site will provide flexible commercial manufacturing capacity that could be scaled to meet demand for any potential product.
Outside of the Visp location, Lonza’s facility in Nansha, China, will contribute to produce Kodiak’s biopolymer and its Portsmouth, US, location will manufacture the monoclonal antibody.
Eyeing approval
The project at the center of the partnership is Kodiak’s lead drug candidate, KSI-301, which is an antibody conjugated with a phosphorylcholine biopolymer that inhibits vascular endothelial growth factor.
KSI-301 is currently being studied in Phase III trials for various eye conditions, including wet age-related macular degeneration (Wet AMD), diabetic macular edema, retina vein occlusion, and non-proliferative diabetic retinopathy.
Kodiak refers to its antibody biopolymer conjugate platform, used to produce KSI-301, as delivering ‘generation 2.0 retinal medicines’. The older generation it is hoping to surpass with its product candidate are treatments such as Novartis’ Beovu (brolucizumab) and Regeneron’s Eylea (aflibercept).
The existing treatments on the market have competed over frequency of dosing and Kodiak is looking to differentiate its potential product in exactly the same way. It is being studied to extend dosing over Eylea in Wet AMD by potentially three months, for a regular dosing schedule every five months.
However, the company is looking to recover from a setback in February of this year, when KSI-301 did not meet its primary endpoint of showing non-inferiority compared to Eylea in a Phase IIb/III study. The failure saw Kodiak’s share price drop by 80%, while its stock now remains far below highs of $128 reached in November 2021, as it currently hover around the $7 mark.
Beyond KSI-301, Kodiak has two further product candidates contained in its pipeline, in KSI-501 and KSI-601, which are also being investigated for eye-related conditions.
