• 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 …

• The com­pa­nies will con­tinue to col­lab­o­rate to discover and de­vel­op the next gen­er­a­tion of engi­neered alpha-beta T cells
• Editas Medicine to re­ceive a $70 million pay­ment and may be eli­gible for future mile­stone and royalty pay­ments

Cambridge, MA (Press Release) – Editas Medicine, Inc. (Nasdaq: EDIT), a lead­ing genome edit­ing com­pany, to­day an­nounced an amended col­lab­o­ration with Celgene Corpo­ra­tion (Nasdaq: CELG) under which the parties may re­search, de­vel­op, and com­mer­cial­ize au­tol­o­gous and allo­geneic alpha-beta T cell med­i­cines for the treat­ment of cancer and auto­immune dis­eases. Under the terms of the amended agree­ment, Editas Medicine will re­ceive a pay­ment of $70 million.

“Celgene is the leader in ad­vanc­ing inno­va­tive cell med­i­cines to treat blood cancers, and we are ex­cited to …

Shanghai, China (Press Release) – CARsgen Thera­peutics Co. Ltd., a clin­i­cal-stage bio­pharma­ceu­tical com­pany to­day an­nounced that the United States Food and Drug Admin­istra­tion (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) desig­na­tion to its inves­ti­ga­tional CT053 CAR-T cell ther­apy. CT053 is a fully human anti-BCMA (B Cell Maturation Antigen) au­tol­o­gous chi­meric an­ti­gen re­cep­tor (CAR) T Cell ther­apy for the treat­ment of re­lapsed and/or re­frac­tory mul­ti­ple myeloma (rrMM).

RMAT desig­na­tion was based on clin­i­cal data from an on­go­ing CT053 phase 1 study in heavily pre-treated mul­ti­ple myeloma patients in China. Updated data from CT053 …

Gaithersburg, MD (Press Release) – Arcellx, a privately-held bio­pharma­ceu­tical com­pany, to­day an­nounced that it has raised $85 million in an oversubscribed Series B financing. Proceeds will be used to ad­vance the Com­pany’s ARC-T + sparX pro­grams, in­clud­ing clin­i­cal devel­op­ment of a bivalent BCMA-targeted cell ther­apy in mul­ti­ple myeloma, and a CD123-targeted ther­apy in acute myeloid leukemia. The Series B will also fund earlier stage ARC-T + sparX pro­grams for patients with solid tumors and dis­eases outside on­col­ogy.

Participants in the Series B in­clude both existing and new in­vestors to Arcellx. New in­vestors Aju …

Nanjing, China (Press Release) – IASO Biotherapeutics (IASO BIO), a clin­i­cal stage bio­technology com­pany ad­vanc­ing the devel­op­ment of inno­va­tive ther­a­pies for cancer, and Innovent Biologics, Inc. (Innovent) (HKEX:01801), a world-class bio­pharma­ceu­tical com­pany that de­vel­ops and com­mer­cial­izes high quality med­i­cines, an­nounced to­day that IASO BIO has re­ceived National Medical Products Admin­istra­tion (NMPA) ap­prov­al for an Inves­ti­ga­tional New Drug Appli­ca­tion (IND) for CT103A – an inno­va­tive ther­apy for the treat­ment of re­lapsed re­frac­tory mul­ti­ple myeloma (rr/mm) patients. IASO Bio and Innovent will start a Phase Ib/II study to con­firm the R2PD and move to phase II …

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, …

Summit, NJ and Cambridge, MA (Press Release) – Celgene Corpo­ra­tion (Nasdaq: CELG) and bluebird bio, Inc. (Nasdaq: BLUE) to­day an­nounced the com­ple­tion of en­roll­ment for the KarMMa pivotal study of bb2121, the com­pa­nies’ lead inves­ti­ga­tional anti-BCMA CAR T cell ther­apy can­di­date for patients with re­lapsed and re­frac­tory mul­ti­ple myeloma. bb2121 is being devel­oped as part of a Co-Development, Co-Promote and Profit Share Agreement be­tween Celgene and bluebird bio.

“We con­tinue to be ex­cited about bb2121 as a poten­tial first-in-class BCMA-targeted ther­apy for patients with mul­ti­ple myeloma,” said Alise Reicin, M.D., Pres­i­dent, Global …