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 …

• Newest desig­na­tion for JNJ-4528 is sup­ported by Phase 1b/2 CARTITUDE-1 study in adults with re­lapsed or re­frac­tory mul­ti­ple myeloma
• Initial re­­sults from CARTITUDE-1 study to premiere at the American Society of He­ma­tol­ogy Annual Meeting

Raritan, NJ (Press Release) – The Janssen Pharma­ceu­tical Com­panies of John­son & John­son an­nounced to­day that the U.S. Food and Drug Admin­istra­tion (FDA) has granted Break­­through Therapy Desig­na­tion for JNJ-68284528 (JNJ-4528), an inves­ti­ga­tional B cell maturation an­ti­gen (BCMA)-directed chi­meric an­ti­gen re­cep­tor T cell (CAR-T) ther­apy in pre­vi­ously treated patients with mul­ti­ple myeloma. Break­­through Therapy Desig­na­tion is granted to expedite the devel­op­ment and regu­la­tory re­view of an inves­ti­ga­tional med­i­cine that is in­tended to treat a serious or life-threatening con­di­tion. The criteria for Break­­through Therapy Desig­na­tion …

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 …

• Legend to re­ceive an up­front pay­ment of $350 mil­lion, as well as addi­tional devel­op­ment, pro­duc­tion per­for­mance, regu­la­tory and sales mile­stone pay­ments
• Legend and Janssen to co-develop and co-promote CAR T-cell ther­apy for mul­ti­ple myeloma
• Profits and costs to be shared 50/50 world­wide, ex­clu­sive Greater China where 70 per­cent to Legend and 30 per­cent to Janssen

Nanjing, China (Press Release) – Legend Biotech, a sub­sid­i­ary of GenScript Biotech Corpo­ra­tion (HKEx: 1548) that de­vel­ops inno­va­tive CAR T-cell immuno­therapy targeting mul­ti­ple myeloma, an­nounced to­day it has executed a stra­te­gic col­lab­o­ration agree­ment to jointly de­vel­op and com­mer­cial­ize the LCAR-B38M based prod­ucts with Janssen Biotech, Inc. ("Janssen").

According to the terms of the agree­ments, the com­pa­nies have agreed to jointly share the devel­op­ment, pro­duc­tion and com­mer­cial­iza­tion ac­­tiv­i­ties, with a 50/50 profit-loss sharing agree­ment for the world-wide mar­ket …

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 …