Catalent Pharma Solutions and Nascent Biologics have signed a product development agreement in which Catalent will engineer a cell line expressing Nascent’s proprietary pritumumab antibody using Catalent’s GPEx technology, and will subsequently produce purified monoclonal antibody to support Nascent’s Phase I/II human clinical trials with pritumumab for treatment of brain cancers, such as astrocytomas and glioblastomas.
GPEx technology is used to generate mammalian cells with high yields and stability, which will help speed the drug to clinic.
Mark Glassy, Ph.D., CEO of Nascent, observed, “We are committed to bring this potential new treatment to patients afflicted with this terrible disease. Our first clinical data are very encouraging and we look forward to working with Catalent to gather the key clinical data that will enable further development to be 'fast tracked' with relevant regulatory agencies on a worldwide basis. Nascent Biologics is in the process of forming a commercial partnership for further clinical development, registration, and marketing of its Pritumumab product.” Pritumumab's early trials showed a ninefold increase in five-year survival rates.
“We are delighted to be part of a program that will not only validate our GPEx technology as a leading system for the manufacture of biologic products, but will also aid in significantly improving the treatment outcomes for such a serious and untreatable disease,” said Kent Payne, vice president and general manager of Catalent’s Biologics business.