Novasep performs process development and cGMP bioconjugation of the XB002 ADC at its ADC manufacturing unit on its Le Mans site, in France.
The CDMO declined to disclose the duration of the manufacturing agreement with Exelixis.
Khalid Shah, senior VP, pharmaceutical operations and supply chain, Exelixis, said Novasep’s ADC process development and manufacturing capabilities were integral to its 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.”
XB002 is the first ADC in Exelixis’ growing biologics pipeline to enter clinical development; the ADC is 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, said the developer.
Following the US Food and Drug Administration’s acceptance of its Investigational New Drug (IND) 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.
Production of ADC payloads, drug linkers and monoclonal antibodies
ADCs are particularly complex to produce because they are composed of a biological part – the monoclonal antibody, and a chemical part - the linker and the highly potent payload. The conjugation is the critical process step where both parts are assembled.
Novasep has emerged as a key CDMO provider in the ADC arena, after a series of investments in both payload and bioconjugation manufacturing, with the French company noting in May increasing customer demand for such manufacturing services.
"Novasep has a number of agreements in the ADC field, for clinical and/or commercial manufacturing, the majority of which are confidential," a spokesperson told us.
It opened its Le Mans bioconjugation facility back in 2017, with it ploughing €12m (US$14.2m) into those operations at the time. At the outset, the standalone had two flexible GMP production suites equipped with 10L to 400L vessels to support both clinical and commercial manufacturing of ADCs. Today, it allows commercial-scale production of ADC payloads, drug linkers and monoclonal antibodies.
Novasep said the plant passed an inspection by France's regulator, ANSM, earlier this year.
The CDMO has been divesting assets of late as well. In January this year, it set in motion a deal to sell its chromatography equipment division to Sartorius Stedim Biotech. The unit employs around 100 people, the majority working at Novasep’s site in Pompey, France.
That same month saw Thermo Fisher Scientific acquire Novasep’s viral vector manufacturing business, Henogen, for €725m. That business is run out of two locations - in Seneffe and Gosselies, Belgium; the viral vector operations include more than 7,000 square meters of state-of-the-art clinical and commercial manufacturing capacity.