First inves­ti­ga­tional prod­uct being rec­om­mended for Break­­through Therapy Desig­na­tion in China

Somerset, NJ (Press Release) – Legend Bio­tech Corpo­ra­tion (NASDAQ:LEGN) an­nounced to­day that the China Center for Drug Evaluation, National Medical Products Admin­istra­tion (CDE, NMPA) has rec­om­mended Break­­through Therapy Desig­na­tion (BTD) for ciltacabtagene autoleucel (cilta-cel; LCAR-B38M CAR-T cells), an inves­ti­ga­tional B-cell maturation an­ti­gen (BCMA) targeted chi­meric an­ti­gen re­cep­tor (CAR) T-cell ther­apy being studied for the treat­ment of adults with re­lapsed or re­frac­tory mul­ti­ple myeloma (RRMM).

The BTD for cilta-cel (LCAR-B38M CAR-T cells) is based on the on­go­ing Phase 2 CARTIFAN-1 study being con­ducted in China (MMY2002, NCT03758417, CTR20181007), the on­go­ing Phase 1b/2 CARTITUDE-1 study …

PRIME (PRIority MEdicines) desig­na­tion based on clin­i­cal study re­­sults eval­u­ating safety and ef­fi­cacy of novel CAR-T ther­apy in the treat­ment of patients with ad­vanced re­lapsed or re­frac­tory mul­ti­ple myeloma

Beerse, Belgium (Press Release) - The Janssen Pharma­ceu­tical Com­panies of John­son & John­son to­day an­nounced that the Euro­pean Medicines Agency (EMA) has granted a PRIME (PRIority MEdicines) desig­na­tion for the com­pany’s inves­ti­ga­tional B-cell maturation an­ti­gen (BCMA) chi­meric an­ti­gen re­cep­tor T-cell (CAR-T) ther­apy, JNJ-68284528 (JNJ-4528). PRIME offers en­hanced inter­action and early dialogue to optimise devel­op­ment plans and speed up evaluation of cutting-edge, scientific ad­vances that target a high unmet med­i­cal need.¹

“The PRIME desig­na­tion of this novel BCMA CAR-T ther­apy highlights the value of regu­la­tory inno­va­tion in the Euro­pean Union,” said Sjaak Bot, …

Planned Start of Clinical Program and Clearance of U.S. Food and Drug Admin­istra­tion Inves­ti­ga­tional New Drug Appli­ca­tion Reflect Progress in Strategic Partnership with Legend Bio­tech

Spring House, PA (Press Release) – The Janssen Pharma­ceu­tical Com­panies of John­son & John­son an­nounced to­day the initiation of a Phase 1b/2 clin­i­cal devel­op­ment pro­gram studying JNJ-68284528 (developed based on Legend's LCAR-B38M), a chi­meric an­ti­gen re­cep­tor T cell (CAR-T) ther­apy directed against B cell maturation an­ti­gen (BCMA), in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma. The planned start of the Phase 1b/2 study (68284528MMY2001), scheduled to begin en­roll­ment in the sec­ond half of 2018, follows the U.S. Food and Drug Admin­istra­tion (FDA) clear­ance of the Inves­ti­ga­tional New Drug (IND) appli­ca­tion sub­mitted by Janssen.

As …

LCAR-B38M CAR-T ther­apy (JNJ-68284528) to be devel­oped as part of stra­te­gic part­ner­ship be­tween Legend and Janssen

Piscataway, NJ (Press Release) – Legend Bio­tech, a sub­sid­i­ary of GenScript Bio­tech Corpo­ra­tion (HKEx: 1548), an­nounced to­day that the U.S. Food and Drug Admin­istra­tion (FDA) has authorized its devel­op­ment part­ner, Janssen Bio­tech, Inc. ("Janssen"), to com­mence a Phase 1b/2 clin­i­cal trial in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma (MM) to eval­u­ate the safety and ef­fi­cacy of LCAR-B38M (JNJ-68284528), a Chimeric Antigen Receptor T cell (CAR-T) ther­apy. Scheduled to begin en­roll­ment in the sec­ond half of 2018, the Phase 1b/2 study (68284528MMY2001) is part of a col­lab­o­ration be­tween Legend Bio­tech and Janssen that …

CAR-T BCMA in De­vel­op­ment for Patients with Multiple Myeloma

Horsham, PA (Press Release) – Janssen Bio­tech, Inc. (“Janssen”), a Janssen Pharma­ceu­tical Com­pany of John­son & John­son, an­nounced to­day that it has entered into a world­wide col­lab­o­ration and license agree­ment with Legend Bio­tech USA Inc. and Legend Bio­tech Ireland Limited (“Legend”), sub­sid­i­aries of Genscript Bio­tech Corpo­ra­tion, to de­vel­op, manu­fac­ture and com­mer­cial­ize a chi­meric an­ti­gen re­cep­tor (CAR) T-cell drug can­di­date, LCAR-B38M, which spe­cif­i­cally targets the B-cell maturation an­ti­gen (BCMA). LCAR-B38M is cur­rently ac­cepted for re­view by the China Food and Drug Admin­istra­tion (CFDA) and in the planning phase of clin­i­cal stud­ies in the United …