Novasep, a supplier of services and technologies for the life sciences industry, has signed a manufacturing services agreement with Exelixis, an oncology-focused biotech, for the cGMP clinical production of XB002, a next-generation tissue factor-targeting antibody-drug conjugate (ADC) for oncology applications.
 
XB002 is a novel ADC composed of a human monoclonal antibody against tissue factor that is conjugated to a cytotoxic agent and leverages proprietary linker-payload technology. After binding to tissue factor on tumor cells, XB002 is internalized, and the cytotoxic agent is released, resulting in targeted tumor cell death. Following the U.S. Food and Drug Administration’s acceptance of Exelixis’ Investigational New Drug filing in April 2021, Exelixis initiated a phase 1 clinical trial of XB002 in patients with advanced solid tumors in the second quarter of 2021.
 
Novasep performs process development and cGMP bioconjugation of the XB002 ADC at its state-of-the-art ADC manufacturing unit on its Le Mans site, in France. This site, which now has more than 15 years’ experience in supporting ADC drug innovators, is utilizing its specialized technologies and expertise to support Exelixis’ XB002 clinical supply needs.
 
“As the first ADC in our growing biologics pipeline to enter clinical development, XB002 is an important program for Exelixis,” said Khalid Shah, senior vice president, pharmaceutical operations and supply chain, Exelixis. “Novasep’s ADC process development and manufacturing capabilities were integral to our ability to initiate XB002’s first phase 1 study on an aggressive timeline this spring. We look forward to leveraging Novasep’s highly specialized ADC expertise as work on the XB002 clinical development program continues.”
 
Michel Spagnol, CEO, Novasep, said, “The antibody drug conjugate clinical pipeline continues to strengthen thanks to innovators such as Exelixis. These therapies have the potential to serve as new treatment options for patients around the world and our aim is to accompany their development. We are proud to support Exelixis with our manufacturing services.