Catalent to produce antibody for Nascent Biologics

Published: 17-Apr-2012

For the treatment of brain cancers such as astrocytomas and glioblastomas


Catalent Pharma and Nascent Biologics have signed a cancer antibody product development deal.

Under the terms of the agreement, 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 of the antibody for the treatment of brain cancers, such as astrocytomas and glioblastomas. GPEx technology is used to generate mammalian cells with high yields and stability, which is expected to help speed the drug to clinic.

Mark Glassy, chief executive of Nascent, said: ‘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.’

He added that Nascent is in the process of forming a commercial partnership for further clinical development, registration, and marketing of its Pritumumab product.

‘We are delighted to be part of a programme 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.

Glioblastoma, a form of brain cancer, afflicts 10,000 Americans each year, with a one-year survival rate of 50% and a five-year survival rate of 3%. There is currently no effective treatment for the disease.

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