• 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 …

European Patent EP3004337 Upheld by the EPO in Favor of Cellectis, Refers to the Method of Preparing T-Cells for Immunotherapy Using the RNA-Guided CRISPR-Cas9 Nuclease System

New York, NY (Press Release) – Cellectis (Euronext Growth: ALCLS; Nasdaq: CLLS), a bio­pharma­ceu­tical com­pany focused on devel­op­ing immuno­therapies based on gene-edited allo­geneic CAR T-cells (UCART), today announced that European Patent EP3004337, which claims a method of preparing T-cells for immuno­therapy using the CRISPR-Cas9 sys­tem, initially granted on August 2, 2017, has been upheld by the European Patent Office (EPO) fol­low­ing an op­po­si­tion pro­ce­dure ini­ti­ated in May 2018.

European Patent EP3004337 claims a method of genetically modifying T-cells by in­tro­duc­tion into the cells and/or ex­pres­sion in the cells of an RNA-guided endonuclease, and …

New York, NY (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) an­nounced to­day that it has com­pleted its ac­qui­si­tion of Celgene Corpo­ra­tion (NASDAQ:CELG) fol­low­ing the receipt of regu­la­tory ap­prov­al from all gov­ern­ment author­i­ties re­quired by the merger agree­ment and, as an­nounced on April 12, 2019, ap­prov­al by Bristol-Myers Squibb and Celgene stock­holders.

Upon com­ple­tion of the ac­qui­si­tion, pur­su­ant to the terms of the merger agree­ment, Celgene became a wholly owned sub­sid­i­ary of Bristol-Myers Squibb Com­pany. Under the terms of the merger, Celgene share­holders re­ceived for each share, 1.00 share of Bristol-Myers Squibb common stock, …

• Combination regi­men reduces the risk of dis­ease pro­gres­sion or death by 44 per­cent in newly diag­nosed patients who are trans­plant in­eli­gible¹
• Since launch, dara­tu­mu­mab has been used to treat more than 100,000 patients world­wide²

Beerse, Belgium (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson announced today that the European Com­mis­sion (EC) has granted mar­ket­ing authori­sa­tion for Darzalex®(dara­tu­mu­mab) in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (DRd) for the treat­ment of newly diag­nosed multiple myeloma patients who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The approval was based on results from the Phase 3 MAIA (MMY3008) study, published in The New England Journal of Medicine³ earlier this year and presented at the American Society of Hematology …

• DARZALEX® approved in Europe in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone as treat­ment for adult patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant
• Approval follows pos­i­tive opinion by European Com­mit­tee for Medicinal Products for Human Use (CHMP) in Octo­ber
• Approval based on data from Phase III MAIA study

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq: GMAB) announced today that the European Com­mis­sion (EC) has granted mar­ket­ing authori­za­tion for DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (Rd) as treat­ment for adult patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The EC approval follows a pos­i­tive opinion issued for DARZALEX by the CHMP of the European Medicines Agency (EMA) in Octo­ber 2019. In August 2012, Genmab granted Janssen Biotech, Inc. (Janssen) an …