• Study met its pri­mary end­point and key sec­ond­ary end­point, demonstrating deep and durable re­sponse­s in a heavily pre-treated mul­ti­ple myeloma patient pop­u­la­tion
• Safety results are con­sis­tent with the data pre­sented in CRB-401 study

Princeton, NJ and Cambridge, MA (Press Release) – Bristol-Myers Squibb Com­pany (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) to­day an­nounced pos­i­tive top-line results from KarMMa, a pivotal, open-label, single arm, multi­center, Phase 2 study of idecabtagene vicleucel (ide-cel; bb2121). KarMMa, which eval­u­ated the ef­fi­cacy and safety of the com­pa­nies’ lead inves­ti­ga­tional BCMA-targeted chi­meric an­ti­gen re­cep­tor (CAR) T cell ther­apy can­di­date for patients with re­lapsed and re­frac­tory mul­ti­ple myeloma, met its pri­mary end­point and key sec­ond­ary end­point.

KarMMa en­rolled 140 patients, of whom 128 …

• 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 …

• Harpoon grants AbbVie option to license world­wide rights to HPN217 (BCMA), a TriTAC for the treat­ment of multiple myeloma planned for IND filing this year
• Expanded TriTAC discovery col­lab­o­ration in­cludes up to six addi­tional targets selected by AbbVie
• Two agree­ments provide for a total of $50 million in up­front and up to $50 million in a contingent mile­stone pay­ment for first patient treated with HPN217 in a clin­i­cal trial

South San Francisco, CA and North Chicago, IL (Press Release) – Harpoon Thera­peutics, Inc. (NASDAQ: HARP), a clin­i­cal-stage immuno­therapy com­pany devel­op­ing a novel class of T cell engagers, and AbbVie Inc. (NYSE: ABBV), a global bio­pharma­ceu­tical com­pany, today announced an ex­clu­sive world­wide option and license trans­action for HPN217, Harpoon’s B cell maturation an­ti­gen (BCMA)-targeting Tri-specific T cell Activating Construct (TriTAC®), and an ex­pan­sion of their existing discovery col­lab­o­ration for up to six addi­tional targets. These agree­ments build upon the …

Newark, CA (Press Release) – Teneobio, Inc., a clin­i­cal-stage bio­technology com­pany devel­op­ing engi­neered bispecific anti­bodies for the treat­ment of cancer announced today that it has re­ceived orphan drug desig­na­tion by the U.S. Food and Drug Admin­istra­tion (FDA) for the treat­ment of multiple myeloma.

“New and better treat­ment options are needed for multiple myeloma. While there are a number of BCMA-targeting agents cur­rently in clin­i­cal devel­op­ment, TNB-383B, an anti-BCMAxCD3 cur­rently in Phase I, is a bispecific com­prised of a unique T-cell engager designed to maximize the thera­peutic window for this class of drugs,” said …

• Ongoing Phase 1/2a Study of CD19 CAR-NK with Pivotal Study Expected to Enroll Patients in 2021
• Potential to be the First CAR Cell Therapy Approved for Outpatient Admin­istra­tion

Houston, TX and Osaka, Japan (Press Release) – The University of Texas MD Anderson Cancer Center and Takeda Pharma­ceu­tical Com­pany Limited (TSE:4502/NYSE:TAK) (“Takeda”) to­day an­nounced an ex­clu­sive license agree­ment and re­search agree­ment to de­vel­op cord blood-derived chi­meric an­ti­gen re­cep­tor-directed natural killer (CAR NK)-cell ther­a­pies, ‘armored’ with IL-15, for the treat­ment of B-cell malig­nan­cies and other cancers.

Under the agree­ment, Takeda will re­ceive access to MD Anderson’s CAR NK plat­form and the ex­clu­sive rights to de­vel­op and com­mer­cial­ize up to four pro­grams, in­clud­ing a CD19-targeted …

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 …