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 was formed in De­cem­ber 2017 to de­vel­op CAR-T ther­apy for MM globally.

LCAR-B38M (JNJ-68284528) is an au­tol­o­gous CAR-T ther­apy that targets B cell Maturation Antigen (BCMA), a mol­e­cule ex­pressed on the surface of mature B lym­pho­cytes and malignant plasma cells. The inves­ti­ga­tional ther­apy ex­presses an identical CAR pro­tein as Legend's LCAR-B38M CAR-T prod­uct, which was eval­u­ated in a first-in-human clin­i­cal study (Legend-2) con­ducted in mul­ti­ple sites by Legend Bio­tech in China.

The Phase 1b/2, open-label, multi­center study will eval­u­ate the safety and ef­fi­cacy of JNJ-68284528 in adults with re­lapsed or re­frac­tory mul­ti­ple myeloma. The pri­mary objective of the Phase 1b portion of the study is to char­ac­ter­ize the safety and estab­lish­ the dose of JNJ-68284528, which was in­formed by the Legend-2 first-in-human study. The pri­mary objective for the Phase 2 portion of the study is to eval­u­ate the ef­fi­cacy of JNJ-68284528 (primary end­point: over­all re­sponse rate [partial re­sponse or better] as defined by the Inter­na­tional Myeloma Work­ing Group re­sponse criteria).

"This is a very ex­cit­ing moment, as we celebrate the achieve­ment of this crit­i­cal mile­stone with our stra­te­gic part­ner Janssen," said Dr. Frank Zhang, Chairman and Chief Exec­u­tive Of­fi­cer of GenScript Bio­tech Corpo­ra­tion. "We are very pleased with the pace of progress already achieved through the diligent efforts of the Janssen and Legend teams, reflecting our goal of bringing this im­por­tant thera­peutic op­tion to patients as soon as pos­si­ble."

"This mile­stone dem­onstrates tre­men­dous progress, achieved within six months of estab­lish­ing our devel­op­ment part­ner­ship with Janssen, and reflects the prod­uctive and col­lab­o­rative rela­tion­ship formed be­tween the teams at both or­ga­ni­za­tions that are work­ing to bring this pro­gram for­ward swiftly," said Dr. Yuan Xu, Chief Exec­u­tive Of­fi­cer of Legend Bio­tech.

About LCAR-B38M

LCAR-B38M is a dual epitope Chimeric Antigen Receptor T cell (CAR-T) immuno­therapy prod­uct devel­oped by Legend Bio­tech. Au­tol­o­gous T cells isolated from patients are ge­net­ic­ally modified to ex­press the chi­meric an­ti­gen re­cep­tors on the cell surface, allow­ing the CAR-T cells to spe­cif­i­cally recog­nize and bind the mul­ti­ple myeloma (MM) bio­­marker pro­tein BCMA and kill MM can­cer cells.

About Legend Bio­tech

Legend Bio­tech is a sub­sid­i­ary of GenScript Bio­tech Corpo­ra­tion (HKEx: 1548), with its global pres­ence in the United States, Hong Kong, Ireland and Nanjing China. Legend Bio­tech engages and concentrates on the con­struc­tion of CAR-T cell ther­apy plat­form, and it has built up its own pro­pri­e­tary in­tel­lec­tual prop­er­ty position. Its LCAR-B38M based prod­ucts have dem­onstrated out­stand­ing over­all re­sponse rate (ORR) in a serious of pre-clinical stud­ies treating re­frac­tory mul­ti­ple myeloma. At present, around 200+ em­ploy­ees globally located have been com­mitting in con­tin­uous re­search and devel­op­ment process aiming to provide revolutionary CAR-T and other forms of cell ther­a­pies to can­cer patients. Learn more at www.LegendBiotech.com

About GenScript Bio­tech Corpo­ra­tion

GenScript Bio­tech Corpo­ra­tion (HKEx: 1548) provides reagents services for re­searchers in basic life sciences, trans­la­tional and biomedical fields, as well as pre-clinical anti­body drug devel­op­ment, through its global op­er­at­ing entities located in the United States, Hong Kong, Ireland, the Netherlands, Japan and China. The diverse port­folio of GenScript encompasses extensive services in gene syn­the­sis and molecular biology, peptide syn­the­sis, pro­tein ex­pres­sion and engi­neer­ing, custom anti­body devel­op­ment and engi­neer­ing, in vitro/in vivo pharmacology as well as variety of catalogue prod­ucts for re­search. Two sub­sid­i­aries of GenScript, under the brand name of Bestzyme Bio­tech and Legend Bio­tech engaged in Industrial Enzymes and CAR-T as well as other forms of spe­cif­ic cell immuno­therapies re­spec­tive­ly, have both made rapid progress and break­­through in their business devel­op­ment. Learn more at www.GenScript.com

Source: Legend Bio­tech.