CMO Cytovance Biologics is extending its manufacturing agreement with Precision Biologics to advance clinical trials with its leading monoclonal antibody candidate, which is being developed as a therapeutic candidate for pancreatic and colorectal cancers.
Precision has contracted Cytovance Biologics as its CMO to provide technology transfer and additional cGMP manufacturing services of the potential drug, known as ensituximab or NEO-102, in support of its ongoing Phase II clinical trials.
Albine Martin, COO of Precision Biologics, told BioPharma-Reporter.com the “extension is designed to fulfil our drug requirements entering into Phase III and beyond as needed.”
Cytovance will use both single-use and reusable technologies for the manufacturing of ensituximab, Martin added. Cytovance also offers process development, cGMP cell banking and support services from its Oklahoma City facilities.
“The ultimate site of manufacturing during commercialization will depend upon the partnership strategy/options for [Precision Biologics], it is hard to predict,” Martin said, when asked if the partnership with extend into commercial manufacturing.
Martin also noted Cytovance’s continued investments to support large scale manufacturing, which comes as small biopharma companies look to increasingly outsource their manufacturing work.
The announcement with Precision also follows Cytovance’s capacity expansion to produce more biologics from its Oklahoma City headquarters. It also follows Cytovance’s recent deal with Pamilco Biopharma to manufacture their mAbs to treat infections.
“The process development team is very critical for projects entering the early stage,” Martin said, noting the Cytovance team “had the technical expertise and ‘partnership’ culture.”
“Our state-of-the-art facilities and experienced staff are prepared to continue the delivery of clinical materials for Precision Biologics,” Darren Head, President and CEO of Cytovance, said. “We are proud to be an established partner with Precision Biologics and support them in their expanded clinical trial program.”
Precision Biologics is also developing proprietary cancer vaccines, several of which have demonstrated success in human trials.