Austrian vaccine developer Intercell has signed up Transgenomic to develop a manufacturing process for production of an immune-stimulating oligonucleotide which will be used as a component of one or more of Intercell's novel vaccine candidates.
The contract also covers the development of analytical methods, investigational new drug (IND)-supporting studies, stability experiments and the manufacture of preclinical material.
Subsequent development work and oligonucleotide manufacture will be done at Transgenomic 's facility in Boulder, Colorado, while one one of the key building blocks used in the oligonucleotide's manufacture, phosphoramidites, will be supplied by Transgenomic's plant in Glasgow, Scotland. Transgenomic has enough capacity to supply enough of the drug to conduct all phases of clinical testing.
The oligonucleotide under development is one of two synthetic components of Intercell 's proprietary adjuvant IC31. IC31 constitutes a combination of a synthetic peptide and a synthetic oligonucleotide and, when delivered as part of a vaccine formulation, it increases efficacy by stimulating multiple arms of the immune system.
Robert Zak, Intercell's head of production and quality said that there is currently a limited pool of industry expertise to take oligonucleotide pharmaceuticals rapidly from R&D into the clinic. The deal with Transgenomic allows the Austrian company to develop such substances without having to commit to the significant long-term fixed costs associated with having similar resources in-house, he added.