PolyTherics moves lead candidate into development
DSM BioSolutions to manufacture HiPEG IFN alpha-2a
DSM BioSolutions, DSM's microbial fermentation CMO business unit in The Netherlands is to manufacture PolyTherics' lead biobetter product, HiPEG IFN alpha-2a.
DSM has started development, scale-up and manufacture of the recombinant his-tagged IFN alpha-2a. PolyTherics will transfer its HiPEG PEGylation method to DSM to facilitate scale-up.
London, UK-based PolyTherics has applied its HiPEG site-specific PEGylation technology to interferon alpha, which has resulted in a product that it says has eight-fold higher activity than a marketed product in vitro, and a comparable half-life in a preclinical study.
The HiPEG technology attaches poly(ethylene) glycol (PEG) to a histidine tag at the end of the protein. PolyTherics is currently seeking partners for the development of HiPEG IFN alpha-2a for hepatitis C.
DSM and PolyTherics aim to develop a robust process to produce sufficient material for preclinical development and then for cGMP production of HiPEG IFN alpha-2a for clinical development.
Keith Powell, ceo of PolyTherics, said: ‘The transfer of the production of our lead product to a contract manufacturer is a major milestone for PolyTherics and is the beginning of the development stage of its first biobetter drug.’
No financial terms were disclosed.
