In a race to get BCMA CAR-T candidates to market, J&J and Legend are adding a new EU manufacturing facility in Belgium to the fold as they prepare to file.
The site is a part of a joint investment with J&J to expand its global manufacturing capacity. It will develop and commercialize cilta-cel, also known as ciltacabtagene autoleucel, an investigational therapy for patients with relapsed and refractory multiple myeloma.
“The new location in Belgium is an ideal choice for Legend to launch our European manufacturing presence allowing us to tap into the area’s vast talent pool and leverage the strong Belgian life sciences ecosystem,” SVP of global technical operations Liz Gosen said in a press release. “We are excited to expand our existing robust manufacturing network to support the production and delivery of cilta-cel for patients across the globe.”
Cilta-cel is currently being reviewed by regulators in the US and the EU. Ahead of ASCO, J&J and Legend unveiled Phase II trial data that showed a 95% overall response, with a 75% stringent complete response. It received breakthrough designation from the FDA in December 2019, in Europe in February 2020 and in China in August 2020.
Legend’s plant will be operational by 2023. The facility will add to Legend’s existing manufacturing facilities in Nanjing, China, Raritan, NJ and Somerset, NH