Stockholm, Sweden (Press Release) – XNK Thera­peutics AB ("XNK") to­day an­nounced it has re­ceived Orphan Drug Desig­na­tion (ODD) from the U.S. Food and Drug Admin­istra­tion (FDA) for its lead­ing inves­ti­ga­tional drug can­di­date in the treat­ment of mul­ti­ple myeloma (MM).

Receiving ODD status from the FDA for the treat­ment of mul­ti­ple myeloma is a crit­i­cal next step for the de­vel­op­ment of XNK's lead­ing inves­ti­ga­tional drug can­di­date. XNK has already re­ceived ODD status in the EU.

"Obtaining an ODD by the FDA is a sig­nif­i­cant mile­stone for XNK and our goal of taking the present …

Boston, MA (Press Release) – OncoPep, Inc. to­day an­nounced a licensing agree­ment with MANA Thera­peutics for use of its EDIFY™ plat­form for the de­vel­op­ment of an au­tol­o­gous multi-tumor an­ti­gen adoptive T cell ther­apy for the treat­ment of mul­ti­ple myeloma and solid tumors, as an addi­tional T cell focused im­mu­no­ther­apeutic for its prod­uct pipe­line.

“The addi­tion of a multi-antigen adoptive T cell ther­apy to our pipe­line ex­pands the breadth of our immuno-oncology pro­grams in mul­ti­ple myeloma in addi­tion to solid tumors, and pro­vides patients with another po­ten­tial treat­ment op­tion for a dis­ease for which …

With the start of its sec­ond clin­i­cal trial, NexImmune ex­pands de­vel­op­ment of its unique non-genetically engi­neered T cell immuno­therapies across a range of hema­to­logic malig­nan­cies

Gaithersburg, MD (Press Release) – NexImmune, a clin­i­cal-stage bio­technol­ogy com­pany devel­op­ing a port­folio of unique non-genetically-engi­neered T cell im­muno­therapies, an­nounced to­day that it has dosed the first patient in its Phase 1/2 clin­i­cal trial for NEXI-002. NEXI-002 is a patient-derived cel­lu­lar prod­uct that con­tains pop­u­la­tions of nat­u­rally-occurring CD8+ T cells directed against sev­er­al mul­ti­ple myeloma (MM)-specific an­ti­gen targets. It is the sec­ond clin­i­cal prod­uct NexImmune has gen­er­ated with its AIM nanoparticle tech­nology.

“While the pri­mary objective in this trial with NEXI-002 is to dem­onstrate safety and tol­er­a­bil­ity, we also hope to see ini­tial …

• 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 …

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 …

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 …