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. …

• FDA set a target action date of March 27, 2021
• Ide-cel is the first CAR T cell ther­apy ac­cepted for regu­la­tory re­view for mul­ti­ple myeloma

Princeton, NJ and Cambridge, MA (Press Release) – Bristol Myers Squibb (NYSE: BMY) and blue­bird bio, Inc. (Nasdaq: BLUE) to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) has ac­cepted for Priority Review their Biologics License Appli­ca­tion (BLA) for idecabtagene vicleucel (ide-cel; bb2121), the com­pa­nies’ inves­ti­ga­tional B-cell maturation an­ti­gen (BCMA)-directed chi­meric an­ti­gen re­cep­tor (CAR) T cell immuno­therapy, for the treat­ment of adult patients with mul­ti­ple myeloma who have re­ceived at least three prior ther­a­pies, in­clud­ing an immuno­modu­la­tory agent, a pro­te­a­some in­hib­i­tor and …

Increasing BCMA Surface Expression and Reduced Soluble BCMA Levels with Gamma Secretase Inhibitor Niro­gace­stat May Enhance Clinical Benefit in Com­bi­na­tion with PBCAR269A, an Allogeneic BCMA-Targeted CAR T Cell Product

Durham, NC and Stamford, CT (Press Release) – Pre­ci­sion BioSciences, Inc. (Nasdaq: DTIL), a clin­i­cal stage bio­technol­ogy devel­op­ing allo­geneic CAR T and in vivo gene correction ther­a­pies with its ARCUS® genome edit­ing plat­form, and Spring­Works Thera­peutics, Inc. (Nasdaq: SWTX), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on devel­op­ing life-changing med­i­cines for patients with severe rare dis­eases and can­cer, to­day an­nounced they have entered into a clin­i­cal trial col­lab­o­ration agree­ment. Per the agree­ment, PBCAR269A, Pre­ci­sion BioSciences’ wholly-owned inves­ti­ga­tional allo­geneic chi­meric an­ti­gen re­cep­tor (CAR) T cell ther­apy can­di­date targeting B-cell maturation an­ti­gen (BCMA), will be eval­u­ated in com­bi­na­tion …

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 the U.S. Food and Drug Admin­istra­tion (FDA) has granted Fast Track Desig­na­tion to PBCAR269A for the treat­ment of re­lapsed / re­frac­tory mul­ti­ple myeloma. This is the com­pany’s sec­ond allo­geneic chi­meric an­ti­gen re­cep­tor (CAR T) cell ther­apy to re­ceive Fast Tack Desig­na­tion for which the FDA pre­vi­ously granted Orphan Drug Desig­na­tion.

“Fast Track Desig­na­tion will help us expedite our allo­geneic CAR T cell ther­apy pro­gram …

First inves­ti­ga­tional prod­uct being rec­om­mended for Break­­through Therapy Desig­na­tion in China

Somerset, NJ (Press Release) – Legend Bio­tech Corpo­ra­tion (NASDAQ:LEGN) an­nounced to­day that the China Center for Drug Evaluation, National Medical Products Admin­istra­tion (CDE, NMPA) has rec­om­mended Break­­through Therapy Desig­na­tion (BTD) for ciltacabtagene autoleucel (cilta-cel; LCAR-B38M CAR-T cells), an inves­ti­ga­tional B-cell maturation an­ti­gen (BCMA) targeted chi­meric an­ti­gen re­cep­tor (CAR) T-cell ther­apy being studied for the treat­ment of adults with re­lapsed or re­frac­tory mul­ti­ple myeloma (RRMM).

The BTD for cilta-cel (LCAR-B38M CAR-T cells) is based on the on­go­ing Phase 2 CARTIFAN-1 study being con­ducted in China (MMY2002, NCT03758417, CTR20181007), the on­go­ing Phase 1b/2 CARTITUDE-1 study …

• BLA sub­mission based on re­­sults from pivotal Phase 2 KarMMa study eval­u­ating ide-cel in heavily pre-treated patient pop­u­la­tion
• Companies are com­mit­ted to work­ing with the FDA to rapidly ad­vance ide-cel through the regu­la­tory re­­view process

Princeton, NJ and Cambridge, MA – Bristol Myers Squibb (NYSE: BMY) and blue­bird bio, Inc. (Nasdaq: BLUE) to­day an­nounced the sub­mission of their Bio­logics License Appli­ca­tion (BLA) to the U.S. Food and Drug Admin­istra­tion (FDA) for idecabtagene vicleucel (ide-cel; bb2121), the com­pa­nies’ inves­ti­ga­tional B-cell maturation an­ti­gen (BCMA)-directed chi­meric an­ti­gen re­cep­tor (CAR) T cell immuno­therapy, for the treat­ment of adult patients with re­lapsed and re­frac­tory mul­ti­ple myeloma. This sub­mission provides fur­ther details on the Chemistry, Manu­fac­tur­ing and Con­trols (CMC) module to address the out­stand­ing …

• Phase 1 clin­i­cal trial eval­u­ating the off-the-shelf anti-BCMA CAR T can­di­date CYAD-211 for the treat­ment of re­lapsed / re­frac­tory mul­ti­ple myeloma (r/r MM) ex­pected to begin by year-end 2020
• CYAD-211 rep­re­sents the com­pany’s first allo­geneic CAR T clin­i­cal can­di­date using shRNA tech­nology

Mont-Sain-Guibert, Belgium (Press Release) – Celyad Oncology SA (Euronext & Nasdaq: CYAD), a clin­i­cal-stage bio­technol­ogy com­pany focused on the dis­cov­ery and de­vel­op­ment of chi­meric an­ti­gen re­cep­tor T cell (CAR T) ther­a­pies for cancer, to­day an­nounced that the com­pany’s Inves­ti­ga­tional New Drug (IND) appli­ca­tion for CYAD-211, the com­pany’s first-in-class short hairpin RNA (shRNA)-based allo­geneic CAR T can­di­date and sec­ond non-gene edited off-the-shelf pro­gram, is in effect with the U.S. Food and Drug Admin­istra­tion (FDA). The com­pany’s lead allo­geneic can­di­date from its next-gener­a­tion CYAD-200 series, CYAD-211 targets B-cell …