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 the U.S. Food and Drug Admin­istra­tion (FDA) has lifted the clin­i­cal hold on the Phase 1 MELANI-01 trial eval­u­ating the UCARTCS1 prod­uct can­di­date for the treat­ment of patients with re­lapsed or re­frac­tory mul­ti­ple myeloma (MM).

Cellectis worked closely with the FDA over the past months, to address the agency’s re­quests, which in­clude ad­just­ments to the MELANI-01 clin­i­cal protocol de­signed to en­hance patient safety. …

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 the MELANI-01 trial has been placed on clin­i­cal hold by the U.S. Food and Drug Admin­istra­tion (FDA).

This clin­i­cal hold which im­pacts one of the three Cellectis prod­uct can­di­dates cur­rently in clin­i­cal stud­ies, was ini­ti­ated fol­low­ing the sub­mission of a safety report re­gard­ing one patient en­rolled in the MELANI-01 study at dose level two (DL2), with re­lapsed and re­frac­tory mul­ti­ple myeloma. This patient, …

Phase 3 trial did not meet pri­mary end­point of pro­gres­sion-free sur­vival in patients not eli­gible for trans­plant

Princeton, NJ (Press Release) – Bristol Myers Squibb Com­pany (NYSE: BMY) to­day an­nounced top­line re­­sults from ELOQUENT-1, a Phase 3, ran­dom­ized, open-label trial eval­u­ating the com­bi­na­tion of Empliciti (elo­tuzu­mab) plus Revlimid (lena­lido­mide) and dexa­meth­a­sone (ERd), versus Revlimid and dexa­meth­a­sone alone (Rd), in patients with newly diag­nosed, pre­vi­ously untreated mul­ti­ple myeloma who are trans­plant in­eli­gible. Both treat­ments were admin­istered con­tin­uously until dis­ease pro­gres­sion. At final analysis, the addi­tion of Empliciti did not show a statistically sig­nif­i­cant im­prove­ment in pro­gres­sion-free sur­vival (PFS), the study’s pri­mary end­point. The safety profile of ERd was generally con­sis­tent …

Cellectis’ UCARTCS1 MELANI-01 Trial Commenced at MD Anderson Cancer Center

New York, NY (Press Release) – Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Euronext Growth: ALCLS; Nasdaq: CLLS), a bio­pharma­ceu­tical com­pany focused on devel­op­ing immuno­therapies based on gene-edited off-the-shelf CAR T-cells (UCART), to­day an­nounced the Com­pany has dosed the first patient in its UCARTCS1 clin­i­cal trial, MELANI-01, the first allo­geneic off-the-shelf CAR-T prod­uct can­di­date the U.S. Food and Drug Admin­istra­tion (FDA) has cleared to enter into clin­i­cal devel­op­ment for re­lapsed / re­frac­tory mul­ti­ple myeloma (R/R MM). The UCARTCS1 clin­i­cal trial is a Phase 1 dose-escalation study to eval­u­ate the safety, ex­pan­sion, persistence and clin­i­cal ac­­tiv­ity of UCARTCS1 cells …

• Median pro­gres­sion-free sur­vival and over­all re­sponse rate doubled among patients re­ceiv­ing EPd com­pared to poma­lido­mide and low-dose dexa­meth­a­sone alone
• Second Empliciti-based com­bi­na­tion approved in Europe for patients with re­lapsed and re­frac­tory mul­ti­ple myeloma

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE: BMY) to­day an­nounced that the Euro­pean Com­mis­sion (EC) has approved Empliciti (elo­tuzu­mab) plus poma­lido­mide and low-dose dexa­meth­a­sone (EPd) for the treat­ment of adult patients with re­lapsed and re­frac­tory mul­ti­ple myeloma who have re­ceived at least two prior ther­a­pies, in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor (PI), and have dem­onstrated dis­ease pro­gres­sion on the last ther­apy. This ap­prov­al is based on data from the ELOQUENT-3 trial in which EPd doubled both median pro­gres­sion-free sur­vival (PFS) and …

Here in “Space City,” we’ve been celebrating an im­por­tant mile­stone. It was 50 years ago when the unthinkable was accomplished, and we became a lunar people. On July 20, 1969 at 10:56 p.m., astronauts Neil Armstrong and Edwin “Buzz” Aldrin became the first men to walk on the Moon. With astronaut Michael Collins piloting the capsule, Houston Capcom monitoring the mis­sion, and more than half a billion people watching on television, Armstrong climbed down the ladder and proclaimed: "That's one small step for a man, one giant leap for mankind."

The total mis­sion duration …

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) to­day an­nounced that the Com­mit­tee for Medicinal Products for Human Use (CHMP) of the Euro­pean Medicines Agency has adopted a pos­i­tive opinion on a Type-II variation appli­ca­tion for Empliciti (elo­tuzu­mab) plus poma­lido­mide and low-dose dexa­meth­a­sone (EPd) for the treat­ment of adult patients with re­lapsed and re­frac­tory mul­ti­ple myeloma who have re­ceived at least two prior ther­a­pies, in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor (PI), and have dem­onstrated dis­ease pro­gres­sion on the last ther­apy. The CHMP recom­men­da­tion will now be reviewed by the Euro­pean Com­mis­sion, …