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 …

Stockholm, Sweden (Press Release) – CellProtect Nordic Pharma­ceu­ticals AB ('CPNP') has been notified by the Euro­pean Com­mis­sion that its cell ther­apy can­di­date CellProtect has re­ceived orphan drug desig­na­tion for the treat­ment of mul­ti­ple myeloma. CellProtect is manu­fac­tured from the patient's own blood and is the first drug can­di­date, con­sist­ing of au­tol­o­gous ex vivo activated and ex­panded nat­u­ral killer (NK) cells, which has re­ceived such desig­na­tion in Europe.

CPNP has carried out a clin­i­cal phase I/II trial in patients with mul­ti­ple myeloma where CellProtect has been studied as a supple­mental treat­ment to au­tol­o­gous stem …

Designations based on pre­lim­i­nary clin­i­cal data from on­go­ing phase I study of bb2121 in heavily pre-treated mul­ti­ple myeloma

Summit, NJ and Cambridge, MA (Press Release) – Celgene Corpo­ra­tion (NASDAQ:CELG) and bluebird bio, Inc. (NASDAQ:BLUE) to­day an­nounced that bb2121, a chi­meric an­ti­gen re­cep­tor T-cell (CAR-T) ther­apy targeting b-cell maturation an­ti­gen (BCMA) in pre­vi­ously treated patients with mul­ti­ple myeloma, has been granted Break­through Therapy Desig­na­tion (BTD) by the U.S. Food and Drug Admin­istra­tion (FDA) and PRIority MEdicines (PRIME) eligibility by the Euro­pean Medicines Agency (EMA).

BTD desig­na­tion and PRIME eligibility for bb2121 were based on pre­lim­i­nary clin­i­cal data from the on­go­ing phase 1 study CRB-401. Updated data from CRB-401 is scheduled to be …

• The trial is a dose escalation study eval­u­ating safety and feasibility of T-cell Natural Killer Receptor NKG2D in patients with acute myeloid leukemia or mul­ti­ple myeloma
• No dose limiting toxicity re­ported of the last patient of the sec­ond dose level
• First patient of third dose level (10^7 cells) started cell processing

Mont-Saint-Guibert, Belgium (Press Release) – Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and devel­op­ment of engi­neered cell ther­a­pies, with clin­i­cal pro­grams in cardio­vascular dis­ease and immuno-oncology, to­day an­nounced the com­ple­tion of the 21-day safety follow-up of the last patient en­rolled in the sec­ond dose level in the Phase I/IIa clin­i­cal trial eval­u­ating the safety and feasibility of its NKR-2 T-cell ther­apy using T-cells with NKG2D re­cep­tor in cancer patients suffer­ing from acute myeloid leukemia …

• Celgene has agreed to exercise its op­tion to ex­clu­sively license bb2121 under global stra­te­gic col­lab­o­ration
• bluebird bio to re­ceive $10 million op­tion exercise pay­ment from Celgene

Cambridge, MA (Press Release) – bluebird bio, Inc. (Nasdaq:BLUE), a clin­i­cal-stage com­pany com­mit­ted to devel­op­ing poten­tially trans­for­ma­tive gene ther­a­pies for severe ge­netic dis­eases and T cell-based immuno­therapies for cancer, an­nounced treat­ment of the first patient in a Phase 1 study of its prod­uct can­di­date bb2121 in patients with re­lapsed / re­frac­tory mul­ti­ple myeloma. bb2121 is a chi­meric an­ti­gen re­cep­tor T cell (CAR T) ther­apy targeting B cell maturation an­ti­gen (BCMA), and bluebird bio is devel­op­ing bb2121 in col­lab­o­ration with Celgene Corpo­ra­tion. bluebird bio also …

• No dose limiting toxicity re­lated to the inves­ti­ga­tional treat­ment re­ported at 30 days post treat­ment of the first patient of the sec­ond dose-level
• The trial is a dose escalation study eval­u­ating safety and feasibility of a CAR T-cell ther­apy in patients with acute myeloid leukemia or mul­ti­ple myeloma.

Mont-Saint-Guibert, Belgium (Press Release) Celyad (Paris:​CYAD) (Brussels:​CYAD) (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and devel­op­ment of engi­neered cell ther­a­pies, with clin­i­cal pro­grams in cardiovascular dis­ease and immuno-oncology, to­day an­nounced the com­ple­tion of the 30-day safety follow-up of the first patient en­rolled in the sec­ond cohort in the Phase I clin­i­cal trial eval­u­ating the safety and feasibility of its NKG2D CAR T-cell ther­apy, in cancer patients suffer­ing from acute myeloid leukemia (AML) or mul­ti­ple myeloma (MM).

Dr. …

Company to webcast in­­vestor event, Sunday, De­cem­ber 6 at 8:30 p.m. ET

Orlando, FL (Press Release) – bluebird bio, Inc. (NASDAQ:BLUE), a clin­i­cal-stage com­pany com­mit­ted to devel­op­ing poten­tially trans­for­ma­tive gene ther­a­pies for severe ge­netic dis­eases and T cell-based im­mun­o­therapies for cancer, an­nounced that pre-clinical data from its anti-BCMA on­col­ogy pro­gram were pre­sented by bluebird bio scientists at the 57th American Society of He­ma­tol­ogy Annual Meeting.

“We be­lieve the unique science and trans­la­tional gene ther­apy plat­forms we have built dif­fer­en­ti­ate bluebird bio in the on­col­ogy field and have the poten­tial to yield im­por­tant new ther­a­pies for patients living with can­cer. Our three on­col­ogy posters at …