Proteon Therapeutics, Inc. is developing novel, first-in-class therapeutics to address kidney and vascular diseases. The company’s lead candidate vonapanitase is an investigational drug intended to improve hemodialysis vascular access outcomes.
Lonza Pharma & Biotech scaled up the lab process for vonapanitase at its Visp, Switzerland-based microbial facility, at which the company has been manufacturing active pharmaceutical ingredients (APIs) for Proteon since 2009.
The agreement's extension is for multiple batches over 10 years for eventual commercial supply, Karen Fallen, VP, head of clinical development and manufacturing, Lonza, told us.
A small-scale process was initially transferred into Lonza’s development labs for process optimization and consistency studies. To support Proteon’s early clinical studies – and potential future commercial requirements – the process has since been scaled up to 1,000L.
Proteon completed enrollment in the Phase III clinical trial, PATENCY-2, in March of this year. Top-line data from the trial, for which Lonza provided three process validation batches at 1,000L commercial scale, is expected in March 2019.
Following a successful trial, Proteon expects to include results from the validation runs in a potential biologics license application (BLA) filing in the second half of 2019 with support from Lonza.
"There is renewed interest in microbial manufacturing due to recent developments in next generation biotherapeutics including antibody mimetics and novel scaffolds," explained Fallen.
"As drug developers focus on addressing unmet therapeutic needs, they are studying novel mechanisms of action which these new molecular formats provide," she added.
Vonapanitase received Breakthrough Therapy, Fast Track, and Orphan Drug designations from the FDA, and Orphan Medicinal Product designation from the European Commission, for hemodialysis vascular access indications.
Proteon also is currently conducting a Phase I clinical trial of vonapanitase in patients with peripheral artery disease (PAD).