J&J, Legend unveil plans for Belgian cell therapy manufacturing facility as the partners await approval for lead drug – Endpoints News

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.

Liz Gosen

“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