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, …

• PBCAR269A Targets BCMA for the Treatment of Re­lapsed / Re­frac­tory Multiple Myeloma and is the Com­pany’s Third Inves­ti­ga­tional Allogeneic CAR T Candidate Advanced to the Clinic
• PBCAR269A is the First Off-the-Shelf Candidate Produced at In-House Manufacturing Center

Durham, NC (Press Release) – Pre­ci­sion BioSciences, Inc. (Nasdaq: DTIL), a clin­i­cal stage bio­technol­ogy com­pany ded­i­cated to im­prov­ing life with its novel and pro­pri­e­tary ARCUS® genome edit­ing plat­form, to­day an­nounced that the first patient has been dosed in a Phase 1/2a clin­i­cal trial of PBCAR269A, its third allo­geneic chi­meric an­ti­gen re­cep­tor (CAR) T cell ther­apy can­di­date. Wholly-owned by Pre­ci­sion, PBCAR269A targets the B-cell maturation an­ti­gen (BCMA) and is being eval­u­ated for the treat­ment of re­lapsed / re­frac­tory mul­ti­ple myeloma.

“PBCAR269A is our third off-the-shelf CAR T can­di­date to …

Applications based on pos­i­tive results from pivotal KarMMa study in re­lapsed and re­frac­tory mul­ti­ple myeloma and QUAZAR®-AML-001 study in acute myeloid leukemia

Princeton, NJ (Press Release) – Bristol Myers Squibb (NYSE: BMY) to­day an­nounced that the Euro­pean Medicines Agency (EMA) has val­i­dated its Marketing Authori­za­tion Appli­ca­tions (MAA) for both idecabtagene vicleucel (ide-cel, bb2121) and CC-486. Validation of each appli­ca­tion con­firms the re­spec­tive sub­missions are com­plete and begins the EMA’s centralized review process.

The MAA for ide-cel, the com­pany’s inves­ti­ga­tional B-cell maturation an­ti­gen (BCMA)-directed chi­meric an­ti­gen re­cep­tor (CAR) T cell immuno­therapy co-developed with bluebird bio, Inc., is for the treat­ment of adult patients with mul­ti­ple myeloma who have re­ceived at least three prior ther­a­pies, in­clud­ing an immuno­modu­la­tory …

• Bristol Myers Squibb to host an in­vestor call to­day at 8:00 a.m. EDT
• bluebird bio to host an in­vestor call to­day at 8:45 a.m. EDT

Princeton, NJ and Cambridge, MA (Press Release) – Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) to­day an­nounced that the com­pa­nies re­ceived a Refusal to File letter from the U.S. Food and Drug Admin­istra­tion (FDA) re­gard­ing the Biologics License Appli­ca­tion (BLA) for idecabtagene vicleucel (ide-cel; bb2121) for patients with heavily pre-treated re­lapsed and re­frac­tory mul­ti­ple myeloma, which was sub­mitted in March 2020.

Upon pre­lim­i­nary review, the FDA de­ter­mined that the Chemistry, Manufacturing and Control (CMC) module of the BLA re­quires fur­ther …

• Bristol Myers Squibb to buy out its ex-U.S. mile­stone and royalty obli­ga­tions to bluebird bio for $200 million
• Bristol Myers Squibb assumes re­spon­si­bil­ity­ for vector manu­fac­tur­ing in ex-US territories
• bluebird to hold conference call and webcast to­day, May 11, 2020 at 8:00AM ET

Cambridge, MA (Press Release) – bluebird bio, Inc. (NASDAQ: BLUE) to­day an­nounced that it has amended its existing co-promotion / co-development agree­ment with Bristol Myers Squibb (BMS) to enable the com­pa­nies to focus their efforts on efficient com­mer­cial­iza­tion of idecabtagene vicleucel (ide-cel; bb2121) in the U.S., the com­pa­nies’ lead inves­ti­ga­tional B-cell maturation an­ti­gen (BCMA)-directed chi­meric an­ti­gen re­cep­tor (CAR) T cell immuno­therapy, cur­rent in review with the FDA.

“Under our amended col­lab­o­ration, we and BMS are redoubling our com­mitment to ide-cel …

Shanghai, China (Press Release) – CARsgen Thera­peutics Co., Ltd., a clin­i­cal-stage bio­pharma­ceu­tical com­pany, to­day an­nounced the Euro­pean Medicines Agency (EMA) Com­mit­tee for Orphan Medicinal Products (COMP) adopted a pos­i­tive opinion on CARsgen's appli­ca­tion for orphan desig­na­tion of its inves­ti­ga­tional CT053 CAR T-cell ther­apy, fully human anti-BCMA (B cell maturation an­ti­gen) au­tol­o­gous chi­meric an­ti­gen re­cep­tor (CAR) T cells for the treat­ment of mul­ti­ple myeloma. CT053 was pre­vi­ously granted orphan drug desig­na­tion by the US Food and Drug Admin­istra­tion in August 2019.

"The COMP's adoption of a pos­i­tive opinion for CT053 orphan drug desig­na­tion is …

Kite and Teneobio will Collaborate on Next-Generation Dual-Targeting CAR T Therapies in Multiple Myeloma Utilizing UniAb® Antibodies

Santa Monica, CA and Newark, CA (Press Release) – Kite, a Gilead Com­pany (Nasdaq: GILD), and Teneobio, Inc. announced the com­pa­nies have entered into a license and col­lab­o­ration agree­ment through which Kite will re­ceive ex­clu­sive rights to cer­tain anti­bodies directed to B-cell maturation an­ti­gen (BCMA). The fully human variable heavy chain of one such anti­body is cur­rent undergoing clin­i­cal evaluation in a chi­meric an­ti­gen re­cep­tor (CAR) format for the treat­ment of patients with multiple myeloma in a Phase 1 clin­i­cal trial at the National Cancer Institute. Kite and Teneobio will also col­lab­o­rate on …